On June 23, 2008, Representative William Delahunt (D-MA) introduced, and the U.S. House of Representatives quickly passed by voice vote, H.R. 6344 – the Responsive Government Act of 2008. The 12-page bill includes several provisions, including the latest iteration of the so-called “Dog Ate My …
On June 2, 2008, First DataBank, a private publisher of prescription drug prices in the United States, announced a new proposed settlement in a class action suit alleging that the company conspired with a wholesaler to inflate the Average Wholesale Price (“AWP”) for certain prescription …
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 June 6, 2008, Wyeth Holdings Corporation and its Fort Dodge Animal Health Division (collectively “Wyeth”) filed a complaint in the U.S. District Court for the District of Columbia against FDA and the U.S. Patent and Trademark Office (“PTO”) requesting declaratory and injunctive relief with …
Hyman, Phelps & McNamara, P.C., the nation’s largest dedicated food and drug practice, seeks a mid-level associate experienced in drug/biologics development and approval for our D.C. office. The ideal candidate will have a scientific or medical background and prior regulatory experience in drug/biologics development issues …
The German Federal Institute for Risk Assessment (“BfR”) has issued a report that discusses recent human data on potential health risks arising from consumption of energy drinks. According to the report, the safety concerns expressed by BfR in a prior expert opinion are “substantiated by …
In a case involving a highly unusual set of facts for FDA-regulated companies, Leiner Health Products, Inc. (Leiner) is seeking to have a plea agreement approved by a Bankruptcy court. The case involves violations of Current Good Manufacturing Practices (cGMPs) for over-the-counter drugs. What also …
FDA has filed an amicus curiae brief with the Second Circuit Court of Appeals that supports a New York City (“NYC”) law requiring all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear calorie content information for each menu …
In late May, Senator Sam Brownback (R-KS) introduced S. 3046 – the “Access, Compassion, Care, and Ethics for Seriously Ill Patients Act” (the “ACCESS Act”). The bill, which is similar to legislation Sen. Brownback introduced in the 109th Congress with the same title (i.e., S. …
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 …
As we previously reported, the Food and Drug Administration Amendment Act of 2007 (“FDAAA”) mandates that FDA create a Reportable Food Registry (“Registry”). The purpose of the Registry is to facilitate tracking of problems in the food supply, and to allow a more rapid response …
On May 22, 2008, the Drug Enforcement Administration (“DEA”) issued a final rule to allow every qualified practitioner to offer maintenance or detoxification treatment to 30 patients without obtaining a separate registration regardless of the number of other qualified practitioners within their medical practice. DEA …
Title XI (§ 1112) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) requires pharmaceutical applicants (both brand and generic) to file with the Federal Trade Commission (“FTC”) and the Assistant Attorney General certain agreements executed on or after January 7, 2004. …
A U.S. District Court recently denied the Drug Enforcement Administration’s (“DEA’s”) attempt to use an injunction to suspend a physician’s DEA registration. The court noted that the Controlled Substances Act (“CSA”) provides adequate administrative procedures to suspend a DEA registration. The court also denied the …
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 …
