Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement activities affecting the broad cross-section of FDA-regulated industry. As the largest dedicated FDA law firm, we are happy to help you or your clients navigate the nuances of the laws and regulations affecting the industry.
Disclosure of Confidential Information
- A recent Supreme Court decision lowers the standard for the government to withhold from disclosure confidential commercial or financial information it receives from regulated industry. In their post, Anne Walsh and Ricardo Carvajal describe the impact that the Court decision will have on FDA-regulated entities who routinely submit this type of information to FDA.
- Douglas Farquhar discusses FDA’s power to exercise enforcement discretion. His post focuses on a recent court decision holding that FDA cannot delay or relax enforcement requirements mandated by the Tobacco Control Act, and must require manufacturers of tobacco and other nicotine products to submit applications to market those products.
- In this post by Frank Sasinowski and James Valentine, they highlight the approval of the first systemically administered somatic gene replacement therapy. The approval of Avexis’s Zolgensma (onasemnogene abeparvovec-xioi), for treatment of spinal muscular atrophy (SMA), is a milestone for personalized medicine that targets the root causes of genetic diseases using gene replacement.
- FDA finalized its guidance to assist biosimilar manufacturers to demonstrate interchangeability with a reference product. Sara Koblitz writes about activities since the draft guidance was issued in 2017 and the potential impact the final guidance will have on drug manufacturers seeking to establish interchangeability.
- PMA Panels
- Unique Device Identification (UDI)
Off-Label Promotion and Reporting Violations
- Anne K. Walsh and Adrienne Lenz describe the woes of a device manufacturer held accountable for civil and criminal violations related to its wound dressing product. Not only does this case highlight the steep penalties associated with reporting violations — a $3 million criminal fine in this case – but it also shows that off-label promotion remains a targeted area of interest for the government.
- Kurt R. Karst continues his coverage of the BLOCKING Act, legislation that could make 180-day exclusivity eligibility unpredictable for ANDA applicants. In this latest post, Karst details two alternative versions of the bill that could maintain the 180-day incentive, but would address FDA’s concerns about competition and pricing for drugs.
- Fraud and Abuse
Foods and Dietary Supplements
- Product Labels
- DMHA Regulation
DEA and Cannabis
- John Gilbert and Larry Houck describe proposed legislation that would compel DEA to issue more marijuana manufacturer registrations for research. Their post walks through federal regulation of studies involving the potential medical utility of marijuana and the current requirements for these manufacturers.