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 …
Last week we reported on an influx of food safety bills that have been and that are planned for introduction in both the U.S. House of Representatives and the U.S. Senate. The already crowded field became a little more congested when Representative Rosa DeLauro (D-CT), …
For the third time in as many weeks, FDA has requested public comment to help resolve 180-day exclusivity issues. This time FDA’s request concerns the antinauseant and antiemetic drug granisetron HCl, which is marketed by Roche under the tradename KYTRIL. In late September, FDA solicited …
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 …
In response to recent scares over tainted food imports and E.coli outbreaks in produce, several members of the U.S. House of Representatives and Senate have introduced (and plan to introduce) a variety of bills aimed at improving food safety and security. In late September alone, …
On September 28, 2007, the U.S. Department of Justice announced that Bristol-Myers Squibb (“BMS”) agreed to pay more than $515 Million Dollars to settle off-label promotion, anti-kickback, Average Wholesale Price (“AWP”), and Best Price (“BP”) allegations, and related False Claims Act claims. The enforcement action …
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 27, 2007, the U.S. House of Representatives Committee on Energy and Commerce passed H.R. 970, the Dextromethorphan Distribution Act of 2007, after a legislative “mark-up” session. Similar legislation was introduced in the U.S. Senate in May 2007 (S. 1378) and was referred to …
On September 27, 2007, the U.S. Attorney’s Office for the District of New Jersey announced settlements with five companies (Biomet, Inc., Depuy Orthopaedics, Smith & Nephew, Inc., Zimmer, Inc., and Stryker Orthopedics, Inc.) resolving anti-kickback allegations. The allegation common to all five cases is that each …
On September 18, 2007, FDA’s Center for Drug Evaluation and Research (“CDER”) launched its latest publication, the “Drug Safety Newsletter”. This quarterly electronic publication is intended as an additional source of drug safety information for healthcare professionals and complements existing communications targeted at healthcare professionals …
On September 24, 2007, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking that would expand the classification of dronabinol, commonly known as delta-9-tetrahyrdocannabinol (“THC”), as a Schedule III controlled substance under the Controlled Substances Act. THC is a federally-controlled Schedule I controlled …
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. …
