This Week at FDA: Congress to begin work on user fee reauthorization next week

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 learn the next step in the process to reauthorize some of FDA’s user fee programs, look at a couple newly finalized guidances and read the latest murmurs about Robert Califf’s nomination to lead FDA.

The next stop on the road to the reauthorization of (some) of FDA’s user fee programs is set. The House Energy & Commerce committee announced on Thursday that it will hold a hearing on 3 February to discuss the reauthorization of FDA’s user fee programs for prescription drugs, generics and biosimilars -- PDUFA, GDUFA and BsUFA. Notably, the medical device user fee program – MDUFA – was left off the list. FDA missed the deadline to submit the MDUFA package to Congress as it has failed to reach an agreement on the package with industry.

Drugs and biologics

In an email earlier this week, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni announced that Grail Sipes, deputy center director for regulatory policy at CDER, will be detailed to the White House Office of Science and Technology Policy (OSTP) beginning 7 February to work on biomedical regulatory policy for the administration.

“In this role, Grail will provide biomedical regulatory policy leadership to help coordinate OSTP health and life science priority issues, including pandemic preparedness, digital health and health equity,” Cavazzoni said.

Elizabeth Jungman, director of the Office of Regulatory Policy, “will serve as the center’s primary representative for broad policy matters and issues across CDER,” following Sipes’ departure. Jungman is also charged with overseeing the agency’s strategy for user fee reauthorization.

FDA has released the first quarterly data for its FY2022 GDUFA II performance metrics, which includes the number of abbreviated new drug applications (ANDAs) awaiting FDA action, awaiting final approval after receiving tentative approval and those awaiting applicant action.

The agency also finalized guidance on the technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH), which currently has no approved treatments.

In compounding news, FDA has officially added the first four substances to its 503B Bulks List, which lists bulk drug substances that can be used to compound drugs in an outsourcing facility: diphenylcyclopropenone (DPCP) for topical use only, glycolic acid for topical use only in concentrations up to 70 percent, squaric acid dibutyl ester (SADBE) for topical use only and trichloroacetic acid (TCA) for topical use only. The agency also identified eight substances that will be excluded from the list: diazepam, dipyridamole, dobutamine hydrochloride (HCl), dopamine HCl, edetate calcium disodium, folic acid, glycopyrrolate and sodium thiosulfate (except for topical administration).

FDA also announced an upcoming meeting on electronic submissions and data standards that will be held on 12 April 2022.

And, Orange Book aficionados will want to take a look at the latest annual update of the publication, now in its 42^nd edition.

Medical devices

Nearly three years after issuing a draft version, FDA has finalized its guidance explaining the principles of premarket pathways for combination products. The guidance offers insights on how the agency regulates and reviews combination products, as well as recommendations for determining which type of submissions to pursue. The final guidance has been revised to clarify its applicability across combination product types and provides more details about interacting with the agency.

Earlier this week, FDA released its third annual report on its Accreditation Scheme for Conformity Assessment (ASCA). The report details the pilot program’s progress in 2021 and next steps going forward.

FDA is also extending the comment period on its recent guidance on assessing the credibility of computational modeling and simulation used in medical device submissions through 24 March 2022.

Two device recalls were identified as Class I this week, one recalling some 95,000 units of Medtronic’s HawkOne directional atherectomy system due to the risk of tip damage and the other for Philips Respironics’ Trilogy Evo Ventilators distributed between 15 April and 24 May 2021.

In other device-related news, the Environmental Protection Agency (EPA) announced on Wednesday that it will reconsider a recent rule for chemical plants, and in the meantime will “continue to rely on the agency’s 2016 peer-reviewed value” for ethylene oxide emissions, rather than the Texas Commission on Environmental Quality’s risk value.

What we’re reading

Pfizer has asked to be involved in the FDA’s release of hundreds of thousands of pages of documents related to its review of Pfizer’s COVID-19 vaccine Comirnaty, Reuters reports. Earlier this month, US District Judge Mark Pittman ordered FDA to hasten the release of those documents. According to Reuters, Pfizer’s lawyers want to ensure FDA doesn’t release its trade secrets or confidential commercial information, and that FDA is open to the opportunity.

Our colleagues over at Agency IQ have written a great rundown of the FDA-related provisions of the discussion draft for a bill, dubbed the PREVENT Pandemics Act, intended to strengthen the country’s pandemic preparedness and response to future pandemics.

We’re also reading in Politico that Robert Califf’s nomination for FDA commissioner might be in jeopardy, as he faces skeptical Democrats – five of whom have said they will oppose his nomination – and Republican opposition fueled in part by the agency’s recent moves to ease restrictions on the abortion drug mifepristone.

STAT News sat down with Acting FDA Commissioner Janet Woodcock this week and asked her about the agency’s decision to limit the use of two COVID-19 monoclonal antibodies that have proven ineffective against the omicron variant and pediatric vaccines.

Enforcement corner

This week, FDA released the Form 483 and establishment inspection report it handed to Emergent BioSolutions’ Winnipeg, Manitoba, Canada facility in September 2019. The 483 lists a single observation, citing a deficiency in following procedures designed to prevent microbiological contamination of sterile drug products.

FDA also released a warning letter sent to Chino, California-based firm Health Plus, Inc., citing the company for ensuring that returned drugs meet appropriate standards before being redistributed and other issues related to its test methods and written procedures.

This Week at FDA: Congress to begin work on user fee reauthorization next week

Related topics

Recommended content

Welcome to the new RAPS Digital Experience