By Kurt R. Karst – Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who, Star Wars, and, of course, Star Trek. I remember well the voyages of the starship Enterprise under the …
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Hyman Phelps McNamara
- Generic and Innovator Drugs: The Next GenerationMay 7th, 2013
- FDA Releases Third Annual Report on the Reportable Food RegistryMay 6th, 2013
By Ricardo Carvajal – FDA’s third annual report on the Reportable Food Registry (RFR) confirms the major patterns observed in the first two annual reports: foodborne pathogens and undeclared major food allergens (MFAs) continue to account for the vast majority of RFR entries (Salmonella accounted …
- FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing DebateMay 5th, 2013
By Kurt R. Karst – By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District …
- False Friends: FDA’s “Gift” on NESINA – Present or Poison? It May Depend on Which Hatch-Waxman Language is SpokenMay 3rd, 2013
By Kurt R. Karst – Frau Rommelfanger’s seventh grade German class: that’s where we first learned to appreciate “false friends,” which are pairs of words or phrases in two languages that look or sound alike, but differ significantly in meaning. Never write the word “gift” …
- Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with CautionMay 1st, 2013
Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention. FDA recently issued a warning letter to a company that …
- FDA to Reconsider Approval of Generic BAYTRIL; Court Gives Importance to Unresolved Citizen Petition; Will the Decision Affect FDA Petition Procedures?April 30th, 2013
By Kurt R. Karst – Bayer HealthCare, LLC’s (“Bayer’s”) court challenge to FDA’s approval of Abbreviated New Animal Drug Application (“ANADA”) No. 200-495 submitted by Norbrook Laboratories, Ltd. (“Norbrook”) for Enroflox™ 100, a generic version of Bayer’s fluroquinolone animal drug Baytril® 100 (enrofloxacin) Injectable Solution, …
- HP&M Announces that Joseph Cormier has Joined the Firm as an AssociateApril 30th, 2013
Hyman, Phelps & McNamara, P.C. is pleased to announce that Joseph (“Jay”) W. Cormier, J.D., Ph.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Cormier served as a pharmacologist in the Animal Biotechnology Interdisciplinary Group in FDA’s Center for Veterinary …
- Senate’s HELP Committee Releases Draft Compounding Legislation; Seeks Stakeholders’ Written Comments by May 3, 2013April 29th, 2013
By Karla L. Palmer – The Senate’s Health, Education, Labor and Pensions (“HELP”) Committee released draft legislation on Friday, April 26, 2013, that would replace section 503A of the Federal Food, Drug & Cosmetic Act (“FDCA”), amend other sections, and clarify FDA’s authority to regulate …
- DC Circuit Rules for FDA in SEROQUEL Exclusivity Case; AstraZeneca Not Entitled to 3-Year ExclusivityApril 29th, 2013
By Kurt R. Karst – In a brief opinion handed down last week by the U.S. Court of Appeals for the District of Columbia Circuit, the Court affirmed a July 5, 2012 decision from the U.S. District Court for the District of Columbia granting summary …
- Court Rules that FDA has the Inherent Authority to Rescind a 510(k) Substantial Equivalence Determination if It Does so Within a Reasonable Period of TimeApril 28th, 2013
By Carmelina G. Allis – As we previously reported, ReGen Biologics, Inc. ("ReGen"), which has been acquired by Ivy Sports Medicine, LLC ("Ivy"), filed suit in 2011 challenging FDA’s authority to rescind the 2008 510(k) substantial equivalence determination for the company’s “Menaflex” product, a collagen …
- Tracking and Tracing Congress’ New Track and Trace BillsApril 25th, 2013
By Jessica A. Ritsick & William T. Koustas – Within the last week, members of health committees in the House and Senate unveiled draft bills addressing prescription pharmaceutical supply chain security. The House Energy & Commerce Committee is set to hold a hearing on the …
- HP&M’s Jeff Shapiro to Speak at Harvard Law/Petrie-Flom Center Annual Conference on FDA in the 21st CenturyApril 25th, 2013
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is is holding its annual conference on Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts. This year, the conference will focus on FDA and is titled …
- Court Rules in Novel False Claims Act Case Where One Pharmaceutical Company Sues AnotherApril 24th, 2013
By Delia A. Stubbs – The U.S. District Court for the Central District of California issued a ruling last week in an unusual, if not unprecedented, case arising from alleged federal False Claims Act (“FCA”) violations where one drug manufacture has sued its competitor. In Amphastar …
- FDA Held In Violation of APA for Delay in Issuing FSMA RegulationsApril 24th, 2013
By Ricardo Carvajal – The U.S. District Court for the Northern District of California granted summary judgment to the Center for Food Safety and Center for Environmental Health in their lawsuit (see our previous post here) alleging that FDA’s delay in issuing regulations to implement …
- FDA Proposes to Harmonize Medical Device LabelingApril 22nd, 2013
By Jennifer D. Newberger – FDA is proposing to amend the medical device labeling requirements to allow for use of internationally recognized stand-alone symbols explained in an accompanying symbols glossary. The symbols glossary would include a list of each symbol used in the device labeling and …