By James R. Phelps & Kurt R. Karst – On November 17, 2008, Representatives John Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations of the U.S. House of Representatives, announced their most …
FDA’s Office of Combination Products (“OCP”) recently released a draft guidance entitled “New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.” The draft guidance permits diagnostic imaging device makers to expand labeling for use with a contrast agent or radiopharmaceutical even …
Representative John Dingell (D-MI) has revised several of the drug-related sections of the Discussion Draft of the FDA Globalization Act (“FDAGA”). We first reported on the Discussion Draft, which has received significant attention from industry and stakeholder groups alike, in April 2008. Updated sections of the …
On August 1, 2008, FDA will publish a Federal Register notice announcing the Fiscal Year (“FY”) 2009 user fee rates established under the Prescription Drug User Fee Act (“PDUFA”). A similar notice will also be issued with the FY 2009 user fee rates established under …
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, …
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 …
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 …
On May 1, 2008, a federal judge in the Middle District of Florida brought some measure of closure to FDA’s more than six years of attempts to regulate a self-identified custom device manufacturer. In his May 1st order, Judge G. Kendall Sharp mostly sided with …
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 …
On March 24, 2008, FDA asked the U.S. District Court for the District of Connecticut to dismiss a January 22, 2008 Amended Complaint alleging that the Agency improperly denied HiFi DNA Tech, LLC’s petition for reclassification of an HPV nested DNA polymerase chain reaction (PCR) …
Last month, we reported on the U.S. Supreme Court’s 8-1 decision in Riegel v. Medtronic, in which the Court provided a definitive decision preempting state tort law claims for medical devices subject to an approved Premarket Approval Application. Immediately after the decision was issued, some members …
Under the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review period” is composed of a “testing phase” and a “review phase.” …
On February 27, 2008, the U.S. Court of Appeals for the Seventh Circuit issued a decision in United States v. Caputo, in which the court generally affirmed a “complex and unusual” district court decision holding criminally liable a corporate Chief Executive Officer (“CEO”) and, remarkably, …
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 …
