A Nor’easter heads to the Nor’east. Autumn colors are appearing a bit tardy and a bit
muted. There are many little people in costumes. And already Christmas decor can be spotted in shops, to which one must turn a blind eye. Life goes fast enough. And the week went fast enough for me, including an 18-hour day yesterday, that meant no postings this week between Weekly Roundups, but we’ll aim for something better next week. In the meantime, here is a bit that happened worth noting:
- Gottlieb and the New Opioid Legislation – This week new legislation was signed into law – the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) – and Dr. Gottlieb took the opportunity to issue a statement to review the steps FDA has taken over the past 18 months with respect to confronting the crisis. He also took note of the new tools that the legislation provides across several domains, He noted that the agency would gain enforcement capacity with new authorities to stop illegal and unapproved drugs from entering the country through international mail facilities, allowing the agency to expand its efforts in those centers. In addition the agency will be able to prohibit future importation by any entity convicted of illegal importation of drugs. FDA gained authority to issue a mandatory recall for any controlled substance if there is a reasonable probability of a serious adverse health consequence, as opposed to the previous mechanism invoking voluntary recalls. In addition, FDA will be able to require specific packaging of opioids and other abuse/overdose related compounds that may discourage longer durations of use as well as enabling the agency to require mail-back return pouches for unused medications. Finally, the legislation will support FDA’s efforts at developing evidence-based guidelines as well as supporting the development of alternatives to opioids to address pain. A one-page summary of the bill can be found here, and a section by section summary here.
- FDA Allows Marketing of Menopausal Test – The agency announced this week that it had permitted the marketing of a Elisa diagnostic test that would serve as an aid in determining a patient’s menopausal status that could in turn result in prompt discussions about preventive care for women experiencing symptoms. That would include ways to prevent bone loss and approaches to address cardiovascular disease. The test measures the level of a hormone that serves as one indicator to assess whether a woman is approaching her final menstrual period, and is used in conjunction with other clinical assessments, unspecified in the FDA release. The test was reviewed through the de novo premarket review pathway for low-to-moderate-risk devices of a new type. The company press release can be found here.
Things to Keep an Eye on This Week
- October 29 – FDA Public Workshop – Clinical Trials to Optimize Outcomes in Early Breast Cancer
- November 1 – Joint Meeting of Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee – Consideration of NDA for treatment for major depressive disorder
- November 2 – Meeting of Psychopharmacologic Drugs Advisory Committee – Consideration of NDA for treatment of post partum depression
Regulatory Developments in Pharma/Biotech/Devices/Food