This Week at FDA: A busy week on the Hill, VRBPAC’s June meeting bonanza, and more

This Week at FDAThis Week at FDA
| 29 April 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 was a busy week for FDA in Congress, with hearings in both chambers touching on FDA’s user fee programs, FY2023 budget request, and more. We also saw FDA release a tentative schedule for several upcoming advisory committee meetings to discuss COVID-19 vaccines. Plus, we learned that Moderna has submitted an emergency use authorization (EUA) request for its vaccine in children under 6 years of age.
 
Earlier today, FDA announced that it is holding dates in June for several upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings to discuss some hot button issues related to COVID-19 vaccines. First, the committee is slated to discuss Novavax’s EUA request for its COVID-19 vaccine in adults on 7 June. The agency is holding three dates throughout the month for the committee to discuss extending the use of Pfizer and Moderna’s vaccines for younger children. On 28 June, the committee is set to meet again to discuss whether the  SARS-CoV-2 strain composition of vaccines should be modified in time for the fall.
 
We also got word that Moderna has submitted an EUA request to expand the use of its COVID-19 vaccine to children ages 6 months to 6 years of age. During his testimony on FDA’s FY2023 budget request, FDA Commissioner Robert Califf told the HELP committee the agency would move quickly to review the request. Previous reports suggested that FDA was considering waiting until it had a similar request from Pfizer in hand so it could potentially authorize both shots at the same time.
 
It was a packed week on the Hill, with FDA’s medical product center directors testifying before the Senate Health, Education, Labor and Pensions (HELP) committee on the agency’s user fee programs on 26 April.  Commissioner Califf appeared before the Senate Appropriations committee on 28 April to discuss the agency’s FY2023 budget request. The House Appropriations hearing on the agency’s FY2023 was originally slated for 27 April, though the hearing was postponed.
 
Other FDA-related hearings this week included a hearing on 27 April on consulting firm McKinsey’s conflicting work on FDA contracts while it was consulting for opioid makers, including Purdue Pharma, and the House Select Subcommittee on the Coronavirus Crisis’ hearing earlier today on political interference at federal health agencies during the pandemic. Health and Human Services (HHS) Secretary Xavier Becerra testified before the House Energy & Commerce committee on 27 April on the administration’s FY2023 budget request for HHS and all its sub-agencies.
 
CDER Director Patrizia Cavazzoni said the center is not currently contracting with McKinsey and that the agency anticipates “that further contracts will not be issued,” while investigations are pending.
 
Drugs & biologics
 
FDA has released data on its generic drug program performance for the first half of FY2022, as well as activity reports for the same period under Section 805 and 807 of the FDA Reauthorization Act.
 
CDER also posted a discussion with Darshini Satchi, deputy director of the Division of Information Disclosure Policy within the Office of Regulatory Policy about the center’s efforts to make materials public while complying with the Freedom of Information Act (FOIA) and other public disclosure laws.
 
CBER, meanwhile announced its annual Patient Engagement & Regenerative Medicine Meeting, which will be held on 24 May 2022.
 
Medtech
 
After a long wait, FDA finally released the meeting minutes for the remainder of its negotiation sessions with industry on the Medical Device User Fee Amendments (MDUFA V) agreement. Minutes for more than a dozen meetings held since last summer were posted this week after the center was criticized for failing to post them on time.
 
FDA issued several alerts about safety issues pertaining to specific medical devices this week. It warned that patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) system who appear to present with pump thrombosis may have a weld defect in their device. The advisory was sent to healthcare providers after Medtronic issued an urgent medical device correction about the issue.
 
Additionally, the agency advised healthcare providers of the risk of airway obstruction when using certain electromyogram endotracheal tubes marketed by Medtronic. The Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube are the only two silicone-based EMG on the market. FDA said it has received reports of “serious adverse events and deaths after airway obstruction for silicone-based EMG endotracheal tubes,” and has not received similar reports regarding PVC-based EMG tubes.
 
Medtronic also recalled its Harmony Delivery Catheter, which is part of its Transcatheter Pulmonary Valve (TPV) system due to the risk of capsule breakage during use. FDA notes that there have been “6 reported complaints from clinical cases, one injury, and no deaths associated with the use of these devices.”
 
In other recall news, FDA announced that Celltrion USA has recalled some point-of-care DiaTrust COVID-19 Ag Rapid Test Kits that have inadvertently been distributed to unauthorized users. The test should only be used by CLIA-certified laboratories.
 
CDRH also qualified the FACE-Q | Aesthetics patient-reported outcome (PRO) as a medical device development tool (MDDT) that can be used facilitate the evaluation of medical devices. The FACE-Q tool is intended to assess the outcomes of aesthetic facial procedures and is comprised of three modules: Self-Perceived Facial Appearance, Health-Related Quality of Life and Adverse Effects of Treatment.
 
The center also classified the autofluorescence detection device for general surgery and dermatological use into class II (special controls).

 

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