By Kurt R. Karst – A recent article published in Roll Call, titled “Hatch-Waxman Act’s Interpretations Threaten Lives, Jobs,” caught our attention. The article was penned by Delegate Donna Christensen (D-VI) (who is chairwoman of the Congressional Black Caucus Health Braintrust) and expresses the strong support …
By Jamie K. Wolszon – FDA announced earlier this week the publication of a much-anticipated draft guidance on in vitro companion diagnostic devices. In the draft guidance, FDA stakes out a policy position that if safe and effective use of a therapeutic depends on a diagnostic, …
By Nisha P. Shah – Under a bill titled, “An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law,” the State of Maine repealed three laws related to the reporting of marketing costs, price reporting, and the disclosure of clinical trials by manufacturers …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) on July 6, 2011 seeking to raise initial registration and renewal fees for all registrants. 76 Fed. Reg. 39,318 (July 6, 2011). Citing increased diversion control activities, DEA justified …
FDA Law Blog has learned that Elizabeth H. Dickinson, who currently serves as Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, will serve as FDA’s Acting Chief Counsel effective on August 7th. As we previously reported, FDA’s current Chief Counsel, Ralph Tyler, recently …
By Dara Katcher Levy – On July 5, 2011, seven pharmaceutical companies submitted a joint Citizen Petition requesting that FDA clarify its policies for industry about four distinct types of manufacturer-communications that often deal with off-label information – Manufacturer Responses to Unsolicited Requests; "Scientific Exchange"; Interactions …
By Kurt R. Karst – A recent article in The RPM Report concerning the apparent fate of the only Priority Review Voucher (“PRV”) issued to date by FDA caught our attention. Kudos to The RPM Report team, which took note of some statements made during a …
By Riëtte van Laack – Last week, Senator Richard Durbin (D-IL) introduced “the Dietary Supplement Labeling Act of 2011” (S. 1310). The bill proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to “improve the safety of dietary supplements.” Durbin’s bill includes a …
By Kurt R. Karst – Earlier this week, Judge Joel A. Pisano of the U.S. District Court for the District of New Jersey issued a 19-page decision in Nostrum Pharmaceuticals, LLC. v. FDA denying the injunctive relief sought by Nostrum in a Complaint and a Motion …
By Anne K. Walsh & John R. Fleder – Companies must proactively prepare for the strong arm tactics the government employs to investigate companies regulated by FDA. A recent case demonstrates that the federal government can act with little regard to companies seeking to represent themselves by …
By Riëtte van Laack – The Food Safety Modernization Act ("FSMA") required that FDA, within 180 days of enactment of the FSMA, publish guidelines clarifying the definition of a new dietary ingredient ("NDI") and requirements for NDI notifications. FDA just made that deadline when it released …
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
By Peter M. Jaensch – On June 29th, 2011, the Washington Legal Foundation (“WLF”) filed an amicus curiae brief in Friedman v. Sebelius, currently pending in the U.S. Court of Appeals for the D.C. Circuit. WLF argues that excluding executives convicted of misdemeanor offenses under the …
By Kurt R. Karst & Jeffrey K. Shapiro – French company PREVOR has filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s determination that PREVOR’s Diphoterine® Skin Wash (“DSW”) is a drug-device combination product with a “drug” primary mode of …
About 18 months after coming to FDA to serve as Chief Counsel, Ralph Tyler will be leaving the Agency, according to an FDA-wide e-mail sent out on June 30th by FDA Commissioner Margaret Hamburg. Prior to joining FDA, Mr. Tyler served as Insurance Commissioner of …
