This Week at FDA: FY2025 budget roadblock, Biosimilar PSGs, 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, US lawmakers paused negotiations over FDA’s FY 2025 budget and FDA sought input on its approach to biosimilar product development guidance.

House lawmakers have pulled the FY 2025 appropriations bill that would fund FDA due to significant differences between Republicans and the Biden Administration. Conservative Republicans objected to the lack of a provision that would limit FDA's ability to allow sales of the abortion drug mifepristone, while the Biden Administration objected to funding reductions, stating that Biden would veto the bill if it came to his desk.

Steve Grossman at the Alliance for a Stronger FDA noted that pulling the bill means that the earliest lawmakers can address the issue will be September. At the same time, he added that the Senate Appropriations Committee has not scheduled a floor discussion on their version of the bill yet.

This week, FDA said it wants input from industry on its approach to offering more specific product development guidance to biosimilar sponsors. Specifically, the agency wants to know whether it should establish product class-specific guidance that addresses “common development issues” or product-specific guidances, as it does for generic drugs. While the agency didn’t commit to developing such guidance under the Biosimilar User Fee Act (BSUFA III) reauthorization, it said it is looking for a new model to advance the development of biosimilars.

As such, FDA asks whether it should develop product class-specific or product-specific guidances, and whether it should focus on products or classes for which there are no approved biosimilars. The agency is asking for input by 23 October 2024.

FDA approved Millicent's oral birth control drug Femlyv (norethindrone acetate and ethinyl estradiol) on Monday. The drug is the first dissolvable birth control pill by agency, which noted that the main ingredients in the drug were approved back in 1968, so there is ample data on its performance, and the new version will help women who have difficulty swallowing pills.

As FDA continues to fight to implement its new rule to oversee laboratory-developed tests (LDT), the agency published a new page of most frequently asked questions to help stakeholders understand how it intends to regulate the diagnostics tests. It said it plans to continuously update the page with information such as upcoming webinars, guidances and other information that may be useful to stakeholders.

On the topic of regulating LDTs, this week FDA noted that it plans to use its enforcement discretion to not regulate LDTs used to diagnose Highly Pathogenic Avian Influenza (HPAI) that are conducted by laboratories that are certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA). The agency said it would also not issue emergency use authorizations (EUA) for such tests, as there is no current section 564 public health emergency declaration that would enable it to do so.

The Department of Health and Human Services (HHS) announced it has expanded its public health emergency declaration for the avian influenza A (H79N) virus to include the broader gamut of influenza A viruses that can potentially lead to a pandemic. The agency noted that the viruses pose a significant potential for a public health emergency, which is a matter of national security and health.

FDA is allowing stakeholders more time to comment on its request for feedback regarding its information technology and customer experience strategies. Stakeholders now have until 30 August to provide their feedback.

FDA’s Pediatric Advisory Committee is scheduled to meet on 18 September to discuss postmarketing safety reviews of more than 40 drugs, biologics, and medical devices.

Two FDA guidances on clinical trials are currently pending review by the White House Office of Management and Budget, a final guidance entitled Conducting Clinical Trials With Decentralized Elements, and a draft guidance on Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice.

Drugs & Biologics

The Center for Biologics Evaluation and Research (CBER) updated a Standard Operating Policy and Procedure (SOPP) for staff when scheduling and conducting meetings with sponsors, which now includes guidance on conducting meetings via camera. The SOPP only applies to products covered under the Biosimilar User Fee Act (BsUFA), the Generic Drug User Fee Act (GDUFA), and the Prescription Drug User Fee Act (PDUFA).

The Office of Therapeutic Products (OTP) announced three upcoming public meetings in September. They include a meeting on 4 September where FDA will give sponsors tips on its do's and don'ts, a 5 September town hall for sponsors of cell therapy and tissue-engineered products on chemistry, manufacturing, and controls (CMC) readiness for late-stage investigational new drug (IND) applications, and the first in a series of meetings on 20 September to hear about patient safety perspectives for gene therapies for rare diseases.

FDA published several guidances this week, including a final guidance on how sponsors can electronically submit their over-the-counter drug monographs.

This week, FDA asked for feedback on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs) in follow-on recombinant peptide products reviewed under the 505(b)(2) pathway. The agency is seeking input on methods of detection, identification, and quantification of HCPs for such products, as well as insights on the use of in vitro, in silico immunogenicity assessment of HCPs in recombinant peptide products. FDA notes that “differences in recombinant expression systems used during the peptide production could result in quality attribute differences, including in the HCP profile, which in turn could contribute to differences in immunogenicity risks between a follow-on recombinant peptide product and the listed drug.

Amid the growing demand for weight-loss drugs, including Novo Nordisk’s semaglutide drugs Wegovy and Ozempic, FDA is warning that it has received reports of dosing errors related to compounded versions of the drugs, which may vary in concentration and presentation from one compounder to another. FDA said that some patients required medical attention or hospitalization, and in some cases, patients took 5 to 20 times the intended dose of the drugs.

In a newly posted warning letter, FDA admonished Vietnamese over-the-counter drugmaker Yahon Enterprise for various product testing failures, including releasing drugs without adequate quality control testing, failing to perform identity testing for ingredients such as ethyl alcohol and benzylkonium chloride used to manufacture OTC drugs, and failure to adequately establish expiration dates.

FDA on Thursday approved Sun Pharma’s oral JAK inhibitor Leqselvi (deuruxolitinib) to treat adults with severe alopecia areata.

Medtech

Jeff Shuren, who has served as director of the Center for Devices and Radiological Health (CDRH) for almost 15 years, dropped a bombshell this week when he announced he would be leaving the agency by the end of the year. He said he had planned on leaving back in 2020 but stuck around to help manage the COVID-19 pandemic.

Michelle Tarver, deputy CDRH director and chief transformation officer, will take over next week as acting director, and the agency will begin the process of finding a new permanent replacement.

CDRH's Digital Health Center of Excellence's (DHCoE) Troy Tazbaz and John Nicol wrote a blog post about lifecycle management (LCM) of AI-enabled products in the health care system. The FDA officials detailed DHCoE's work on the topic and encouraged further stakeholder engagement.

On 7 August, CDRH will host another webinar in its series of town halls to discuss medical device sterilization as it works to try to encourage companies to ween off using ethylene oxide (ETO) to clean their products. The meeting will address bioburden, bacterial endotoxin, and packaging integrity testing for sterile medical devices.

Criticare Technologies received a warning letter dated 12 July for failing to meet FDA's current good manufacturing practice (cGMP) requirements. While the agency received a response to a 3 June Form 483 letter, it said it was inadequate and failed to address several issues, mainly maintaining proper corrective and preventive action (CAPA) procedures.

This Week at FDA: FY2025 budget roadblock, Biosimilar PSGs, and more

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