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    • FDA Law Blog Named One of the “Top 50 Medical Ethics Blogs”December 16th, 2008

      The accolades keep rolling on in . . . .   USPharmD has named the FDA Law Blog one of the “Top 50 Medical Ethics Blogs.”  According to them, we will help you “[s]tay on top of current legal issues in the medical field.”  And all …

    • Celebrities and Bloggers Beware: The FTC’s Proposed Revisions to its Endorsement and Testimonial Advertising Guides Address New Advertising TechniquesNovember 25th, 2008

      By Cassandra A. Soltis The Federal Trade Commission (FTC) is seeking comments on proposed revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising.  The Guides, although advisory in nature, set forth the principles the FTC will follow in reviewing endorsements and testimonials …

    • Public Service Announcement: Don’t Trust FDA Impersonators . . .November 17th, 2008

      By Jeffrey N. Wasserstein – First, it was the son of the former Nigerian dictator who wanted my bank account information (I’m still waiting for the bank transfer, by the way!).  Now, apparently FDA “special agents” are in on the act.  In a scam originating out …

    • Supreme Court Clarifies Preliminary Injunction Standard; Food and Drug Lawyers Should Take NoteNovember 13th, 2008

      By Kurt R. Karst –       On November 12, 2008, the U.S. Supreme Court issued its opinion in Winter v. Natural Resources Defense Council, Inc.  The case concerns the Navy’s power to use “mid-frequency active” sonar in military training exercises.  The Court, dividing 6-3 (Chief Justice …

    • The Times They are A-Changing: The Baucus Plan – What Health Care Reform Could Look Like in the New CongressNovember 13th, 2008

      By Jeffrey N. Wasserstein & William T. Koustas – On November 12, 2008, Senate Finance Committee Chairman Max Baucus released a white paper detailing what he sees as the substantial problems in our health care system.  The paper, titled “Call to Action: Health Reform 2009” …

    • Two HP&M Attorneys Named Best Food and Drug Lawyers in Washington, DCNovember 2nd, 2008

      The FDA Law Blog would like to congratulate our colleagues Jim Phelps and Jeff Gibbs on being named among the best Food and Drug Lawyers in Washington, DC, according to "Washington DC's Best Lawyers," in association with the Legal Times.  We've always thought they were …

    • Off-label Promotion Qui Tam Suits – a YouTube Video by HP&M’s John R. FlederOctober 24th, 2008

      Hyman, Phelps & McNamara, P.C.’s John R. Fleder has now appeared in a Washington Legal Foundation “Legally Brief” YouTube video.  In the 6-minute video Mr. Fleder notes the recent increase in federal False Claims Act cases initiated by private whistleblowers based on alleged “off-label” use promotional activities involving pharmaceutical companies, and explains why recent court rulings have dismissed …

    • European Drug Industry Calls on EU to Curb Parallel Trading of PharmaceuticalsOctober 22nd, 2008

      Earlier this month, European drug makers called on the European Union (“EU”) to act on the issue of parallel trading of pharmaceuticals by confining prices for drugs to the specific EU member country they are initially sold.  Drug makers argue that some form of price …

    • Hyman, Phelps & McNamara, P.C. Announces Two New Directors and Of CounselOctober 19th, 2008

      Hyman, Phelps & McNamara, P.C. is very pleased to announce that Anne Marie Murphy and Michelle L. Butler have been named Directors of the firm, and that Larry K. Houck has been named Of Counsel.  Ms. Murphy’s practice focuses on drug development issues. She serves …

    • Professorial Musings on the FDA and the FDC ActOctober 13th, 2008

      Inside Health Policy recently reported on the writings of several professors who opined on courts’ deference to the FDA.  The writings discussed in the Inside Health Policy piece were from the July 2008 Cornell Law Review, which devoted an entire issue to “Symposium: U.S. Food …

    • FDA Law Blog Named One of the Best Health Care Policy BlogsSeptember 22nd, 2008

      As any blogger can tell you, writing a blog is a labor of love.  It takes a lot of time to put together thoughtful and informative posts – and before the news gets stale.  So, when our blog is mentioned as one of the top …

    • A Noteworthy Fraud and Abuse Compliance Event for the Medical Device IndustrySeptember 22nd, 2008

      Jeffrey K. Shapiro of Hyman, Phelps & McNamara, P.C. will be speaking at American Conference Institute’s 8th National Conference on Reducing Legal Risks in the Sale and Marketing of Medical Devices, November 17-18, 2008 at the Allerton Hotel on the Magnificent Mile in Chicago, IL. …

    • CBI’s Pharmaceutical Congress on Paragraph IV DisputesSeptember 3rd, 2008

      Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of FDALawBlog.net) will be speaking at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes, October 15 – 16, 2008, at the Marriott Philadelphia Downtown in Philadelphia, Pennsylvania.  A copy of …

    • Congress Enacts Legislation to Strengthen CPSCAugust 17th, 2008

      On August 14, 2008, the President signed into law Public Law No. 110-314, the Consumer Product Safety Improvement Act of 2008. The new law contains a number of provisions relating to children’s products, including lead.  It also contains provisions relating to the administrative functions that …

    • A Noteworthy Event for the Drug and Device IndustriesAugust 15th, 2008

      Robert A. Dormer of Hyman, Phelps & McNamara, P.C. will be speaking at American Conference Institute’s FDA Boot Camp conference, September 22-23, 2008 at the Sheraton Boston Hotel in Boston, MA. Click here for a copy of the agenda. At the event, preeminent members of the …