This Week at FDA: Spring Unified Agenda, COVID vaccine update, 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, we got a glimpse at FDA’s latest regulatory agenda, the House Appropriations Committee favorably reported its FY 2024 spending bill that includes funding for FDA, and FDA’s outside advisors recommended updating COVID-19 vaccines to the Omicron XBB lineage.

The Department of Health and Human Services has released its Spring 2023 Unified Agenda, detailing the proposed and final rules it plans to issue. The agenda includes 78 rules pertaining to FDA, including a final Quality System Management Regulation (QMSR) slated for December 2023, and a proposed rule to explicitly regulate laboratory developed tests (LDTs) as medical devices that could arrive by August 2023. While the rules each carry an action date, it is common for rules to fall behind schedule.

The House Appropriations Committee on Wednesday advanced legislation to fund FDA in FY 2024 in a 34-to-27 vote along party lines. The bill includes $6.579B for FDA, an increase of $16M above the FY 2023 level, far below the $7.2B called for in the Biden administration’s FY 2024 budget proposal. The bill would also undo moves by FDA to enable distribution of the abortion drug mifepristone by mail.

On Thursday, FDA’s Vaccines and Related Biological Products Advisory Committee unanimously recommended that COVID-19 vaccine composition should be updated to a monovalent formulation with an XBB-lineage of the Omicron variant, which accounts for nearly all recent infections in the US. FDA said the committee “expressed a preference for XBB 1.5,” for a 2023-2024 vaccination campaign.

Officials from the National Institutes of Health (NIH) and FDA Commissioner Robert Califf are calling for more research and reduced barriers to develop better fentanyl test strips amid the opioid overdose epidemic. Because FDA does not regulate fentanyl test strips intended to detect the presence of the drug, the officials said that the “research community will need to set quality standards to improve the accuracy of drug-checking tools,” though the agency “would welcome the opportunity to work with test-strip manufacturers on point-of-care devices intended for testing human specimens.”

Drugs & biologics

The Wall Street Journal reports that drugmakers could save 11 million trees per year if prescription drug prescribing information could be provided in electronic format. “If the U.S. follows Japan and other countries in switching to digital information, it would mean around 90 billion sheets of paper would be saved a year,” the Journal writes, citing estimates by the Environmental Paper Network.

FDA published several warning letters this week, including one to A&Z Pharmaceutical, Inc. for promoting its dietary supplements as being able to treat various health conditions, as well as warning letters to drug compounders Carolina Infusion and Pharmacy Plus, Inc., both citing insanitary conditions at their facilities.

FDA granted accelerated approval to Roche’s Columvi (glofitamab-gxbm) on Thursday to treat adults with certain types of relapsed or refractory diffuse large B-cell lymphoma after two previous lines of therapy.

FDA has scheduled a two-day virtual workshop along with the International Pharmaceutical Regulators Program (IPRP) Biosimilars Working Group in September to discuss whether comparative clinical efficacy studies are needed in biosimilar development programs.

The agency has also rescheduled a meeting of its Nonprescription Drugs Advisory Committee (NDAC) to review the generally recognized as safe and effective (GRASE) status of oral phenylephrine as a nasal decongestant.

According to Bloomberg, FDA has found more issues at an Intas Pharmaceuticals facility during an inspection in May. The company was handed a Form 483 following an inspection at another one of its facilities late last year, which prompted the agency to issue an Import Alert for that facility, banning the import of all but 25 “medically necessary drugs for which there are shortage implications” from being imported.

Endpoints reports that FDA is working with Accord Healthcare to increase the supply of two critical chemotherapy drugs, cisplatin and carboplatin, which are currently in shortage.

Pfizer this week notified health care professionals and FDA of an impending shortage of its penicillin drugs Bicillin L-A and Bicillin C-R due to a supply interruption. The company said it will prioritize the production of Bicillin L-A formulations used for adult patients, and that it expects the supply of other formulations to deplete in Q2 and Q3 of this year.

FDA has updated its list of off-patent, off-exclusivity drugs without an approved generic.

Medtech

The Clinical Decision Support (CDS) Coalition recently sent a letter to FDA Commissioner Robert Califf, arguing that a majority of companies developing machine learning algorithms for use in CDS are likely not compliant with a CDS software guidance finalized last year. The coalition said the guidance violates the law and wants to work with FDA to develop a new guidance.

After issuing a safety communication earlier this year concerning neonatal incubators that may release toxic chemicals, FDA issued an update this week specifically addressing GE HealthCare's Giraffe OmniBed Carestation and Giraffe Incubator Carestation. GE says healthcare facilities can air out the devices before use by having them hooked up on maximum heat and humidity for a week to allow high levels of formaldehyde to dissipate.

This Week at FDA: Spring Unified Agenda, COVID vaccine update, and more

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