When Hyman, Phelps & McNamara, P.C. launched the FDA Law Blog 2 years ago today – Is that 14 in “blog years”? It certainly seems like it, if not more! – we could hardly imagine how successful it would become and how our subscribers (and the …
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- FDA Law Blog Turns Two “Blog Years” OldMarch 6th, 2009
- Obama 10-Year Budget Blueprint Includes Initiatives For Medicare, Medicaid, FDAFebruary 26th, 2009
By Cassandra A. Soltis & Alan M. Kirschenbaum – Today the Obama Administration released a summary of its 10-year budget proposal entitled “A New Era of Responsibility – Renewing America’s Promise.” The document provides a high level outline of priorities – details reportedly will be released in April. …
- CPSIA Developments – Phthalate Prohibitions and Lead Content LimitsFebruary 9th, 2009
By Michelle L. Butler – With the effective date for a number of requirements imposed by the Consumer Product Safety Improvement Act (“CPSIA”) quickly approaching (February 10, 2009), the Consumer Product Safety Commission engaged in a flurry of activities. We recently reported on the Commission’s decision …
- CPSIA’s Effects on FDA-Regulated Products to be Discussed At Upcoming ICPHSO ConferenceFebruary 9th, 2009
Hyman, Phelps & McNamara, P.C.’s Anne Marie Murphy will present at the International Consumer Product Health and Safety Organization’s (“ICPHSO’s”) 16th Annual Meeting and Training Symposium, which is scheduled to take place from February 24-27, 2009 at the Florida Hotel and Conference Center in Orlando, …
- CBI Conference Will Evaluate the Legal, Regulatory and Economic Landscape in the U.S. and Abroad for Biosimilars and Follow-On BiologicsFebruary 6th, 2009
The Center for Business Intelligence (“CBI”) will hold its 2nd Annual Summit on Biosimilars and Follow-On Biologics on March 10-11, 2009. The Conference will be held at the Marriott Baltimore Inner Harbor at Camden Yards in Baltimore, Maryland. A copy of the conference brochure is …
- 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 …