This Week at FDA: Guidance tsunami continues, questions about FDA’s accelerated approval pathway

This Week at FDAThis Week at FDA | 21 October 2022 |  By 

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. The US Food and Drug Administration (FDA) has continued its guidance dump since its user fee programs were reauthorized by Congress last month.
In just the past week, the agency has published or updated at least 10 draft and final guidances regarding drugs, biologics and medical devices. They include guidances related to several programs under the Prescription Drug User Fee Act (PDUFA VII) and an update to FDA’s breakthrough devices program.
Additionally, the Center for Devices and Radiological Health (CDRH) published its annual list of guidances it will prioritize this year, though many of the guidances are those it was unable to complete during the last fiscal year. Regulators are again prioritizing topics such as how to transition COVID-19-related products from emergency use authorization (EUA) to regular marketing authorizations and digital health products.
Drugs & Biologics
FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted 14-1 this week to yank Covis Pharma’s controversial preterm birth drug Makena from the market. The agency’s expert advisors agreed that the company’s confirmatory trial from 2018 failed to demonstrate benefit to pregnant women or their babies. Peter Stein, director of FDA’s Office of New Drugs, said the experience raises questions about the agency’s accelerated approval process. Similarly, FDA Commissioner Robert Califf said the pathway needed reforming.
FDA extended the user fee goal date for Biogen’s experimental amyotrophic lateral sclerosis (ALS) drug tofersen. In July, the agency granted the new drug application (NDA) priority review and set a PDUFA date for 25 January 2023. However, after additional information provided by the sponsor in response to questions raised by regulators, FDA extended the action date to 25 April 2023.
Following FDA’s expanded authorization of bivalent COVID-19 mRNA boosters to children this month, the European Medicines Agency (EMA) also recommended authorization of Moderna’s bivalent booster for those 12 and over. The booster includes components of the original SARS-CoV-2 virus as well as the Omicron BA.4/5 subvariants.
After learning from early stumbles from the COVID-19 pandemic, the Biden administration announced an ambitious new strategy this week to test future pathogens within 12 hours of discovery and mass producing a corresponding diagnostic test within 90 days. The White House said it also wants to be able to develop a vaccine for the pathogen within 100 days, mass manufacture it for Americans within 130 days and work with international partners to supply it to high-risk populations within 200 days.
Despite threats from the drug lobby group PhRMA to hold Democrats accountable for passing legislation that allows the federal government to negotiate certain Medicare drug prices, the organization has continued to contribute to Democratic candidates. The group’s political action committee donated $2,000 towards the New Democrat Coalition Action Fund on 22 August, according to reports.
Across the ocean, a French judge opened a formal indictment to determine if Merck KGaA used misleading information when it switched the formulation of the hypothyroidism drug Levothyrox, also known as Euthyrox. Several years ago, the company reworked the compound but soon thereafter patients began to show adverse reactions.
Panelists at the 18th Biosimilar Medicines Conference in hosted by Medicines for Europe in Brussels discussed the state of biosimilar authorization in the European Union. They proposed removing the requirement for confirmatory efficacy trials to make it more affordable for industry get biosimilars to market.
FDA this week published the final report from 36-months of post-market data from the Coloplast transvaginal mesh for pelvic organ prolapse (POP) surveillance study. It found the device had similar effectiveness to native tissue repair but also comes with additional risks and concluded that the mesh should stay off the market.
The agency also extended the comment period for a hotly anticipated draft guidance on labeling for LASIK surgery equipment by another month to 25 November. While scores of stakeholders have written to the agency about the guidance representing a wide range of views, it said some have asked for more time to share their thoughts on the matter.
US regulators issued another class I recall to Philips for certain Amara Full Face, DreamWisp Nasal, DreamWear Full Face, Wisp, Wisp Youth Nasal and Therapy Mask 3100 masks due to a serious safety concern. FDA said the recalled masks have magnetic headgear clips to hold them in place but they can potentially cause injury or death if people who use them, or people near a person using a recalled mask, have certain implanted metallic medical devices or metallic objects in the body.
During a webinar hosted by the Alliance for a Stronger FDA, Suzanne Schwartz, director of CDRH's Office of Strategic Partnerships and Technological Innovation, said the agency plans to finalize a guidance on medical device cybersecurity by the end of the current fiscal year. She also redoubled calls for new device shortage reporting requirements which industry has been pushing back against as being too administratively burdensome.


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