This Week at FDA: EtO, user fee woes, and product specific guidances

This Week at FDAThis Week at FDA | 05 August 2022 |  By 

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 Environmental Protection Agency (EPA) said it would publish a new rule by year’s end that could have serious consequences for the ethylene oxide (EtO) sterilizers and the medtech industry; the head of the US Food and Drug Administration (FDA) tried to assure staff he’s doing all he can to ensure the user fee programs are reauthorized on time; and more.
The EPA this week published a list of EtO sterilization plants that may be associated with higher rates of cancer in neighboring communities. It also said it would publish a long-awaited rule by the end of the year that could force more EtO plants to shut down.
Following the EPA’s announcement Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH), published a statement on the work the agency has been doing to reduce reliance on EtO sterilization. He cautioned that half of all medical devices in the US are sterilized with the gas and restricting its use could have serious consequences for patients.
One of the biggest issues over the past few years has been reauthorization of the various user fee programs. While COVID-19 has been blamed for delaying negotiations between the FDA and industries, the hold-up now seems to be in Congress. FDA Commissioner Robert Califf tried to assure his staff that he’s doing his best to press lawmakers to pass a reauthorization bill before the programs expire and the agency may be forced to lay off user fee-funded employees.
Speaking during a webinar with the Alliance for a Stronger FDA, FDA Principal Deputy Commissioner Janet Woodcock said that the last time user fee reauthorization was delayed, it set the agency back 18 months in terms of restaffing.
Politico reports that Jane Henney, a former FDA commissioner, has been tapped by the Reagan-Udall Foundation to lead an FDA-requested external review of key agency offices on human food safety and tobacco regulation. The announcement comes amid heavy criticism of the FDA for its handling of the infant formula shortage.
Califf has repeatedly been cornered by lawmakers to finger FDA officials who dropped the ball in preventing the crisis – a demand he’s resisted by stating the matter is an ongoing investigation.
An ongoing priority for the Biden Administration and the FDA has been to increase trial diversity. A STAT News op-ed this week lays out the case for increasing trial diversity by arguing it can spur innovation and that lack of diversity costs billions of dollars.
This week the FDA made a strong push to raise awareness around the risks of breast implants. The agency updated several web pages and published information on studies about the risks associated with the plastic surgery.
More specifically, the FDA updated its web pages Things to Consider Before Getting Breast Implants, Medical Device Reports for Systemic Symptoms in Women with Breast Implants, and Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma so patients are better aware of the potential risks before getting breast implants.
The FDA also published a web page to update stakeholders on how COVID-19 tests may be affected as new variants of the SARS-CoV-2 virus take hold around the world. The agency says COVID-19 diagnostic tests are generally designed to detect all known variants though they are typically not able to identify the variant. Regulators say they are continuing to look into how specific test performance may be affected by known variants of the virus.
According to Medtech Dive, a new survey has found that while cybersecurity attacks are increasingly leading to negative consequences such as longer patient hospital stays and theft of patient data, hospitals are spending a very small portion of their budget on medical device cybersecurity.
Drugs & Biologics
It was a big week for announcements about generic drugs. FDA recently issued a draft guidance providing instructions for how generic drug manufacturers can electronically submit expedited individual case safety reports (ICSRs) for serious adverse events through the FDA Adverse Event Reporting System (FAERS).
The agency has published a new web page to update stakeholders on its most recent actions and activities related to complex generics. The website includes information on approvals, upcoming events, guidances and other resources.
The FDA also published a web page on upcoming product-specific guidances (PSG) for complex generic drug product development. It provides information on the active ingredients, the route of administration and dosage form, and the reference listed drug (RLD) application number for new PSGs complex generic drug products under development.
After weeks of being criticized for its handling of the monkeypox outbreak in the US, the Biden Administration finally declared it a public health emergency. The declaration means the FDA may now decide certain products could be allowed on the market to combat the outbreak under emergency use authorization (EUA) such as the ACAM2000 and Jynneos vaccines, and the TPOXX antiviral drug.


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