This Week at FDA: Inspections restart, Califf making the rounds, and more

Regulatory NewsRegulatory News | 04 February 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. This week, we look at some of the emerging news impacting Robert Califf’s nomination to be FDA commissioner, plus some new reports from FDA on drug safety, clinical pharmacology, and its strategic priorities for CDRH.
 
Earlier today we heard from an FDA official that the agency will be resuming its routine domestic surveillance inspections starting Monday. FDA has halted much of its inspectional activities since late December due to the omicron variant. The agency has since put out a statement to that effect.
 
FDA’s lack of a permanent commissioner has weighed on the minds of many over this past year, but that doesn’t guarantee that we’ll see a smooth confirmation process. The New York Times wrote that Califf faces a “steep climb” to assume the role, and both STAT and Politico reported on pledges Califf made in the last week to Sens. Ron Wyden (D-OR) and Elizabeth Warren (D-MA) to try to secure their support. According to Wyden, Califf reportedly said he would “take strong action to hold companies accountable for producing the required scientific evidence after obtaining accelerated approval,” if confirmed, while Politico reports that Califf committed to a more stringent ethics pledge to nab Warren’s support.
 
This was a big week for FDA-related reports. FDA itself put out several reports, including CDRH’s annual report and strategic priorities through 2025 (more on that to come), as well as annual reports on CDER’s drug safety priorities and clinical pharmacology.
 
This week, the House officially kicked off the user fee reauthorization process by holding the first congressional hearing on the reauthorization of FDA’s human drugs and biosimilars user fee programs, with testimony from two of FDA’s center directors and top industry officials. Read more on the hearing here.
 
Speaking of the House, the America COMPETES Act passed in the lower chamber today. The bill contains several provisions that would impact FDA and the pharmaceutical industry if passed, including giving FDA mandatory drug recall authority and expanding the use of advanced and continuous manufacturing.
 
Drugs & biologics
 
In the drugs and biologics space, FDA issued several draft and final guidances this week. The guidances cover population pharmacokinetics, formal meetings with OTC sponsors, assessing pressor effects of drugs, immunogenicity labeling, and an immediately effective guidance on nonclinical considerations for mitigating nonhuman primate supply constraints during the pandemic. We’ll have more coverage of some of those guidances next week.
 
In other major news this week, FDA has proposed rules for licensing standards for wholesale drug distributors and third-party logistics providers (3PLs) after years of delays.
 
Per a safety communication from FDA on Thursday, the agency is investigating a possible increased risk of death associated with TG Therapeutics’ lymphoma drug Ukoniq (umbralisib). FDA identified the potential risk while evaluating a clinical trial in a related type of cancer. “Because of the seriousness of this safety concern and the similarities between the two types of cancer for which this drug is approved and the type of cancer that was studied in the clinical trial, we are alerting patients and health care professionals that we are re-evaluating this risk against the benefits of Ukoniq for its approved uses,” FDA wrote. The agency has suspended enrollment of new patients in other studies of the drug and said it may hold a public meeting to further discuss the findings and the drug’s continued marketing.
 
FDA also announced it will host a webcast on 16 March to discuss the FDA-EMA parallel scientific advice program and present the agencies’ five-year review of the program.
 
Medical devices
 
FDA is extending the comment period on its recent guidance on notifying the agency about medical device shortages under the new authority granted to the agency under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
 
The agency also issued classification orders for four types of medical devices into class II (special controls), including alternate controller enabled infusion pumps, carbon dioxide gas controlled tissue expanders, photoplethysmograph analysis software for OTC use, and systems for detection of microorganisms and antimicrobial resistance using reporter expression.
 
What we’re reading
 
The Reagan-Udall Foundation for the FDA published a report today that looks into the lessons learned about the clinical evaluation of therapeutics for COVID-19. The 21-page report is based on discussions from a workshop last September. Some of the key recommendations of the report include advanced planning to ensure effective clinical trial design and building out clinical trial infrastructure that can readily shift to conducting pandemic research.
 
We also read this viewpoint in JAMA Internal Medicine about the practice of extending pharmaceutical monopolies by patenting safer uses for drugs. “Rather than simply patenting a drug’s active ingredient, formulation, or therapeutic uses, some companies have also obtained patents on how to safely use the therapy, such as dosing strategies aimed at reducing adverse effects in certain groups of patients. These patents may delay generic entry if the FDA insists that such safety information remain on the label, regardless of whether the information is clinically meaningful,” the authors of the viewpoint write.

 

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