By David C. Gibbons & Alan M. Kirschenbaum – At 3 am on October 30, 2015, the Senate passed H.R. 1314, the Bipartisan Budget Act of 2015 (“BBA”), which had already passed the House on October 28, and is expected to be signed imminently by the …
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Hyman Phelps McNamara
- Bipartisan Budget Bill Extends Medicaid Drug Rebate Program Price Increase Penalty to Generic DrugsNovember 2nd, 2015
- Warning Letter? What Warning Letter? . . . Latest Developments in Pacira and a Look at FDA’s History of Withdrawing Warning LettersOctober 30th, 2015
By David C. Gibbons & Anne K. Walsh – Background In a previous post we described the recent challenge by Pacira Pharmaceuticals, Inc. (“Pacira”) to FDA’s authority to restrict a manufacturer’s promotional activities. See Pacira Pharms., Inc. v. FDA, No. 15-7055 (S.D.N.Y. Sept. 8, 2015). Pacira’s allegations …
- Using Bad Names: FTC Says FDA’s Naming Proposal for Biologics will Impede Competition from BiosimilarsOctober 29th, 2015
By James C. Shehan – On October 27th, the FTC submitted comments objecting to the FDA’s draft guidance on Nonproprietary Naming of Biological Products. In the comments and an accompanying press release, the FTC asserts that the proposal may reduce price competition in biologic drug markets, …
- FDA Publishes Interim Guidance on Compounding Using Bulk Drug Substances and Once Again Establishes a Time Period for Comments and NominationsOctober 28th, 2015
By Karla L. Palmer – FDA announced (here and here) earlier this week the availability of two draft guidances (here and here) for compounders using bulk substances under FDCA Sections 503A and 503B. FDA also published final guidance for compounders under Section 503A (see our previous post addressing that …
- Cross-Motions for Summary Judgment Filed in PRADAXA Patent Term Extension DisputeOctober 28th, 2015
By Kurt R. Karst – Hatch-Waxman Patent Term Extension (“PTE”) disputes never get old for this blogger. There’s often some new twist for FDA or the U.S. Patent and Trademark Office (“PTO”) to consider, as shown in a recent PTE denial for a patent concerning the …
- Do You Really Want to Be An Executive In An FDA-Regulated Company?October 26th, 2015
By James R. Phelps – Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer, reviewed enforcement policies that the Department of Justice will follow. Appropriate to the forum, he focused …
- Just One Letter Off: HP&M’s Karla Palmer to Speak at FBA Annual Litigation ConferenceOctober 26th, 2015
Join the Federal Bar Association (FBA) and its Federal Litigation Section on Tuesday, October 27 in Washington, DC for the Annual FBA Federal Litigation Conference! Expert panelists and judges will be discussing hot topics including but not limited to cyber security, electronic evidence, and tips …
- Congress Continues Spree of Proposing Alternative Incentives for Product Development: the Qualified Infectious Disease Tax Credit (Part 2)October 25th, 2015
By Kurt R. Karst – Last week we posted on one of two bills recently introduced in Congress that continues a trend to push for (or reward) new product development by offering an incentive different from the standard grants of patent and non-patent marketing exclusivities (S. 2055, the …
- DEA Considering Rulemaking on Suspicious Order ReportingOctober 23rd, 2015
By Larry K. Houck – Ruth Carter, Chief of the Drug Enforcement Administration’s (“DEA”) Office of Liaison and Policy Section, was among the presenters who addressed the 31st Annual Conference of the National Association of State Controlled Substance Authorities (“NASCSA”) this week in Scottsdale, Arizona. Ms. …
- Congress Continues Spree of Proposing Alternative Incentives for Product Development: the “CBRN Countermeasure PRV” (Part 1)October 22nd, 2015
By Kurt R. Karst – Last month we posted on a bill introduced in the U.S. Senate – S. 2041, the Promoting Life-Saving New Therapies for Neonates Act of 2015 – that would amend the FDC Act to add Section 530 to create a transferable “Neonatal …
- NEJM Study on Dietary Supplement Adverse Events Deserves Closer ScrutinyOctober 21st, 2015
By James R. Phelps & Wes Siegner – “Bad reactions to dietary supplements are sending thousands of Americans to the ER every year, a new study shows.” That’s the attention-getting lead in a CBS News story dated October 15. It was based on a study report …
- You Win Some, You Lose Some: Federal Circuit Denies En Banc Review in BPCIA Dispute & Otsuka Files Suit Over 3-Year ExclusivityOctober 19th, 2015
By Kurt R. Karst – Predicting the future is a tricky business. Predictions don’t often pan out, even when most or all of the indicators prognosticators use say something will (or will not) happen. We have a pretty decent track record of guessing how a case …
- A Long Overdue Revision to the Intended Use RegulationOctober 18th, 2015
By Jeffrey K. Shapiro – A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. The intended use of …
- HRSA Loses the Battle, and Maybe the War, Over the Orphan Drug RuleOctober 16th, 2015
By Jennifer M. Thomas & Michelle L. Butler – The U.S. District Court for the District of Columbia ruled decidedly in favor of PhRMA and against the government earlier this week in PhRMA v. HHS, No. 14-1685 (Oct. 14, 2015), potentially concluding a protracted fight between the Health …
- HP&M Adds Two FDA Attorneys to its RanksOctober 15th, 2015
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Jenifer R. Stach and Dr. Charlene Cho have joined the firm as associates. Ms. Stach works as a general practice associate and provides counsel on regulatory matters related to foods, over-the-counter drugs, medical devices, cosmetics, …