The shrinking number of advisory committee meetings

Politico

6 hours ago

Driving the Day
MAKARY'S ROUNDTABLES — FDA Commissioner Marty Makary seems to be shifting traditional advisory committee panels to review and provide recommendations on drug and medical device products in favor of communicating his regulatory priorities through podcasts or by roundtable discussion.
'FDA's new leadership team appears to see little value to the advisory committee forum as a venue to communicate important regulatory ideas or to provide public cover for potentially controversial regulatory actions,' TD Cowen's Rick Weissenstein wrote in a Thursday research note.
While the year is not yet over, the FDA has held or scheduled only nine advisory committee meetings in 2025. That's a sharp drop from his predecessor's 38 advisory committee meetings in 2024, 45 meetings in 2023 and 21 meetings in 2022, according to the FDA's calendar.
Dr. Reshma Ramachandran, co-director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, raised concern that the roundtables have been moderated by political appointees.
'Unlike advisory committees where there would be a robust vetting process for members, there seems to be none besides making sure they generally align with ideological views,' Ramachandran said. 'It's also surprising to see limited participation from FDA career scientists whereas at an advisory committee meeting, they would be offering the agency's scientific view on a specific issue or question.
Last month, Senate appropriators dinged Makary for holding roundtables on talc, infant formula and cell and gene therapies without accepting public comments.
'The Committee is concerned that the agency did not allow public participation or provide for public comments and panelists did not disclose potential conflicts of interest,' the lawmakers wrote in a nonbinding committee report.
At the time, HHS called the characterization a 'misleading political attack.' But following its recent expert panel on menopause and hormone replacement therapy for women on July 17, the FDA opened a docket for the public to submit feedback, which is slated to remain open until Sept. 24.
'This request is part of the FDA's effort to understand various perspectives on these safety considerations and the use of hormone therapy for menopause-related conditions in clinical practice,' the agency said on the meeting's webpage.
HHS did not respond to a request for comment.
IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. August recess is here — and we're around for source coffees.
Send tips to David Lim ([e-mail], @davidalim or davidalim.49 on Signal) and Lauren Gardner ([e-mail], @Gardner_LM or gardnerlm.01 on Signal).
Eye on the FDA
KEEP YOUR SHOES ON — In what sounds more like an airline's pre-check-in program, the FDA is launching its own PreCheck program — although this one fast-tracks new drug-manufacturing sites in the U.S.
The new effort, announced Thursday by FDA Commissioner Marty Makary, aims to give manufacturers more frequent agency communication while they design pharmaceutical manufacturing facilities, construct the new buildings and stand up pre-production of medicines.
The FDA also plans to conduct pre-application meetings to provide proactive feedback on drugmakers' chemistry, manufacturing and controls, a crucial part of drug applications.
Looking ahead: The FDA is scheduled to hold a public meeting on Sept. 30 to discuss efforts to onshore manufacturing of drug and biological products and where to present a draft framework for the FDA PreCheck program.
'The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply,' Makary said in a statement.
Fun fact: A former Center for Devices and Radiological Health official granted anonymity tells your host that the FDA previously wanted to use the PreCheck name for a different program — ultimately named the Software Precertification Pilot Program — but backed off because of the Transportation Security Administration's well-known program.
In the courts
MEDICARE PRICE TALK WIN — The drug industry took another loss in its series of legal challenges to the 2022 law allowing Medicare to negotiate drug prices on Thursday — this time with the 2nd U.S. Circuit Court of Appeals rejecting Boehringer Ingelheim's challenge and upholding a lower court ruling denying its claims.
In its appeal, Boehringer — maker of the blockbuster diabetes drug Jardiance — argued that the program's construction violates its constitutional rights to free speech and due process and that CMS violated regulatory procedures law when it issued price agreements without taking public comment.
'The choice to participate in a voluntary government program does not become involuntary simply because the alternatives to participation appear to entail worse, even substantially worse, economic outcomes,' Circuit Judge William Nardini wrote in the decision.
What's next: Boehringer could ask the 2nd Circuit for an en banc rehearing, in which all of the circuit's sitting judges would consider its arguments, or petition the Supreme Court to take the case. We're watching closely now that the industry has seen three losses — including for AstraZeneca and the U.S. Chamber of Commerce — at the appellate level.
Boehringer did not respond to a request for comment.
Also Thursday: A federal district court in Texas sided with the government in PhRMA's Inflation Reduction Act challenge, echoing other courts' determinations on the industry's constitutional claims.
MEDICAL DEVICES
PFAS IN DEVICES — The FDA's medical device center wants patients to know it currently does not believe there is a reason to restrict the use of per- and polyfluoroalkyl substances, or PFAS, in medical devices. That evaluation comes ahead of the anticipated release of the Trump administration's Make America Healthy Again report recommendations for action.
'The PFAS used in medical devices are not the same as those identified as being potentially harmful to people in other contexts,' the FDA said in a newly posted webpage. 'The PFAS materials used in medical devices (known as fluoropolymers) have a long history of use.'
The agency said fluoropolymers are typically made of molecules 'too large to pass through cell membranes' and therefore are 'very unlikely to cause toxicity to patients.'
'We appreciate the FDA's confirmation that the PFAS used in medical technologies, such as lifesaving implanted devices, have a long track record of safety,' Scott Whitaker, CEO of medical device manufacturer trade group AdvaMed, said in a statement.
AROUND THE AGENCIES
FTC CHALLENGES VALVE DEAL — The Federal Trade Commission wants to stop Edwards Lifesciences' effort to acquire JenaValve Technology — a move the antitrust agency says could slash competition in a specialized heart valve market and potentially lead to higher prices for patients. The type of valve is called a transcatheter aortic valve replacement for aortic regurgitation, known as TAVR-AR.
'Edwards' attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves,' Daniel Guarnera, director of the FTC's Bureau of Competition, said in a press release.
The FTC Commission voted 3-0 to issue an administrative complaint and authorize staff to pursue a temporary restraining order and a preliminary injunction to block the transaction.
Edwards said it plans to continue to pursue approval of the acquisition, which it argues will speed the availability and use of the treatment.
'Edwards disagrees with FTC's decision and believes it will limit the availability of an important treatment option for patients suffering from aortic regurgitation,' the company said in a statement.
Pharma Moves
Julie Tierney is joining health care consulting firm Leavitt Partners as a principal. She previously was the deputy director of the FDA Center for Biologics Evaluation and Research and was chief of staff to former FDA Commissioner Robert Califf and former Acting FDA Commissioner Janet Woodcock.
Document Drawer
The White House Office of Information and Regulatory Affairs is reviewing a rescission of the FDA's laboratory-developed tests final rule.
The FDA has lifted its recommended pause of the use of the chikungunya vaccine Ixchiq in people ages 60 and older.
WHAT WE'RE READING
Efforts to encourage states to expand Medicaid coverage of anti-obesity drugs could be challenged by strained state budgets, Bloomberg Law's Celine Castronuovo reports.
The Commonwealth Fund's Kristi Martin published an overview of how the 340B drug pricing program works and why it is attracting criticism.