On July 15, 2008, FDA issued a final rule exempting investigational drugs used in phase 1 studies (as described in 21 C.F.R. § 312.21 of FDA’s IND regulations) from the Current Good Manufacturing Practice (“CGMP”) requirements in 21 C.F.R. Part 211. This exemption does not …
When Congress enacted the Federal Food, Drug, and Cosmetic Act (“FDCA”) in 1938, it required New Drug Applications (“NDAs”) for “any” new drug. At the time, approximately half of the drugs in this country were compounded, not manufactured. Today, while the percentage of compounded prescriptions …
On July 18, 2008, in a rare “win” (depending on which side you are on) on a motion for reconsideration, the U.S. District Court for the Southern District of Indiana (Indianapolis Division), vacated the court’s September 2007 decision in Tucker v. SmithKline Beecham Corp., in …
On June 10, 2008, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) announced the release of a newly revised version of the “Code on Interactions with Healthcare Professionals,” which is a voluntary code focusing on the industry’s interactions with healthcare professionals as they relate to …
On June 26, 2008, ranking Republican of the U.S. House of Representatives Energy and Commerce Committee, Representative Joe Barton (R-TX), along with several co-sponsors, introduced the “Strengthening of FDA Integrity Act of 2008” (H.R. 6378). According to an Energy and Commerce Committee Republicans press release, …
On June 11, 2008, the Accreditation Council for Continuing Medical Education (“ACCME”) issued for comment a proposal “that the commercial support of continuing medical education end.” The proposal is intended to provoke debate on whether unbiased CME is possible when funded by individual pharmaceutical or …
On June 27, 2008, the District of Columbia Department of Health proposed regulations to implement Title 1 of the SafeRx Amendment Act of 2008 (“SafeRx Act”), which FDA Law Blog previously reported on in January 2008. Under the proposed regulations, pharmaceutical detailers in the District …
Are state law personal injury suits against drug and device manufacturers preempted by federal regulation of these products? This question has been the subject of much litigation since the early 1990s. The U.S. Supreme Court has issued a string of decisions in this area, with one …
On April 3, 2008, Representatives Frank Pallone, Jr., (D-NJ), Chairman of the House Energy and Commerce Committee Subcommittee on Health, and Nathan Deal (R-GA), ranking Republican of the Subcommittee on Health, sent a letter to a diverse group of 35 stakeholders, such as AARP, PhRMA, …
On May 28, 2008, FDA announced the issuance of a proposed rule to amend the Agency’s regulations concerning the format and content of the “Pregnancy,” “Labor and Delivery,” and “Nursing Mothers” labeling subsections of the “Use in Specific Populations” labeling section for human prescription drug …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by three Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “FDA Moves Against Marketed Unapproved Human Drugs,” was written by Susan J. Matthees and John R. Fleder and …
FDA recently announced that on June 5 and 6, 2008, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will hold a public meeting to discuss the Agency’s plans to launch a pilot program on the testing and review …
“The Constant Gardener,” a 2001 novel and 2005 movie, revolves in part around an ethically questionable drug trial a foreign drug company conducts in Africa. Real life events have also occurred where a company was accused of ethical violations during the conduct of foreign clinical …
On April 17, 2008, U.S. Representatives Steve Buyer (R-IN) and Jim Matheson (D-UT) introduced H.R. 5839, the “Safeguarding America’s Pharmaceuticals Act,” which would substantially expand federal drug pedigree requirements. Among other things, the legislation would authorize destruction of counterfeit drugs at ports-of-entry, revise federal drug …
Earlier this year, we reported on a provision in Title VIII of the FDA Amendments Act (“FDAAA”) requiring the responsible party of an “applicable clinical trial” (for both drugs and devices) to certify that the new requirements of Public Health Service Act (“PHS Act”) § …
