This Week at FDA: Adcomms, guidances, warning letters 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. FDA has been particularly busy this week with advisory committee meetings, guidances and its top officials making news on the agency’s future.

The advisory committee system is at the top of mind for many in the pharmaceutical community. Earlier in the week, briefing documents from US Food and Drug Administration (FDA), reviewers determined that nirsevimab, an antibody drug to prevent respiratory syncytial virus (RSV) infections in infants made by Sanofi and AstraZeneca, was safe and effective. Two days later, an advisory committee voted unanimously to recommend its approval.

Similarly, FDA staff backed Eisai and Biogen's Alzheimer's disease drug Leqembi (lecanemab-irmb), which currently has accelerated approval for a limited population. An advisory committee met on 9 June to discuss whether to recommend its full approval; however, at the time of writing this article, the external experts had not voted on the question.

The use of advisory committees has been a controversial topic over the past year after FDA approved Biogen’s Alzheimer’s disease drug Aduhelm (aducanumab-avwa) despite the lack of a recommendation from its advisory committee.

FDA Commissioner Robert Califf has said he wants to limit the therapeutic areas in which advisory committees are called on to recommend or not recommend a product. Others at FDA do not seem to agree. At a meeting held in conjunction with the annual meeting of the American Society of Clinical Oncology, Richard Pazdur, director of the FDA Oncology Center of Excellence, said he believes allowing the experts to vote on such issues is important.

Califf and other FDA officials have also called for giving advisory committees more flexibility to allow experts with certain conflicts of interest to serve, even though the agency can issue waivers. For example, this week, FDA removed David Weisman, a Pennsylvania neurologist and consultant to Eisai and Biogen, from the advisory committee that considered approval of Biogen's Leqembi Alzheimer's drug.

Peter Marks, director of the Center for Biologics Evaluation and Research, made news discussing the lessons the agency learned from the pandemic and how it plans to apply them. He said FDA is facing a significant inspection backlog that will take the remainder of the year to clean up and that the agency is struggling to hire mid-level managers in cell and gene therapies. FDA Chief of Staff Julie Tierney made similar comments on staffing at the agency in general during a webinar with the Alliance for a Stronger FDA earlier in the week.

FDA released several guidances this week, including one that updates its recommendations for good clinical practices (GCPs) which the agency says is meant to modernize the design and conduct of clinical trials and make them more agile. The guidance has been adapted from the recently updated International Council for Harmonisation (ICH) E6(R3) draft guideline.

FDA also published guidance on assessing user fees under the current Generic Drug User Fee Amendments (GDUFA III). The guidance details the types of user fees authorized by GDUFA III, the processes for submitting payments, the consequences for failing to pay generic drug user fees, and the process for requesting a reconsideration of a user fee assessment previously developed under earlier GDUFA authorizations.

FDA published a final guidance on clinical drug interaction studies with combined oral contraceptives (COC) meant to detail the agency's thinking on how it evaluates drug-drug interactions (DDI) on COCs and DDI study designs. It also recommends how sponsors should communicate their study results with the agency and apply risk mitigation strategies in labeling to address potential risks associated with increased or decreased exposure to COCs.

Finally, FDA also published final guidance meant to help abbreviated new drug application (ANDA) sponsors when they want to file optional attachments to their applications. More specifically, the guidance helps them prepare cover letters that go with controlled correspondence to the Office of Generic Drugs (OGD), original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.

On Capitol Hill, lawmakers are paying attention to bills, including the Pandemic and All-Hazards Preparedness (PAHP) Act. The House Energy and Commerce (E&C) health subcommittee is scheduled to meet Tuesday, 13 June, to discuss a number of bills they may want to attach to PAHP.

Drugs & Biologics

SpringWorks Therapeutics announced that FDA has added 3 months to its timeline for considering nirogacestat, a gamma secretase inhibitor to treat desmoid tumors, which are noncancerous growths in connective tissues. The company says the agency wants more time to review the data, but it hasn't asked for more data or studies.

Foghorn Therapeutics, says FDA has given it the all-clear to proceed with a Phase I clinical trial for its monotherapy dose escalation study of FHD-286 for the treatment of acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Last year, regulators put a safety hold on the trial, which the company says it suspects was due to cases of fatal differentiation syndrome, a known side effect of AML and MDS treatments.

FDA published import alerts to two Indian drug manufacturers including Intas Pharmaceuticals. The drugmaker was cited for failing to meet import inspection requirements and the agency has said it may refuse to import drugs made by the company until they come into compliance with current good manufacturing practice (CGMP) regulations though it listed more than two dozen drugs as exempt from the list to avoid a shortage.

Similarly, Sun Pharmaceutical Industries was cited for not meeting CGMP regulations but a dozen drugs made by the company were exempted to avoid a shortage.

On the home front, FDA issued a warning letter to drug compounder ImprimisRx NJ for failing to maintain sanitary conditions to manufacture their products and for producing drugs that had different potency from what was labeled. The agency also cited the California company for misbranding its drug products.

Similarly, FDA issued Pennsylvania-based drugmaker RemedyRepack a warning letter for failing to follow CGMP regulations including establishing adequate written procedures for cleaning and maintenance of equipment. It was also cited for thoroughly investigating any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.

Medtech

This week, FDA updated its medical device shortages list by removing a number of products from the list including certain radiology products such as coils, magnetic resonance devices, and MRI breast biopsy grid plates under the MOS product code. It also noted a few products including certain automatic external defibrillators and assisted reproduction labware which have been discontinued by the manufacturers.

FDA also issues a warning letter to Steiner Biotechnology in Nevada for failing to conform to Quality System Regulations (QSR). In particular, the agency says the company failed to establish and maintain adequate procedures to control the design of their devices, ensure process validation, and establish and maintain adequate procedures to ensure that their products conform to specified requirements.

On a positive note, FDA granted marketing authorization to Cue Health for their Cue COVID-19 molecular test. It’s the first at-home over the counter (OTC) test granted marketing authorization to detect the SARS-CoV-2 virus using the traditional premarket review pathway.

This Week at FDA: Adcomms, guidances, warning letters and more

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