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 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 Carmelina G. Allis – We previously reported that Synthes, Inc., Norian Corporation, and four of Synthes’s executives had been charged by the United States government for allegedly violating several provisions of Titles 18 and 21 of the United States Code. The defendants allegedly conducted clinical …
By Carmelina G. Allis – We previously reported that the State of New Jersey had entered into an agreement with Synthes, Inc. to settle allegations that the company failed to disclose financial conflicts of interest among doctors who conducted clinical testing on its products. Now, …
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 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 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 Susan J. Matthees – Last year we reported that FDA had moved to dismiss a lawsuit alleging that FDA had improperly denied HiFi DNA Tech, LLC’s (“HiFi’s”) petition for reclassification of an HPV nested DNA polymerase chain reaction detection device from Class III to Class …
By Jennifer B. Davis – The April 9, 2009 Federal Register will contain the official notice of an FDA order requiring manufacturers of 25 types of Class III “preamendments” devices to submit information on such devices, including adverse safety and effectiveness data not already submitted …
By Jennifer B. Davis – Earlier this week, the United States Court of Appeals for the Eleventh Circuit in Atlanta issued its opinion in United States v. Endotec, Inc., an appeal from the United States District Court for the Middle District of Florida. We previously …
Hyman, Phelps & McNamara, P.C. (“HP&M”) has issued a detailed analysis of the Supreme Court’s recent ruling in Wyeth v. Levine. A copy of the analysis, written by James P. Ellison and Carrie S. Martin, is available here. In Wyeth, the Court ruled that, based …
By Bryon F. Powell – On March 11, 2009, the Massachusetts Department of Public Health ("DPH") Public Health Council unanimously approved a final rule on Pharmaceutical and Medical Device Manufacturer Conduct. This vote came just seven months after Massachusetts’ Governor Deval Patrick signed into law …
By James P. Ellison – Despite the Supreme Court’s 2008 ruling in Riegel v. Medtronic, in which the Court found express preemption for devices subject to premarket approval based on express statutory language, the judge in Minnesota overseeing multi-district device litigation granted the plaintiffs’ motion to …
By Ricardo Carvajal & Susan J. Matthees – The FDA Globalization Act (“FDAGA”) of 2008 was “meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety” of products over which the agency has jurisdiction. When we commented on …
