By JP Ellison – We previously posted (here and here) about the Supreme Court case that will be argued next month in which the parties are debating the proper interplay between the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and the Lanham Act. Briefly, the issue …
By Kurt R. Karst – It was only about a year ago when the topic du jour was generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic …
By John A. Gilbert, Jr. & Larry K. Houck – A bill introduced in the Maryland House of Delegates, HB 0596, would require wholesale distributors to notify their pharmacy customers at least thirty days prior to “imposing a limit on the quantity” of prescription drugs or …
By Anne K. Walsh – Yes, this post relates to yet another off-label settlement between a pharmaceutical company and the federal government. But some aspects of this recent settlement, coupled with other recent cases, might indicate noteworthy trends in how these cases are being resolved. The …
By Robert A. Dormer – Every breath you takeEvery move you makeEvery bond you breakEvery step you takeI'll be watching you Every single dayEvery word you sayEvery game you playEvery night you stayI'll be watching you Our apologies to Sting and The Police, but we were reminded of the …
By Allyson B. Mullen – On February 18, 2014, the FDA issued the Final Guidance “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” (the “Pre-Sub Guidance”). FDA, Guidance for Industry and FDA Staff, Requests for Feedback …
By Delia A. Deschaine & Larry K. Houck – In just shy of three months following receipt of the Department of Health and Human Services (“HHS”)’s rescheduling recommendation, see prior post here, DEA announced the issuance of a Notice of Proposed Rulemaking (“NPRM”) Thursday to reschedule all …
By Jay W. Cormier & Anne K. Walsh – It was a big day in January 2009 when FDA finally issued guidance for manufacturers governing the distribution of medical journal articles and reference publications. While some guidance was better than no guidance, FDA received several comments …
By Riëtte van Laack – Last week, FDA announced the long awaited proposal for revisions to the regulations (here and here) for the format and mandatory information included in the Nutrition Facts Box (“NFB”) and the Supplement Facts Box (“SFB”), and for the calculation of the …
By Kurt R. Karst – It’s “Exclusivity Week”! First there was FDA’s Draft Guidance that, if finalized, would reinterpret the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act to award NCE exclusivity to a newly approved Fixed-Dose Combination (“FDC”) drug containing an …
By JP Ellison – On February 25th, the Solicitor General’s Office weighed in on whether the Supreme Court should take up a case involving False Claims Act allegations arising out of alleged off-label promotion of a drug. The case is Nathan v. Takeda, and the United States …
By Riëtte van Laack – The Over-the-Counter (“OTC”) drug regulatory framework was established by FDA more than 40 years ago in the OTC Drug Review. The procedure was intended to lead to a monograph which described the active ingredients and conditions that are generally recognized as …
By Allyson B. Mullen & Jeffrey N. Gibbs – The end of 2013 marked the first anniversary of CDRH’s Refuse to Accept Policy for 510(k)s (the “RTA”). FDA, Guidance for Industry and FDA Staff, Refuse to Accept Policy for 510(k)s (December 2012). Therefore, we thought it …
By Wes Siegner – The following organizations filed joint comments on November 26, 2013 voicing strong opposition to the food provisions of FDA’s final IND Guidance and requesting that FDA reopen the comment period to permit comment on the food provisions of the guidance, which FDA …
By Ricardo Carvajal, Diane B. McColl & JP Ellison – The Center for Food Safety filed suit in the DC District Court challenging FDA’s allegedly “unlawful action of exempting substances that are [GRAS] from regulation as food additives under a proposed rule for more than fifteen …
