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 …
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Medical Devices
- HPM Posts Summary of H.R. 3962 Provisions Directly Affecting Drug and Device ManufacturersNovember 2nd, 2009
- Affordable Health Care for America Act Introduced in HouseOctober 29th, 2009
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 …
- Update – Bill Introduced to Give FDA Greater Power to Remove Problem ResearchersOctober 28th, 2009
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 …
- Tenth Circuit Affirms Civil Money Penalties Against Device Manufacturer and President for Failure to Submit Medical Device ReportsOctober 28th, 2009
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 …
- Healthcare Reform Bill Emerges From Senate Finance Committee With Changes But No Increase in Drug/Device Fees and RebatesOctober 5th, 2009
By Alan M. Kirschenbaum – Last Friday the Senate Finance Committee completed its mark-up of the “America’s Healthy Future Act of 2009.” The Committee is awaiting scoring by the Congressional Budget Office before it votes on the bill this week. Earlier we reported on the original …
- FDA Issues Proposed Rule on cGMPs for Combination ProductsSeptember 29th, 2009
By Jeffrey K. Shapiro – FDA’s Office of Combination Products (“OCP”) recently issued a proposed rule (74 Fed. Reg. 48,423) setting forth current good manufacturing practice (“cGMP”) requirements for combination products. The proposed rule does not independently establish new requirements; rather, it clarifies which set of …
- Healthcare Reform Update: Senate Finance Committee Mark-Up Adds Tweaks Favorable to Generics; House Energy and Commerce Begins Second Mark-Up TomorrowSeptember 22nd, 2009
By Alan M. Kirschenbaum – The Senate Finance Committee began today to mark up its healthcare reform bill, the America’s Healthy Future Act of 2009. In a previous post, we provided an outline of the provisions of the Chairman’s Mark that would specifically affect drug …
- Is Industry Atwitter? FDA Announces Public Meeting on the Promotion of Products via the Internet and Social MediaSeptember 21st, 2009
By Carrie S. Martin – On September 21, 2009, FDA announced in a Federal Register notice that the Agency plans to hold a public hearing to discuss issues regarding the promotion of FDA-regulated products – specifically prescription drugs, prescription biologics, and medical devices – via the …
- SFC Chairman’s Mark of Health Care Reform Bill Rivals House Counterpart in Discounts and Fees Imposed on Drug and Device CompaniesSeptember 16th, 2009
By Alan M. Kirschenbaum – Today the Senate Finance Committee (“SFC”) released the Chairman’s Mark of the “America’s Healthy Future Act of 2009,” which currently is scheduled for Committee mark up next Tuesday, September 22. Among the various health reform proposals in the House and Senate, …
- FDA Sets Fiscal Year 2010 Drug and Device User Fees; Rate Increases for Most FeesAugust 4th, 2009
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 …
- Senate Committee Asks: CME – Higher Learning or Higher Earning?August 2nd, 2009
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 …
- Two Synthes Inc. Execs Enter Guilty PleasJuly 22nd, 2009
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 …
- The United States Files Criminal Charges Against Orthopedic Device Manufacturers and Four ExecutivesJune 18th, 2009
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, …
- Vermont Passes Sweeping Law that Prohibits, Requires Disclosure of Gifts from Drug, Device, and Biologics Makers to PhysiciansMay 28th, 2009
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 …
- New Draft Guidance on Presentation of Risk Information in Promotion: A Study in Summarizing DDMAC LettersMay 27th, 2009
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 …