This Week at FDA: User fee reauthorization hits a snag, Novavax EUA, and more

Regulatory NewsRegulatory News
| 15 July 2022 | By Michael Mezher 

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, top Republican on the Senate health committee introduced a “clean” FDA user fee reauthorization bill that could throw a wrench into the already tight timeframe for the package. We also saw FDA authorize Novavax’s adjuvanted COVID-19 vaccine and learned that the agency has delayed its decision on whether to approve a BeiGene cancer drug due to domestic COVID-19 restrictions in China.
With little time remaining to reauthorize FDA’s user fee agreements, Senate Health, Education, Labor and Pensions (HELP) committee Ranking Member Richard Burr (R-NC) on Thursday introduced a “clean reauthorization” bill that strips out several riders from the bill that was advanced to the Senate floor last month. The move could imperil the reauthorization package, as HELP Chair Patty Murray and the leaders of the House Energy & Commerce Committee have voiced their opposition to Burr’s legislation.

Energy & Commerce Chair Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA) said in a joint statement that “[a]ny delay is unacceptable, especially after the House passed the bipartisan Food and Drug Amendments of 2022 more than five weeks ago by an overwhelming vote of 392-28. We urge Senate leaders to bring our strong bipartisan package to the floor for a vote before August. There is no reason for the Senate to reject the strongest and best path forward to ensure this reaches the president’s desk.”
On the appropriations front, CQ Roll Call reports that House Appropriations committee Chair Rosa DeLauro (D-CT) plans to pass all the House FY2023 appropriations bills ahead of the August recess. Roll Call notes that “bipartisan, bicameral appropriations negotiations have stalled,” and that Senate Appropriations Chair Patrick Leahy (D-VT) intends to release the Senate’s spending bills without markups by the end of the month.
One of the biggest announcements of the week was FDA’s authorization of Novavax’s adjuvanted COVID-19 vaccine in adults 18 and older. The agency has expressed hope that the vaccine, which relies on a more traditional platform than the mRNA vaccines developed by Pfizer/BioNTech and Moderna, will be more palatable to individuals who have held off on getting vaccinated so far.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so,” said FDA Commissioner Robert Califf.
Pharma & biotech
We also learned that FDA has completed its inspection of Bavarian Nordic’s Denmark facility where it makes Jynneos, which was approved in 2019 to prevent smallpox and monkeypox in adults, following a critical report in New York Magazine last week. Speaking to the Washington Post CBER Director Peter Marks said the inspection has wrapped up and that the agency is hoping to have some 800,000 doses of the vaccine delivered to the US by the end of the month.
Reuters reports that FDA was unable to conduct a preapproval inspection of BeiGene’s facility in China due to local COVID-19 travel restrictions, resulting in an indefinite deferral of the company’s application for its cancer drug tislelizumab. “We are working with our partner, Novartis, to facilitate the required inspections and bring tislelizumab to patients with second-line esophageal cancer in the U.S. following regulatory approval,” said BeiGene Chairman and CEO John Oyler.
Endpoints reports that Teva Pharmaceuticals has asked the Supreme Court to uphold the practice of “skinny labeling,” which is the marketing generic for only non-patented indications of a reference drug, following a Federal Circuit court ruling in February.
We also learned that FDA is has been asked to review the first over-the-counter (OTC) birth control pill that would be available to Americans. Perrigo subsidiary HRA Pharma said it applied for an OTC switch for its Opill (norgestrel) progestin-only oral contraceptive.


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