By Nisha P. Shah – FDA recently issued a white paper revealing that the Agency intends to strengthen its review of medical devices for home use, such as hemodialysis equipment, wound therapy care, intravenous therapy devices, and ventilators, as more hospital patients are being discharged …
By Kurt R. Karst – It seems to be a popular headline these days: “FDA Sued Over [take your pick].” Following the frenetic losartan 180-day litigation – which is still not over, as FDA has filed a petition for panel rehearing and rehearing en banc …
By Jeffrey K. Shapiro – We are beginning to suspect that the new transparency of this Administration is a lot like the old transparency. Or, as The Who sang in We Won’t Get Fooled Again, “meet the new boss / same as the old boss.” The …
By Jeffrey K. Shapiro – In October 2009, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a report entitled, “Adverse Event Reporting for Medical Devices” (“OIG Report”). The OIG’s Report has not received the attention it deserves. The OIG report …
By Alan M. Kirschenbaum & Kurt R. Karst – On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“PPACA”) (Pub. L. No. 111-148 ). A companion bill, the Health Care Education Affordability Reconciliation Act of 2010 (H.R. 4872), which …
By Kurt R. Karst – Just one day after FDA Commissioner, Dr. Margaret Hamburg, testified last week before the U.S. Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies on FDA’s Fiscal Year 2011 budget request, which includes new user fees, …
By Susan J. Matthees – A new preemption decision has just come down from a California appeals court (the sixth circuit appellate district). In two consolidated cases, McGuan v. Endovascular Technologies, Inc., et al. and Johnson v. Endovascular Technologies, Inc., the appeals court upheld a lower …
By Peter M. Jaensch – On January 4, 2010, the Washington Legal Foundation (“WLF”) filed an amicus curiae brief in support of Ortho Biotech Products’ petition for a writ of certiorari in the Supreme Court of the United States, urging review of the decision in …
By Alan M. Kirschenbaum – On January 5, 2010, FDA released a “Guidance for Industry on New Contrast Indication Considerations for Device and Approved Drug and Biological Products.” The primary purpose of the Guidance is to establish a process that allows imaging device manufacturers to …
By Alan M. Kirschenbaum, Kurt R. Karst & J.P. Ellison – On Thursday morning, the U.S. Senate passed, by a 60-39 vote, H.R. 3590, the Patient Protection and Affordable Care Act. Last weekend, Sen. Harry Reid (D-NV) unveiled a 383-page Manager’s Amendment to the bill. …
By Carmelina G. Allis – Earlier this month, the United States Court of Appeals for the Second Circuit rendered a summary order affirming the District Court’s judgment for dismissal of the case. We previously reported that FDA had moved to dismiss HiFi DNA Tech, LLC’s (“HiFi’s”) …
By Alan M. Kirschenbaum & Kurt R. Karst – Last Thursday we reported on the release by the House of H.R. 3962, the health care reform bill that will soon be considered on the House floor. As we have done with other health care reform …
By Alan M. Kirschenbaum & Kurt R. Karst – Earlier today, House Speaker Nancy Pelosi (D-CA) unveiled the Affordable Health Care for America Act (H.R. 3962). The bill, which is the latest version of the House’s healthcare reform proposal and the one that will go …
By Susan J. Matthees – On October 27th, on the heels of the release of the Government Accountability Office’s report in which the Office is critical of FDA’s oversight of clinical investigators (see our previous post), Rep. Joe Barton (R-TX) introduced H.R.3932, the Strengthening of …
By JP Ellison – Last year we posed the question “Are the Stars Lining Up for FDA Civil Penalties?” The intervening year has not answered that question, but a recent decision from the Tenth Circuit affirming civil penalties against TMJ Implants, Inc. (“TMJI”) and its founder …
