By William T. Koustas – Last week, FDA announced the approval of Onsolis (fentanyl buccal soluble film) with a substantial Risk Evaluation and Mitigation Strategy ("REMS"), as well as a boxed warning. Onsolis is a potent opioid that is administered through the mucous membranes of …
By Anne Marie Murphy – FDA’s final rule requiring IRBs that review FDA-regulated clinical investigations to register through a system maintained by the Department of Health and Human Services (“HHS”) takes effect on Tuesday, July 14, 2009. In the Federal Register notice announcing the final …
By Susan J. Matthees – The Institute of Medicine (“IOM”) has released a report and a list of priorities for comparative effectiveness research to be funded by The American Recovery and Reinvestment Act of 2009 (the stimulus bill). The IOM list contains 100 priority topics, …
By Jamie K. Wolszon – Earlier this month, a U.S. District Court for the Northern District of California judge refused to dismiss a criminal indictment of the former Chief Executive Officer (“CEO”) of InterMune for misbranding and wire fraud charges connected to the off-label promotion …
On June 12th, the U.S. House of Representatives voted 307-97 on final passage of H.R. 1256 – The Family Smoking Prevention and Tobacco Control Act. The U.S. Senate overwhelmingly passed the bill on June 11th with a 79-17 vote. President Obama is expected to sign …
By Susan J. Matthees – Last week, FDA announced a new grant program available to help support the development of new animal drugs to treat minor species or minor disease in major species (horses, dogs, cats, chickens, turkeys, cattle and pig). The Minor Use and Minor …
By Jamie K. Wolszon & Jeffrey N. Wasserstein – The Vermont legislature recently passed S. 48, a bill that would prohibit manufacturers of prescription drug, device, and biologics products from providing certain kinds of gifts or payments to physicians and other health care providers, and …
By Dara Katcher Levy & Roger C. Thies – For the past several years, industry has relied on Warning and Untitled Letters to determine DDMAC’s “current” thinking on the presentation of risk information in various promotional pieces. On May 26, 2009, FDA issued a draft …
By William T. Koustas & Carrie S. Martin – On May 7, 2009, FDA announced that it is requiring both approved testosterone gel products to include boxed warnings on their labels and to implement a REMS. The two products are indicated for testosterone replacement therapy …
By JP Ellison – In a Memorandum to the heads of Executive Departments and Agencies dated May 20, 2009, with the Subject Line “Preemption” (the “May 20, 2009 Memorandum”), President Obama stated that “executive departments and agencies have sometimes announced that their regulations preempt State …
By David B. Clissold – FDA’s meeting guidance “Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products” was issued in final form in February 2000. On May 19, 2009, FDA released Revision 1 to that guidance, now entitled “Guidance for Industry: Formal …
By William T. Koustas, Dara Katcher Levy, and John R. Fleder – On April 28, 2009, Smoking Everywhere, Inc. (“SE”) sued FDA to “stop FDA from improperly exceeding its delegated authority by attempting to regulate electronic cigarettes” to the extent that FDA declared such products to …
By Carrie S. Martin – On April 29, 2009, FDA issued a final rule requiring new labeling for over-the-counter (“OTC”) pain relievers and fever reducers, also known as internal analgesic, antipyretic, and anti-rheumatic drug products (“IAAAs”). The rule revises 21 C.F.R. Part 201 to require manufacturers …
By Kurt R. Karst – “Is the Obama Administration Poised to Undo FDA’s Preemption Stance?” We posed this question in a post earlier this year after a pre-publication version of a 96-page final rule concerning new organ-specific warnings and related labeling for Over-The-Counter (“OTC”) Internal …
By Susan J. Matthees – At the request of the Centers for Disease Control and Prevention ("CDC"), FDA announced last night that it would issue Emergency Use Authorization ("EUA") of flu medicines and diagnostic tests in response to the recent swine flu outbreak. Two antiflu …
