Trump Administration Updates for the Life Sciences Industry Q4 Edition
CDC Advisory Panel Ends Universal COVID-19 Vaccine Recommendations
On Friday, September 19, the Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to end universal COVID-19 shot recommendations, advising vaccination after consultation with a medical professional and with expanded risk disclosures. Subsequently, on October 7, the CDC updated its COVID-19 vaccine recommendations without comment. For pregnant individuals, the CDC updated its guidance from "No Guidance" to "vaccination is based on shared clinical decision-making." Similarly, for many other individuals CDC changed its recommendation to "vaccination is based on shared clinical decision-making." On Friday, December 5, ACIP held another meeting in which it voted to remove its universal recommendation for infants to receive the Hepatitis B vaccine, instead recommending "individual-based decision making, in consultation with a health care provider."
FDA Issues Guidance on Cell and Gene Therapy Products and Regenerative Medicine Therapies
On Wednesday, September 24, the Food and Drug Administration (FDA) issued three draft guidance documents relating to cell and gene therapy products and regenerative medicine therapies. The three draft guidance documents, titled "Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products," "Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations," and "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions," include recommendations reported to improve data collection processes and to facilitate FDA assessment.
Office of Science and Technology Policy Releases RFI on AI Technology
On Friday, September 26, the Office of Science and Technology Policy released a request for information (RFI) relating to any existing federal statutes, regulations, guidance documents, or other materials that "unnecessarily hinder the development, deployment, and adoption of artificial intelligence (AI)." The RFI notes that application of AI regulation in certain industries, including health care, where regulations were designed around human clinicians, could be based on outdated assumptions developed prior to the development of AI.
FDA Expands Early Alert Communications Program
On Monday, September 29, FDA announced that it is expanding Early Alert communications and will be issuing Early Alerts for potentially high-risk removals or corrections for all medical devices. The expansion follows the FDA pilot program which began in November 2024 and was intended to minimize the time between FDA's awareness of potentially high-risk medical device removal or correction and FDA's public communications of such topics. Early Alerts are posted by FDA in the Medical Device Recalls and Early Alerts database.
CMS Issues Final Guidance for Drug Price Negotiations
On Tuesday, September 30, CMS released final guidance for the Medicare Drug Price Negotiation Program for initial price applicability year 2028 and for manufacturer effectuation of the maximum fair price in 2026, 2027, and 2028. Starting in 2028, drugs or biological products payable under Medicare Part B are added to the negotiation program. Additionally, the guidance establishes requirements to identify renegotiation-eligible drugs and to select drugs for renegotiation and expands the Orphan Drug Exclusion.
FDA Announces New ANDA Prioritization Pilot
On Friday, October 3, FDA announced "a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs)." Under the pilot, "ANDA applicants who conduct any required bioequivalence testing in the United States and whose products are made in the U.S. using exclusively domestic sources for APIs are eligible for priority review." To apply for such priority review, applicants reference the pilot program as the basis for prioritization and must provide information that demonstrates that their ANDA qualifies.
FDA Releases Final Guidance on Acute Leukemia Treatment Data
On Tuesday, October 14, FDA released final guidance, titled "Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias." The guidance includes "technical recommendations for the data sets containing the data elements for response assessments and summary level response outcomes used to evaluate efficacy in clinical trials of drugs and biological products … in New Drug Applications … and Biologics License Applications … for treatment of acute leukemias." Most significantly, the guidance provides "the recommended domains, variables, and controlled terminologies to use for the data elements submitted for FDA's review."
White House Announces Agreement to Expand Access to Fertility Medications
On Thursday, October 16, President Trump announced an agreement with pharmaceutical manufacturer EMD Serono to expand access to an in vitro fertilization medication. The agreement also provided that EMD Serono will offer other medicines that come to market at most favored nation prices.
FDA Awards First National Priority Vouchers
On Thursday, October 16, FDA announced the first nine recipients of vouchers under the new Commissioner's National Priority Voucher pilot program. According to FDA, each "recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing." Recipients "will receive a decision within 1-2 months following filing of a complete application for a drug or biologic" and "will receive enhanced communications with review staff throughout the development process prior to their final submission and during the review period." Read more here.
FDA Issues Filing Checklists to Prevent Submission Delays
On Thursday, October 23, FDA announced the publication of filing checklists used by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable. The checklists were published in an effort to reduce the amount of significant filing errors that result in agency determinations of refusal to file applications, which cause significant delays for sponsors.
FDA Issues Draft Guidance Aimed at Accelerating Biosimilar Drug Development
On Wednesday, October 29, FDA announced new draft guidance intended to simplify biosimilarity studies and reduce unnecessary clinical testing. The guidance describes considerations regarding a comparative efficacy study to support a demonstration of biosimilarity in a biologics license application submitted under Section 351(k) of the Public Health Service Act.
Health Providers Prepare for 340B Rebate Pilot Program
On Thursday, October 30, U.S. Health Resources & Services Administration (HRSA) released the names of nine drugs approved for its "340B Rebate Model Pilot Program," set to begin January 1, 2026. Read more here. [link to larger drug pricing article]
CMS Announces Calendar Year 2026 Medicare Physician Fee Schedule
On Friday, October 31, CMS issued its final rule announcing final policy changes for Medicare payments effective January 1, 2026. The changes include restructuring to significantly reduce reimbursement for skin substitutes, as well as changes to the Medicare Prescription Drug Inflation Rebate Program that will remove 340B units from Part D rebate calculations.
FDA Announces Restrictions on Prescription Fluoride Supplements for Children Under Three
On Friday, October 31, HHS announced that FDA had advised against prescribing fluoride supplements to children under age 3, citing limited evidence of benefit and concerns about overexposure leading to dental fluorosis. The guidance marks a shift from prior practices that often recommended supplements in areas without fluoridated water. Pediatric and dental groups are reassessing their recommendations in light of FDA's position, emphasizing topical fluoride and overall oral hygiene instead. The agency further sent notices to four companies outlining potential enforcement against marketing of fluoride-containing products labeled for use in children.
HHS Removes FDA Warnings on Hormone Replacement Therapy Products for Menopause
On Monday, November 10, HHS announced in a press release that FDA would remove broad "black box" warnings from menopausal hormone replacement therapy products after a comprehensive scientific review, expert panel, and public comment period.
NIH Announces Updated Funding Strategy
On Friday, November 21, NIH announced an updated, "unified strategy that will help guide clearer and consistent funding decisions across all Institutes, Centers, and Offices." According to NIH, new funding policies will now "consider peer review information in its entirety" and not rely on funding paylines. NIH stated that prior to this, "around half" of the Institutes, Centers, and Offices set paylines "based on peer review scores or percentiles as part of their funding decision process."
FDA Tests Faster Follow-Up Process for Drug Reviews
On Wednesday, November 19, FDA launched a pilot program to provide drugmakers with faster clarifications after formal meetings, allowing companies to email a single follow-up question to an FDA review group and receive a response within three business days. Run by the Office of New Drugs since October, the pilot has already produced several clarifications following issuance of official meeting minutes. FDA Commissioner Marty Makary said the goal is to deliver prompt, clear feedback, and the agency plans to expand the approach to other parts of the FDA over time.
CDC Updates Website to State Claim That Vaccine Do Not Cause Autism Is Not Evidence-Based
On Wednesday, November 19, CDC updated its vaccine safety webpage to say that the statement "Vaccines do not cause autism" is not evidence-based. Although the page still bears the headline "Vaccines do not cause autism," an asterisk notes the language remains on the website due to a Senate agreement.
Trump Administration Lowers Prices for 15 Medicare Drugs
On Wednesday, November 25, CMS announced that pharmaceutical companies agreed to reduce Medicare prices for 15 widely used drugs after a second round of negotiations under a 2022 law, with the new prices set to take effect in 2027 and expected to generate billions in savings for taxpayers and seniors.
Read the full Innovative Insights: Legal Updates in Life Sciences | Fourth Quarter 2025.
