This Week at FDA: PDUFA VII guidance, COVID strain selection meeting, and more

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, FDA issued new guidance on its Prescription Drug User Fee Amendments (PDUFA VII) program and released the final version of the International Council for Harmonisation’s (ICH) Q9(R1) Quality Risk Management guideline. The agency also announced an upcoming advisory committee meeting to select the strain composition of future COVID-19 shots.

This week, FDA issued a guidance that details the ins and outs of its (PDUFA VII program. The 20-page guidance explains the changes to the structure of the program in its latest iteration and provides an overview of the various fees the agency collects, as well as other topics such as fee waivers, what happens if a company fails to pay fees and the process and procedures for paying fees.

Next month, FDA’s Vaccines and Related Biological Products Advisory (VRBPAC) committee will meet to make recommendations on the strain selection for upcoming COVID-19 vaccinations for the 2023-2023 vaccination campaign. The meeting mirrors the process used by the agency for strain selection for annual influenza vaccines.

On Thursday, FDA approved the first-ever vaccine to prevent respiratory syncytial virus (RSV), GlaxoSmithKline’s Arexvy, which is indicated to prevent the disease in individuals ages 60 and older. The agency is in the process of reviewing an RSV vaccine developed by Pfizer to the same age group and is expected to issue a decision on that vaccine by the end of the month. Pfizer is also seeking approval of its vaccine for maternal use of the vaccine to protect infants from RSV after they are born; an advisory committee is scheduled to review the indication on 18 May.

“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” said CBER Director Peter Marks. GSK is required to conduct a postmarketing study to evaluate the risk of Guillain-Barré syndrome and acute disseminated encephalomyelitis (ADEM) and has committed to assessing the risk for atrial fibrillation.

On Friday, FDA sent out “Dear Colleague” letters ahead of FY 2024 PDUFA VII user fee invoices. Recipients are instructed to respond to the letters no later than 1 June 2023.

The drug lobby PhRMA, joined by the Advanced Medical Technology Association (AdvaMed),
The Consumer Healthcare Products Association (CHPA) and the National Association of Manufacturers, this week filed an amicus brief with the US Circuit Court of Appeals for the Fifth Circuit in support of FDA in the case involving the agency’s approval of the abortion drug mifepristone. The groups said the court previously erred in overriding FDA’s and imposed requirements that go beyond what’s written in the statute.

Reuters reports that FDA staff have raised concerns about Perrigo’s request for an Rx-to-OTC switch for its birth control pill.

According to Politico, the White House is struggling to find a leader for its new Office of Pandemic Preparedness and Response. The Biden administration reportedly sought FDA’s Chief Medical Officer Hilary Marston for the role, though Marston declined the job.

CDC Director Rochelle Walensky will resign from her post at the end of June as the nation transitions away from the emergency phase of the COVID-19 response.

Drugs & biologics

FDA this week released its latest quarterly data for its generic drug program. In the second quarter of FY 2023, the agency said it approved 6 priority abbreviated new drug applications (ANDAs), and that there were 47 priority ANDAs awaiting FDA action and 60 applications awaiting applicant action. The agency also approved 15 competitive generic therapies and had 132 applications with the designation awaiting its action by the end of the quarter and 174 applications awaiting applicant action.

The agency also released monthly generic drug activity figures for March 2023. The agency said it approved 96 ANDAs, 4 of which were first generics and 16 of which were first-cycle approvals.

On Wednesday, FDA issued its final version of the ICH Q9(R1) Quality Risk Management guideline.

CBER announced that a shortage of Emergent Travel Health’s cholera vaccine Vaxchora has been resolved, two years after the company announced it would temporarily discontinue the vaccine’s manufacture due to the COVID-19 pandemic’s impact on international travel.

A new report from the Government Accountability Office (GAO) finds that better data could improve understanding of federal contributions to drug development. The report recommends that the National Institutes of Health (NIH) should require awardees to name NIH and disclose its support in patent applications and calls on the agency to outline a process for researchers to access NIH microdata so they can better study the NIH’s contributions to novel drug development.

FDA announced this week that it has published the remaining five final administrative orders for OTC monographs as required by the Coronavirus Air, Relief, and Economic Security (CARES) Act. The agency also revised its final administrative order for OTC antacid products.

Endpoints reports that FDA cited quality issues at Eli Lilly and Rentschler facilities during inspections that took place in recent months. FDA cited Lilly with three observations at its Indianapolis, Indiana facility following an inspection in October 2022 related to its aseptic practices. The agency cited Rentschler with five observations, including citations for issues related to microbial contamination, environmental monitoring and quality unit procedures, at its Laupheim, Germany facility following an inspection in late-February and early-March 2023.

Politico reports that outside experts are calling for reforms to FDA’s advisory committee process as fewer committee meetings are being convened to review novel therapies.

Medtech

On Thursday, FDA announced it has released three new and five updated regulatory science tools for medical devices.

FDA is advising consumers and healthcare providers not to use and to dispose of certain lots of SD Biosensor, Inc. Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics. FDA said it has “significant concerns of bacterial contamination” in the liquid solution provided in the test kit. According to the agency, about half a million tests were distributed to CVS Health and another 16,000 tests were sent to Amazon.

Earlier this week, FDA posted a new video offering cybersecurity tips to healthcare facilities.

This Week at FDA: PDUFA VII guidance, COVID strain selection meeting, and more

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