This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more

Regulatory NewsRegulatory News | 12 November 2021 |  By 

Welcome to Week 2 of This Week at FDA. We've again gathered the week’s news from (and about) FDA. Each Friday, we'll be covering agency activities and enforcement actions, filings in the Federal Register, new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop shop for FDA updates.

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The House Committee on Oversight and Reform informed the consulting firm McKinsey late last week of the committee’s investigation into “McKinsey’s consulting services on behalf of industries causing public harm, the company’s conflicts of interest, and its apparent failure to monitor and prevent harmful practices.” McKinsey, says the letter, has advised Oxycontin maker Purdue Pharma as well as opioid distributors and retail pharmacies, while at the same time consulting for the US Food and Drug Administration (FDA) to the tune of over $140 million, “creating the potential for significant conflicts of interest.”
To address the deemed final order and proposed order for over-the-counter (OTC) sunscreen drugs, FDA plans a 15 December webinar that will give an overview of the regulatory history for sunscreens. Earlier that same day, the agency will offer a webinar giving a broad overview of FDA’s OTC monograph reform, highlighting deemed final orders and changes in OTC drug review after the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). 
FDA’s recent Coronavirus update details the agency’s new emergency use authorization for the iHealth COVID-19 Antigen Rapid Test for at-home use, and the issuance of the first 510(k) for the BioFire COVID-19 Test 2. The agency also authorized the release of two more batches of Johnson & Johnson’s COVID-19 vaccine manufactured at the troubled Emergent facility in Baltimore, Maryland. “While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues on this matter with Janssen and Emergent BioSolutions management,” wrote FDA. 
FDA’s acting chief, Janet Woodcock, gave opening remarks at the Association for Accessible Medicines’ 2021 GRx+Biosims Conference this week. “While our agency does not play a direct role in drug pricing, we can — by encouraging development of lower-cost generic and biosimilar products — support competition in the health care market,” said Woodcock. Read more coverage of the conference here
Enforcement corner
We saw two noteworthy warning letters this week. The first went to Infusion Options, whose Brooklyn warehouse had sterility problems including drugs “stored on the floor of a bathroom that appeared to be actively used as such,” along with labeling and current good manufacturing practices (CGMP) issues. For now, the firm has ceased operations. A contract testing laboratory also received a warning about its lax control over data acquisition systems, lack of an adequate audit trail, and lack of quality unit oversight for electronic lab monitoring operations. 
CBER’s Office of Compliance and Biologics Quality issued another untitled letter concerning unauthorized stem cell products this week. The recipients, owners of Colts Neck Stem Cells and Regenerative Medicine, drew FDA’s ire for advertising claims on its company Facebook page such as “KIDNEY DISEASE STEM CELL MIRACULOUS SUCCESS!” and “her chronic wound got better in 10 days after injecting stem cells...she avoided amputatio[n].” This is the 17th such letter issued this year; in April, CBER head Peter Marks said that the agency’s period of enforcement discretion against such infractions is coming to an end.
Other device news
FDA’s Center for Devices and Radiologic Health (CDRH) released a summary of the 2 November meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The panel considered the problem of Type III endoleaks with Endologix AFX endovascular graft systems. According to the summary, the panel believes that more clinical data are needed for full evaluation of the entire AFX family of devices. The sponsor’s current mitigation strategies were deemed inadequate to address the “clinically meaningful risk of Type III endoleaks,” though the panel stopped short of recommending that the device be withdrawn. 
In other device news, CDRH announced a class I recall for custom convenience kits marketed by Windstone Medical Packaging, because of a plunger defect in the Cardinal Health saline-filled syringe included in the kits. The agency also announced that it has updated its template for sponsors seeking an EUA for at-home COVID-19 tests.
From the journals
The behavior of the influenza virus has lessons to teach us about how we address vaccines against SARS-CoV-2, said the University of Michigan’s Arnold Monto in a New England Journal of Medicine editorial this week. “The successful public–private collaboration in selecting influenza strains offers a model for dealing with such issues,” wrote Monto, who has been the acting chair of FDA’s vaccines advisory committee through the COVID-19 pandemic. He added, “SARS-CoV-2 vaccines will be used globally, and the strain or strains contained in future vaccines will need to be chosen globally, in consultation with the manufacturers.”  
About 10% of all recent generic applications requested competitive generic therapy (CGT) designation, according to a JAMA research letter from Harinder Singh Chahal, of FDA’s Office of the Commissioner, and other FDA coauthors. “A sizable fraction of generic applicants requested CGT designation, and many drugs approved with CGT exclusivity eligibility marketed within 2.5 days after approval, which can benefit the health care system and patients,” according to the FDA officials.
A pair of studies led by Yale’s Joshua Wallach appeared this week in JAMA Network Open, examining FDA’s accelerated approvals from 2009-2018. Wallach and his colleagues found that real-world evidence could not easily be substituted for confirmatory postapproval clinical trials. These postapproval trials, though, don’t really last much longer than pivotal trials, calling into question one justification for allowing early approval based on surrogate endpoints. Our coverage of both studies is here
What we’re reading and watching
The Biden administration announced this week that it plans to invest an additional $650 million into expanding access to rapid diagnostic tests for COVID-19. The funds will be used “to ramp up US domestic manufacturing capacity,” by purchasing raw materials and finished tests, according to the announcement. The US Department of Health and Human Services is taking other actions to bring costs down and boost availability of rapid, over-the-counter COVID-19 tests.
The Duke-Margolis Center for Health Policy held its 13th annual Sentinel Initiative public workshop on 8 and 9 November. Topics addressed by FDA officials and other participants included how to improve causal inference for generation of real-world evidence, an update on work that’s being done to build robust evidence generation systems, and how Sentinel and FDA’s Biologics and Effectiveness Safety (BEST) systems have been used for near-real-time data gathering during the pandemic. The full workshop is now viewable on the Duke-Margolis center’s website.


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