Science Archives · Policy Print https://policyprint.com/category/science/ News Around the Globe Wed, 05 Jul 2023 13:40:37 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 https://policyprint.com/wp-content/uploads/2022/11/cropped-policy-print-favico-32x32.png Science Archives · Policy Print https://policyprint.com/category/science/ 32 32 New Zealand Can’t Arrest Its Way Out of the Gang Problem, Science Chief Warns https://policyprint.com/new-zealand-cant-arrest-its-way-out-of-the-gang-problem-science-chief-warns/ Sun, 16 Jul 2023 08:00:00 +0000 https://policyprint.com/?p=3304 The prime minister’s chief science advisor is warning New Zealand cannot arrest its way out of the gang…

The post New Zealand Can’t Arrest Its Way Out of the Gang Problem, Science Chief Warns appeared first on Policy Print.

]]>

The prime minister’s chief science advisor is warning New Zealand cannot arrest its way out of the gang problem.

Professor Dame Juliet Gerrard has quietly released a new report which examines the context within which gangs exist in New Zealand.

It was requested last year by former prime minister Jacinda Ardern, “to support a policy agenda to reduce gang harm in our communities”.

The government has long been under pressure to control gang crime, with opposition parties accusing Labour of being soft on crime.

The report concludes there is no quick way of reducing gang harm.

Reducing harm, the report said, would require tackling the underlying and unsolved societal issues, including inequity, intergenerational trauma, housing and family violence.

“All of which serve to narrow the choices of those in our society who experience complex and inter-connected stressors,” it said.

While the report makes no specific recommendations, it does suggest introducing policies on family harm, youth offending and drug harm reduction.

The report said a public health approach “does not come at the expense of enforcement” but stressed “we can’t and won’t arrest ourselves out of the “gang problem”.

Legislative and police efforts to address gangs might deliver immediate outcomes, the report said, but longer-term interventions would be required to “build the society that we want in the long term.”

Enforcement serves a purpose but is not the only solution, it added.

“The evidence indicates that interventions such as ‘scared-straight’ or boot camp approaches are ineffective. And a ‘zero tolerance’ style of policing builds distrust in the communities that police are tasked to serve.

“It creates alienation and dislocation from communities and risks fuelling gang membership and increasing gang dislocation and isolation.

“We know that targeted enforcement efforts run the risk of strengthening internal gang cohesion, reinforcing anti‐social attitudes, and simply displacing offending elsewhere rather than addressing the problem at its root,” the report said.

The report suggested greater focus on prevention – which could include targeted programmes or poverty reduction and increased access to healthcare – to limit the number of young people joining gangs.

It said a young person having strong ties with their family, school and community would also reduce the chance of them being involved in a gang.

Investment to ensure young people “enjoy” those strong ties “offers the most hope of diminishing gang harm in the long term.”

The report said preventing young people from joining gangs was likely more cost effective than trying to facilitate disengagement.

Political parties respond

Minister of Police Ginny Andersen said the government welcomed the report.

“It identifies that there are no quick fixes when it comes to gangs and the underlying social issues that drive gang membership and activity.”

Andersen said government action was focused on both stopping the harm that gangs do as well as well as creating opportunities to ensure people do not enter gangs in the first place.

“Our investments have seen nearly 700 additional police working on, and an additional $94 million invested in, tackling gangs and organised crime.

“This is showing results with nearly 40,000 charges laid and over 400 firearms seized through Operation Cobalt.”

The National Party doubled down on its tough-on-gangs rhetoric, its police spokesperson Mark Mitchell saying he disagreed with the report.

“I would call on the gang leaders to stand up and recognise the fact that the gang culture has a very negative effect on not only the communities that they’re in but their own members, their families and their children. “

ACT New Zealand leader David Seymour

David Seymour Photo: RNZ / Angus Dreaver

ACT Party leader David Seymour dismissed the report as little more than a doorstop – of no comfort to victims.

“They’re attempting to claim that if only the authorities are nice to gangs and treat them as friends they’ll start being nice back.

“Thankfully for them Labour has subjected New Zealanders to a real world experiment. They don’t improve their behaviour, in fact they get worse.”

The Green Party’s justice spokesperson Golriz Ghahraman said successive governments had stoked fear over gangs for votes.

“People are very naturally fearful of crime, in particular violent crime, and it’s always easier to tell them it’s a simple solution. The tough on crime rhetoric has been that simple solution.”

Ghahraman added it would take political willpower to adopt an approach that actually works.

“When will the politicians have the courage and the integrity to say to the public, actually we have the solutions, they’re a bit more complicated and you know what they take to resource.”

‘This isn’t an either or situation’

Dame Juliet told Morning Report a focus on prevention would accompany police action on criminal offending.

“We definitely need to tackle organised crime – the question is which specific legislation you might use to do that,” she said.

History suggested using existing laws was more effective rather than gang-specific laws. A zero-tolerance approach risked fuelling gang membership in the long term.

“A focus on criminal offending rather than the jackets they are wearing is thought to be more successful by lots of experts.”

Gangs were a global issue but New Zealand was unusual with gang members often family members as well. For children born into a gang or the mother of a child getting out of that environment could be hard but there were interventions to get in early to break that cycle.

“Understanding those family dynamics can guide some successful interventions to support people to make better choices than joining a gang.

“If you think about a child excluded from school, and is on a path to joining a gang, wrapping round interventions with that young person to support them into making better choices, open up more possibilities than they’re seeing in their present life, is something that can accompany the police-type approaches.

“This isn’t an either or situation – these are to accompany short-term law enforcement approaches that focus on criminal offending itself.”

Source: RNZ News

The post New Zealand Can’t Arrest Its Way Out of the Gang Problem, Science Chief Warns appeared first on Policy Print.

]]>
Ministry of Energy of Kyrgyzstan, NovaWind JSC sign MoU on wind energy projects https://policyprint.com/ministry-of-energy-of-kyrgyzstan-novawind-jsc-sign-mou-on-wind-energy-projects/ Thu, 11 May 2023 16:07:00 +0000 https://policyprint.com/?p=2954 The Ministry of Energy of Kyrgyzstan and NovaWind JSC have signed a memorandum of understanding and cooperation on…

The post Ministry of Energy of Kyrgyzstan, NovaWind JSC sign MoU on wind energy projects appeared first on Policy Print.

]]>
The Ministry of Energy of Kyrgyzstan and NovaWind JSC have signed a memorandum of understanding and cooperation on implementation of wind energy projects, the Ministry of Energy said.

The sides intend to consider and study possibility of cooperation in construction and operation of wind farms in Kyrgyzstan.

“Our country has a big potential in electricity generation. I am convinced that development of wind energy projects will not only diversify national energy portfolio and will enhance reliability of electricity supplies, but will also increase tax receipts for the budget and create new work places. I am confident our cooperation will allow to use natural resources for the benefit of our country and its people,” Minister Talaibek Ibraev said.

Director General of NovaWind JSC Grigory Nazarov said despite external restrictions, cooperation with friendly countries keeps growing.

“The signed agreement paves the way for new prospects for wind energy projects. We have a big experience in construction and operation of wind farms. 7 wind farms successfully operate in 3 regions in the south of Russia already. Emergence of wind farms in Kyrgyzstan will not only enhance reliability of electricity supplies in the region and improve its quality, but will also make contribution into increase of green energy share. Hopefully, our cooperation will be successful,” Grigory Nazarov said.

NovaWnd JSC is wind energy division of Rosatom Corporation. The company was founded in September 2017.

The post Ministry of Energy of Kyrgyzstan, NovaWind JSC sign MoU on wind energy projects appeared first on Policy Print.

]]>
Belarus To Terminate Cooperation With France in Culture, Education, Science https://policyprint.com/belarus-to-terminate-cooperation-with-france-in-culture-education-science/ Sat, 06 May 2023 12:12:00 +0000 https://policyprint.com/?p=2924 Belarus is going to terminate the agreement with France on cooperation in the field of culture, education, science…

The post Belarus To Terminate Cooperation With France in Culture, Education, Science appeared first on Policy Print.

]]>
Belarus is going to terminate the agreement with France on cooperation in the field of culture, education, science and technology, and the media.

Report informs citing the Belarusian media that the bill has been posted on the National Legal Internet Portal.

From what date this agreement ceases to operate is not specified.

“To recognize as invalid the Law of the Republic of Belarus dated December 2, 2010 No. 203-З ‘On ratification of the agreement between the government of the Republic of Belarus and the government of the French Republic on cooperation in the field of culture, education, science and technology, mass media’ from the moment the agreement is terminated,” the document notes.

The agreement was signed in Paris in January 2010. It provided for close cooperation in the field of education, when Belarusian students studied French with the use of modern methods and could receive education in France, while French students could, in turn, come to Belarus to study.

The post Belarus To Terminate Cooperation With France in Culture, Education, Science appeared first on Policy Print.

]]>
Indian Space Policy: ISRO to focus on R&D https://policyprint.com/indian-space-policy-isro-to-focus-on-rd/ Mon, 01 May 2023 18:00:00 +0000 https://policyprint.com/?p=2882 The Indian Space Research Organisation will transition out from manufacturing operational space. The new Indian Space Policy, which…

The post Indian Space Policy: ISRO to focus on R&D appeared first on Policy Print.

]]>

The Indian Space Research Organisation will transition out from manufacturing operational space.

The new Indian Space Policy, which was made public on Thursday, April 20, 2023, has said the Indian Space Research Organisation shall transition out from manufacturing operational space systems and focus its energies on research and development in advanced technologies.

The Indian Space Policy-2023, which was approved by the Cabinet Committee on Security on April 6, also permits non-government entities (NGEs) to offer national and international space-based communication services, through self-owned, procured or leased geostationary orbit (GSO) and non-geostationary satellite orbit (NGSO) satellite systems.

NGSO is a reference to low earth orbit or medium earth orbits that are home to satellites providing broadband internet services from space.

The policy also encourages NGEs to establish and operate ground facilities for space objects operations, such as telemetry, tracking and command (TT&C) Earth Stations and Satellite Control Centres (SCCs).

It also allows NGEs to undertake end-to-end activities in the space sector through the establishment and operation of space objects, ground-based assets and related services such as communication, remote sensing and navigation.

It encouraged NGEs to use Indian orbital resources and/or non-Indian orbital resources to establish space objects for communication services over India and outside.

The policy encouraged NGEs to manufacture and operate space transportation systems, including launch vehicles, shuttles, as well as design and develop reusable, recoverable and reconfigurable technologies and systems for space transportation.

It also encouraged NGEs to engage in the commercial recovery of an asteroid resource or a space resource.

“Any NGE engaged in such a process shall be entitled to possess, own, transport, use, and sell any such asteroid resource or space resource obtained in accordance with applicable law, including the international obligations of India,” it said.

Industry leaders welcome policy

Industry leaders welcomed the policy and described it as a “futuristic” one that will position India and launch the Indian Space Sector in the 21st century.

“This policy provides the much needed clarity on all space activities especially regarding space communication and other Applications,” Lt Gen A K Bhatt, Director General Indian Space Association, told PTI.

He said the policy will be a catalyst for development of a robust innovative and globally competitive space ecosystem in India.

The policy also states that Indian consumers of space technology or services — such as communication, remote sensing, data services and launch services — whether from the public or the private sector, shall be free to directly procure them from any source.

The government unveiled space sector reforms in 2020 by opening it up for private participation and the new space policy, published on the Indian Space Research Organisation (ISRO) website on Thursday, has been formulated as an overarching, composite and dynamic framework to implement the reform vision.

The policy states that ISRO, as the national space agency, will focus primarily on the research and development of new space technologies and applications and on expanding the human understanding of outer space.

To achieve this goal, the policy said ISRO shall carry out applied research and development of newer systems so as to maintain India’s edge in the sector in the areas of space infrastructure, space transportation, space applications, capacity building and human spaceflight.

It said the space agency shall transition out from the existing practice of being present in the manufacturing of operational space systems.

“Hereafter, mature systems shall be transferred to industries for commercial exploitation. ISRO shall focus on R&D in advanced technology, proving newer systems and realization of space objects for meeting national prerogatives,” the policy stated.

The policy stated that the Indian National Space Promotion and Authorisation Centre (IN-SPACe) shall function as an autonomous government organisation, mandated to promote, handhold, guide and authorise space activities in the country.

The policy made it clear that NewSpace India Limited (NSIL), as the public sector undertaking under the Department of Space, shall be responsible for commercialising space technologies and platforms created through public expenditure.

It also mandated NSIL to manufacture, lease or procure space components, technologies, platforms and other assets from the private or the public sector on sound commercial principles.

The policy also tasked NSIL to service the space-based needs of users, whether government entities or non-government entities, on sound commercial principles.

It said the Department of Space shall oversee the distribution of responsibilities outlined in this policy and ensure that the different stakeholders are suitably empowered to discharge their respective functions without overlapping into the others’ domains.

Source: The Hindu

The post Indian Space Policy: ISRO to focus on R&D appeared first on Policy Print.

]]>
India releases space policy detailing public and private cooperation guidelines https://policyprint.com/india-releases-space-policy-detailing-public-and-private-cooperation-guidelines/ Wed, 26 Apr 2023 18:00:00 +0000 https://policyprint.com/?p=2869 After much anticipation and a series of consultations and feedback from various stakeholders, India has finally released its…

The post India releases space policy detailing public and private cooperation guidelines appeared first on Policy Print.

]]>

After much anticipation and a series of consultations and feedback from various stakeholders, India has finally released its much-awaited policy establishing guidelines and rules for the country’s space ecosystem.

On Thursday, the Indian Space Research Organisation (ISRO) released the final version (PDF) of its “Indian Space Policy 2023,” receiving approval from the country’s supreme decision-making body earlier this month.

The policy emphasizes the Indian government’s aim to “augment space capabilities” and brings “regulatory certainty” to the space sector reforms that were announced in 2020. It also sketches out the role and responsibilities of the newly formed Indian National Space Promotion and Authorization Center (IN-SPACe), which works with private players, including space tech startups in the country, to develop solutions and services for the space sector.

“IN-SPACe shall function as an autonomous government organization, mandated to promote, hand-hold, guide and authorize space activities in the country. For this purpose, IN-SPACe shall periodically issue guidelines and procedures, that would, among other things, promote ease of doing business,” the policy states.

In addition to private participants, IN-SPACe will collaborate with academia, as well as national and global industry players to boost space developments in the country. The policy also defines that the center should “issue guidelines for meeting safety and security requirements for space objects.”

The policy allows startups to “undertake end-to-end activities in space sector through establishment and operations of space objects, ground-based assets and related services, such as communication, remote sensing, navigation, etc.,” subject to the guidelines issued by IN-SPACe.

Separately, ISRO has defined its role to focus “primarily on research and development of new space technologies and applications, and for expanding the human understanding of outer space.” The space agency will enable “free and open” data access from its remote sensing satellites of ground sample distance of 5 meters and higher to private and public participants in the space sector. Additionally, it will make archived satellite data and satellite-derived thematic data from remote sensing satellites available on a “free and open” basis for research and development purposes.

The space agency will also transition from manufacturing operational space systems and will collaborate and partner with national and global industry and academia to focus on R&D in space science, technology and applications, per the framework.

Alongside ISRO, the framework defines the responsibilities of NewSpace India Limited and the Department of Space.

NewSpace India Limited is tasked with commercializing space technologies and managing the production, leasing, and procurement of space assets from both private and public players. Meanwhile, the Department of Space will lead implementation of the space policy and ensure that responsibilities are properly distributed among the different stakeholders.

Indian Space Association (ISpA) director general Lt. Gen. AK Bhatt said the policy provided much-needed clarity on all space activities and would help create opportunities for private players.

“It also clearly defines the role of IN-SPACe, as a single-window agency for the authorization of Space activities by government entities as well as NGEs (non-government entities). With this policy clarity, we are confident that IN-SPACe and DoT will work speedily to ensure necessary clearances for private players in India,” he added.

The association counts space tech startups, including Mayfield-backed AgniKul and Singapore’s SIG-invested Skyroot Aerospace, as members, as well as private companies such as Bharti Airtel and OneWeb.

Private participants, including startups in the country’s space sector, have also asked the government to introduce a foreign direct investment policy to help attract global investors. Details on that front are yet to be announced, though.

The new policy comes months after the government released its draft for consultations last year as a significant update to the initial set of rules released in 2017.

In the last few months, the Indian government has been working toward bolstering space activities in the country to make it an attractive market for customers around the globe.

Among other developments, the government’s recent data shared in the parliament shows that as many as 388 foreign satellites were launched by ISRO’s launch vehicles in the last eight years, including 37 until March. Microsoft also recently partnered with the space agency to work with local space tech startups.

Source: Tech Crunch

The post India releases space policy detailing public and private cooperation guidelines appeared first on Policy Print.

]]>
Holding Ai Accountable: Ntia Seeks Public Input to Develop Policy https://policyprint.com/holding-ai-accountable-ntia-seeks-public-input-to-develop-policy/ Fri, 21 Apr 2023 18:00:00 +0000 https://policyprint.com/?p=2817 As artificial intelligence (AI) powered applications continue to increase in popularity, the National Telecommunications and Information Administration (NTIA)…

The post Holding Ai Accountable: Ntia Seeks Public Input to Develop Policy appeared first on Policy Print.

]]>

As artificial intelligence (AI) powered applications continue to increase in popularity, the National Telecommunications and Information Administration (NTIA) now seeks comments and public input with the aim of crafting a report on AI accountability.

Given the recent rise in popularity of AI-powered applications such as ChatGPT, government and business officials have begun to express concern over the potential dangers and risks associated with such technology, including the use of such applications to commit crimes, infringe intellectual property rights, spread misinformation, and engage in harmful bias. In light of this, regulators in multiple countries have begun to consider ways to encourage use of AI-powered applications in ways that are legal, effective, ethical, safe, and trustworthy.

On March 16, 2023, the US Copyright Office launched an initiative to examine the copyright law and policy issues raised by AI technology, including the scope of copyright in works generated using AI tools and the use of copyrighted materials for machine-learning purposes. The UK government published its AI regulatory framework on April 4, 2023. Now, NTIA has issued an AI Accountability Request for Comment (RFC) through which it is seeking more general feedback from the public on AI accountability measures and policies.

REQUEST FOR COMMENT

With the RFC, the Biden administration is taking a step toward potential regulation of AI technology, which may involve a certification process for AI-powered applications to satisfy prior to release. The RFC states that NTIA is seeking feedback on “what policies can support the development of AI audits, assessments, certifications and other mechanisms to create earned trust in AI systems.” In particular, the announcement indicates that NTIA is seeking input on the following topics:

  • What types of data access are necessary to conduct audits and assessments
  • How regulators and other actors can incentivize and support credible assurance of AI systems along with other forms of accountability
  • What different approaches might be needed in different industry sectors, e.g., employment or healthcare

The RFC lists 34 more targeted questions, including the following:

  • What is the purpose of AI accountability mechanisms such as certifications, audits, and assessments?
  • What AI accountability mechanisms are currently being used?
  • How often should audits or assessments be conducted, and what are the factors that should inform these decisions?
  • Should AI systems be released with quality assurance certifications, especially if they are high risk?
  • What are the most significant barriers to effective AI accountability in the private sector, including barriers to independent AI audits, whether cooperative or adversarial? What are the best strategies and interventions to overcome these barriers?
  • What are the roles of intellectual property rights, terms of service, contractual obligations, or other legal entitlements in fostering or impeding a robust AI accountability ecosystem? For example, do nondisclosure agreements or trade secret protections impede the assessment or audit of AI systems and processes? If so, what legal or policy developments are needed to ensure an effective accountability framework?

NEXT STEPS

The NTIA stated that its RFC questions are not exhaustive and that commentors are not required to respond to all of the questions presented.

In the RFC, the NTIA states that it will rely on these comments, along with other public input on this topic, to draft and issue a report on AI accountability policy development, focusing especially on the AI assurance ecosystem.

The RFC was published in the Federal Register on April 13, 2023, making written comments due by June 12, 2023.

Our intellectual property team is available to assist those making submissions to the NTIA in response to the RFC.

Source: Morgan Lewis

The post Holding Ai Accountable: Ntia Seeks Public Input to Develop Policy appeared first on Policy Print.

]]>
Congress’ Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues https://policyprint.com/congress-year-end-appropriations-package-brings-fda-legislative-changes-leaves-unresolved-policy-issues/ Mon, 16 Jan 2023 15:58:33 +0000 https://policyprint.com/?p=2668 In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did…

The post Congress’ Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues appeared first on Policy Print.

]]>

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

The post Congress’ Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues appeared first on Policy Print.

]]>