This Week at FDA: MDUFA’s turn in Congress, another COVID vaccine adcomm, and more

This Week at FDAThis Week at FDA
| 25 March 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, we learn that the House Energy and Commerce committee will finally take up legislation to reauthorize the Medical Device User Fee Amendments (MDUFA) next Wednesday. Plus, we look at upcoming developments on COVID-19 vaccines and a much-anticipated advisory committee meeting on Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug.
 
This week, FDA finally released its commitment letter for the Medical Device User Fee Amendments (MDUFA V) agreement after a lengthy delay. Now, the House Energy and Commerce committee has announced a hearing on legislation to reauthorize the program. “Next week, we’ll hear from FDA and stakeholders on the importance of reauthorizing this successful program to maintain the agency’s gold standard review process, encourage technological innovation, and promote better patient outcomes,” said Committee Chair Frank Pallone (D-NJ) and Health Subcommittee Chair Anna Eshoo (D-CA).
 
FDA has also left a “save the date” on its website for a public meeting on 19 April to discuss the MDUFA V agreement.
 
The other big news of the week was FDA’s announcement of an advisory committee meeting next month to discuss a potential second round of boosters, as well as the selection of specific strains of the SARS-CoV-2 virus for vaccines targeting new variants. While both Pfizer and Moderna have submitted requests to authorize a second booster of their COVID-19 vaccines, the meeting will not address any “product-specific” applications, and no votes will be held. “Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat. Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward,” said Center for Biologics Evaluation and Research Director Peter Marks.
 
According to the Pink Sheet, FDA is “actively working” to fill the void left by Marion Gruber and Philip Krause, who departed the agency last year.
 
Drugs & biologics
 
On Thursday, we learned that FDA issued a complete response letter (CRL) for Eli Lilly and Innovent’s nonsquamous non-small cell lung cancer drug sintilimab in combination with pemetrexed and platinum chemotherapy. The rejection follows an advisory committee meeting last month that focused on the companies’ China-only clinical trial strategy. During the meeting, FDA officials and its advisors cast doubt on the strategy, with committee members voting 14-1 to recommend that new clinical trials be conducted to demonstrate applicability to US patients and medical care.
 
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet Wednesday to review Amylyx Pharmaceuticals’ new drug application (NDA) for its experimental ALS treatment sodium phenylbutyrate/taurursodiol powder for oral suspension, known as AMX0035. The meeting comes after a reversal from FDA after intense pressure from patients and advocates. Read more ahead of the meeting from the AP and Endpoints.
 
In other COVID-19 vaccine news, STAT reports that Moderna will ask FDA to authorize its mRNA vaccine in children between 6 months and 6 years of age.
 
We’re also reading about FDA’s move to press forward with plans to study consumer disclosures for drugs with accelerated approval in AgencyIQ, despite some concerns about the proposed research.
 
Medical devices
 
This week, FDA sent a letter to health care personnel advising them on strategies to conserve prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/flush syringes due to a shortage of the devices. The syringes have been added to FDA’s device shortage and discontinuance lists. The agency notes increased demand and a discontinuance of three SKUs from Cardinal Health, all of which were subject to a Class I recall last year.
 
FDA also announced a recall of certain Celltrion USA DiaTrust COVID-19 Ag rapid test kits labeled “for research use only” after the agency said some lots of the tests “were distributed to customers who would be unlikely to have used these tests for research use only and may not have the proper training to safely collect nasopharyngeal swab samples from people.” Additionally, it identified Philips Respironics’ recall of some of its V60 and V60 Plus ventilators as a Class I recall, due of the presence of expired adhesive that “could cause a capacitor support bracket to become loose and potentially damage the capacitors, which would cause the ventilator to stop providing ventilation to the patient,” and may not cause an alarm to sound.
 
We’re also reading that Google has submitted data to FDA in hopes clearing a new feature of its Fitbit smartwatch to passively monitor heart rate data for atrial fibrillation. More on that at The Verge.

 

© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

5;6;11;18;20;25;31;