This Week at FDA: Califf considering diagnostic reform rulemaking, Ashley says goodbye

This Week at FDAThis Week at FDA | 28 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. Compared to the torrent of guidances issued over the past few weeks, the US Food and Drug Administration (FDA) was relatively quiet this week. Agency leaders who attended and spoke at the Medtech Conference in Boston this week again called for diagnostic reform legislation and said they may consider federal rulemaking to get it done.
The medical device lobby group AdvaMed hosted its annual Medtech Conference where FDA Commissioner Robert Califf and Jeff Shuren, director of the Center for Device and Radiological Health, advocated for passage of the Verifying Accurate Leading-edge IVCT Development (VALID) Act as part of the December omnibus spending bill.
Back at its headquarters, the FDA published an updated final guidance elaborating on the principles it will rely on when deciding to issue deficiency letters. The number of deficiency letters issued by the agency has gone up in recent years and the agency aims to bring more clarity to device and diagnostic sponsors by detailing the circumstances under which they may get a deficiency letter. It also updated a guidance on medically necessary drugs (MND) to encourage manufacturers to develop emergency production plans.
Also this week, the FDA announced it was postponing an advisory committee meeting to discuss Laboratoire HRA Pharma’s Opill (norgestrel), a nonprescription, once-daily  oral contraceptive so staff can review new information. It’s Office of Tissues and Advanced Therapies (OTAT) announced it will host a second virtual town hall to answer stakeholder questions related to cell therapy chemistry, manufacturing, and controls (CMC), including regulated tissue-engineered medical products. CDRH also is hosting a 2-hour workshop with agency heads to discuss medical device risks on 15 November.
Now that the user fees have been renewed, the FDA published its Fiscal Year (FY) 2023 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives and the FY 2022 New Research Awards List. The priority initiatives address scientific challenges that the generic industry and FDA’s generic drug program identified as being significant challenges over the next five years as part of GDUFA III.
The FDA’s Center for Drug Evaluation and Research this week announced that Donald Ashley, director of the Office of Compliance will retire 23 November. Deputy Director Jill Furman will serve as acting office director.
Drugs & Biologics
Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) said this week that the COVID-19 booster shot people are getting now may not be the last they need for the coming year. As the SARS-CoV-2 virus continues to rapidly evolve, he thinks it’s conceivable that people may need updated boosters sooner.
Seres Therapeutics said the FDA has accepted its biologic license application (BLA) for SER-109, a microbiome candidate to prevent recurrent C. difficile infection (rCDI). According to the company, the agency has given is a Prescription Drug User Fee Amendment (PDUFA) date of 26 April 2023, and the agency has not planned an advisory committee to get external input before deciding.
The FDA has turned down a citizen petition by law firm Foley Hoag to pull the accelerated approval designation for Jazz Pharmaceuticals’ Zepzelca, for the treatment of small cell lung cancer (SCLC). When used with chemotherapy, the drug failed to beat chemotherapy alone in a Phase 3 trial in patients who had progressed after one prior platinum-containing therapy. The FDA says it has signed off on two other Phase 3 studies as the drug’s new confirmatory trials.
Generic drug maker Teva says surging energy costs in Europe risks pushing out companies critical to the manufacture of essential medicines in the region. While essential generic medicines have been under pressure in Europe due to cost of making active pharmaceutical ingredients (APIs) and pushed manufacturing to place such as China and India, the war in Ukraine and the associated increase in energy cost is accelerating an exodus of manufacturers.
This week the European notified body association (TEAM-NB) published a position paper intended to help manufacturers manage and benefit from off-label use of their products. While it's not legal to use regulated medical device off-label, the position paper tries to take a pragmatic approach.
European researchers are warning that orphan and pediatric cardiac devices may become unavailable due to market pressures and restrictions under the EU Medical Device Regulation. They said there is an urgent need to develop and implement policies to protect such products and ensure a more sustainable European system.
The FDA published a document on digital health highlighting areas of research that internal and external stakeholders consider important to explore. It details the current digital health regulatory landscape, areas of interest in digital health for stakeholders to consider, and areas of interest that are likely to arise in the future.
Royal Philips NV announced it was cutting 4,000 jobs to reduce expenses amidst a costly recall of sleep apnea devices. The news comes just days after CEO Roy Jakobs took the helm from Frans van Houten.


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