A Look Ahead In Life Sciences: What We Are Tracking In The Third Quarter Of 2025 And Beyond

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments.

What We Are Tracking in Third Quarter 2025

Expand the sections below to learn more about trending topics in the third quarter of 2025 and beyond.

Reconciliation Bill: On March 15, 2025, President Trump signed into law a short-term funding bill providing appropriations to federal agencies through September 30, 2025. On May 22, 2025, the House of Representatives passed a draft reconciliation bill — the so-called "One Big, Beautiful Bill — that included measures to require pharmacy benefit manager (PBM) reforms as well as a fix to the orphan drug exemption issues under the Inflation Reduction Act (IRA). It also included significant work requirements for Medicaid recipients. On July 1, 2025, the Senate passed a slimmed-down version of the bill that does not include the PBM provisions. The bill was passed July 3 by the House of Representatives – including the orphan drug fix to the IRA – and was signed into law by the President on July 4.

Priority Setting of Trump Administration: We are closely monitoring developments related to the Trump administration's likely priorities. On April 15, President Trump signed Executive Order 14273 ("Lowering Drug Prices by Once Again Putting Americans First") to push for additional drug reforms, such as developing policies on PBM reform, streamlining and improving drug importation, reducing Medicare Part D premiums, and fixing the so-called "pill penalty" under the IRA. Later, on May 12, 2025, President Trump issued his "Most-Favored-Nation" (MFN) Executive Order, which advances the administration's policy of equalizing drug prices across country borders by indexing US prices to much lower prices in other developed countries. The Department of Health and Human Services (HHS) indicated that it has created initial MFN targets for some pharmaceutical manufacturers and is in discussions with manufacturers about how to lower their prices.

Dramatic Deregulation Plans: On May 13, 2025, HHS and the FDA announced a public request for information (RFI), due July 14, 2025, "seeking input from the American public on how to dramatically deregulate across all the areas the Department touches. Specifically, HHS welcomes submissions explaining how regulations, guidance, paperwork requirements, and other regulatory obligations can be repealed." The RFI includes a number of specific questions on which HHS and FDA seek public input. As of July 1, more than 100 comments had been posted to the RFI docket. Additional comments on deregulatory activities may be submitted to the docket here.

FDA Approval Setbacks: We are monitoring recently announced setbacks in marketing application approvals, including in late May for Stealth BioTherapeutics' Barth syndrome candidate, for which FDA issued a complete response letter. The rare disease community, in particular, is closely watching for program setbacks to gauge the new administration's support in expediting product approvals for rare diseases. The news on July 7 that FDA approved KalVista's hereditary angioedema treatment following a mid-June PDUFA delay due to FDA resource constraints raises some question as to whether delays will attach to other programs in FDA's current approval queue.

New Tariffs: The multiple new tariffs implemented and proposed by the Trump administration may have material impacts on companies exposed to products imported into the United States. Commercial-stage companies in particular may elect to reconsider aspects of their historical supply chains, or at least account for hefty new border taxes. We are actively monitoring changes to US tariff policy; please reach out to Nate Cunningham with any questions.

Preclinical and Clinical Research

How Companies Develop Their Products

• On June 26, 2025, the FDA's Center for Drug Evaluation and Research (CDER) published its annual "Drug Trials Snapshots" summary report, which provides information about the demographic data of participants in the key clinical trials supporting FDA approval of the 50 novel drugs approved by CDER in 2024. Of note, several of these trials involved a very low percentage of US participants, and four reportedly involved no US participants. This may fuel further discussion about the extent to which the FDA permits reliance on foreign data in support of approvals.
• On June 18, 2025, the FDA published a press announcement stating that the agency has halted new clinical trials that "involve sending Americans' living cells to foreign labs in hostile countries for genetic engineering and subsequent infusion back into U.S. patients." Without citing specific companies, the announcement states that some of these trials failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans' sensitive genetic data to misuse by foreign governments, including adversaries. The FDA and the National Institutes of Health are reviewing all relevant clinical trials that relied on a specific exemption under an April 2025 Department of Justice (DOJ) data security rule and noted that additional enforcement and policy measures could be forthcoming.
• On June 17, 2025, the FDA announced the Commissioner's National Priority Voucher (CNPV) program, in which selected sponsors receive nontransferable vouchers that can be redeemed for expedited review. The FDA describes the CNPV as a "novel" priority program that "shortens its review time from approximately 10-12 months to 1-2 months following a sponsor's final drug application submission." The CNPV does not apply to combination products or medical devices. The program can be applied to drug candidates in any area of medicine and will focus on companies that are aligned with the following: addressing a health crisis in the US, delivering more innovative cures for the American people, addressing unmet public health needs, and increasing domestic drug manufacturing as a national security issue. The CNPV process includes an all-hands-on-deck review approach by a multidisciplinary team of physicians and scientists who will "pre-review the submitted information and convene for a 1-day 'tumor board style' meeting." The FDA plans to provide a limited number of vouchers to companies aligned with US national priorities. A voucher issued by the FDA could either be directed at a specific product or awarded to a company as an "undesignated voucher" that the company could use for a new drug at its discretion and consistent with the CNPV program's objectives. These vouchers are expected to be granted in 2025 during a one-year pilot phase of the program, after which the FDA may increase the number of CNPVs that it awards. The FDA concurrently published a frequently asked questions document, "FAQs: Commissioner's National Priority Voucher Program." We are monitoring for further communications from the FDA related to the CNPV program, including information about progress, application and qualification processes, and outcomes.
• Vouchers awarded under the FDA's rare pediatric disease priority review voucher (PRV) program remain transferable. However, as previously reported, the PRV program's authorization expired in 2024. After September 30, 2026, the FDA may not award any rare pediatric disease PRVs. Companies have continued to announce the receipt of rare pediatric disease designations — including therapies for Duchenne muscular dystrophy, retinitis pigmentosa, and familial dysautonomia — suggesting that the FDA continues to review and grant these designations. Although these recently granted designations are ineligible for PRV vouchers under current law, receipt of a designation will become important if and when the program is reauthorized. The Give Kids a Chance Act of 2025 (H.R. 1262 and S.932) was introduced in both the House and Senate and includes reauthorization of the rare pediatric disease PRV program, but this legislation has not advanced in the House or Senate.
• On June 16, 2025, Qi Liu, FDA's Co-Chair of the CDER AI Council, spoke at Goodwin's inaugural AI & Drug Discovery Symposium, highlighting a strong upward trend in AI-driven activities and data inclusion in product development and approvals. Her remarks can be viewed here.
• On June 16, 2025, the FDA published a final guidance, "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions." The guidance finalizes and describes the facility information to be submitted in a pre-submission facility correspondence (PFC) and outlines how the FDA will use the information to set a review goal for a priority abbreviated new drug application (ANDA). The PFC is the correspondence that generic drug applicants use to provide information to the FDA about the facilities involved in their product's manufacturing and testing. The submission of the PFC is required no later than 60 days before submitting an application. The PFC is designed to provide the FDA with the information it needs to determine whether the agency needs to perform preapproval inspections of the facilities. Notably, the Federal Register notice states that the final guidance was found by the FDA to be "deregulatory in nature," signaling a continuation of the FDA's deregulatory pattern under the Trump administration.
• On June 13, 2025, the FDA Rare Disease Innovation Hub opened a public docket to solicit input on topics for future Rare disease Innovation, Science, and Exploration (RISE) workshops by December 31, 2025. The FDA seeks to identify topics that are cross-cutting or common across multiple diseases or a class of diseases. As of July 1, 2025, only 13 comments had been received; additional comments can be submitted here. On September 3, 2025, the Duke-Margolis Institute for Health Policy and FDA Rare Disease Innovation Hub will hold the next RISE workshop titled, "On the RISE: Controls in Rare Disease Clinical Trials for Small and Diminishing Populations," in Washington, DC and streamed remotely for those interested in attending. Registration is available here and the agenda, once available, will be posted on the same link.
• On June 9, 2025, HHS Secretary Robert F. Kennedy Jr. announced the removal of sitting members of the Advisory Committee for Immunization Practices (ACIP), an advisory committee that makes recommendations on the safety, efficacy, and clinical need of vaccines to the Centers for Disease Control and Prevention (CDC). As noted in the HHS announcement, under "President Trump's Restoring Gold Standard Science executive order, the new ACIP members will ensure that government scientific activities are informed by the most credible, reliable, and impartial scientific evidence available."
• On April 10, 2025, the FDA announced a strategic document, "Roadmap to Reducing Animal Testing in Preclinical Safety Studies." The road map aims to phase out animal testing requirements for certain drug products, emphasizing the adoption of new approach methodologies (NAMs), beginning with monoclonal antibodies. It also aims to improve safety assessment, lower costs, and accelerate timelines by validating and implementing these alternative methods in place of traditional animal studies. The FDA is taking a phased approach, first focusing on monoclonal antibodies before moving on to other kind of products. The road map proposes several alternative testing methods, also referred to as NAMs, including the following: in vitro human-derived systems (such as "organs-on-chips"), computer modeling and simulation, ex vivo human tissues, and high-throughput cell-based screening.
• On April 10, 2025, the UK government signed into law a new clinical trials framework — the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 — that signals a significant development in the UK's clinical trials regulatory framework. The amendments provide a more flexible regime to make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK, and make clinical trials more patient-centered. Following an implementation period, the updated regulation will become fully effective on April 28, 2026.
• We are monitoring the effects of the Innovative Licensing and Access Pathway (ILAP), which relaunched in January 2025 in the UK. The ILAP aims to accelerate the time to patient care for transformative new medicines and drug-device combinations by providing a single integrated platform for collaboration among developers, the Medicines and Healthcare products Regulatory Agency (MHRA), the UK Health Technology Assessment (HTA) bodies, and the National Health Service (NHS). Companies that are granted access to the ILAP will benefit from tailored guidance and support from the regulatory bodies involved in ILAP from the early stages of clinical development, with the aim of reducing the end-to-end timeline for research and development, regulatory approval, and access to the medicine or technology for patients. The MHRA published guidance in January 2025 on the updated ILAP.
• The published guidance from the Committee for Advanced Therapies of the European Medicines Agency (EMA) on quality, nonclinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials became effective on July 1, 2025. It aims to streamline development while ensuring safety and scientific rigor for gene therapies, somatic cell therapies, and tissue-engineered products.

FDA, EMA, and MHRA Approval

Deciding Whether a Company Can Market or Sell a Specific Product

Pharmaceuticals and Biologics

• On June 24, 2025, the FDA's drug and biologic centers jointly issued a draft guidance, "Q1 Stability Testing of Drug Substances and Drug Products," that outlines stability data expectations for drug substances and drug products to support drug product marketing, marketing authorization applications, and (if applicable) drug master files. The draft guidance provides stability-related guidance for several product categories — such as advanced therapy medicinal products, vaccines, and other complex biological products, including combination products — that are not covered under existing stability guidance documents. Additionally, the draft guidance furthers the FDA's goal of providing an internationally harmonized approach to conducting and presenting data on stability testing for drug substances and drug products.
• On June 2, 2025, the FDA announced the internal deployment of Elsa, a generative AI tool powered by a large language model "designed to assist with reading, writing, and summarizing." According to the FDA, "As the tool matures, the agency has plans to integrate more AI in different processes, such as data processing." Current deployments announced by the FDA range from the review of clinical protocols to scientific and safety reviews to identification of inspection targets. On June 17, 2025, an FDA official also announced that AI was being used to summarize regulatory docket comments.
• On May 5, 2025, the FDA's biologic center announced that it is withdrawing two final guidance documents originally published in the Federal Register on January 7, 2025, and reissuing them as draft guidance documents. The FDA explained that the draft guidance documents — "Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and "Recommendations to Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" — were revised in response to comments made on the now-withdrawn final guidance documents in January 2025. When the new draft guidance documents become finalized, both documents will recommend that establishments making donor eligibility determinations implement recommendations in the guidance documents within a specified time frame.
• We are continuing to monitor the implementation of the European Commission's legislative proposals — Regulation 2023/0131 and Directive 2023/0132 — to replace the current EU regulatory framework for medicines (including those for rare diseases and for children). The proposals, announced on April 26, 2023, aim to reduce costs, expedite the introduction of new medicines, and prevent medicine shortages. Read our summary of these proposals here. The European Commission provided the legislative proposals to the European Parliament and the European Council for their review and approval, and in April 2024, the European Parliament proposed amendments to the legislative proposals. Read our summary of these proposed amendments here. Once the European Commission's legislative proposals are approved (with or without amendment), they will be adopted into EU law.
• We are continuing to monitor the implementation of the Windsor Framework in the UK. The medicines aspects of the Windsor Framework have applied since January 1, 2025. This new framework fundamentally changes the previous system under the Northern Ireland Protocol, including the regulation of medicines in the UK. In particular, the MHRA is now responsible for approving all medicines destined for the UK market (i.e., Great Britain and Northern Ireland), and the EMA no longer has a role in approving medicines destined for Northern Ireland under the EU centralized procedure. The MHRA may grant a single UK-wide marketing authorization for all novel medicinal products sold in the UK, enabling medicines to be sold in a single pack and under a single authorization throughout the UK. Medicines marketed in the UK are also required to carry a "UK only" label to differentiate them from those sold within the EU. The MHRA has published a collection of guidance notes on the main changes introduced by the Windsor Framework relating to medicines. On March 11, 2025, the MHRA updated five guidance documents on the following topics: advertising and promotion, wholesalers and manufacturers, pharmacovigilance, UK-wide licensing for human medicines, and labeling and packaging of medicinal products. On June 3, 2025, the MHRA updated another guidance note, "UK parallel import licences following agreement of the Windsor Framework".
• We are continuing to monitor the effects in the UK of the International Recognition Procedure (IRP) (effective January 1, 2024), which replaced the European Commission Decision Reliance Procedure. According to the MHRA's May performance data, the MHRA has been successful on key performance indicator metrics for determining medicines license applications through the IRP within its targets of 60 days and 110 days (depending on the IRP route). The IRP allows the MHRA to consider the expertise and decision-making of medicine regulators in Australia, Canada, the EU, Japan, Singapore, Switzerland, and the US when approving a new medicine. The decentralized and mutual recognition reliance procedure, which allowed the MHRA to have regard for approvals in the EU under these procedures, has been incorporated under the umbrella of the IRP.

Medical Devices and Medtech

• On June 5, 2025, the FDA issued a draft guidance, "Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers," providing information about the transfer or sale of a 510(k) clearance from one 510(k) holder to another. The draft guidance discusses instances when a submission of a new 510(k) would not be required related to a transfer or sale of a 510(k) clearance, and instances in which entities must use the existing 510(k) to list a device. The FDA is accepting comments through August 4, 2025.
• On May 29, 2025, FDA's device and biologic centers jointly issued a final guidance, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program," that supersedes two prior guidance documents issued on June 2, 2023, and February 19, 1998. The final guidance provides an overview of mechanisms available to submitters to request interactions related to medical device submissions, provides clarification and additional information on the scope of Q-Submission types, and offers better delineation on how to obtain feedback for different types of questions as well as improved examples. The interactions can include written feedback and/or a meeting related to a potential or submitted medical device.
• On March 31, 2025, the FDA's device and biologic centers jointly issued a final guidance, "Evaluation of Sex-Specific Data in Medical Device Clinical Studies," that provides guidance on the study and evaluation of sex-specific data in medical device clinical studies. The introductory page of the final guidance notes that it was originally issued in August 22, 2014. The final guidance is aimed at improving the quality and consistency of available data regarding the performance of medical devices in both sexes, and outlines the FDA's expectations about sex-specific patient enrollment, data analysis, and reporting of study information.
• We are continuing to monitor the effects of Regulation (EU) 2017/745 (the European Medical Device Regulation, or MDR), which has been applicable in the EU since May 26, 2021. In June 2025, the European Commission Medical Device Coordination Group updated the guidance note on the qualification and classification of software as a medical device under the MDR.
• Medical devices with a valid certificate under the previous EU Medical Devices Directive must be fully transitioned to the MDR (subject to fulfillment of certain conditions) by December 31, 2027, for higher-risk medical devices (except for custom-made Class III implantable devices, for which the relevant date is May 26, 2026) and by December 31, 2028, for lower-risk medical devices. The MDR also requires the use of the EU's medical device database, EUDAMED, which effectively outlines the life cycle of medical devices by collating and processing information about those medical devices and related companies, such as the manufacturers of those devices. EUDAMED will contain six modules related to: (1) actor registration (e.g., manufacturer, authorized representative, distributor, or importer); (2) unique device identification/device registration; (3) notified bodies and certificates; (4) clinical investigations and performance studies; (5) vigilance and post-market surveillance; and (6) market surveillance. Modules (1), (2), and (3) are already available, and modules (4), (5), and (6) are under development. The use of EUDAMED is not yet mandatory. There will be a gradual rollout of EUDAMED, requiring manufacturers to provide information about their products to available EUDAMED modules without waiting for the remaining modules to be developed. This mandatory registration is expected to take effect in early 2026.
• We are monitoring the introduction of changes to the medical devices legislation in Great Britain, following a public consultation on the future regulation of medical devices (see here). The first piece of legislation, which took effect on June 16, 2025, implements changes to the post-market surveillance requirements for medical devices in Great Britain, with the aim of facilitating greater traceability of incidents. Further legislation will be put in place later in 2025 and in 2026 to introduce new premarket requirements, including an international reliance procedure for approval of certain medical devices for the Great Britain market.
• The MHRA has published new guidance on the characterization, regulatory qualification, and classification of digital mental health technology. It clarifies how software and AI-based tools are assessed as medical devices, supporting developers in navigating UK regulatory pathways.

In Vitro Diagnostics and Laboratory Testing

• On March 31, 2025, the US District Court for the Eastern District of Texas issued an opinion invalidating the FDA's May 6, 2024, final rule (LDT Rule), which aimed to phase out the agency's policy of enforcement discretion for laboratory-developed tests (LDTs). On May 30, 2025, the deadline for the FDA to appeal the decision from the Eastern District of Texas lapsed, vacating the LDT Rule, which would have required compliance with the FDA's in vitro diagnostic (IVD) regulations, including regulations pertaining to premarket clearance or approval.
• The transition periods for in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR), passed by the European Parliament, have been extended (subject to fulfillment of certain conditions) until December 31, 2027, for higher-risk IVDs and until December 31, 2029, for lower-risk IVDs. The IVDR requires manufacturers to submit by May 26, 2025, all applications for higher-risk IVDs that they want to transition to the IVDR; applications for the transition of lower-risk IVDs must be submitted by May 26, 2027. The IVDR also requires manufacturers to have in place a quality management system in accordance with the IVDR by May 26, 2025, and a signed contract with an EU notified body for review and conformity assessment by September 26, 2025, for higher-risk IVDs, and by September 26, 2027, for lower-risk IVDs.
• The Medical Device Coordination Group (MDCG) held a governance workshop on April 3, 2025, and a second workshop on June 4, 2025, to discuss "a vision of MDR/IVDR that delivers maximum utility with minimum friction, with a view to identifying the challenges posed by different tasks/functions within the current MDR/IVDR governance structure and to start exploring possible more efficient ways of organising responsibilities in the system to address such challenges."

Commercial Requirements

How Companies Manufacture, Promote, and Monitor Their Approved Products

• On June 27, 2025, FDA announced the elimination of the Risk Evaluation and Mitigation Strategies (REMS) for the currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies Abecma (idecabtagene vicleucel), Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel), Yescarta (axicabtagene ciloleucel). This action reflected the Agency's determination that the REMS are no longer necessary to assure that the benefits of these therapies outweigh their risks. The elimination of the REMS removes requirements such as certification for hospitals and their associated clinics and the need to have on-site, immediate access to tocilizumab. FDA Chief Medical and Scientific Officer and CBER Director Vinay Prasad stated that this decision is expected to expedite the delivery of these therapies and reduce burdens on providers, and FDA Oncology Center of Excellence Director Richard Pazdur cited the greater experience that physicians and institutions have with identifying and managing toxicities associated with these CAR T products, noted that this approach may "facilitate patient access ... while continuing to prioritize safety."
• On June 26, 2025, the FDA announced a final guidance on conducting remote regulatory assessments, recognizing the utility of remote regulatory assessments (RRAs) in contexts outside the COVID-19 pandemic. The FDA notes that, "FDA intends to use a risk-based approach to determine whether to initiate or request an RRA. Factors that may be considered include, but are not limited to, establishment location, inspection history, complexity of product and process, and travel restrictions. Programs and centers within FDA may assess risk in the context of a potential RRA differently based on those and other factors."
• We are monitoring for updates regarding any actions by HHS Secretary Kennedy to place additional requirements or restrictions on direct-to-consumer (DTC) pharmaceutical marketing in a push to potentially shift the pharmaceutical industry away from engaging in DTC marketing.
• On May 6, 2025, the FDA announced its intent to "expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients." One-fifth of the FDA's annual inspection activity involves foreign inspections at foreign sites that historically have received advance notice of inspection plans, providing an opportunity for the sites to prepare and ensure inspection readiness. The FDA's announcement notes, "FDA is authorized to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection."
• On May 5, 2025, President Trump issued an executive order to promote domestic manufacturing, including a direction to FDA to, within 6 months: (1) review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing and take steps to eliminate any duplicative or unnecessary requirements in such regulations and guidance; (2) maximize the timeliness and predictability of agency review; and (3) streamline and accelerate the development of domestic pharmaceutical manufacturing.
• The FDA issued an "exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners" beyond the prior-issued stabilization period for the Drug Supply Chain and Security Act (DSCSA). The FDA defined "eligible trading partners" as "trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data." The FDA indicated its goal was to avoid supply chain disruptions to medicine distributions. Importantly, trading partners utilizing the exemption do not need to notify the FDA. The exemption period varies by eligible trading partner as follows:
  • Wholesale distributors: August 27, 2025
  • Dispensers with 26 or more full-time employees: November 27, 2025
  The FDA has also issued exemptions for small dispensers (pharmacies) and their trading partners, providing additional time for implementation until November 27, 2026. Specifically, the FDA defines "small dispensers" as those where, as of November 27, 2024, the company owning the dispenser had 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. Importantly, the FDA notes that pharmacies must make their own determination whether they qualify as a small dispenser under this definition, and no submission is necessary to inform the FDA of utilization of this exemption. Trading partners that do not qualify under one of these exemptions and require additional time can submit to the FDA a request for a waiver or exemption, but while such exemption or waiver is pending, they must continue their efforts to meet the FDA's requirements. As the exemption period for wholesale distributors is ending this quarter, companies whose systems are not yet compliant will need to seek a waiver or exemption from the FDA while actively continuing to progress their implementation efforts.
• In February 2024, the FDA published its final rule harmonizing its device good manufacturing practice requirements to align more closely with the international consensus standard for devices by converging with the quality-management system requirements used by other regulatory authorities from other jurisdictions. The final rule will take effect February 2, 2026.

Coverage and Reimbursement

Whether Government or Commercial Payers Are Willing to Pay for a Product, How Much They Are Willing to Spend, and Under What Circumstances

On April 4, 2025, the Centers for Medicare & Medicaid Services (CMS) published its final rule for Medicare Advantage and Medicare Part D in 2026. The rule did not expand Medicare and Medicaid coverage for GLP-1s, nor did the rule address the use of AI in prior authorization decisions, which had been anticipated in the rule.

On May 12, 2025, CMS released its draft guidance for the Medicare Drug Price Negotiation Program for program year 2028, soliciting comments from interested stakeholders by June 26.

On May 13, 2025, CMS issued a solicitation for public comments on how CMS can best advance a seamless, secure, and patient-centered digital health infrastructure. CMS has invited input from stakeholders on how the agency can drive development and adoption of digital health technologies; strengthen interoperability and secure access to health data; identify barriers preventing exchange of health information; and reducing the administrative burden on stakeholders. Comments were due to CMS on June 16.

Also on May 13, 2025, CMS announced a new strategic direction for the Center for Medicare and Medicaid Innovation (CMMI) that would focus on promoting evidence-based disease prevention; empowering people to achieve their health goals through tools and information sharing; and driving provider choice by making it easier for providers to participate in CMMI models. (Earlier this year, in March 2025, CMS announced that it would end several of its CMMI models related to the delivery of primary care and end-stage renal disease treatment, among other areas, and that it would scale back a model that provides integrated care to kids. The agency also indicated that it will not implement two previously announced but not implemented models—the Medicare $2 drug list and a program to accelerate clinical evidence.)

Information is available here.

Pharmaceuticals and Biologics

• Via our IRA web page, we are continuing to follow how the IRA of 2022 will affect Medicare and commercial reimbursement for pharmaceutical and biologic products. Companies manufacturing all 15 drugs covered under Medicare Part D have signed agreements to participate in the Medicare Drug Price Negotiation Program for 2027. We are also actively tracking ongoing constitutional challenges to the IRA's drug price negotiation program.
• In addition, the final version of the One Big Beautiful Reconciliation bill (H.R. 1) which was passed by Congress and signed into law on July 4, included a fix to the orphan drug exemption issue under the IRA (namely, the provision of the IRA that exempts orphan drugs from drug price negotiation, but only if the drug has one orphan designation and treats one rare indication). The reconciliation bill eliminates these restrictions and make the exemption available to all orphan drugs, regardless of the number of designations or indications.
• We had been monitoring H.R. 946 (the ORPHAN Cures Act), which would have similarly expanded the orphan drug exemption to the IRA's drug price negotiation program.
• Congress is considering numerous proposed PBM reforms in both the House and the Senate. Legislative proposals include, but are not limited to, eliminating rebates; divorcing service fees from the price of a drug, discount, or rebate; prohibiting spread pricing; limiting administrative fees; requiring PBMs to report formulary placement rationale; promoting transparency; and requiring health insurers that own PBMs to divest those PBMs. PBM reform and transparency measures have become a key policy topic in Washington and continue to be front and center for policymakers. This includes provisions that were in the May 22, 2025, reconciliation bill passed by the House but were removed from the version passed in the Senate.
• Certain states are pursuing cost containment efforts through prescription drug affordability boards (PDABs) and similar entities. While many PDABs have been granted authority to promote drug price transparency and reporting, some states have granted PDABs more expansive authority, including to set upper payment limits (UPLs) on select high-price drugs. The adoption and implementation of UPLs may put downward pressure on drug prices and affect a drug manufacturer's future revenues.
• We are monitoring the implementation of Regulation (EU) 2021/2282 (the HTA Regulation) on health technology assessment (HTA), which has been applicable since January 12, 2025. An HTA is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, and robust manner. Previously, after obtaining the appropriate authorization a for health technology, a manufacturer was required to apply to different HTA agencies in various EU member states before making that new health technology broadly accessible. The HTA Regulation aims to harmonize various procedures and standards by ensuring that health technology developers can submit only once and at the EU level any information, data, analyses, and other evidence required for the contemplated joint clinical assessment. The HTA Regulation will have a phased rollout but will eventually become applicable for all medicines with new active substances that receive marketing authorization in the EU under the centralized procedure. The rollout is as follows: (1) January 12, 2025, for oncology and advanced therapy medicinal products; (2) January 12, 2028, for orphan medicinal products; and (3) January 12, 2030, for all other applicable medicinal products.

Medical Devices and Medtech

• We continue to monitor whether and how CMS intends to implement the final Transitional Coverage for Emerging Technologies (TCET) rule. Released on August 6, 2024, the rule describes a process for leveraging the current national coverage determination and coverage with evidence development protocols to speed up Medicare coverage of medical technology that has been granted "breakthrough" status by the FDA. Notably, CMS anticipates that it will accept around five TCET candidates each year, with quarterly review cycles depending on when applications are received.
• We are also monitoring S. 1717, the Ensuring Patient Access to Critical Breakthrough Products Act of 2025, which would provide for more prompt Medicare coverage of medical devices that have received breakthrough status from the FDA.
• In addition, we are monitoring S. 1399, the Health Tech Investment Act, which would establish a stable reimbursement pathway for medical devices authorized by the FDA that rely on AI and machine learning (ML), also known as algorithm-based healthcare services.
• We are monitoring S. 1702/H.R. 3288, the Access to Prescription Digital Therapeutics Act of 2025, which would provide for Medicare and Medicaid coverage of evidence-based software applications used to prevent, manage, or treat medical conditions.

Compliance, Fraud and Abuse, and Transparency

Companies' Interactions With Their Customers and Other Stakeholders

Recent Fraud and Abuse and Compliance-Related Actions:

• On May 9, 2025, drug company Assertio Therapeutics agreed to pay $3.6 million to resolve claims that it caused the submission of false claims for transmucosal immediate-release fentanyl drug Lazanda, a nasal spray. The government alleged that Assertio focused its marketing efforts on pain specialists who were prescribing high volumes, including placing these prescribers on a speaker's bureau and advisory boards.
• On June 20, 2025, the Office of Inspector General (OIG) issued an unfavorable opinion regarding a medical device company's proposal to pay the costs its customers otherwise would incur for a third-party company to screen and monitor the company for exclusion from federal healthcare programs and to ensure compliance with certain other legal requirements.
• On June 25, 2025, OIG issued a favorable opinion regarding a proposed arrangement pursuant to which a medical device manufacturer would offer up to $2,500 to reimburse purchasers for actual incurred in association with a needle stick injury caused by the failure of a device that it manufactures.

Privacy

Companies' Interactions With Patient Data

• The enforcement delay for most provisions of US DOJ regulations implementing Executive Order 14117 on Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ended on July 7, 2025. The regulations target foreign access to "bulk sensitive personal data" of US persons by countries of concern—the People's Republic of China (including Hong Kong and Macao), Russia, Iran, North Korea, Cuba, and Venezuela—and certain entities and individuals connected to these countries. Specifically, the regulations prohibit transactions involving data brokerage or human genomic and other "omic" data with "covered persons" associated with countries of concern, and they restrict certain transactions involving vendors, employees, and investors affiliated with countries of concern that would allow access to sensitive personal data — including health data — meeting "bulk" thresholds. The bulk thresholds vary by data type: For example, the threshold for human genomic data is 100 US persons, while the threshold for personal health data is 10,000 US persons. Transactions that are restricted (but not prohibited) can proceed subject to the implementation of prescribed cybersecurity requirements. While the rules include exemptions for certain activities relating to clinical research, including transactions involving de-identified data that are necessary for regulatory approvals, the narrow scope of such exemptions could implicate commercial relationships with counterparties that have ties to the listed countries, including for clinical trial data (for details, see our client alert). Certain due diligence and audit provisions will become enforceable on October 6, 2025.
• States are continuing to propose laws to protect consumer health information. For example, on June 25, 2025, Connecticut's governor signed into law amendments to the Connecticut Data Privacy Act (CTDPA) that strengthen the CTDPA's protections for health data and other sensitive data categories. The amendments, which come into force on July 1, 2026, extend the definition of sensitive data to include, among others, data revealing disability or treatment, status as nonbinary or transgender, and information derived from genetic or biometric data. They also require express consent to "sell" such sensitive data. The amendments also remove applicability thresholds for companies that handle sensitive data, meaning that such companies can be subject to Connecticut law if they do business in Connecticut, regardless of the number of state residents whose data they collect. Together with last year's amendments extending the CTDPA to "consumer health data," the CTDPA will now closely track the requirements of Washington's My Health My Data Act, which is generally considered the strongest state consumer health privacy law in the country (see Goodwin's client alert for more information).
• On July 1, 2025, the US Senate voted to remove a proposed moratorium on state AI policymaking from the Trump administration's "One Big Beautiful Bill" (OBBB) budget reconciliation package. With the rapid development and adoption of AI technologies, AI regulation has proliferated across states, with specific focus on the use of AI to make "consequential decisions." The proposed moratorium would have blocked states from enforcing such AI laws for a period of five or 10 years, leaving AI regulation to the federal government. With the removal of the proposed moratorium from the OBBB, we expect the frenzied pace of state AI policymaking to continue.
• The European Health Data Space (EHDS) Regulation was published in the EU Official Journal on March 5, 2025, bringing the EHDS into effect on March 25, 2025. The next phase (between 2025 and 2027) will focus on drafting secondary legislation, including implementing and delegating acts that will define the technical specifications required for EHDS operations. Following this (between 2027 and 2029), member states will prepare to meet their obligations under the EHDS (such as creating data hubs and integrating with EU-wide data frameworks). The main objectives of the EHDS are to improve individual access to and control over patient health data in the EU and to facilitate cross-border research and innovation in health. See Goodwin's blog posts here and here for further details.
• On June 27, 2025, a U.S. Bankruptcy Court approved a bid from the nonprofit TTAM Research Institute to purchase the data assets of consumer genetic testing company, 23andMe. 23andMe's Chapter 11 bankruptcy proceedings led to concerns from regulators, including the U.S. Federal Trade Commission (FTC) and several state attorneys-general, about privacy risks relating to the disposition of the company's database of genetic testing data. A report by the bankruptcy proceeding's privacy ombudsman found that disclosures in the company's privacy policy could be read to restrict the sale of genetic data. In approving the bid, the Bankruptcy Court will require TTAM Research Institute, a nonprofit led by 23andMe's co-founder Anne Wojcicki, to adhere to 23andMe's prior privacy policies and public commitments regarding genetic and other personal information. The public attention to 23andMe's bankruptcy proceeding reflects a continued focus by regulators and policymakers on privacy concerns associated with genetic data. In 2025, three states adopted laws protecting genetic privacy, joining the ten other states that enacted similar laws in the past several years, and recent state consumer privacy laws have counted genetic data among the categories of "sensitive" personal data requiring heightened protections.

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