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 …
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Medical Devices
- Meet The New Transparency – Same as The Old TransparencyApril 7th, 2010
- The MDR Reporting System Badly Needs Reform: As A First Step, Malfunction MDRs Should Be EliminatedMarch 30th, 2010
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 …
- Health Care Reform Becomes Law – HP&M Issues Summary of Drug and Device ProvisionsMarch 24th, 2010
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 …
- Rep. Hinchey Introduces the FDA Improvement Act of 2010; the Bill Would Unravel User Fee Legislation, Among Other ChangesMarch 15th, 2010
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, …
- California Appeals Court Backs MDA PreemptionMarch 14th, 2010
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 …
- WLF Urges Supreme Court Review of Ortho Biotech Decision; Argues that the False Claims Act is Intended to Combat Fraud, not Legitimate Product PromotionJanuary 11th, 2010
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 …
- FDA Issues Final Guidance on New Contrast Indications for Imaging DevicesJanuary 7th, 2010
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 …
- Healthcare Reform Update: Senate Passes Amended Bill with Drug/Device Rebates and Fees Largely Intact and New Fraud and Abuse ProvisionsDecember 24th, 2009
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. …
- Update: Court of Appeals Upholds Lower Court’s Ruling in HiFi’s Reclassification Petition Denial CaseDecember 22nd, 2009
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”) …
- HPM Posts Summary of H.R. 3962 Provisions Directly Affecting Drug and Device ManufacturersNovember 2nd, 2009
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 …
- 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 …