Regulatory Focus™ > News Articles > 2022 > 5 > This Week at FDA: Upcoming VRBPAC meetings, Califf on the Hill and ARPA-H gets official

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Posted 27 May 2022 | By Michael MezherFerdous Al-Faruque 

This Week at FDA: Upcoming VRBPAC meetings, Califf on the Hill and ARPA-H gets official

3746 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, FDA announced the dates for three upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings to review the Moderna and Pfizer/BioNTech vaccines for younger children, Novavax’s COVID-19 vaccine and SARS-CoV-2 strain composition for modified vaccines.
 
First on the agenda is VRBPAC’s 7 June meeting to review Novavax’s emergency use authorization (EUA) request for its vaccine in adults 18 and older.
 
The following week, the committee will reconvene on 14 and 15 June to review requests from Moderna and Pfizer/BioNTech to amend their EUAs to allow for younger children who have not previously been eligible for COVID-19 vaccination to receive a primary series of the vaccines. Moderna has requested FDA expand its EUA to infants 6 months of age to adolescents 17 years of age, while Pfizer/BioNTech are seeking to expand their authorization to infants 6 months of age to children 4 years of age.
 
On 28 June, VRBPAC will meet again to discuss “whether and how the SARS-CoV-2 strain composition of the COVID-19 vaccines should be modified.
 
On Wednesday, Robert Califf took heat from lawmakers on the agency’s response to the infant formula crisis during a House Energy & Commerce committee hearing. The New York Times reports that Califf told the committee about “egregiously unsanitary” conditions at Abbott Nutrition’s Sturgis, Michigan facility. Califf also owned up to the agency’s lacking response, telling the committee that “FDA’s timeliness of interviewing the whistleblower and getting into the facility for a for-cause inspection were too slow and some decisions could have been more optimal,” Reuters reports.
 
We also finally saw the demise of the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule, which was pushed through in the final days of the Trump administration. The rule, which cause most Department of Health and Human Services (HHS) regulations to expire if they are not reviewed every 10 years, was postponed earlier this year while HHS reviewed the claims made in a lawsuit seeking to stop the rule’s implementation. HHS has now withdrawn the rule in its entirety. “We no longer agree with our previous decision-making in promulgating the SUNSET final rule, because that decision-making was predicated on: (1) an inaccurate assessment of the effects of this rule, as indicated in the comments on both the SUNSET proposed rule and Withdrawal NPRM, and as discussed in the current RIA; (2) errors of law; and (3) a different set of policy priorities,” HHS said.
 
 
HHS Secretary Xavier Becerra on Wednesday announced the establishment of the Advanced Research Projects Agency for Health (ARPA-H) and named Adam Russell, who has extensive experience at the Intelligence Advanced Research Projects Activity (IARPA) and then at the Defense Advanced Research Projects Agency (DARPA), as its acting deputy director.
 
Drugs & biologics
 
FDA has extended the comment period on its proposed rule for national standards for licensure for wholesale drug distributors and third-party logistics providers by 90 days. Interested parties have until 6 September 2022 to submit comments to ensure they are considered.
 
The Center for Drug Evaluation and Research’s (CDER) Office of Generic Drugs (OGD) published an article this week discussing a recent analysis of how in vitro testing conditions impact aerodynamic particle size distribution (APSD) and droplet size distribution for commercial solution and suspension metered dose inhalers.
 
FDA recently also proposed new regulations that would amend current good manufacturing practice (CGMP) requirements and postmarketing safety reporting for certain medical gases. If finalized, the agency says the regulations would clarify what obligations various entities that manufacture, process, pack, label, or distribute certain medical gases have while also reducing regulatory burdens.
 
Medical devices
 
FDA plans to hold a number of meetings over the next two months including a public workshop 7-9 June on addressing medical device supply chain issues. As the US has faced product shortages during the pandemic, the agency says the meeting aims to bring stakeholders together to talk about how to work together to strengthen medical device supply chains.
 
In another class I recall associated with faulty catheter tips, FDA announced that Abbott is recalling certain lots of its Dragonfly OpStar imaging catheter because the marker band farthest from the catheter tip (proximal marker) may become loose and, in two instances, has been observed to separate from the catheter while being used on a person.
 
The Verifying Accurate Leading-edge IVCT Development (VALID) act contained within the Senate’s FDA user fee reauthorization bill is creating controversy between industry and consumer advocates. The legislation would give FDA broader authorities to regulate in vitro diagnostics, and in particular laboratory developed tests (LDTs). The proposed language, however, has medtech industry groups and patient advocacy groups at loggerheads, Medtech Dive reports. While industry groups want more flexibility for legacy diagnostics, patient advocacy groups are arguing for narrowing what diagnostics will be regulated to ensure high-risk tests don’t slip through the cracks.

 

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