This Week at FDA: FDA postpones VRBPAC, QSR on the horizon, and Califf’s upcoming vote

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, we look at the breaking news that FDA is postponing its upcoming advisory committee meeting to review Pfizer and BioNTech’s request to authorize their COVID-19 vaccine in children 6 months through 4 years of age. We also saw FDA’s proposal to harmonize its Quality System Regulation (QSR) with ISO 13485:2016 has made it through Office of Management and Budget (OMB) review, and we get word that the Senate might vote on Robert Califf’s nomination to be FDA commissioner as early as next week.

Driving the news today is FDA’s announcement that it will postpone the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review Pfizer and BioNTech’s emergency use authorization (EUA) request for the companies’ COVID-19 vaccine in children ages 6 months through 4 years of age. The meeting was originally scheduled for next Tuesday.

FDA said it is postponing the meeting to allow for more time to collect and evaluate data on a third dose in that population, based on emerging data from an ongoing clinical trial.

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said in a press release.

What we’re reading

This week, we saw that Senate Majority Leader Chuck Schumer (D-NY) filed cloture on Robert Califf’s nomination, setting up a confirmation vote as early as next Tuesday, Politico and STAT report. In recent weeks, Califf’s nomination appeared to be imperiled, which prompted a push by public health advocates and the White House to shore up support for the former commissioner. Both publications quoted Senate Majority Whip Dick Durbin (D-IL) as saying the vote will be close.

In major medical device news, FDA’s long-awaited move to harmonize the QSR with ISO 13485:2016 has cleared OMB review, with some modifications to the agency’s proposal. Both Medtech Insight and MedtechDive have more to say on the proposed rule and OMB’s review.

We also get an update on the status of the MDUFA V negotiations. FDA and industry have yet to reach an agreement on the five-year program and FDA missed its deadline to submit the MDUFA V package to Congress last month. Now, Medtech Insight reports that the two sides have scheduled five upcoming meetings to try to hash out a deal.

Several outlets reported on statements made by President Joe Biden calling for action to lower drug prices in the US. Biden’s statements come amid concerns over inflation and a renewed focus on healthcare and inequity during the COVID-19 pandemic.

Drugs & biologics

On Friday, FDA issued an EUA for Eli Lilly’s monoclonal antibody bebtelovimab to treat mild to moderate COVID-19 in adults and children ages 12 and older who weigh at least 40kg and who are at high risk of progression to severe COVID-19. The authorization comes on the heels of the Biden administration’s announcement that it had purchased 600,000 courses of the treatment.

FDA also announced an upcoming public meeting to review the final assessment of its hiring and retention practices under PDUFA VI and BsUFA II.

On Thursday, during an at-times contentious advisory committee meeting, FDA officials and most of the members of its Oncologic Drugs Advisory Committee (ODAC) cast doubt on Eli Lilly and Innovent’s biological license application (BLA) for the companies’ PD-1 inhibitor sintilimab. The companies submitted the application relying solely on data from a clinical trial conducted in China, raising questions about the applicability of the data to the US population and medical practice, as well as concerns about data integrity and the handling of informed consent during the trial.

We also looked at some new guidance out this week, including draft guidance on clinical pharmacology for antibody-drug conjugates and developing opioid-alternatives for acute pain.

In other pharmaceutical news, the industry group PhRMA announced that Takeda’s Ramona Sequeira will be the first woman to serve as the group’s board chair.

Medical devices

FDA has once again updated its list of Accreditation Scheme for Conformity Assessment (ASCA) accredited testing laboratories, bringing the total number of accredited labs to 84. North American Science Associates (NAMSA) remains the only lab accredited for the biocompatibility consensus standards under the pilot.

Continuing a string of recent device classification orders, FDA classified two device types into class II (special controls), spore test strips and adjunctive predictive cardiovascular indicators.

This Week at FDA: FDA postpones VRBPAC, QSR on the horizon, and Califf’s upcoming vote

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