By Kurt R. Karst – The recent addition of numerous patents to the Orange Book covering various GlaxoSmithKline (“GSK”) drug products, such as VENTOLIN (albuterol sulfate), FLOVENT (fluticasone propionate), ADVAIR (fluticasone propionate; salmeterol xinafoate), and SEREVENT (salmeterol xinafoate), begs the question why? Many of the new patent …
By Dara Katcher Levy & Roger C. Thies – For the past several years, industry has relied on Warning and Untitled Letters to determine DDMAC’s “current” thinking on the presentation of risk information in various promotional pieces. On May 26, 2009, FDA issued a draft …
By William T. Koustas & Carrie S. Martin – On May 7, 2009, FDA announced that it is requiring both approved testosterone gel products to include boxed warnings on their labels and to implement a REMS. The two products are indicated for testosterone replacement therapy …
By Michelle L. Butler – On May 20, 2009, the President signed the Fraud Enforcement and Recovery Act of 2009 (“FERA”), which is purported to be aimed at improving enforcement of fraud, including fraud related to Federal assistance and relief programs. Among other things, this …
By JP Ellison – In a Memorandum to the heads of Executive Departments and Agencies dated May 20, 2009, with the Subject Line “Preemption” (the “May 20, 2009 Memorandum”), President Obama stated that “executive departments and agencies have sometimes announced that their regulations preempt State …
By Ricardo Carvajal – According to a DOJ press release, a federal judge has handed down a 63-month sentence to a seafood company president convicted of participating in a conspiracy to falsely label a certain type of fish from Vietnam to avoid paying federal tariffs. …
By Kurt R. Karst – The Washington Legal Foundation is publishing a Legal Backgrounder authored by Hyman, Phelps & McNamara, P.C., attorneys Robert A. Dormer and Kurt R. Karst. The article, titled “The Drug User Fee Catch-22,” argues that FDA should be more flexible in receiving and …
By JP Ellison – Today Attorney General Eric Holder and HHS Secretary Kathleen Sebelius announced the creation of a new interagency effort, the Health Care Fraud Prevention and Enforcement Action Team (HEAT), to combat healthcare fraud. Medicare appears to be the primary focus of the …
By David B. Clissold – FDA’s meeting guidance “Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products” was issued in final form in February 2000. On May 19, 2009, FDA released Revision 1 to that guidance, now entitled “Guidance for Industry: Formal …
By JP Ellison – On May 18, 2009 the U.S. Department of Justice and sixteen states announced that they had intervened in whistleblower (qui tam) lawsuits pending in federal district court in Massachusetts against drug manufacturer Wyeth, alleging false claims act violations under federal and …
By JP Ellison – We previously reported on the President’s FOIA Memorandum and the Attorney General’s FOIA Guidelines encouraging discretionary disclosure. Today, the D.C. Circuit handed the Administration a FOIA win that shows the importance of such discretionary disclosures, given FOIA’s exemptions. In CREW v. …
By Kurt R. Karst – On May 18th, the U.S. Senate confirmed (by voice vote) President Obama’s pick to head FDA – Dr. Margaret Hamburg. Among other things, Dr. Hamburg has worked extensively on bioterrorism issues. For six years in the 1990s, Dr. Hamburg served …
By Alan M. Kirschenbaum – The Senate Finance Committee released a white paper today outlining policy options that the Committee is considering to offset the cost of upcoming health care reform legislation. The proposed options include lifestyle taxes (e.g., alcohol excise taxes), reductions in subsidies …
By Kurt R. Karst & Frank J. Sasinowski – Earlier this week, we posted on a recent district court decision affirming the validity of a Patent Term Extension (“PTE”) for a patent covering an enantiomer of a previously approved racemate. The court’s decision relied heavily on …
By William T. Koustas, Dara Katcher Levy, and John R. Fleder – On April 28, 2009, Smoking Everywhere, Inc. (“SE”) sued FDA to “stop FDA from improperly exceeding its delegated authority by attempting to regulate electronic cigarettes” to the extent that FDA declared such products to …
