By Ricardo Carvajal – Several nonprofit groups sued FDA for its failure to respond to a May 2006 citizen petition asking that products of nanotechnology be subject to specific regulatory requirements, and that FDA stop the marketing of sunscreens that contain nanoparticles. The complaint alleges that …
By Jennifer D. Newberger – To finish out a year in which the Center for Devices and Radiological Health ("CDRH") issued what appeared to be an unprecedented number of draft guidance documents, CDRH issued two more on December 27, 2011. This blog post discusses one such …
By Jamie K. Wolszon & Alan M. Kirschenbaum – FDA has issued two important documents bearing on communications regarding off-label uses and (in one of the documents) not-yet-approved products. The first, which was posted on FDA’s web site earlier this week, was a draft guidance on …
By Ricardo Carvajal – Earlier this month, the HHS Office of Inspector General ("OIG") issued a report that identifies a number of “significant weaknesses” in FDA’s oversight of food facility inspections conducted by state agencies under contract with FDA. OIG found that FDA: “failed to ensure that …
By Alan M. Kirschenbaum & Nisha P. Shah – In the December 19, 2011 Federal Register, CMS published a long-awaited proposed regulation to implement the transparency report requirements of the Patient Protection and Affordable Care Act. Hyman, Phelps & McNamara, P.C. has prepared a summary of …
By JP Ellison – We have previously posted both on FDA’s renewed focus on misdemeanor prosecutions of “responsible corporate officers” under the Park doctrine generally, and on the use of that doctrine against four Synthes executives (see here, here, here, here, and here). Two recent opinions …
By Jennifer D. Newberger – The Government Accountability Office (“GAO”) recently issued a report on pediatric device development. The report “(1) describes barriers to developing pediatric devices, (2) describes how pediatric device consortia have contributed to the development of pediatric devices, and (3) examines FDA data …
In a new Legal Backgrounder published by the Washington Legal Foundation, Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer and Jeffrey N. Gibbs write that a recent Florida federal district court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have …
By Riëtte van Laack – In a December 12, 2011 decision, Judge R. Leon of the District Court for the District of Columbia granted Defendants’ Motion to Dismiss an action by Physicians Committee for Responsible Medicine (Plaintiff) requiring that Defendants FDA and USDA withdraw the “MyPyramid” …
By Jennifer M. Thomas – A Government Accountability Office (“GAO”) Report released on December 15, 2011, the same day as a Senate Committee hearing, finds that FDA needs increased authority in order to address the growing problem of drug shortages. In her statement before the Senate …
By Jennifer D. Newberger – On Thursday, December 15, 2011, Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Herb Kohl (D-Wis.) introduced the “Medical Device Patient Safety Act.” This bill contains two distinct proposals: (1) to give FDA the authority to track and trend device recalls, …
By Susan J. Matthees – The National Advertising Division (“NAD”) of the Council of Better Business Bureaus recently concluded that claims that Procter & Gamble’s Crest Sensitivity Treatment & Protection Toothpaste could provide relief from sensitive teeth “within minutes” should be discontinued. Colgate-Palmolive brought the challenge …
By Ricardo Carvajal – On November 18, the United States District Court for New Jersey granted FTC’s motion for a finding that Lane Labs violated an order agreed to by the parties in 2000. In part, that order requires Lane Labs’ health-related marketing claims to be …
By Kurt R. Karst – We had hoped that our post from earlier this week, titled Pending DESI Program Proceedings – The List, would stimulate some discussion. And it did. One comment in particular that we received from an authoritative source caught our attention and deserves greater …
By James R. Phelps – Many seasoned FDA watchers are surprised by the kerfuffle raised when HHS overturned FDA’s plan to allow Plan B emergency contraception available over the counter (see here and here). This is first time HHS has publicly put its thumb on the …
