This Week at FDA: Virtual adcomms, new guidances, 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 a top FDA official discussed the virtual future of advisory committees, House Republicans offered an alternative bill to address concerns about drug shortages, and more.

While FDA has started holding some in-person meetings, Politico noticed that FDA has scheduled seven advisory committee meetings through the end of September, all of which are virtual. The decision hints at a virtual future for advisory committee meetings, and some experts are concerned that virtual meetings won't be as effective.

FDA's Chief Scientist Namandjé Bumpus this week said during a call with the Alliance for a Stronger FDA that future advisory committee meetings will likely be hybrid or virtual to allow for a wider range of experts to participate in them, and that the agency is working to streamline the expert onboarding process.

Peter Marks, director of FDA's Center for Biologics Evaluation and Research (CBER), told Fierce Biotech FDA has learned a lot over the years about the kind of data they want to see when giving accelerated approvals for rare disease treatments. He added that the agency is developing policies on confirmatory studies to evaluate surrogate endpoints for products granted accelerated approval.

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) has floated a bill to address ongoing concerns about drug shortages. House Democrats tried to introduce language in the Pandemic and All-Hazards Preparedness Act (PAHPA) last month to tackle the issue, but Republicans refused to allow any of their amendments to move forward.

The US Preventative Services Task Force plans to convene a meeting to discuss COVID-19 screening requirements now that the public health emergency (PHE) has ended, according to STAT. The decision to call a meeting was spurred by Democratic Senators who want insurers to continue to cover the cost of the test for everyone.

STAT's Adam Feuerstein and Matthew Herper shared their insights on Republican presidential candidate and former Roivant Sciences CEO Vivek Ramaswamy's criticisms of FDA and whether his arguments hold water. The two journalists chalked up many of Ramaswamy remarks as “hyperbole and misrepresentation” and “libertarian fantasy.”

FDA announced this week that it is accepting submissions from stakeholders, including device manufacturers and distributors, to participate in its Experiential Learning Program (ELP). The program gives FDA staff a chance to work directly with medtech stakeholders to learn about how they work to develop products and handle the premarket review process from their end. The submission period is open from 3 August 2023 to 5 September 2023.

Drugs & biologics

This week, FDA finalized a critical guidance on recommended acceptable intake limits for nitrosamine impurities in drugs. The guidance comes five years after US and EU regulators identified nitrosamine impurities in several angiotensin II receptor blocker (ARB) drugs, triggering recalls and heightened scrutiny of nitrosamine impurities in other classes of drugs.

The agency also finalized a guidance explaining its process for granting waivers, exceptions and exemptions from the product tracing, verifications, product identification and authorized trading partners requirements of the Drug Supply Chain Security Act (DSCSA).

FDA announced two draft guidances related to the President’s Emergency Plan for AIDS Relief (PEPFAR) program. One guidance addresses single-entity antiretroviral (ARV) and ARV fixed-combination drug products used in PEPFAR to treat human immunodeficiency virus-one (HIV-1) infections, and the other addresses user fee waivers, reductions and refunds for such products under the program. Both guidances will replace earlier guidances on the same topics when finalized.

FDA has updated its monthly report on how the Generic Drug User Fee Program is going which includes data from October 2022 to June 2023. The report shows the agency has approved 571 generic drugs and tentatively approved 135 generic drugs since October, of which 76 approvals and 12 tentative approvals were given in June.

FDA approved GlaxoSmithKline's endometrial cancer drug Jemperli (dostarlimab-gxly) with carboplatin and paclitaxel. It also approved Harm Reduction Therapeutics' RiVive as the second over-the-counter non-prescription naloxone hydrochloride nasal spray to treat opioid overdoses.

Two lots of Lupin's birth control pill Tydemy (drospirenone/ethinyl estradiol/levomefolate calcium) may not be as effective due to a manufacturing error and could result in unexpected pregnancies, according to FDA. Lupin told the agency in July that it was recalling the lots which were distributed in the country from 3 June 2022 to 31 May 2023.

Medtech

Starting 1 October, FDA says it will expand its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to include products evaluated by its Office of Neurological and Physical Medicine Devices: Office of Health Technology 5 (OHT5). The pilot is currently only open to products evaluated by its Office of Cardiovascular Devices: Office of Health Technology 2 (OHT2). TAP is part of commitments made by the Center for Devices and Radiological Health (CDRH) to medtech industry under the Medical Device User Fee Amendments (MDUFA V) deal.

Baxter has issued a class I recall for its SIGMA Spectrum Infusion Pump with Master Drug Library and Spectrum IQ Infusion System with Dose IQ Safety Software due to concerns that they are giving false alarms after recent software upgrades. The problem could interrupt or delay treatment and lead to clinician fatigue that may ultimately cause injury or death, according to FDA.

Abbott has stopped selling its Trifecta valves after FDA issued a safety communication earlier this year warning healthcare providers that the products were at risk for early structural valve deterioration (SVD) based on a literature review. The heart valve replacement devices are meant to fix certain other heart valves and if they fail could lead to death.

This Week at FDA: Virtual adcomms, new guidances, and more

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