On October 15, 2007, FDA issued two Federal Register notices announcing the availability of draft guidance documents related to serious adverse event reporting for OTC drugs and dietary supplements. The first draft guidance is titled “Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed …
Earlier today, FDA issued a Federal Register notice explaining the new Direct-to-Consumer (“DTC”) user fee program established by the FDA Amendments Act of 2007 (“FDAAA”) and requesting companies to notify the Agency within 30 calendar days whether they intend to participate in the program during …
Many pharmacies send letters to consumers advising them about refill or alternative products. Generally, these “refill reminders” are paid for by pharmaceutical manufacturers. A recent decision, however, will require more specific disclosure about the funding of such letters in the future. The Superior Court of …
Buried in Title V of the recently-enacted FDA Amendments Act ("FDAAA") is a provision requiring FDA, with certain limitations, to either publish final regulations to provide for the addition of a toll-free number to product labeling to report adverse events, or to make the Agency’s …
Earlier today, Hyman, Phelps & McNamara, P.C. issued its detailed summary and analysis of the recently-enacted FDA Amendments Act (“FDAAA”). A copy of the summary and analysis is available here. FDAAA reauthorizes several user fee and pediatric-related laws, and includes a host of new provisions, …
The U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a report critical of FDA’s clinical trial oversight along with recommendations to improve such oversight. Congress requested the OIG report after a series of news articles published in 2005 highlighted …
On October 4, 2007, FDA issued a Federal Register notice announcing that the Agency will hold a public meeting to address the possible creation of a third category of drugs for the U.S. market – so-called Behind-the-Counter (“BTC”) drugs. Such drugs would be available without …
Earlier today, FDA announced a new initiative, called the Generic Initiative for Value and Efficiency (“GIVE”), which is intended to increase the number and variety of generic drug products. According to Gary Buehler, R.Ph., Director of FDA’s Office of Generic Drugs (“OGD”): GIVE is an initiative …
On September 28, 2007, the Washington Legal Foundation (“WLF”) asked the Supreme Court to review the U.S. Court of Appeals for the District of Columbia Circuit’s recent ruling in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach concerning access to experimental therapies. …
We previously reported on several cases involving FDA-regulated products and certain preemption of state law issues. Yesterday the Supreme Court agreed to hear (i.e., granted Cert. [see page 5]) in one of those cases – Warner-Lambert v. Kent. The case concerns Warner-Lambert’s REZULIN (troglitazone), certain …
Late today, the U.S. Senate passed FDA reform legislation by unanimous consent. The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007. Earlier in the day there was some concern that the Senate vote on the …
House and Senate staff have reportedly reached an agreement on omnibus FDA reform legislation that would, among several other things, reauthorize the Prescription Drug User Fee Act (“PDUFA”) through fiscal year 2012. Earlier today, a “staff agreement” (427 pages) and summary of the legislation was …
Many pharmaceutical manufacturers are already struggling under the regulatory burden associated with the various requirements of state gift reporting statutes. That burden may soon be made heavier. Earlier this month, Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) introduced legislation that would require drug, biologic, …
In a September 7, 2007 “Legal Opinion Letter” published by the Washington Legal Foundation, attorneys Arnold I. Friede and John F. Kamp criticize legislation introduced earlier this year that would disallow a tax deduction for certain Direct-To-Consumer (“DTC”) prescription drug advertisements. The bill, H.R. 2823, …
Over the summer we posted on several preemption cases involving FDA-regulated products. In July, we reported that the Supreme Court agreed to hear Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant …
