This Week at FDA: Kennedy revamps ACIP, FDA seeks consumer advisors, MDUFA meeting scheduled

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, all members of the CDC’s vaccine advisory committee were dismissed, FDA asked consumer advocates to volunteer for its advisory committees, and the first public meeting to start the next device user fee program negotiations was scheduled.

Early this week, Health and Human Services Secretary Robert Kennedy Jr. dismissed all 17 members of the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP). He had previously told lawmakers during his confirmation hearings that he would not change the vaccine advisory committees.

Explaining his actions in an op-ed in the Wall Street Journal, Kennedy said there's a crisis of public trust toward health agencies. While some may say it is due to misinformation and antiscience attitudes, he argued there has been a history of conflicts of interest in public health agencies, a lack of willingness to challenge scientific consensus, and "skewed science that has plagued the vaccine regulatory apparatus for decades."

“Today, we are taking a bold step in restoring public trust by totally reconstituting the Advisory Committee for Immunization Practices (ACIP). We are retiring the 17 current members of the committee, some of whom were last-minute appointees of the Biden administration,” said Kennedy. “Without removing the current members, the current Trump administration would not have been able to appoint a majority of new members until 2028.”

The decision caught pushback from the scientific community and other stakeholders.

“We have just demonstrated that politics will overrun science in this administration,” Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told STAT News. “It scares me to think of what’s ahead.”

“I’ve never seen anything this damaging to public health happen in my lifetime,” a recently dismissed ACIP committee member told CNN on anonymity. “I’m shocked. It’s pretty brazen. This will fundamentally destabilize vaccination in America.”

Two days later, Kennedy announced eight new members of ACIP who will serve at its 25 June meeting to discuss vaccine recommendations. Several of the members have previously served on ACIP, and some have also served on VRBPAC.

"The slate includes highly credentialed scientists, leading public-health experts, and some of America’s most accomplished physicians," said Kennedy. "All of these individuals are committed to evidence-based medicine, gold-standard science, and common sense. They have each committed to demanding definitive safety and efficacy data before making any new vaccine recommendations.”

However, the announcement of the new members also received significant pushback.

NPR reported that the American Medical Association (AMA) is concerned about the lack of transparency and proper vetting of the new ACIP members. The report also noted that some new members, such as Robert Malone, a physician, and Martin Kulldorff, an epidemiologist and biostatistician, have a history of questioning COVID-19 policies. Malone, for instance, also falsely stated that the COVID-19 vaccines increased risks to people who have previously been infected with the SARS-CoV-2 virus, according to NPR.

Sen. Bill Cassidy (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, previously stated that he voted for Kennedy’s confirmation because he was promised he would not make changes to ACIP. Reuters reported that Kennedy, however, says that he made no such promise but instead said he would allow the senator to pick an ACIP member of his choosing for the committee, which he will grant the senator.

FDA wants consumer organization volunteers to participate in its external advisory committees. The agency said it seeks voting and non-voting consumer representatives for the committees. Those interested in participating or nominating someone else should contact the agency by 28 July.

FDA will host a meeting of its pediatric advisory committee on 9 July to discuss postmarket safety reviews of drugs, devices, and biologics across its product centers. These include Medtronic's Activa neurostimulator, Merck's human papillomavirus vaccine Gardasil 9, and Kaleo's Auvi-Q (epinephrine) auto-injector.

Drugs & Biologics

FDA plans to schedule a series of public meetings entitled Rare disease Innovation, Science, and Exploration (RISE) workshops as part of its Prescription Drug User Fee Amendments (PDUFA VII) commitments. To prepare for the meetings, the agency has asked stakeholders to provide feedback on common challenges to developing treatments for multiple diseases or a class of diseases.

Capricor Therapeutics announced that despite a recent Form 483 from FDA, the agency's Cellular, Tissue, and Gene Therapies Advisory Committee is scheduled to meet on 30 July to discuss whether to recommend its biologics license application (BLA) for deramiocel (human allogeneic cardiosphere-derived cells) to treat cardiomyopathy in people with Duchenne Muscular Dystrophy (DMD). The BLA has priority review and a PDUFA target action date of 31 August. As noted by AgencyIQ in FDA Today: Life Sciences, as of 13 June the agency has removed the notice about the advisory committee meeting.

FDA approved several cancer drugs, including Nuvation Bio's kinase inhibitor Ibtrozi (taletrectinib) to treat people with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) and Merck's Keytruda (pembrolizumab) to treat certain patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

The agency also approved UroGen Pharma's Zusduri (mitomycin intravesical solution) to treat recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). As AgencyIQ reported in FDA Today: Life Sciences, the agency approved the drug despite the Oncologic Drugs Advisory Committee (ODAC) voting 5-4 that the drug had not proven its risks outweighed its benefits because it was tested in a single-arm pivotal trial.

Medtech

FDA will host the first public hybrid meeting on 4 August to kick off the next Medical Device User Fee Amendments (MDUFA VI) negotiations. Before the meeting, the agency asks stakeholders to provide feedback on how they think MDUFA V has performed, what aspects of the program should be reduced or discontinued, what features should be added, and if there are any fee structure changes they recommend.

FDA proposed reclassifying in situ hybridization (ISH) test systems used with certain cancer drugs from class III devices to class II devices with special controls. The agency also announced it is classifying clinical mass spectrometry microorganism identification and differentiation systems, devices used to detect and identify fungal nucleic acids directly in respiratory specimens, and radiological computer-assisted detection and diagnosis software as class II devices.

This Week at FDA: Kennedy revamps ACIP, FDA seeks consumer advisors, MDUFA meeting scheduled

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