Earlier this year, President Bush signed Executive Order 13439 establishing the Interagency Working Group on Import Safety (“Working Group”). The Working Group, chaired by Department of Health and Human Services Secretary Mike Leavitt, was charged with conducting a comprehensive review of current import safety practices …
The U.S. Court of Appeals for the Seventh Circuit, in its recent opinion in United States v. Global Distributors, Inc., remanded for reconsideration to the U.S. District Court for the Northern District of Illinois (Eastern Division) the imposition of the maximum allowable monetary penalties under …
Yesterday, Representatives Henry Waxman (D-CA) and Tom Allen (D-ME) and Senator Ted Kennedy (D-MA) announced plans to introduce the Non-Prescription Drug Modernization Act of 2007 (“NDMA”). The bill comes in the wake of recent concern over the use of Over-the-Counter (“OTC”) cough/cold drugs in children …
In September, we reported that FDA established a public docket (#2007N-0417) soliciting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues concerning the diabetes drug acarbose (marketed by Bayer Pharmaceuticals under the tradename PRECOSE). Specifically, FDA’s September 26, 2007 letter states: As …
Title VI of the recently-enacted FDA Amendments Act (“FDAAA”) amended the FDC Act to establish a non-profit corporation whose purpose is to advance FDA’s Critical Path Initiative to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” (The …
In our second installment of the “Lighter Side” (our first post is available here) we pass along to you an article from The Birmingham News, which reported on a comical case of a “shaming penalty” the CEO of a medical device company agreed to as …
Earlier this year, after the success of the Department of Health and Human Services’ Pandemic Flu Leadership Blog (and no doubt also due to the success of FDA Law Blog), Secretary Michael Leavitt decided to test the waters of blogdom with his own blog, aptly …
The Department of Health and Human Services’ (“DHHS”) Office of Inspector General (“OIG”) recently announced its Fiscal Year 2008 Work Plan. The OIG Work Plan, issued annually, sets forth various projects to be addressed during the coming fiscal year by the Office of Counsel to …
Earlier this month, Senator Bernie Sanders (I-VT) announced the introduction of the “Medical Innovation Prize Act of 2007” (S. 2210). If enacted, the bill would replace the current patent and non-patent market exclusivity system for drugs that has been in place since the enactment of …
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 …
We previously reported on a May 2007 Proposed Decision Memorandum issued by the Centers for Medicare and Medicaid Services (“CMS”) that would restrict the use of Erythropoiesis Stimulating Agents (“ESAs”) in cancer-related anemia and similar conditions. The proposed memorandum was finalized in a July 30, …
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), …
