By Kurt R. Karst – On August 12th, FDA announced the publication of final regulations concerning “Expanded Access to Investigational Drugs for Treatment Use” and “Charging for Investigational Drugs Under an Investigational New Drug Application.” Both rules will be officially published in the August 13th …
By Kurt R. Karst & Michelle L. Butler – Winston Laboratories, Inc. (“Winston”) recently sued FDA after the Agency denied a waiver of the Prescription Drug User Fee Act (“PDUFA”) application fee assessed with respect to the company’s human drug application (NDA No. 22-403) for …
By Kurt R. Karst – Earlier this week FDA issued several Federal Register notices setting the Fiscal Year (“FY”) 2010 user fee rates for human drugs under the Prescription Drug User Fee Act (“PDUFA”), for medical devices under the Medical Device User Fee and Modernization …
By Alan M. Kirschenbaum – As we reported on August 2, the House Energy and Commerce Committee last Friday reported out its healthcare reform bill, the America’s Affordable Health Choices Act (H.R. 3200). In order to help finance healthcare reform, the bill contains numerous provisions that …
By Carrie S. Martin – Last Wednesday, the Senate Special Committee on Aging held a hearing to discuss the conflicts of interest presented by the funding of continuing medical education (“CME”) by pharmaceutical and medical device companies. Lewis Morris, Chief Counsel to the Office of …
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 …
