The Monetary Authority of Singapore (MAS) said it will maintain the prevailing rate of appreciation of its exchange rate-based policy band known as the Nominal Effective Exchange Rate, or S$NEER.

The width and the level at which the band is centred did not change.

“Barring any further global shocks, the Singapore economy is expected to strengthen in 2024, with growth becoming more broad-based. MAS core inflation is likely to remain elevated in the earlier part of the year, but should decline gradually and step down by Q4, before falling further next year,” MAS said in a statement.

Maybank economist Chua Hak Bin said the central bank is maintaining the current tightening bias as both core and headline inflation gauges are above 3% and historical comfort zones.

Core inflation in December was 3.3% year-on-year, slowing from its peak of 5.5% early last year.

MAS said core inflation is projected to ease to an average of 2.5–3.5% for 2024 after rising in the current quarter because of a 1 percentage point sales tax hike from January that MAS said will have a “transitory impact”.

Gross domestic product (GDP) was up 2.8% on a yearly basis in the fourth quarter of last year, according to advance estimates published by the trade ministry in early January.

GDP for the full year of 2023 was 1.2%, and the trade ministry projects GDP to grow by 1-3% in 2024.

“Prospects for the Singapore economy should continue to improve in 2024,” said the MAS, although both upside and downside risks to the inflation outlook remain.

OCBC economist Selena Ling said that suggests the MAS is on an extended policy pause for now.

“April monetary policy is likely another hold and the earliest window for an easing could only come later in the year when core inflation eases more convincingly,” she said.

The MAS policy decision on Monday was the first under its new review schedule, in which the central bank will make policy announcements every quarter instead of semi-annually.

The central bank left monetary policy unchanged in April and October last year, reflecting growth concerns, having tightened policy at five consecutive reviews prior to that.

As a heavily trade-reliant economy, Singapore uses a unique method of managing monetary policy, tweaking the exchange rate of its dollar against a basket of currencies instead of domestic interest rates like most other countries.

Source: Reuters

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Covering hundreds of pages on how other governments have “jailed, tortured, or even killed” political opponents, human rights defenders, and journalists, the report kept silent on the thousands of Americans who have lost their lives due to mass shootings, police brutality, and racism discrimination, said the journal.

“America’s historical trajectory shows that it has always viewed human rights as a tool for hegemony and uses it selectively as an excuse to label countries as human rights violators. Under the pretext of defending human rights, the U.S. invaded Iraq, Syria, Libya, and Afghanistan, but all of these war-torn countries suffered the murder of innocent civilians and catastrophic infrastructure destruction,” it noted.

“Sadly, the U.S. does not uphold the common international standards or guarantee human rights from a fair and impartial standpoint when promoting human rights diplomacy and managing human rights matters. It always exercises double or even multiple standards,” it said.

“Critics argue that the annual report has nothing to do with human rights but is a tool to malign rivals and coerce other countries,” it added.

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“U.S. State Department officials since (Joe) Biden took office have often said that ‘diversity and inclusion makes us stronger, smarter, more creative and more innovative.’ And while that talking point was music to the ears of many U.S. government employees of color, a stark reality proves otherwise,” the report noted.

U.S. Secretary of State Antony Blinken was quoted in a Wall Street Journal article that highlighted widespread discrimination and harassment as revealed by an internal State Department survey, saying, “I’ve been clear that fully addressing the Department’s shortcomings when it comes to diversity, equity, inclusion, and accessibility isn’t something we’d be able to achieve overnight,” according to the report.

Fritz Berggren, a white foreign service officer whose personal blog is filled with antisemitic and anti-Black content, is still employed at the State Department. U.S. taxpayer dollars should not be used to retain “unrepentant employees who publish racist rants and do not represent American values,” it said.

If the United States aspires to lead by the power of example on the global stage, then a drastic effort to promote inclusion is the only viable path forward, it added. 

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“President Biden explained that the United States will continue to compete vigorously with the PRC, including by investing in sources of strength at home and aligning efforts with allies and partners around the world.

President Biden and President Xi reiterated their agreement that a nuclear war should never be fought and can never be won and underscored their opposition to the use or threat of use of nuclear weapons in Ukraine,” reads the statement.

In a statement after their meeting that lasted a little over three hours., Xi Jinping called Taiwan the “first red line” that must not be crossed in US-China relations, Chinese state media said.

President Xi pointed out that China is highly concerned about the current situation in Ukraine. He noted the four points about what must be done he had proposed soon after the outbreak of the crisis and the four things the international community must do together he had suggested recently.

The two sides had set up a mechanism for more frequent communications and Secretary of State Antony Blinken will travel to China to follow up on discussions.

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The excise policy – 2021-22 came under the scanner after Delhi LG Vinai Kumar Saxena recommended a CBI probe into the alleged irregularities in its implementation. Former Delhi Deputy CM Manish Sisodia has already been arrested by CBI in this case.

he top foreign policy aide to Turkish presidential challenger Kemal Kılıçdaroğlu has told Newsweek he is hopeful that a new Turkish parliament will approve Sweden’s delayed accession to NATO before alliance members meet for their next summit this summer—if President Recep Tayyip Erdogan loses next month’s election.

Ünal Çeviköz told Newsweek that the six-party opposition bloc, which is headed by long-time Republican People’s Party (CHP) leader Kılıçdaroğlu, is “optimistic” on Sweden’s proposed accession, which has been stuck in limbo for several months amid heated disputes between Stockholm and Erdogan.

Kılıçdaroğlu is running slightly ahead of Erdogan in public opinion polls ahead of the May 14 election, raising the possibility that the latter’s 20 years in power might soon come to an end.

Kılıçdaroğlu has said he plans to revitalize Turkish relations with NATO allies and European Union partners which have suffered under Erdogan, who critics say has increasingly turned to authoritarianism tinged by Islamist populism to retain power.

“I hope it will be realized before the NATO summit in Vilnius, but it might fall a little bit short,” Çeviköz said of Sweden’s proposed accession to the alliance.

“It simply depends upon the post-electoral period, the functioning of the parliament, the formation of the new government.”

Swedish Saga

Any new government and new parliament are expected to be in place by mid-June, around a month before the NATO summit in the Lithuanian capital. With Finland already having joined in April, NATO members are hopeful that the July 11-12 meeting will serve as a formal celebration of the alliance’s expansion to 32 members, including Sweden.

Turkey is still refusing to approve Sweden’s bid, and is demanding Stockholm crack down on the activities of Kurdish political and militant groups operating within its territory. Sweden has long been a center for exiled Kurdish activists, and a fundraising hub for Kurdish groups fighting in Syria and elsewhere.

Some of those groups are linked to the Kurdistan Workers’ Party (PKK), which has waged a decades-long guerrilla campaign in Turkey. The U.S. and EU both list the PKK as a terrorist organization.

Sweden has already passed new legislation to clamp down on militant organizations. It also lifted a 2019 arms embargo on Turkey put in place after Ankara’s incursion into Syria targeting the Syrian Kurdish People’s Defense Units (YPG), a militia that is linked to the PKK and forms the core of the Syrian Democratic Forces (SDF) which has fought alongside American troops against Islamic State militants.

But this was not enough for Erdogan, who also demanded extradition of Kurdish terror suspects and those accused of links to the failed 2016 Turkish coup, which Ankara blames on U.S.-based preacher Fethullah Gülen. More than 300,000 people have been arrested in Turkey since 2016 for suspected ties with Gülen.

The standoff has toxified public opinion in both countries. Turks were especially outraged in January when a far-right Danish activist burned a Koran in front of the Turkish embassy in Stockholm.

Sweden is now waiting for further anti-terror legislation to come into force on June 1. A Turkish government source told the Daily Sabah this week that the bill would not guarantee an end to Ankara’s opposition.

Çeviköz, though, told Newsweek that a new government led by Kılıçdaroğlu would look kindly at the new law.

“We are reassured by Swedish counterparts that the introduction of that new law will, in a way, appease the expectations of Turkey as far as Sweden’s combat against terrorism is concerned,” he said.

“This law will enable Sweden to pay tribute to the sensitivities of Turkey as far as the PKK terrorist issues are concerned. Once this happens, it will be a process which will remove all the basic hurdles in front of Swedish membership in NATO. And it will allow the next government to look in a better and an optimistic manner on their membership of NATO.”

The Russia Problem

Çeviköz said that a Kılıçdaroğlu-led government will generally look to build foreign “trust and confidence” in Turkey, which under Erdogan has often been a source of intra-NATO tensions and disputes with the EU.

He said a new government would continue Turkish efforts to mediate between Ukraine and Russia in the ongoing war, and maintain Ankara’s role in overseeing the Black Sea grain export deal.

“To find an overall development for peace between Russia and Ukraine, it’s a matter of European security architecture and it is not only Turkey,” Çeviköz said.

Though a NATO member, Turkey has somewhat straddled the growing gulf between Moscow and its EU-NATO adversaries. Turkey is heavily dependent on Russian energy—state-owned Gazprom provided some 45 percent of all Turkish domestic gas demand in 2021—and Russia is, in the words of the Turkish Foreign Ministry, “one of the most important trade partners.”

Amid the Western sanctions offensive on Moscow, Turkey has seen its trade with Russia increase by 87 percent.

Though he said a new government would not mirror EU sanctions against Russia, Çeviköz did say that a Kılıçdaroğlu-led administration would adopt more intense scrutiny of Turkish firms accused of helping Russia bypass the measures and source dual-use goods.

“We are also trying to take the necessary measures not to allow this to happen,” he said. “We will be certainly looking at it more carefully.”

Çeviköz said an opposition-led Turkey would look to “to diversify and to diminish the dependence on a certain source” when it comes to energy.

Still, Çeviköz said Turkey will not be off-limits to Russian President Vladimir Putin. “If a presidential visit is considered from either party to the other, then we will certainly be looking at it,” he said.

The recent International Criminal Court arrest warrant for Putin, he added, is not relevant to Turkey as the country is not a party to the agreement. “There is not anything to be discussed on that level,” he said.

‘Trust’ in Turkey

Çeviköz said the combined opposition is “quite confident” of success in the looming elections. But what if Erdogan wins again? “We don’t consider this as a possibility,” Çeviköz replied.

“The paradigm, not only in Turkey, but overall in the world is the confrontation between democratic forces and authoritarianism,” he said. “Turkey is going to prove that the authoritarian tendencies could be defeated by a democratic and free elections […] Democracy will prevail. And if it doesn’t, then it will be a dark hole in the region.”

A Kılıçdaroğlu-led administration, Çeviköz said, will be looking to make peace with those so often rankled by Erdogan’s foreign policy over the past two decades, starting with historic rival Greece. Athens and Ankara have been involved in multiple territorial disputes in the eastern Mediterranean, with huge reserves of undersea oil and natural gas at stake.

Turkish and Greek vessels have clashed at sea, and Erdogan even warned in December that Turkish missiles can reach Athens.

“One of the priorities will be certainly in relations between Turkey and Greece,” Çeviköz said, suggesting a recent thaw in ties following the February earthquake that devastated parts of eastern Turkey and northern Syria gives some hope for improved bilateral ties. “I think there is a very optimistic opportunity there,” he said.

Long-term, Çeviköz said the Turkish opposition also has an eye on renewed EU accession talks, which have been frozen since 2018 amid democratic backsliding under Erdogan.

“It is a very long-term process,” Çeviköz said of Ankara’s EU ambitions. “First, we have to create the trust and confidence of Turkey, with the international community […] Once this happens, certainly further developments and progress will follow.”

Turkey under Kılıçdaroğlu will also be looking to revive ties with neighboring Syria, whose dictatorial leader Bashar al-Assad has—with extensive Russian and Iranian help—all but won the brutal civil war against a variety of domestic and foreign-backed rebel groups.

Turkey occupies a swath of northern Syria it says is required to protect the southern Turkish border, but Çeviköz said an opposition administration would be willing to re-evaluate its military presence there if there is a détente with Damascus. The return of some four million Syrian refugees now living in Turkey is a top priority across party lines.

“It is the intention of the next government to incentivize the voluntary return of Syrians,” Çeviköz said. “Dialogue is absolutely necessary between Ankara and Damascus.”

The EU and U.S. are still cold on Assad, refusing to re-establish ties after more than a decade of trying to oust the dictator. “I don’t think that it’s going to damage the Turkish relations with the U.S.” Çeviköz said of a potential thaw between Ankara and Damascus.

“If we can achieve that kind of reassurance and confidence between the two countries, certainly, there will be a time when there will not be a necessity for reassuring Turkey’s security by presence of Turkish armed forces in the Syrian territory,” he added.

Source: The HIndu

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In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes.

Although the Senate Health, Education, Labor and Pensions (HELP) Committee (but not the Senate) and the House of Representatives advanced significant FDA-related legislative changes, the ultimate user fee reauthorization signed into law ended up being a relatively “clean” reauthorization of the applicable user fee programs. Congress nevertheless included many FDA-related legislative changes in the Consolidated Appropriations Act, 2023 (“Omnibus” or “Act”), which President Biden signed into law on December 29, 2022.¹

This client alert highlights FDA-related provisions in the Omnibus, including but not limited to those in the FDA-specific title, the Food and Drug Omnibus Reform Act (FDORA). This legislation represents the culmination of the user fee reauthorization legislative process for the prescription drug, medical device, generic drug and biosimilar user fee programs. The stage is now set for FDA to implement these provisions, some of which require rulemaking, guidance or other agency actions. Despite the scope of this legislation, numerous significant policy issues were not addressed, and will potentially be considered by Congress in 2023 and beyond.

Key Takeaways

• The Omnibus, including FDORA, makes important changes to several aspects of device and drug premarket review, and drug marketing exclusivity, while also enhancing or clarifying important aspects of agency enforcement authority; many of these provisions will require FDA implementation in 2023.
• Regulation of cosmetics is significantly revamped, and will also require agency implementation beginning in 2023.
• The Omnibus reauthorizes a variety of important FDA programs, such as funding incentives for orphan drugs and rare disease products.
• Numerous policy reforms under consideration in the 117th Congress were not included, notably the VALID Act (reform of in vitro diagnostics regulation), changes to the regulation of dietary supplements and revisions to device shortage reporting; the new Congress may continue to consider these and other areas of FDA.

1. Appropriations

After months of negotiations between House and Senate Appropriations leadership, the Consolidated Appropriations Act, 2023 (P.L. 117-328) passed the Senate by a vote of 68-29 on December 22. The House passed the Omnibus on December 23 by a 225-201 vote and President Biden signed the bill into law on December 29. The Omnibus provides the FDA a total of $3.5 billion in discretionary funding, a $226 million increase above the fiscal year 2022 funding level. With user fees, total FDA funding for fiscal year 2023 is $6.6 billion. Along with program reauthorizations, the Omnibus directs FDA to use $35.8 million for medical safety, $41 million for food safety activities, $122 million for cross-cutting initiatives and $50 million for accelerating medical development as authorized by the 21st Century Cures Act.

2. Preparedness

The Omnibus includes the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act).² The enactment of the PREVENT Pandemics Act reflects the culmination of a multiyear, bipartisan legislative process with the goal of strengthening our nation’s medical and public health preparedness and response framework. The timing of the enactment of these reforms and the ongoing COVID-19 response efforts raise questions about how Congress may approach reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), provisions of which are set to expire at the end of the current fiscal year (September 30, 2023). Key themes of the PREVENT Pandemics Act include structural leadership changes, increasing accountability and transparency around preparedness and response activities through more rigorous and frequent reporting requirements, and the importance of partnerships and innovation as part of a nimble, all-hazards preparedness framework. The PREVENT Pandemics Act also includes new funding opportunities. Additional information regarding the PREVENT Pandemics Act and PAHPA Reauthorization is available here.

3. Drugs and Biologics

The provisions of FDORA include some, but not all, of the drug policy riders that were initially considered as part of the FDA reauthorizing legislation impacting pharmaceutical products, which we noted in our previous client alerts here and here. The following is an assessment of select provisions of FDORA that may be of the greatest interest to drug and biologic sponsors and other stakeholders:

a. Exclusivity, Orphan and Rare Disease Issues

Several FDORA provisions impact the scope and qualifications for various FDA market exclusivities.

• Interchangeable Biosimilar Exclusivity: Under section 351(k)(6) of the Public Health Service Act, 42 U.S.C. 262(k)(6), the first FDA-approved interchangeable biosimilar to a reference product receives exclusivity blocking the approval of any other interchangeability designations for the earlier of 12 months after the interchangeable product is marketed (or 18 months after its approval even if it is not marketed), 18 months after the conclusion of litigation by final court decision or settlement or 42 months after approval of the interchangeable if litigation is ongoing. Section 3206 of FDORA now allows for multiple “first” interchangeable biosimilars to qualify for those periods of exclusivity, if they are approved on the same day. This change will significantly alter the competitive landscape for interchangeable biosimilars, providing a considerable incentive for companies to have an approvable product on the first possible day permitted under the Act (which is 12 years from the date of approval of the reference product).³ Presumably, this would tend to significantly drive down market prices for interchangeable biosimilars (and further drive up rebates for the reference drug) where multiple sponsors have approved products in the market simultaneously. In addition to this weakening of the value of a first interchangeability designation, the industry will be closely watching for other legislative proposals that would weaken the interchangeability designation altogether.
• Enantiomer Exclusivity: Section 3105 of FDORA amends section 505(u) of the Food, Drug and Cosmetic Act (“FD&C Act”) to clarify that sponsors of section 505(b)(2) applications for an enantiomer may rely on bioavailability studies of an already approved racemic drug, and still be entitled to the five years of market exclusivity available under section 505(j) of the Act. Prior to this change, the statute was more broadly worded to disallow the five-year exclusivity if the application relied on “any clinical investigations” of the already approved drug.
• Therapeutic Equivalence Determinations: FDA is required to make “therapeutic equivalence” (i.e., “A” rated) determinations based on sponsors’ data submissions, including for filings under section 505(b)(2) of the FD&C Act. Section 3222 now requires FDA to make those determinations, if requested by the sponsor in the application, either at the time of approval or not later than 180 days afterward.  FDA must make the determination for already approved applications 180 days after receipt of a request by the sponsor, or for applications submitted but not approved as of the effective date of the Omnibus bill, 180 days after the approval.
• Orphan Drugs: FDORA did not include a provision included in the Senate HELP Committee mark up of FDA user fee legislation last year, which would have applied orphan drug exclusivity only to the same approved use or indication within a rare disease or condition by allowing FDA to approve the same drug from different manufacturers if the products are intended to treat different patient populations. It remains to be seen whether the orphan drug exclusivity issues will be revisited in the new Congress, and how and whether FDA will address pending orphan drug exclusivity applications. However, FDORA includes a reauthorization of FDA’s Orphan Products Grants Program,⁴ increasing the scope of the program and its budget and requires FDA to create a Rare Disease Endpoint Advancement Pilot Program (RDEA) to facilitate work between the agency and sponsors to develop new rare disease endpoints “including surrogate and intermediate endpoints.”⁵

b. Accelerated Approvals

Section 3210 contains several detailed reforms to the current FDA approach to accelerated approvals under FD&C Act section 506(c). Although FDA has taken the position that it has authority to revoke a drug’s approval based on new safety or efficacy data (or certain other reasons), and has requested that sponsors voluntarily remove their accelerated approval drugs from the market in several cases, section 3210 clarifies FDA’s authority to do so with new specific procedures and processes that must be followed in such cases. These include notice to the sponsor, meetings with the agency, an opportunity for the sponsor and public to formally comment and for FDA to respond, as well as holding an advisory committee at the request of the sponsor.

Post-approval studies for accelerated approval drugs now must be specified by FDA (which may include enrollment targets, a study protocol and milestones including a target date for study completion). FDA also may require that certain of those studies already be underway at the time of accelerated approval. Section 3210 further amends section 506(c) to specifically indicate that in certain cases only one post approval study could be required by FDA (vs. the current statute’s requirement for “studies”). Under the new provisions of section 3210, if FDA does not require post-approval studies as part of an accelerated approval, it must give the public notice of why they are not being required. Sponsors now must update FDA on the progress of such studies every 180 days, starting with 180 days after the initial accelerated approval is granted. The law also now explicitly makes failure to conduct the required studies a violation of the FD&C Act, by amending section 331 with new section “(ggg),” which requires sponsors to conduct such post-accelerated approval studies “with due diligence” and to “submit timely reports.” As such, the law leaves open the question of whether a violation can occur where the sponsor is in fact conducting the study.

c. Animal Testing

Section 3209 amends section 505 of the FD&C Act to enable sponsors to support their drug approval packages with pre-clinical testing that is in vitro, in silico or in chemico, or a nonhuman in vivo test. Thus, for the first time, sponsors may deploy non-animal testing such as computer modeling to fully support the FD&C Act’s required demonstrations of efficacy and/or safety. This section also specifically amends the Public Health Service Act to allow for non-animal biosimilar toxicity testing.

4. Cross-Cutting Issues

a. Clinical Trials

The Omnibus requires sponsors to submit diversity action plans for certain studies for drugs and devices, and requires FDA to issue or update its guidance regarding these plans.⁶ FDA is also required to take steps to modernize clinical trials through issuing a variety of guidance documents and convening workshops, including relating to historically underrepresented populations in clinical studies;⁷ flexibilities afforded during the COVID-19 pandemic;⁸ digital health technologies in clinical trials; decentralized clinical trials; and use of seamless, concurrent and other innovative clinical trial designs to support expedited development and review applications for drugs.⁹ FDA is also instructed to work with foreign regulators to facilitate international harmonization of regulation of decentralized clinical trials, digital health technologies in clinical trials and use of innovative clinical trial designs.¹⁰

b. Exchange of Product Information Prior to Approval

Section 3630 is a legislative adoption of the main themes already contained in FDA’s existing 2018 final guidance on Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities (the “Payor Guidance”). Under that guidance, FDA invoked its enforcement discretion as to certain off-label and pre-approval communications about drugs or devices to “entities with knowledge and expertise in the areas of health care economic analysis.” Technically, section 3630 amends section 502 of the FD&C Act’s “adequate directions for use” exception to misbranding violations by adding to the exception the “provision of truthful and not misleading product information to a payor, formulary committee or other similar entity with knowledge and expertise in the areas of health care economic analysis” as to both investigational drugs and devices (meaning off-label uses), and pre-approval and pre-clearance products. The exception is, as was the case in the Payor Guidance, limited to circumstances where the entity is “carrying out its responsibilities for the selection of drugs or devices…,” which may mean that communication of the same information in a different context is not protected by the exception. The statute also similarly requires affirmative disclosure that the safety and efficacy of the product or use being discussed has not yet been established, as well as other important data disclosures. In addition, section 3630 requires the Government Accountability Office (GAO) to do a study of the kinds of information provided by sponsors to payors under these new provisions, although it does not specify how GAO will collect such information since these payor materials are not necessarily required to be filed with FDA on a Form 2253.

5. Medical Devices

The Omnibus legislation adopts a number of substantive changes to medical device law that had been contemplated during deliberations on the user fee reauthorization, and made a number of clarifications to FDA’s authority:

• Predetermined Change Control Plans: Sponsors of devices may now include with their section 510(k) and premarket approval (PMA) submissions proposed change control plans pursuant to which the sponsor could make certain changes to the approved or cleared device without requiring a new marketing submission.¹¹
• Cybersecurity: Devices that could be vulnerable to cybersecurity threats are required to include in their marketing submissions information relating to device security, identification of cybersecurity vulnerabilities and a software bill of materials.¹²
• De Novo/CLIA Waiver Dual Submissions: Sponsors of in vitro diagnostics authorized under emergency use authorizations (EUAs) may submit a single submission for de novo classification and Clinical Laboratory Improvement Amendments (CLIA) waiver designation.¹³
• Data Transparency: The agency shall seek access to data funded by FDA that may be used in regulatory decision-making for devices, provide it to the implicated manufacturers to the extent possible, and report to Congress every two years on device emerging signal communications and their resolution.¹⁴
• Real World Evidence: FDA shall issue guidance addressing the use of real world data and real world evidence to support device submissions, including the use of evidence obtained as a result of the use of devices under EUAs.¹⁵
• CFGs: Congress clarified that Certificates to Foreign Governments (CFGs) are available for device establishments located outside the United States for cleared or approved devices that are offered for import into the United States.¹⁶
• Enforcement Authorities: The Omnibus made numerous changes or clarifications to FDA enforcement and oversight tools, including authorizing FDA to ban a device for a particular intended use (rather than necessarily banning the device for all uses);¹⁷ strengthening enforcement tools relating to counterfeit devices;¹⁸ and clarifying FDA’s inspectional authority relating to non-restricted devices¹⁹ and registration requirements for foreign device (and drug) establishments.²⁰

There were other device-related provisions that Congress did not include in the Omnibus. Notably, the VALID Act, which would have significantly reformed the regulation of in vitro diagnostic tests including those offered by laboratories, was not included. Nor were proposed revisions to device shortage reporting or other potential changes to device regulatory pathways.

6. Cosmetics

The Omnibus includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which constitutes the most significant expansion of FDA’s authority to regulate cosmetics since passage of the FD&C Act of 1938. Of note, MoCRA establishes a regulatory framework for cosmetics more similar to that of other FDA-regulated products, including requirements with respect to:

• Adverse event reporting;
• Maintenance and inspection of adverse event records;
• Good manufacturing practices;
• Registration and product listing;
• Safety substantiation;
• Product labeling, including identifying fragrance allergens in such product labeling;
• Mandatory recall authority; and
• Records access and inspections.

MoCRA expressly preempts certain requirements under the FD&C Act, but also provides express limitations with respect to such preemption under certain circumstances.

MoCRA also directs FDA, not later than one year after enactment, to propose regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products, and issue final regulations not later than 180 days after the date on which the public comment period on the proposed regulations closes. MoCRA also directs FDA to assess and issue a report regarding use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetics and the scientific evidence regarding the safety of such use in cosmetics products, including any risks associated with such use.

7. Infant Formula

The Omnibus includes provisions related to the safety and availability of infant formula. Most notably, the Omnibus requires the establishment of an Office of Critical Foods within FDA’s Center for Food Safety and Applied Nutrition. This new office is charged with responsibility for oversight, coordination and facilitation of activities related to critical foods, which are defined as infant formula or a medical food (as defined in section 5(b)(3) of the Orphan Drug Act). The Omnibus directs FDA to apply a 30-day premarket submission requirement—as opposed to a 90-day requirement—in the instance of a shortage of infant formula. The Omnibus also seeks to harmonize international infant formula requirements by allowing the agency to enter into agreements with other countries regarding the inspection of foreign-manufactured infant formula. Further, it requires specific actions by FDA with respect to inspections of infant formula manufacturing facilities, such as annual inspections, including unannounced inspections. The Omnibus calls for a national strategy to increase the resiliency of the infant formula supply chain.

A new section 424 of the FD&C Act sets forth requirements for manufacturers of critical foods, including:

• Notification to FDA in the event of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the United States within five business days after such discontinuance or such interruption.
• Developing, maintaining and implementing, as appropriate, risk management plans that identify and evaluate risks to the supply of the food, as applicable, for each establishment in which such food is manufactured.

8. FDA Program Reauthorizations

A number of FDA-administered programs requiring reauthorization were only reauthorized until mid-December 2022 in the user fee reauthorization signed into law on September 30, 2022. The Omnibus reauthorized a number of these for longer periods of time, including orphan drug grants, the Best Pharmaceuticals for Children Act incentive, the Critical Path Public-Private Partnership, third-party device review and third-party device establishment inspections, the humanitarian device exemption incentive program, the Pediatric Device Consortia Grants program, reporting requirements relating to generic drug applications and priority review applications, and a provision relating to drugs containing single enantiomers.

Source : Akingump

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The EU-US Trade and Technology Council continues to be a valuable initiative for transatlantic cooperation – even if the outcomes of the negotiations will not always make the news

On 5 December, the leadership of the European Commission and US cabinet officials met in Washington, DC for the third ministerial summit of the EU-US Trade and Technology Council (TTC). The TTC initiative, launched in September last year, aims to facilitate continuous transatlantic cooperation on key technology and trade issues. Recently, however, disagreements between the European Union and the United States have overshadowed that cooperation – and threatened to disrupt the summit.

The “Buy American” provisions in the US Inflation Reduction Act (IRA) have frustrated EU leaders, who fear that massive subsidies for American industry will result in companies fleeing Europe. The Biden administration, meanwhile, is dissatisfied with the EU’s hesitance to leverage the TTC more aggressively against China. These disputes, an apparent lack of concrete new outcomes, and the exclusion from TTC negotiations of some of the biggest transatlantic tech and trade issues – such as the IRA or the legal conundrum of transatlantic data flows – have led many observers to conclude that the TTC’s days are numbered.

But, just as the TTC summit in May involved some exaggeration of the initiative’s success stories, the doomsday judgments on the current state of play are also misled. These dire prognoses largely stem from unrealistic expectations, as well as an incomplete understanding of the TTC’s scope and the functioning of the EU – which are closely linked.

Understanding the TTC

The European Commission and the Biden administration established the TTC as a non-binding instrument. In doing so, they took lessons from the failed Transatlantic Trade and Investment Partnership initiative and the damage the Trump era caused to relations between the EU and the US. The TTC’s non-binding setup puts the European Commission in the driving seat, with limited roles for member states and the European Parliament. This simplifies negotiations and facilitates an agile approach to addressing common evolving challenges. However, it also means that the scope and applicability of TTC decisions are inherently limited.

At the inaugural TTC summit, the EU and the US made the modest commitment to “coordinate approaches to key global technology, economic and trade issues … and to base policies on shared democratic values”. Crucially, both sides emphasised that TTC cooperation would not interfere with the regulatory autonomy of the EU and the US. So, grand expectations that the TTC would permit swift regulatory alignment, for example in the governance of digital platforms, were naive at best.

Similarly, the desire in the US to mould the TTC into a geopolitical vehicle aimed at China is mostly incompatible with EU reality. Ursula von der Leyen’s “geopolitical Commission” may, at least partially, share the United States’ ambitions and have a somewhat solidified position on China. But that is not the case for the 27 member states and for the union as a whole. European foreign and security policy continues to be shaped predominantly in EU capitals – not in Brussels – and is often insufficiently aligned between member states.

The issue of export controls in the TTC context illustrates this. At the Paris summit, leaders – and accordingly the media – hailed the coordinated and unprecedented EU and US technology export controls against Russia and Belarus as one of the TTC’s greatest success stories. Certainly, TTC engagement between the European Commission and White House officials played a role in facilitating the swift coordination of those controls. But, in the end, it was member states that negotiated and decided upon the measures in the Foreign Affairs Council, outside the auspices of the TTC. Importantly, it was the imminent security threat of a war in the EU’s neighbourhood that forced member states to swiftly align.

This is fundamentally different from leveraging the TTC to get the EU on board the United States’ new approach to strategic technology export controls against China, through which it aims to limit the country’s military and technology development. Although the EU acknowledged the geostrategic significance of broader allied export controls at the TTC’s inaugural summit, the bloc’s reality means the power to implement such controls largely lies with member states, not the European Commission. And, crucially, threat perception and economic dependencies with regards to China differ between EU member states, as well as between the EU and the US.

It should therefore be no surprise that the US has as yet failed to convince key member states to follow its export control approach against China. And it would be unreasonable to expect the TTC, a commission-led tech and trade initiative, to deliver concrete outcomes on this security policy issue. The TTC’s configuration and the realities of EU foreign policy mean the initiative simply cannot become the immediate geopolitical tool the US envisages.

The value of the TTC

Nevertheless, the TTC can make valuable contributions to nudging the geopolitical needle; it can facilitate coordination, foster mutual understanding, enshrine common policy principles, and aid in the development of compelling narratives – thereby setting the tone and baseline for further actions. But these small steps are difficult to sell as the grand milestones political leaders and the media like to see.

One such small step is this week’s announcement of two TTC initiatives for secure digital infrastructure projects in Jamaica and Kenya. The projects themselves will have limited impact and will hardly be headline grabbing. But they are a clear EU-US response to China’s assertive global infrastructure investments. This new transatlantic cooperation on connectivity investments in third countries, involving a variety of important stakeholders – including development and financing institutions – can have lasting and meaningful effects. Therefore, a proposed memorandum of understanding between the US Development Finance Corporation and the European Investment Bank to increase cooperation in connectivity financing, if followed through, will be of geopolitical significance.

Moreover, although the TTC cannot facilitate full regulatory alignment in technology policy between the EU and US, the initiative can help advance a common understanding on underlying principles – which can have far-reaching effects. The release of a joint roadmap towards common terminologies and metrics to assess the trustworthiness and risk of artificial intelligence (AI) is a case in point. An agreement on a common taxonomy and approach to risk management could pave the way for joint AI standards. This, in turn, would strengthen the positioning of the EU and the US in international standards bodies and help disseminate transatlantic standards across the globe. But, much like a memorandum of understanding on digital development cooperation, a shared repository of metrics to measure AI trustworthiness is unlikely to make the news.

TTC-facilitated convergence in these and other areas may fall short of full regulatory alignment, but it can advance common principles and reduce barriers to trade and research cooperation – with small steps working towards broader, long-term goals.

Room for improvement

This is not to say that the TTC has been an all-out success. Indeed, it is frustrating to see transatlantic friction result in the neglect of some areas in which more cooperation is urgently needed. For example, if the EU and the US do not find a way to collaborate more closely on 6G development, there is a real risk that China’s Huawei will dominate global markets. The issue featured prominently in previous summits, but it now appears to have been pushed down the TTC agenda. This is likely because the US administration, under pressure from US industry lobbyists, continues to pursue premature promises of Open RAN as a way of diversifying the market in favour of new American competitors. But this comes at the cost of cooperation with the EU in building Western 6G technology champions that can compete against Chinese giants.

Such disagreements, alongside the tensions over “Buy America” and the EU’s geopolitical immaturity, endanger continued TTC cooperation. Yet, the initiative has not exacerbated these issues; instead, it provides additional incentives to resolve them. It is vital for EU and US officials – despite misconceptions about and frustration with the TTC – to defend and push the initiative, which remains a valuable vehicle to achieve positive long-term impact.

It seems a reminder is necessary that the TTC is primarily a mechanism “to coordinate approaches to key global technology, economic and trade issues … and to base policies on shared democratic values”. The TTC will not resolve all transatlantic trade and tech issues. The EU will not become a US-like geostrategic force overnight. The US will not become an EU-like digital regulation frontrunner any time soon. And TTC summits will not always create big (positive) headlines. Once that is clear on both sides of the Atlantic, the TTC can continue to make valuable contributions towards a transatlantic market for emerging technologies and digital transformation based on common values.

Source: ECFR.EU

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CERB intended to aid workers, ‘should not result in a windfall for the employer,’ says court

The BC Court of Appeal has found that the Canada Emergency Response Benefit (CERB) is not deductible from damages in a wrongful dismissal case stemming from pandemic lay-offs. It is the first ruling from an appellate court on the issue.

In Yates v. Langley Motor Sport Centre Ltd., 2022 BCCA 398, the BC Court of Appeal dealt with how “compensating advantages” applied. Also known as collateral benefits, compensating damages arise when the plaintiff benefits from a gain connected to the defendant’s breach – either an indemnity for the plaintiff’s loss or a benefit that the plaintiff would not have received but for the defendant’s breach.

Since the CERB program ended in September 2020, there has been conflicting case law across the country about whether it is deductible from damages in a wrongful dismissal case, says Lia Moody, managing partner for the Vancouver office and Western Canada practice leader at Samfiru Tumarkin LLP.

She says the BC case law has swayed toward deductibility, starting with Hogan v. 1187938 B.C. Ltd., 2021 BCSC 1021, and others have followed suit. But then came Slater v. Halifax Herald Limited, 2021 NSSC 210, which went the other way, and Moody was eager to apply its principles to other CERB-deductibility cases.

“I read that decision, and it just really stuck with me,” she says. “It very quickly became my pet project.”

“I really felt strongly about the fact that CERB should not be deducted from a wrongful-dismissal damages award.”

Moody represented Shelby Yates, the appellant employee in Yates v. Langley Motor Sport Centre. Yates worked as a marketing manager and event coordinator for Langley Hyundai in Langley, BC. When the COVID-19 pandemic hit, Yates’ employer put her on a temporary lay-off, and she began collecting from CERB at the end of March 2020.

Following the amended provisions of the Employment Standards Act, once Yates remained laid off past Aug. 30, her termination date was deemed retroactive to the beginning of the lay-off period. She brought a claim for wrongful dismissal against Langley Hyundai, and BC Supreme Court Justice Andrew Mayer awarded her five-months’ salary instead of notice but deducted $10,000 – representing the CERB payments – from her damages.

“One of the reasons why this really bothers me is because there’s a finding that the employer had breached the contract, that the employer was in the wrong in not having provided her severance,” says Moody.

“The argument that I made at the Court of Appeal, and the driving basis behind my feelings and argument on it, is that an employer shouldn’t be able to subsidize their breach of contract with a government-funded, taxpayer-funded program that’s designed to help the employees get through the COVID-19 pandemic.”

In Yates v. Langley Motor Sport Centre, Chief Justice of the Court of Appeal Robert Bauman wrote the reasons for the panel, including Justice Susan Griffin and Justice Joyce DeWitt-Van Oosten. They allowed the appeal on the issue of CERB deductibility.

Justice Bauman sets out three main policy considerations, identified by the Supreme Court of Canada, which are relevant in determining whether a benefit should be deducted from a plaintiff’s damages: “punishment, deterrence, and the provision of incentives for socially responsible behaviour.”

Justice Mayer had erred in his analysis of the deductibility issue by “failing to allude to or grapple with” these three policy considerations, said Justice Bauman.

Because CERB payments are intended to be an indemnity for workers’ losses because of COVID, which caused Langley Hyundai to lay off Yates and breach the employment contract, the appellate court found that the case did present a compensating advantage problem. Considering the “broader policy considerations,” however, they concluded that these benefits should not be deducted from the damages.

“First, as a matter of overall impression, it seems wrong for a defendant employer who has breached the employment contract with the plaintiff to enjoy, effectively, a windfall from an income support program designed to benefit workers impacted by the COVID-19 pandemic,” said Justice Bauman. “If a windfall is to result, it seems to better reflect the intention of Parliament that it go to the worker.”

He said the policy consideration that “tips the balance against deductibility” involves three issues: “the desirability of equal treatment of those in similar situations, the possibility of providing incentives for socially desirable conduct, and the need for clear rules that are easy to apply.”

Where an employee’s temporary lay-off period expires, the ESA puts the termination date at the beginning of the lay-off period, and CERB benefits for that entire period are in question. But for the employee terminated the day before the end of the temporary lay-off period, their notice period begins at that point and benefits received beforehand are not deductible. “Overall, the desirability of equal treatment of those in similar situations favours not deducting CERB,” said Justice Bauman.

This example also represents the opposite of socially responsible conduct, he said, and non-deductibility removes “incentives for undesirable conduct” by eliminating the incentive for employers to “manipulate matters by the timing of their termination” in allowing the temporary lay-off period to lapse.

As to the “need for clear rules,” CERB was intended as a brief “exceptional benefits program designed to apply broadly, quickly, and simply.” In Yates’ case, “the actual deduction from the award must await the realization of any income tax impacts,” which threatens that goal, said Justice Bauman.

Ultimately, he adds, the compensating-advantage problem addresses a situation where, with both the benefit and damages, the employee is better off after the breach than before. But CERB was an “emergency measure” during an “unprecedented global pandemic” where, despite CERB, many people still lost their livelihoods. “It strikes me as out of step with that reality to conclude that the combination of CERB and damages awards leaves individuals ‘better off’ after their employment was terminated than before.”

Most of the decisions that have dealt with CERB’s deductibility have grappled with the “open-ended” question of whether the plaintiff will be required to pay CERB back to the government, says Moody.

But Justice Bowman called this “a bit of a fruitless exercise.” Whether CERB is repayable has nothing to do with the employer. It is between the employee and the government, he said.

Source: Canadian Lawyermag

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LHC Group and UnitedHealth Group have extended their merger agreement as the feds take a deeper look at the deal.

The agreement was extended until March 28, 2023, and the two companies now expect the merger to close in the first quarter of 2023, according to a filing with the Securities and Exchange Commission.

That the insurance giant intended to acquire LHC, a home health provider, was announced in March, and the deal is valued at about $5.4 billion. UnitedHealth said it plans to fold LHC into its Optum subsidiary as part of its provider arm, Optum Health, which is one of the country’s largest employers of physicians.

LHC Group would add 30,000 employees who provide more than 12 million home health services annually.

The Federal Trade Commission (FTC) issued a second request for information in June on the deal. In the filing, LHC Group said that both companies have certified “substantial compliance” with the FTC.

The ongoing FTC probe is the second major issue that the companies have encountered on the path to closing this merger. An LHC shareholder sued the company in May, arguing LHC withheld key details in its documents recommending shareholders approve the sale to UnitedHealth.

It’s also the second major acquisition by UHG that’s run into concern from federal regulators. The Department of Justice (DOJ) sued to block the company’s purchase of Change Healthcare, though UnitedHealth prevailed in court as a federal judge allowed the merger to move forward.

DOJ is planning an appeal, though that challenge would now pit it against a closed deal and companies that have begun integration.

Source: Fierce Health Care

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With the clock ticking on the postelection lame-duck session of Congress, tech reformers are pushing for votes on a package of bills that stalled over the summer. Three bills—the American Innovation and Choice Online Act, the Open App Markets Act, and the Journalism Competition and Preservation Act—would write special competition rules for large tech companies in ways that could fundamentally change how tech platforms moderate content like hate speech, disinformation, and incitement to violence. The Senate Judiciary Committee has sent all three bills to the Senate floor. But whether any of these three bills becomes law likely depends on whether Democrats and Republicans can hold a fragile coalition together in which each side ignores the thing that scares them most about the other: Republicans’ fear of big government that interferes in the market, and Democrats’ fear of harmful content proliferating online.

Over the past few years, Democrats and Republicans have made common cause in seeking to rein in Big Tech. But the two parties have struggled to find areas of agreement on a wide range of other critical issues, ranging from environmental policy to health care. Nevertheless, in seeking to reform the rules governing competition in the tech sector, Republican Sen. Ted Cruz (Texas) has stood alongside Democratic Sen. Amy Klobuchar (Minn.) to try to curb Big Tech power, and Republican Rep. Ken Buck (Colo.) has joined hands with Democratic Rep. David Cicilline (R.I.) to advance antitrust legislation. Despite Democrats’ and Republicans’ long-standing disagreements and their conflicting visions of what a better internet might look like, what has been the magic formula that has enabled them to work together?

The answer is simple: Republicans support proposals to reform antitrust law when—and only when—Democrats include provisions that would make it harder for tech platforms to moderate content in ways conservatives think disadvantage them. 

Despite the clear political benefits of this strategy, it requires Republicans and Democrats to subsume other competing values and priorities beneath the goal of curbing tech platform power. For Republicans, it requires them to brush aside their distaste for government interference with the free market and for giving government agencies more power to regulate business practices. Democrats must pretend that limiting platforms’ ability to moderate harmful content on their platforms is not directly at odds with their concerns about the proliferation of exactly this type of online content. Democrats have pressured tech companies to be more rigorous in restricting hate speech, content that could harm people of color and women, and misinformation about elections, public health, and the environment. But restricting platforms’ ability to differentiate between content providers based on viewpoint will make it harder for them to moderate this harmful speech.

The most prominent example of this strategic compromise is Klobuchar’s proposed American Innovation and Choice Online Act (AICOA). AICOA would bar large tech platforms from adopting policies that would give preference to their own products over others’. For example, when users search for a restaurant in their area, Google might not be able to provide a unit at the top of their feed that includes a phone number, directions, and a link to online ordering. But the bill also holds companies liable if they “discriminate in the application or enforcement of the terms of service of the covered platform among similarly situated business users.” A further requirement—“in a manner that would materially harm competition”—was added to that provision, and others, in an effort to protect content moderation (by focusing on economic harms), but no one really knows what it would mean in practice. 

Taken together, these provisions would restrict platforms’ ability to enforce their content standards: A covered platform that takes action to moderate content could be dragged into court if they are accused of making anti-competitive decisions on what content to host or remove. During Senate debates on the bill, Cruz noted, approvingly, that AICOA would “make some positive improvement on the problem of censorship” because “it would provide protections to content providers, to businesses that are discriminated against because of the content of what they produce.” 

A number of Democrats have pleaded with AICOA’s sponsors to amend the bill to ensure that platforms can still take action against hate speech and misinformation, but AICOA remains unchanged. Klobuchar, it seems, simply can’t afford to drop or revise the ban on discrimination by platforms, lest the bill lose crucial Republican support. For now, the bill looks stuck.

The same goes for the Open App Markets Act (OAMA), introduced by Sens. Richard Blumenthal (D-Conn.) and Marsha Blackburn (R-Tenn.). OAMA focuses only on app stores but would make content moderation even harder in that context. The bill purports to ban self-preferencing in app stores’ search results—for example, treating an app “unequally” compared to a platform’s own app or those of its “business partners.” But courts may interpret that provision to ban discrimination more broadly. Courts will likely reach the same result simply because most app developers are “business partners” with the covered platforms, if only because they share revenue from in-app ads and purchases. “Extremist outlets and disinformation sites could sue platforms for blocking them,” warned Rep. Zoe Lofgren (D-Calif.). She explained, Alex Jones’s “Infowars may sue Apple for being kicked out of the app store, while other conservative political outlets are left up.”

The one bill that might actually move—and quickly—is the Journalism Competition and Preservation Act (JCPA). JCPA is supposed to ensure that serious journalistic outlets get paid for their content. But as with AICOA and OAMA, Republicans and Democrats have aligned on a strategy that marries market reform and content moderation. JCPA exempts publishers from antitrust law when they form cartels to collude in negotiating with tech platforms over the “pricing, terms, and conditions” under which platforms can access the content of publishers in a cartel. The JCPA would prevent platforms from discriminating against cartel members based on the “views expressed” by their content, and would prevent cartels of news publishers from denying admission to a publisher based on viewpoint. That means extremist, pseudo-journalistic publishers of hate speech, misinformation, and incitement to violence (such as Gateway Pundit, Infowars, and Project Veritas) could benefit from the bill. Ironically, the same news publishers that have long argued that tech platforms are responsible for proliferating low-quality, dangerous content now support a bill that could limit tech companies’ ability to exclude such content from their platforms.

As with AICOA, JCPA’s hopes for passage depend on maintaining the alliance between Democrats pushing for antitrust reforms and Republicans seeking to limit the power of Big Tech to “censor” speech they favor. When cracks appear in that alliance, the legislation flounders. 

During the markup of the journalism bill, Klobuchar was forced to withdraw JCPA after Cruz introduced an amendment on precisely this issue. After deliberations, the two compromised on new language that says deals struck between cartels and platforms can’t address content moderation or “curation.” Cruz claimed that his amendment “secured significant protections against Big Tech censorship.” He also included a statement of support from the Daily Caller—a publication that the Southern Poverty Law Center has deemed to have a “white nationalist problem”—which said the bill would “prevent[] news organizations from colluding with tech companies to suppress or censor conservative voices.” 

This last-minute compromise illustrates the larger problem: It should prevent cartels organized under JCPA from forcing tech companies to carry content they don’t want. But it won’t stop the law from being weaponized against content moderation. JCPA still bans “retaliation”—a term defined so broadly (“refusing to index content or changing the ranking, identification, modification, branding, or placement of the content”) that essentially any content moderation decision could be framed as “retaliation” against a publisher participating in a negotiation. 

More generally, the new language probably won’t prevent platforms from having to pay for content they don’t want. That’s partly because payment obligations remain tied to “access,” a term defined broadly to include merely “crawling” or “indexing content.” That’s exactly what platforms often do before they can decide whether content violates their community standards. It’s also what happens when users upload content (especially videos) that may be eligible for monetization. The bill would also likely force platforms to pay for content they carry but that they deem ineligible for monetization because it includes, for example, hate speech or harassment.

The alliance between Democrats pursuing antitrust reform and Republicans seeking to protect speech they think helps them appears to be a shrewd political strategy that will increase the possibility of Congress enacting legislation to reform the tech sector. It is clear that both parties recognize its value and have used it as the basis for modifying tech reform proposals to increase their chance of passage. The JCPA was originally introduced by Rep. Cicilline in 2018 during the 115th Congress, and then subsequently reintroduced in the House and the Senate in 2019 during the 116th Congress and in 2021 during the 117th Congress. None of the previous versions of the legislation includes the provisions on viewpoint, and, perhaps not coincidentally, none of the previous versions was voted out of committee.

The alliance also distracts lawmakers from considering substantive possibilities that might be more impactful in addressing the underlying problems. For instance, JCPA’s supporters say they want to support struggling news publishers and increase the quality of local news. So why not tackle that problem directly? Why not consider public interest journalism models, such as through direct support (like PBS and NPR), through tax incentives for nonprofit models (like ProPublica and the Texas Tribune), or through policies that decrease newsroom costs or subscription costs (like Canada’s measures to provide tax rebates for publishers’ labor costs and to increase news subscriptions by making them tax deductible)? These options have been largely absent from the debate—probably because they meet neither Democrats’ desire to curb platform power nor Republicans’ desire to reduce content moderation.

The bills’ downsides may be worthwhile to the proponents of reform. Supporters of AICOA and OAMA argue that a nondiscrimination rule is necessary to promote more competition in the market. JCPA’s supporters argue that publishers must be permitted to collude so that they can negotiate fairly with tech platforms. Perhaps. 

But amid disagreements about the merits of these proposals to reform antitrust enforcement in the tech sector, it is important for policymakers to not pretend that they will come without a cost. Legislators should acknowledge that their efforts to constrain tech company power will also constrain the companies’ power to moderate harmful content, and should more honestly and transparently account for the benefits and costs of this approach. A left-right alliance between critics of tech platforms may make it possible for Congress to pass tech reform, but only at a steep price to company efforts to moderate harmful content on their platforms.

Source: Lawfare Blog

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