Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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 week, the FDA released a long-awaited over-the-counter hearing aid rule, we learned that the Biden Administration got some pushback from Bavarian Nordic for allowing smaller doses of their monkeypox vaccine and the UK became the first country to approve a bivalent COVID-19 vaccine.
Earlier this week, the Biden Administration announced with significant fanfare that the US Food and Drug Administration had created a new category of over-the-counter (OTC) hearing aids that it says will create more competition, lower prices of hearing aids and spur innovation. The rule comes after the agency was slow to move after being mandated to create the new category by Congress in 2017. Eventually, President Biden issued an executive order with a hard deadline to spur the regulators to develop the rule.
At the same time, the agency published a final guidance on personal sound amplification products (PSAP) where the agency delineates between hearing aids and devices that are often used for recreational purposes.
Drugs & Biologics
After the FDA issued an emergency use authorization (EUA) to stretch Bavarian Nordic’s Jynneos monkeypox vaccine, the company reportedly accused the Biden Administration of a breach of contract and threatened to stop future shipments of the vaccine, according to the Washington Post.
Robert Califf, FDA Commissioner, and Peter Marks, Center for Biologics Evaluation and Research Director, also wrote to Bavarian Nordic CEO Paul Chaplin outlining their rationale and the scientific evidence for the dosage and administration change. They acknowledged Chaplin’s concern for potential reactogenicity from intradermal injection of the vaccine but said that was taken into account when issuing the EUA.
But the shortage of the vaccine, initially developed for smallpox, isn’t something new. Politico reports, US officials have known for years they were severely understocked. According to anonymous government officials quoted in the story, the US Strategic National Stockpile should hold more than 120 million doses of Jynneos – enough to vaccinate more than 60 million people with the standard two-dose regimen. As of 2020, only about 21 million doses were on hand. Jynneos was included in the Strategic National Stockpile initially and primarily to address the possible need to vaccinate immunocompromised individuals – who cannot receive another vaccine called ACAM 2000 – against smallpox.
This week, the UK Medicines and Healthcare products Regulatory Agency became the first regulator to approve Moderna’s bivalent mRNA COVID-19 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 to approve bivalent COVID-19 vaccines and seem to be focused on ones that target the BA.4/5 subvariants which have become the dominant strains.
Regarding Moderna’s mRNA vaccines, Stat notes that at the start of 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 play catch up by recently partnering with the Cambridge-based startup Orna Therapeutics to develop mRNA-based vaccines.
In other pharmaceutical news, the FDA finally has announced meeting dates between 17-19 October to discuss withdrawing approval of Covis Pharma’s Makena, a drug intended to reduce premature births. As Endpoints News notes, Makena was first approved more than 10 years ago under the accelerated approval pathway; however, its confirmatory study failed to show the drug works. In 2020 CDER proposed pulling it off the market but the company seems to have drawn out the process pointing to meta-analysis data to support its drug though the FDA has been unphased.
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 isn’t for diagnosing a patient but allows licensed doctors to advise whether a person may have had a change in their vision to warrant seeing a physician 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, has found they are no better than traditional devices in helping patients reduce their blood pressure.
This week the FDA also alerted the public that autoinjector devices used with glatiramer acetate injection may not be compatible for use across all three FDA-approved products. The agency says it has received reports that using an autoinjector that is not compatible with the patient’s prescribed glatiramer acetate injection drug product has resulted in missed and partial doses.