By Kurt R. Karst – Earlier this week, Senate Appropriations Committee Chair Senator Daniel Inouye (D-HI), released the text of the proposed Fiscal Year 2011 Omnibus Appropriations Act. The almost 2,000-page bill, if enacted, would fund the government until September 30, 2011. In addition to an …
By Kurt R. Karst – When we last left you in the battle over FDA’s approval of a generic version of sanofi-aventis U.S. L.L.C.’s (“sanofi’s”) blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection), Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia denied …
By Kurt R. Karst – Last Friday, Teva Pharmaceuticals USA, Inc. (“Teva”) filed its opposition brief to Apotex, Inc.’s (“Apotex’s”) Petition for Writ of Certiorari, which Apotex filed with the U.S. Supreme Court in October asking for a review of the U.S. Court of Appeals for …
By Riëtte van Laack – FDA published a proposed rule that would amend the regulation governing the use of health claims for phytosterols and coronary heart disease. In 2000, FDA issued an interim final rule ("IFR"), 21 C.F.R. § 101.83, for health claims concerning the relationship …
June Stephenson, a 37-year employee in FDA’s Office of Chief Counsel, will retire on December 31, 2010. Ms. Stephenson has been the principal secretary for every chief counsel at FDA since 1974. At a December 8th retirement party, her contributions were recognized by almost all …
By Susan J. Matthees – Last Tuesday, FDA announced the availability of final results from its experimental study of graphic cigarette warning labels. As we previously reported, FDA proposed 36 graphic warning images to accompany the health warning statement required under section 201 of the Family …
By Kurt R. Karst – Earlier today, the U.S. Supreme Court granted certiorari in three cases concerning generic drug preemption - PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501). As we previously reported, the petitions presented almost identical questions for the …
By Alan M. Kirschenbaum – Individuals may have their tax cuts extended, but a new tax on the drug industry is about to begin in 2011, and the IRS has issued a notice to implement it. As we explained in our summary of the Patient Protection …
This week, the Republican Steering Committee selected Congressman Fred Upton (R-MI) to succeed Congressman Henry Waxman (D-CA) as Chair of the House Energy and Commerce Committee in the next Congress. In August 2008, at the Democratic National Convention in Denver, Hyman, Phelps & McNamara’s Frank …
By Ricardo Carvajal – The D.C. Circuit Court of Appeals upheld the D.C. District Court’s grant of an injunction that bars FDA's regulation of e-cigarettes as drug/device products absent claims of intended use to that effect (for our prior posting on the district court decision, see …
The Washington Legal Foundation recently published an article written by HPM attorneys, Ricardo Carvajal and Nisha P. Shah, on the February 2010 Government Accountability Office ("GAO") report that criticized FDA's general oversight of uses of ingredients that are generally recognized as safe (“GRAS”) and the agency's …
By William T. Koustas – The Red Flags Rule (“the Rule”) requires entities covered by it to establish and implement an identity theft prevention program. We have been following this issue for some time now and have previously reported that the FTC last delayed enforcement of …
By Kurt R. Karst – Speculation was running high that the U.S. Supreme Court would be petitioned on whether a patent settlement agreement (what opponents call “pay-for-delay” agreements or “reverse payments”) involving manufacturers of Ciprofloxacin HCl (CIPRO) is per se lawful under the Sherman Act after …
By Ricardo Carvajal – As required by its Good Guidance Practices regulation, FDA published its annual guidance document agenda and request for comment on “possible topics for future guidance document development or revisions of existing [guidance documents].” Among the food-related topics that caught our eye are new …
By Kurt R. Karst – Does “federal law, which imposes a strict set of labeling requirements on manufacturers of Final Monograph [Over-the-Counter (‘OTC’)] drugs, including mandatory product warnings authored by the FDA, [preempt] state-law product liability actions premised on theories of failure to warn[?]” That is …
