This Week at FDA: mRNA boosters for most; Blood lancets reclassified

Regulatory NewsRegulatory News | 19 November 2021 |  By 

Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates, the unveiling of Cures 2.0, and lots of device updates. As usual, we welcome feedback at
Friday morning, the US Food and Drug Administration (FDA) announced an expansion of the emergency use authorizations (EUAs) for the Pfizer and Moderna mRNA COVID-19 vaccines to include a third booster dose for all adults. Boosters had previously been authorized for all recipients of Johnson & Johnson’s one-dose vaccine and for certain older adults and those with comorbidities or occupational or environmental risk factors. 
"Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research, in a statement. The New York Times reports that the Centers for Disease Control and Prevention’s vaccines advisory committee also endorsed the boosters-for-most approach in a Friday afternoon meeting.
The Biden administration announced plans to buy 10 million courses of Paxlovid, Pfizer’s oral antiviral COVID-19 medication, making a $5.3 billion investment in the pills whose EUA is pending. Pfizer requested the EUA on the strength of clinical trial data showing that Paxlovid, when taken together with the HIV antiviral ritonovir, was 89% effective in preventing hospitalization or death in symptomatic COVID-19 patients at high risk. 
Last week, President Joe Biden announced he would nominate Robert Califf to serve as FDA commissioner for the second time. This week, we're reading more about Califf's path to confirmation, including his need for Republican support amid some Democratic opposition and the potential timeline (or lack thereof) for moving his nomination to a vote. (Biden nominates Califf as FDA commissioner, Regulatory Focus 12 November 2021)
We're also following the news that the House of Representatives narrowly passed H.R. 5376, known as the Build Back Better Act, this morning. The $1.75 trillion bill would provide FDA with $300 million for technology and laboratory infrastructure improvements across the agency.
In other Capitol Hill news, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday introduced their Cures 2.0 bill, which is packed with provisions that will impact FDA. (Long-awaited Cures 2.0 bill unveiled, Regulatory Focus 16 November 2021)
Lawyers for the Department of Justice told a court in Texas it would take to release some 330,000 pages of information related to FDA's review of Pfizer and BioNTech's COVID-19 vaccine in response to a suit from a group of researchers seeking access to the documents under the Freedom of Information Act.
Interested parties will have more time to comment on FDA's recent over-the-counter monograph proposed order for sunscreen products. The original comment period for the proposed order ended last week but FDA said it will reopen the comment period until 27 December 2021 to allow more time for the public to submit information related to the active ingredients and other conditions that have become available since 2019. (FDA unveils proposed changes to OTC sunscreen labeling, active ingredients; Regulatory Focus 24 September 2021)
FDA held a Friday workshop on best practices for development and application of disease progression models, hoping the forum will help participants to use these models “to support drug development decisions, share experiences and case studies that highlight the opportunities and limitations in the development and application of disease progression models,” according to FDA’s announcement. 
The biotechnology trade association BIO has launched a website to educate patients about “how clinical trials work, how to enroll in a clinical trial, and what to expect as a clinical trial participant,” according to BIO’s announcement. BIO hopes that the site, called “Clinical Trials: The Power of Participation,” will help boost both numbers and diversity of participants in clinical trials through providing “sound, science-based information.” 
Device news

FDA took final action in the Federal Register today to reclassify certain medical devices. First, FDA down-classified two types of hepatitis C virus (HCV) tests, nucleic acid-based HCV ribonucleic acid tests and HCV antibody tests, from class III (premarket approval) to class II (special controls). "Today’s action allows manufacturers of certain types of Hepatitis C virus (HCV) tests to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than submitting a premarket approval application (PMA), the most stringent type of FDA medical device review," said Timothy Stenzel, director of CDRH's Office of In Vitro Diagnostics and Radiological Health.
The agency also issued a final order to reclassify four types of blood lancets from class I (general controls) up to class II and class III. The types of blood lancets moving to class II include single use lancets with or without an integral sharps injury prevention feature, as well as multiple use lancets for single patient use only. Multiple use blood lancets for multiple patient use are being reclassified to class III and a PMA must be filed by 22 May 2024 for such devices to remain on the market.
EaseVRx, a new virtual reality (VR) system for the reduction of chronic low back pain, entered the market this week through the de novo pathway. The system, which also received breakthrough device designation, uses principles of cognitive behavioral therapy in a VR environment. Patients receive 56 VR sessions over the course of 8 weeks, along with other therapies; EaseVRx is available for home use by prescription. 
On Tuesday, FDA qualified a new medical device development tool that assesses the safety of medical devices in the magnetic resonance (MR) environment via a virtual evaluation process. Med Institute’s computational modeling and simulation tool can predict temperature rise and peak radiofrequency heating of devices placed into the MR environment through iterative simulations.
Cardiac perforation is a risk when leadless pacemakers are implanted, FDA reminded health care providers. Though the risk of perforation is similar with leadless and transvenous cardiac pacing, serious complications are more severe for those receiving leadless pacemakers, according to preclinical studies with Medtronic’s Micra leadless pacemaker, the only leadless pacemaker on the market in the US currently. Micra was placed on the market in 2016; of more than 300 reports of perforation received for the system, more than 90 have resulted in death, according to FDA. 
Citing a recently published article that addresses dosing errors in certain low dose tip (LDT) syringes, FDA concluded that “dosing errors are possible for both traditional syringes and the ENFit LDT syringes, depending on the filling and administration methods used.” The agency recommended that users continue to follow a list of recommendations to follow when using LDT syringes to optimize dose accuracy it first posted in October 2021.
Enforcement corner

An Indianapolis-based neutraceuticals firm was warned this week for failing to meet conditions required of drug compounders under section 503A of the Food, Drug & Cosmetics Act. A 2020 inspection found that Advanced Neutraceuticals, doing business as The Guyer Institute of Molecular Medicine, was operating in insanitary conditions: workers filled syringes and conducted aseptic processing with their bare hands, working in street clothes; the aseptic processing area had “difficult to clean and visibly dirty equipment or surfaces;” and, among other failings, the last environmental monitoring was completed in 2018. The firm may also have produced biological products without a biologics license application (BLA). 
Another firm, Jacksonville-based Matthew 7:25 Inc., doing business as Thrive Pharmacy, also ran afoul of 503A provisions, in part by producing phentermine capsules without valid prescriptions for individual patients. The December 2019 FDA inspection also turned up flavored buprenorphine troches with strengths differing from the labeled concentrations, and observed that some of the firm’s products “might be considered essentially copies of commercially available drug product,” potentially meaning they would fall outside of 503A provisions for compounders.


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