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”) § …
Yesterday, the U.S. House of Representatives Committee on Energy and Commerce released a Discussion Draft of the "Food and Drug Administration Globalization Act of 2008." The “Discussion Draft is meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure …
In a previous post we opined that § 912 of the FDA Amendments Act (“FDAAA”) could represent a fundamental shift in the dividing line between foods and drugs. For our most recent thoughts on that subject, we refer you to the column we recently published …
Earlier this month, FDA announced the release of the Agency’s draft Prescription Drug User Fee Act (“PDUFA”) IV Drug Safety Five-Year Plan. The draft plan is one of the goals FDA agreed to under PDUFA IV, which is the latest reauthorization of PDUFA that was …
Earlier today, the U.S. Court of Appeals for the Third Circuit issued its much anticipated opinion in Colacicco v. Apotex, Inc. (Several parties, including FDA, entered and argued the case as amici for the appellee.) The case concerns whether actions taken by FDA pursuant to …
In our October 2007 summary and analysis of the FDA Amendments Act (“FDAAA”), Hyman, Phelps & McNamara, P.C. noted that FDAAA § 912, concerning a new prohibition against foods to which drugs or biological products are added, is “of potential significance to the development of …
Earlier today, FDA issued a Federal Register notice notifying holders of applications for certain prescription drug products approved under FDC Act § 505(b) (NDA) or § 505(j) (ANDA) and biological products licensed under § 351 of the Public Health Service Act that they will be …
Last week, the Pennsylvania Court of Common Pleas of Philadelphia County (the lowest court of general jurisdiction in Pennsylvania) ruled in Clark v. Pfizer, Inc., Case No. 1819 (June Term 2004) – a class action lawsuit in which the plaintiffs allege that Parke-Davis (then a …
In April 2007, we reported on a complaint filed by a group of non-profit organizations (including the Association of American Physicians & Surgeons, Concerned Women for America, Family Research Council, and Safe Drugs For Women) against FDA (and later Duramed Pharmaceuticals, Inc.) in the U.S. …
On February 29, 2008, Judge Stadtmueller of the United States District Court for the Eastern District of Wisconsin dismissed a lawsuit brought by Schering-Plough Healthcare Products, Inc. (“Schering”) against three manufacturers of prescription polyethylene glycol 3350 (“PEG”), a laxative drug product. In its lawsuit, Schering …
In August 2007, Teva Pharmaceuticals USA submitted a citizen petition to FDA requesting that the Agency relist in the Orange Book U.S. Patent #5,158,952 (“the ‘952 patent”) covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets (approved under NDA #20-272), and to confirm the company’s eligibility for 180-day …
Earlier this year, we reported on Senator Sherrod Brown’s (D-OH) request to the Congressional Research Service (“CRS”) for information concerning FDA’s “Fast Track” designation program “to help determine whether a case exists for changing or eliminating the 10-year-old initiative that was intended to speed the …
Earlier today, the U.S. Supreme Court announced a 4-4 split in Warner-Lambert v. Kent – just a few days after hearing oral arguments on February 25, 2008. The case, which concerns the narrow issue of a Michigan law immunizing drug companies from products liability claims …
Preemption of state law concerning FDA-regulated products (drugs, devices, and foods) has been the hot topic over the past few weeks. First, on February 20, 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that preemption principles and the 1976 Medical Device Amendments bar …
