On June 21st, FDA announced an all-day public meeting dedicated to the Hatch-Waxman Amendments that will take place on July 18, 2017. The meeting, titled “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” is part of Commissioner Gottlieb’s Drug Competition Action Plan, which he …
Although both the U.S. House of Representatives and U.S. Senate are still in the midst of considering legislation – the FDA Reauthorization Act of 2017 (“FDARA”) (H.R. 2430 and S. 934) – to, among other things, reauthorize an alphabet soup of user fee programs, including …
Nevada has become the most recent state to enact a law addressing drug prices. S.B. 539, enacted on June 15, 2017, places new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”) related to diabetes treatments and health care provider (“HCP”) payments. Patient advocacy …
Our postings on the FDC Act typically focus on more straightforward applications of FDA’s regulation of the food and drug world. Drug development, patent dances, off-label promotion prosecutions, newly defined menu labeling—these are some of the many issues we associate with FDA’s activities. But since the …
On June 5th, 2017, the U.S. Supreme Court issued its opinion in Kokesh v. Securities and Exchange Commission. The Court unanimously reversed the Tenth Circuit’s decision below, and ruled that a five-year statute of limitations for the enforcement of “any civil fine, penalty, or forfeiture” …
As we previously reported, FDA recently extended the compliance date for its restaurant menu labeling regulations to May 8, 2018. Just one day before the previous (May 5, 2017) compliance date, FDA published an interim final rule (IFR) that delayed compliance for one year and …
On June 13th, FDA’s Office of Nutrition and Food Labeling “announced” that it intends to extend the compliance date for the new Nutrition Facts requirements. As we previously reported, FDA received several citizen petitions requesting an extension of the compliance date. In addition, some in …
In a relatively infrequent unanimous decision, the U.S. Supreme Court this morning (June 12th) interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) such that the biosimilar patent dance is not mandatory. As regular readers of the FDA Law Blog know, Amgen sued Sandoz for …
As readers of this blog know, natural claims have been and continue to be a frequent basis for consumer class actions. Initially, lawsuits appeared to focus on natural claims for foods (and dietary supplements). However, natural claims for personal care products also have become a …
As we previously noted, the intersection of exclusivity and off-label promotion issues is not common, but quite an interesting issue nevertheless. The intersection of these issues was raised earlier this year when Egalet Corporation (“Egalet”) issued a press release saying that the company had received …
On June 8, 2017, after a long mark-up session, the House Energy and Commerce Committee unanimously (54-0) passed H.R. 2430, the FDA Reauthorization Act of 2017 (“FDARA”). The Senate version of the bill, S. 934, passed out of the Health, Education, Labor, and Pensions Committee …
The Orange Book has undergone – and continues to undergo – a lot of change as a result of FDA’s October 2016 promulgation of final regulations (effective as of December 5, 2016) to implement parts of the December 8, 2003 Medicare Modernization Act (“MMA”). We …
Amgen Inc.’s (“Amgen”) nearly two-week-old lawsuit filed against FDA in the U.S. District Court for the District of Columbia challenging the Agency’s denial of a period of 6-month pediatric exclusivity under the Best Pharmaceuticals for Children Act (“BPCA”) (FDC Act § 505A) applicable to SENSIPAR …
Maryland will become the first state in the United States to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers. H.B. 631, 437th Gen. Assemb., Reg. Sess. (Md. 2017) (hereinafter, “the Bill”). The Bill was passed by the Maryland General Assembly on April 20, …
A recent letter from 65 members of Congress to FDA’s Commissioner Gottlieb has caused a bit of a buzz in the pharmacy compounding world. The letter, dated May 23, 2017, expresses the Congressional signers’ “strong disappointment” with FDA’s recently issued Final Guidance for Industry titled, …
