RA/QA News Roll: Mid November 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
FDA and the Administration Transition
President-elect Trump has nominated Robert F. Kennedy Jr., known for his vaccine skepticism, to lead the HHS. If confirmed, Kennedy would oversee the FDA, potentially influencing policies related to drug approvals, vaccine regulations, and public health initiatives.
Peter Marks, Director of CBER, addressed concerns at the 12th International mRNA Health Conference about the influence of anti-vaccine views among potential policymakers, including those who may join the incoming Trump administration. He remarked, "I like to be respectful of people’s opinions, but to me, this is not an opinion issue. It’s just black and white. We know what the safety profile of these vaccines is. We know how many lives they saved, and I think we’re just going to have to reiterate that and let people make their choices." Marks also spoke at the Milken Institute’s health conference, where he outlined his approach to engaging with vaccine skeptics like Robert F. Kennedy Jr. and reiterated his desire to maintain his position, stating, "I do want to keep my job." 💊
In an interview with MSNBC, Robert F. Kennedy Jr. discussed his intentions to restructure the FDA, specifically targeting departments within the agency that focus on nutrition within its food divisions. Kennedy emphasized the need for significant changes to improve the agency's approach to nutritional health and oversight.
The Trump administration may revisit policies on drug pricing and approval processes. Discussions include revising the Affordable Care Act, adjusting prescription drug price caps, and altering taxpayer-funded healthcare provisions. Such changes could significantly impact pharmaceutical companies and healthcare providers.
The New York Times has reported on the challenges facing Michelle Tarver, the new director of the CDRH. Tarver steps into her role amid significant technological advancements and regulatory pressures. A major challenge highlighted was the election of Donald Trump as president, who has the support of Elon Musk, the owner of Neuralink, a company developing brain-computer interface devices. Musk has openly criticized regulatory bodies, and Trump has proposed giving Musk a role in reforming federal bureaucracy. This scenario could significantly impact the FDA, particularly the CDRH, given its direct oversight of medical devices.
FDA Guidances, Regulations, and Related Documents
The FDA has issued a proposed administrative order to amend its over-the-counter monograph concerning cold, cough, and allergy products. (Read the actual order here.) This amendment aims to remove oral phenylephrine, both hydrochloride and bitartrate forms, from its list of acceptable nasal decongestants. The agency supported its decision with an extensive scientific review that concluded oral phenylephrine is ineffective. This move follows a unanimous vote in September 2023 by an FDA advisory committee in favor of the decision. Public comments on the proposed order are invited for 180 days, ending in early April. The Consumer Healthcare Products Association (CHPA) has opposed the proposal, arguing that phenylephrine (PE) is a key ingredient in many over-the-counter cough and cold medications with a decongestant claim. The CHPA stated, "PE should remain an available option for consumers, because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on." Additionally, the FDA has launched a webpage dedicated to detailing its decision on this matter. 💊
The FDA released a new set of briefing documents ahead of a meeting it held on November 7 of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting centered on a De Novo request for the ProSense Cryoablation System, developed by IceCure Medical Ltd. The discussion specifically addressed the sponsor's proposed indication for the device: "for use in the treatment of patients with early stage, low-risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy." 💉
The FDA has released a new list of product-specific guidances (PSGs) that it plans to revise in order to align with the ICH M13A guideline, which covers bioequivalence testing under fed and fasting conditions. Last week, the agency updated several hundred PSGs, and it plans to revise several dozen more in the near future. This ongoing effort is part of the FDA's commitment to ensure that its guidelines remain current with international standards, particularly in the realm of bioequivalence testing. 💊
FDA General
The FDA's Oncology Center of Excellence (OCE) has recently updated its list of programs and projects, removing "Project Beyond Breakthrough." This initiative aimed to identify and implement best practices to expedite the development of drugs and biological products designated as breakthrough therapies. The OCE continues to lead various other projects to advance oncology product development and regulation. 💊