This Week at FDA: Drug voucher program hits a snag, GOP targets abortion drug, 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 officials and industry raised concerns about a drug review voucher program, Republican lawmakers called for restricting the use of mifepristone, and HHS reportedly removed a webpage with information on bogus autism treatments.

There has been continued concern about the Commissioner's National Priority Voucher (CNPV) program, which prioritizes FDA review of drugs deemed critical to national security and could significantly shorten their review times. The Associated Press reported that the program has raised concerns among officials across the agency that it may be illegal, unethical, and that it may discard the agency's traditional scientific standards.

Unnamed officials who spoke to the AP said that they have received very little information about how the program will be executed. Reviewers were also told they could skip critical review steps to speed products to market.

In related news, Reuters reported that FDA has delayed the review of Sanofi’s diabetes drug Tzield (teplizumab-mzwv) and Disc Medicine’s blood-disorder medicine bitopertin, which are part of the CNPV program, due to safety concerns. Agency reviewers reportedly delayed the review of bitopertin due to concerns about trial data and the risk for abuse, and Tzield after receiving adverse events reports, including a death.

It's also not only FDA officials who are concerned about the CNPV program. Reuters reported that drug executives and advisers have also expressed concerns that the program may not be as scientifically rigorous in evaluating safety and efficacy, which could undermine the agency's credibility. Ultimately, they said it could create legal risks for drugmakers if patients experience serious side effects after the drug has been approved.

The Senate Health, Education, Labor, and Pensions (HELP) committee met this week to discuss the efficacy of the abortion drug mifepristone, which has been under scrutiny of Republican lawmakers who argue that the FDA should not allow it to be prescribed virtually and received through mail order. While organizations such as the American College of Obstetricians and Gynecologists have said there are decades of data to prove the drug is safe and effective, ABC News reported that committee Chair Bill Cassidy (R-LA) argued that physicians should only prescribe the drug based on inpatient visits and urged the Trump administration change its policies to make that happen immediately.

FDA has asked manufacturers of glucagon-like peptide-1 (GLP-1) receptor agonist drugs to remove information about the risk of suicidal ideation and behavior from their labeling after it said it did a comprehensive review of the drugs and found no increased risk to patients. The agency noted the affected products are Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide).

The Department of Health and Human Services has appointed two OB/GYNs, Adam Urato and Kimberly Biss, to the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) who have a history of opposing vaccines and antidepressants. NBC News reported that Biss also has a history of voicing skepticism about the COVID-19 vaccine.

FDA has traditionally maintained a webpage listing unproven and bogus autism scam treatments such as chelation and hyperbaric oxygen therapies that are often promoted and marketed by anti-vaccine activists and the wellness industry. However, Ars Technica reported that the webpage had been quietly deleted, and HHS said it was “retired” during a “routine cleanup” when asked about the matter.

Drugs & Biologics

The Center for Biologics Evaluation and Research (CBER) published two updated Standard Operating Policy and Procedure (SOPP) manuals. The first is for the administrative processing of clinical holds for investigational new drug (IND) applications. Among the changes noted by FDA, the manual has updated information regarding master files and steps on managing INDs referencing the files, and added policy information on when sponsors cannot be reached for hold communications.

The second manual is on administrative processing and review management procedures for IND applications. The changes similarly include added policy on master files, definitions and references for managing IND referencing to master files, and the use of artificial intelligence (AI) reviewers.

FDA approved Sentynl Therapeutics' injection Zycubo (copper histidinate) as the first treatment for Menkes disease in children. The drug is a copper replacement therapy that delivers copper in a form that bypasses the genetic defect in intestinal copper absorption, allowing patients with the rare neurodegenerative disorder to absorb copper.

Atara Biotherapeutics announced this week that FDA issued it another complete response letter (CRL) for its biologics license application (BLA) for its drug Ebvallo (tabelecleucel) to treat patients two years and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). The company said it had resolved a prior CRL with the agency over a good manufacturing practice (GMP) issue, but now regulators say its single-arm study is no longer considered adequate to provide evidence of effectiveness for accelerated approval. They also took issue with the trial’s design, conduct, and analysis.

Medtech

Medline has issued a Class I recall for certain Anesthesia Circuit Kits and other kits containing Anesthesia Circuits, according to the FDA, after receiving reports that they may leak, which could negatively affect ventilation and anesthetic delivery. The company warned consumers to check whether their products have been affected and not to use them if they have.

FDA reported that Draeger has issued a Class I recall for some of its Vapor 2000 and Vapor 3000 anesthetic vaporizers after finding impurities in certain lots due to a manufacturing problem. Consumers were told to check whether their product is part of the recall and stop using it if so.

FDA announced that Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors after finding that some of them may output incorrect low glucose readings. The company says the sensors were all from the same production line and consumers should check out its www.freestylecheck.com web page to determine if their product is affected.

This Week at FDA: Drug voucher program hits a snag, GOP targets abortion drug, and more

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