OPDP Says TV Ad is Out of Bounds with Fourth Untitled Letter of 2024
By Sarah Wicks & Dara Katcher Levy —FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. (AbbVie), for a direct-to-consumer...
View ArticleThe National Products Association Challenges FDA’s Interpretation of the...
By Riëtte van Laack —The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause...
View ArticleFDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
By Steven J. Gonzalez & Lisa M. Baumhardt, Senior Medical Device Regulation Expert —On August 22, 2024, FDA hosted a webinar to provide further guidance on the regulatory requirements it intends to...
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Happy 40th Anniversary Hatch-Waxman! We’re Celebrating By Providing Access to...
By Kurt R. Karst —Forty years ago today—on a sunny Monday, September 24, 1984 at approximately 3:30 PM Eastern Time in the Rose Garden at the White House—President Ronald Reagan signed into law Public...
View ArticleCDER Wants YOU to Tell It How to Improve the Integrated Review; We Have a Few...
By Deborah L. Livornese —FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using...
View ArticleA New Book on Hatch-Waxman – Breaking the Medicine Monopolies: Reflections of...
By Kurt R. Karst —In the Hatch-Waxman Community there are certain folks who are viewed as “the Founders” or pioneers of the law. There are, of course, the names Representative Henry Waxman and Senator...
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Knock, Knock. Who’s There? Breakthrough Device. Breakthrough Device Who?...
By Jennifer D. Newberger —We can all acknowledge that the title of this post is not that funny-at least, not to anyone other than medical device regulatory nerds, such as the author of this post. What...
View ArticleCMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties...
By Alan M. Kirschenbaum & Sophia R. Gaulkin —In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP),...
View ArticleVanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals,...
By Kurt R. Karst —If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda...
View ArticleIndeterminate Change: FDA Releases Draft Guidance on Predetermined Change...
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. Javitt —A recent draft guidance on predetermined change...
View ArticleFirst Constitutional Challenge to FDA’s Civil Money Penalty Authority
By JP Ellison & Anne K. Walsh —It took only 3 months. In June, the Supreme Court ruled that the SEC cannot use its administrative authority to impose civil penalties for securities fraud on the...
View ArticleA Temporary Extension for the Rare Pediatric Disease Priority Review Voucher...
By Mark A. Tobolowsky —The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence. Designed to incentivize the development of...
View ArticleNinth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments
By Steven J. Gonzalez —On September 27, 2024, in U.S. v. California Stem Cell Treatment Center, Inc., a Ninth Circuit panel unanimously held that a stem cell clinic’s Stromal Vascular Fraction (SVF)...
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Skinny-Label Lives to See Another Day
By Sara W. Koblitz —Further talks of the Skinny Label’s demise may be premature, as demonstrated by a new decision from the District Court for the District of Columbia upholding FDA’s interpretation of...
View ArticleBring Out Your Meds! Bring Out Your Meds!
By Larry K. Houck —Eric Idle, as a body collector, immortalized the phrase, “Bring out your dead! Bring out your dead!” in the 1975 comedy classic, Monty Python and the Holy Grail. The Drug...
View ArticleA Reversal on Sequencing? Proposed Legislation Would Allow Patenting of...
By Gail H. Javitt & Jeffrey N. Gibbs —A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic...
View ArticleHomeopathic Industry Group Wants Court to Exclude It From FDA’s Enforcement...
By John W.M. Claud & Deborah L. Livornese & Charles D. Snow —On October 21, 2024, the Alliance for Natural Health USA (“ANH”), and Meditrend Inc., a homeopathic drug company, filed a complaint...
View ArticleFDA Guidance Outlines a Framework for the Evaluation of Long-Term...
By Mark A. Tobolowsky —The neonatal period is a unique and complex period of rapid growth and development throughout the body, thus creating unique and complex challenges in medical product development...
View ArticleAs Jurisprudence Under Loper Bright Develops, Early Scorecard is Mixed
By John W.M. Claud & Sara W. Koblitz & JP Ellison —Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight to...
View ArticleFrom the Porcine to the Ridiculous to the Court of Appeals: Phibro’s Suit...
By Sara W. Koblitz & Charles D. Snow & Karla L. Palmer & John W.M. Claud —As we reported back in January, Phibro Animal Health Corporation challenged FDA’s decision to remove a drug called...
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