This Week at FDA: House subcommittee advances FDA budget bill, new approvals, 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, the House Appropriations subcommittee tasked with overseeing FDA’s budget authority advanced legislation that would provide $3.5 billion in budget authority to the agency for FY 2024.

The amount is essentially flat from the FY 2023 enacted level, and according to the Alliance for a Stronger FDA, does not provide increased funding for several programs called for by the Biden administration, including food safety, cosmetics, opioids and pay raises for agency staff. In its budget proposal, the Biden administration called for $3.914 billion in appropriations for the agency. The Alliance also said it expects the full Appropriations committee to take up the legislation next week.

FDA recently unveiled its latest effort to address inequality in healthcare, called Project ASIATICA, which is focused on raising awareness for Asian American, Native Hawaiian and other Pacific Islander patients with cancer. FDA notes that Native Hawaiian and other Pacific Islander patients are underrepresented in clinical trials for cancer treatments and have worse outcomes following a cancer diagnosis than the general population.

FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks offered insights on the use of common manufacturing platforms for gene therapies while speaking at the Food and Drug Law Institute’s annual conference this week, STAT reports.

STAT also reported that FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted in favor the effectiveness of Pfizer’s maternal respiratory syncytial virus (RSV) vaccine to confer protection against severe disease in their infant offspring. The committee voted favorably on the vaccine’s safety, though the vote was split 10-4 on that question.

The New York Times reports that FDA has raised concerns about pharmacy compounders offering unauthorized copies of Ozempic (semaglutide) amid a shortage of the drug. In some cases, the Times writes, compounders have used semaglutide sodium in place of semaglutide, prompting some state pharmacy boards to ban the practice. “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements that limit the types of active ingredients that can be used in compounding,” wrote Gail Bormel, director of the Office of Compounding Quality and Compliance in a letter to the National Association of Boards of Pharmacy.

In other reporting, the New York Times writes that near-record drug shortages are leading to rationing for cancer patients.

Drugs & biologics

On Thursday, FDA announced it had approved AbbVie’s Rinvoq (upadacitinib) as the first oral treatment for moderate to severe active Crohn’s disease for patients who have had an inadequate or are intolerant to response to other tumor necrosis factor blockers.

The agency also announced on Friday it approved Krystal Biotech’s Vyjuvek as the first topical gene therapy for wound treatment in patients with dystrophic epidermolysis bullosa (DEB) with one or more mutations in the collagen type VII alpha 1 chain (COL7A1) gene.

In other approval news, FDA approved AbbVie’s Epkinly (epcoritamab-bysp) to treat relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma in the third-line setting.

This week, FDA issued its latest batch of new and revised product-specific guidances (PSGs) for generic drug development. The agency released a total of 46 PSGs (25 new and 21 revised), including 34 that target products with no generic competition and 24 for complex generics.

FDA handed a Form 483 to Ipca Laboratories following an inspection of the company’s facility in Gujarat, India. The form cites three observations concerning the company’s failure to thoroughly review unexplained discrepancies and quality control unit lapses.

Biotech firm Prothena announced earlier this week that Billy Dunn, former director of the Office of Neuroscience within the Center for Drug Evaluation and Research (CDER), has joined its board of directors.

Reuters reports that FDA staff have raised “serious” safety concerns for Intercept’s nonalcoholic steatohepatitis (NASH) drug ahead of an advisory committee meeting on Friday.

Medtech

Earlier this week, FDA posted a lengthy warning letter it sent to Texas-based medical device maker Sea-Long Medical Systems last month. The warning letter details 11 Quality System Regulation violations related to complaint handling, process validation, design change procedures, failure to maintain device master records, and more. The warning letter also reprimands the company for promoting its Sea-Long Medical Treatment Hood, which was granted 510(k) clearance in 2001 for use in place of a mask for the purpose of supplying gas/oxygen/air, for new uses.

“Statements on your firm’s website and in materials collected during the inspection indicate that the device is also intended for noninvasive ventilation (NIV), respiratory distress/illness, acute respiratory distress syndrome (ARDS), pressure support ventilation (PSV)/positive end-expiratory pressure (PEEP), COVID-19 treatment, and other additional uses, which constitute major changes or modifications,” FDA wrote in the warning letter.

Reuters reports that FDA has cleared Thermo Fisher’s test for detecting preeclampsia in pregnant women.

FDA’s Center for Devices and Radiological Health (CDRH) announced that its Patient Engagement Advisory Committee will meet in September to discuss health equity in medical devices. “CDRH is committed to working toward ensuring that all patients have access to high-quality, safe, and effective medical devices. This includes ensuring devices are designed to be safe and effective when used by various populations, are evaluated in the diverse populations for which they are intended, and that patients and consumers have the information they need to make decisions about their health, care and quality of life,” CDRH wrote in the meeting announcement.

FDA on Friday announced it has cleared Beta Bionics’ iLet ACE insulin pump and related algorithm-based dosing software, which are intended to be used with a compatible FDA-cleared integrated continuous glucose monitor. “Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology,” said CDRH Director Jeff Shuren.

Government & legal

Earlier this week, President Joe Biden nominated Monica Bertagnolli to direct the National Institutes of Health (NIH). Bertagnolli became the first woman to lead the NIH’s National Cancer Institute (NCI) last year.

The Government Accountability Office this week released its latest Priority Open Recommendations for the Department of Health and Human Services (HHS). The report lists five open recommendations for FDA, including two related to the agency’s food oversight that were made in 2015. Other recommendations pertain to the agency’s oversight of the vaccine supply chain, laboratory safety and foreign drug inspections.

Politico reports that Biden administration attorneys were grilled by judges at the 5^th Circuit Court of Appeals during a hearing on Wednesday concerning the abortion drug mifepristone. The hearing took place after the Supreme Court blocked earlier rulings that would have severely restricted access to the drug. The outcome of the case will have significant ramifications for abortion access, as the mifepristone and misoprostol, another widely used abortion drug, are used in more than half of abortions in the US.

This Week at FDA: House subcommittee advances FDA budget bill, new approvals, and more

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