Regulatory Focus™ > News Articles > 2022 > 6 > This Week at FDA: FDA authorizes COVID vaccines for youngest children; Congress holds budget, pandem

This Week at FDAThis Week at FDA
Posted 17 June 2022 | By Ferdous Al-Faruque 

This Week at FDA: FDA authorizes COVID vaccines for youngest children; Congress holds budget, pandemic hearings

3113 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. It was budget week on the Hill and with that, we saw a number of hearings related to the FY2023 budget and pandemic funding. The biggest news of the week is FDA's authorization of two mRNA COVID-19 vaccines for children as young as 6 months of age. The authorizations comes after months of mounting pressure on the agency and a two-day advisory committee to review the vaccines' safety and efficacy in younger children.
 
On Tuesday, the Senate Health, Energy, Labor and Pensions (HELP) committee approved its version of the FDA user fee reauthorization bill to be brought up for a vote by the entire chamber. It includes a number of key riders and differs significantly from the House version. If passed by the full Senate, both bills will need to be reconciled in conference, with time quickly running out in the legislative year.
 
The Government Accountability Office (GAO) published a public health preparedness report specifically looking at the 2002 Animal Rule, which allows the FDA to approve medical countermeasures based on animal efficacy studies when clinical trials with human subjects are not ethical or feasible. Among the findings, the GAO says the FDA has issued guidance clarifying the types of studies and data needed to demonstrate product efficacy and has approved 16 medical countermeasures under the rule, of which 14 were approved over the past decade.
 
On the Hill
 
The HELP committee also held a contentious hearing this week during which Biden administration officials asked for additional COVID-19 funding, and the House Appropriations agriculture subcommittee forwarded an initial FDA funding bill to the full committee which is expected to be picked up next week.
 
On Monday, two top Democratic lawmakers, Sen. Amy Klobuchar (D-MN) and Rep. Katie Porter (D-CA), asked the Federal Trade Commission (FTC) to investigate whether Janssen and Bristol Myers Squibb illegally coordinated prices of two blockbuster blood thinners, according to a STAT report. The drugs, Eliquis and Xarelto, are reportedly the first and third most expensive pharmacy drugs for the Medicare program.
 
 
Drugs and Biologics
 
A number of former FDA commissioners who were part of a panel at the Food and Drug Law Institute annual conference on Tuesday said the agency needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. The comments come after the agency continues to feel the fallout from its decision to approve the Alzheimer's drug Aduhelm despite a negative recommendation from a panel of experts.
 
In addition to expanding the indications for COVID-19 vaccines, the FDA has published a manual on how it plans to implement a final guidance on the allowable excess volume of injectable drugs and biologics. The guidance tackles the allowable excess volumes during manufacturing of injectable drug products filled into vials and addresses the appropriate drug product net container content sizes for injectable drug products.
  
Regulators also published a draft guidance for consultation on quality risk management (QRM) that aligns with guidelines from the International Council for Harmonisation (ICH). The FDA says the harmonized framework for QRM would enable more effective and consistent risk-based decisions regarding the quality of drug substances and drug products.
 
Eli Lilly’s Olumiant (baricitinib) was approved by the FDA this week for treating alopecia areata, an autoimmune disease leading to hair loss. As reported by NBC News, the drug was originally approved in 2018 to treat rheumatoid arthritis.
 
Devices
 
The FDA’s Center for Devices and Radiological Health (CDRH) announced plans to study how patients weigh the benefits and risks associated with smooth and textured breast implants, including the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is more prevalent among patients with textured breast implants.
 
The agency said it is continuing to monitor the risk of infection associated with the use of water-based heater-cooler devices after a number of such devices were recalled last year. It says it will continue to engage with manufacturers, health care facilities, and public health experts in evaluating new design features for the devices.

The agency also published a draft guidance on non-clinical performance assessment of tissue containment systems used during power morcellation procedures. It includes recommendations for performance testing to support premarket submissions for gynecologic and general laparoscopic power morcellation containment systems.
 
The Apple Watch has been cleared by the FDA for additional indications to track Parkinson’s disease symptoms. Its StrivePD system uses Apple’s Movement Disorder API to collect data on tremors and dyskinetic symptoms of Parkinson’s, allowing patients to record their symptoms and keep tabs on their medication. The Apple Watch already has a number of de novo authorizations for heart conditions.
 
The FDA also finalized a guidance on what to consider when using quantitative imaging algorithms in radiological device submissions. While most imaging diagnostics rely on qualitative readings by trained physicians, imaging devices increasingly rely on quantitative imaging results using machine learning.

 

© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

2;5;6;9;11;18;20;24;25;31;