This Week at FDA: Pallone pushes for greater enforcement, FDA rejects Eli Lilly Alzheimer’s drug, and more

This Week at FDAThis Week at FDA | 20 January 2023 |  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. This week, Ranking Member of the House Energy & Commerce Committee Frank Pallone (D-NJ) wrote to FDA Commissioner Robert Califf and Lawrence Tabak, acting director of the National Institutes of Health (NIH), urging greater enforcement of clinical trial results reporting in Pallone cited recent research that found less than one third of registered trials fail to report results, and many that do fail to report them on time.
“Despite these troubling results, the Food and Drug Administration (FDA) and NIH have only carried out limited enforcement activities for failure to comply with requirements,” Pallone wrote. The congressman noted that FDA did not begin issuing preliminary notices of noncompliance to investigators until 2013, and has sent just four notices of noncompliance since it began sending them out in 2021, none of which have resulted in the agency imposing civil money penalties on delinquent sponsors.
Drugmaker Eli Lilly announced on Thursday that FDA has issued a complete response letter (CRL) declining to grant the company accelerated approval for its Alzheimer’s disease drug donanemab. According to the company, the CRL cited “the limited number of patients with at least 12 months of drug exposure data provided in the submission,” which was filed based on data from a Phase 2 trial. The company said that no other deficiencies were noted in the letter and noted that its Phase 3 confirmatory trial is ongoing.
Califf also spoke at a joint listening session with the US Patent and Trademark Office earlier this week. While acknowledging the need for patents and exclusivity for drugs and biologics to ensure that drugmakers can recoup their investments, he stressed that those protections must be “balanced by legal and regulatory pathways that allow for and encourage generic drug and biosimilar product manufacturers to enter the market.”
Drugs & biologics
This week, FDA released data on its priority and competitive generic therapy (CGT) programs for the first quarter of FY 2023. As of this writing, the agency has approved 186 generic drugs with CGT designation CGT program was launched.

In other news, the International Council for Harmonisation (ICH) announced the adoption of its Q9(R1) guideline on quality risk management (QRM), setting QRM principles and tools that can be applied to different aspects of pharmaceutical quality. As a regulatory member of ICH, FDA is expected to adopt the guidance domestically.
FDA posted a warning letter to drug compounder Optum Infusion Services in Chandler, AZ for inadequate contamination safeguards related to its handling of sterile products. Investigators found the company failed to take appropriate action after vermin was found in the production area; another problem stemmed from an operator placing gloved hands outside the ISO 5 area to retrieve supplies, then re-entering the ISO 5 hood without re-sanitizing their gloved hands.
The agency announced this week that it will convene a public workshop on 8 March to discuss the advantages and disadvantages of using negative controls to assess the validity of non-interventional studies based on real-world evidence (RWE). The workshop will be co-sponsored with the Duke-Margolis Center for Health Policy. At the workshop, FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will also propose projects to develop negative control methods for use in its Sentinel System, Biologics Effectiveness and Safety (BEST) system.
FDA also announced two new oncology approvals on Thursday. Seagen’s Tukysa (tucatinib) in combination with trastuzumab to treat RAS wild-type HER2-positive unresectable or metastatic colorectal cancer, and BeiGene’s Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Bloomberg reported this week that drugmaker Merck & Co. has identified the source of a nitrosamine impurity in its diabetes drugs and intends to resolve the issue sometime this year.
On Friday, FDA alerted patients and health care providers to Medtronic’s latest safety communication related to its HeartWare ventricular assist device. The communication relates to the same battery weld defect that prompted the company’s May 2022 safety communication. In the latest communication, Medtronic requests the return of 12 batteries in the affected devices for further engineering analysis.
Earlier this week, FDA said it wanted input from the public on how it can advance the use of premarket real-world data (RWD) and RWE by funding external organizations other than the National Evaluation System for Health Technology (NEST) as part of its MDUFA V commitments.
FDA on Friday issued a final rule amending and repealing parts of its radiological health regulations for radiation protection during medical procedures, certain records and reporting requirements for electronic products and performance standards for various radiological health devices, such as x-ray systems, lasers and ultrasonic therapy devices. “The Agency is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices,” FDA said in a Federal Register announcement.
FDA also classified two medical devices into class II (special controls) following de novo procedures that began in 2020. The newly classified devices are intense pulsed light devices for managing dry eye and computerized behavioral therapy devices for treating symptoms of gastrointestinal conditions.


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