This week at the FDA: New rule on over-the-counter hearing aids, Bavarian Nordics unhappy with Jynneos EUA

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Regulatory news

| August 19, 2022 | By Ferdous Al-Faruque

Welcome to another episode of This Week at FDA, your weekly source for updates — big and small — about the FDA, drug and medical device regulation, and what we’re reading on the web. This week the FDA issued a long-awaited rule on over-the-counter hearing aids, we learned that the Biden administration had been pushed back by Bavarian Nordic for allowing smaller doses of their vaccine against monkeypox and UK has become the first country to approve a bivalent covid19 vaccine.

Earlier this week, the Biden administration announced to great fanfare that the US Food and Drug Administration had created a new category of over-the-counter hearing aids that it says will create more competition, lower hearing aid prices and stimulate innovation. . The rule comes after the agency was slow to act after being mandated to create the new category by Congress in 2017. Eventually, President Biden issued an executive order with a strict deadline to urge regulators to develop the rule .

At the same time, the agency released a final guide to Personal Sound Amplification Products (PSAPs) where the agency distinguishes between hearing aids and devices that are often used for recreational purposes.

Medicines and biologicals

After the FDA issued an emergency use authorization (EUA) to expand Bavarian Nordic’s Jynneos monkeypox vaccine, the company reportedly accused the Biden administration of breach of contract and threatened to halt future shipments of the vaccine. vaccine, according to the Washington Post.

Robert Califf, Commissioner of the FDA, and Peter Marks, Director of the Center for Biologics Evaluation and Research, also wrote to Bavarian Nordic CEO Paul Chaplin outlining their rationale and the scientific evidence for the change in dosage and administration. They acknowledged Chaplin’s concern about the potential reactogenicity of intradermal injection of the vaccine, but said this was taken into account when issuing the EUA.

But the shortage of the vaccine, originally developed for smallpox, is not something new. Politico reports that US officials have known for years that they are severely undersupplied. According to unnamed government officials cited in the article, the US national strategic stockpile is expected to contain more than 120 million doses of Jynneos – enough to vaccinate more than 60 million people with the standard two-dose schedule. In 2020, only about 21 million doses were available. Jynneos was initially included in the national strategic stock and mainly to meet the possible need to vaccinate immunocompromised people – who cannot receive another vaccine called ACAM 2000 – against smallpox.

This week, the UK’s Medicines and Healthcare products Regulatory Agency became the first regulatory body to approve Moderna’s bivalent COVID-19 mRNA vaccine (mRNA-1273.214). The vaccine targets both the wild-type SARS-CoV-2 virus as well as the BA.2 Omicron variant and subvariants of the virus. The US and EU are still working on approving bivalent COVID-19 vaccines and appear to be focusing on those that target the BA.4/5 subvariants that have become the dominant strains.

Regarding Moderna’s mRNA vaccines, Stat notes that early in the pandemic, drug and vaccine giant Merck turned down an opportunity to partner with Moderna and has since been sidelined. in the race to develop COVID vaccines. However, the company is trying to catch up by recently partnering with Cambridge-based startup Orna Therapeutics to develop mRNA-based vaccines.

In other pharma news, the FDA finally announced meeting dates between Oct. 17-19 to discuss withdrawing approval of Covis Pharma’s Makena, a drug intended to reduce premature births. As Endpoints News notes, Makena was first approved over 10 years ago under the fast-track approval pathway; however, his confirmatory study failed to show that the drug works. In 2020, the CDER proposed to remove it from the market, but the company appears to have extended the process indicating meta-analysis data to support its drug although the FDA has not been in phase.

Medical equipement

Medtech Dive reports that the FDA has given 510(k) clearance to the visibly on-demand, self-administered visual acuity test allowing users to assess their vision online. The software is not intended to diagnose a patient, but allows licensed doctors to indicate whether a person may have had a change in their vision to warrant seeing a doctor in person.

While app-based heart monitors are all the rage these days, Medtech Dive also reports a new study from PCORnet, the National Patient-Centered Clinical Research Network, found they’re no better than traditional devices. to help patients lower their blood pressure.

This week, the FDA also alerted the public that self-injector devices used with glatiramer acetate injection may not be compatible for use in the three FDA-approved products. The agency says it has received reports that using an auto-injector that is not compatible with the patient’s prescribed glatiramer acetate injection medication has resulted in missed and partial doses.

© 2022 Society of Regulatory Affairs Professionals.


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