• where experts go to learn about FDA
  • Page 1 of 212

    Month: August 2008

    • “Male Enhancement” Dietary Supplement Distributor Gets Sentencing Enhancement — 25 Years for FraudAugust 28th, 2008

      According to the Associated Press, a federal court has sentenced Steven Warshak, founder of Berkeley Premium Nutraceuticals, to 25 years in prison for crimes including mail fraud, conspiracy to commit fraud, and money laundering.  In addition, Warshak and other defendants must forfeit money and assets …

    • FTC Announces Workshop and Study on Follow-On Biologic Patent and Non-Patent Exclusivity IssuesAugust 28th, 2008

      2009 is shaping up to be a big year for debate on Follow-On Biologics (“FOBs”).  Earlier this year, Representative Anna Eshoo introduced FOB legislation and the House Energy and Commerce Committee Subcommittee on Health requested comment on various FOB issues.  The legislation and comments submitted …

    • DEA Actions Upheld by D.C. Court of AppealsAugust 27th, 2008

      A recent decision by the U.S. Court of Appeals for the District of Columbia in Chein v. DEA demonstrates the Court’s deference to agency expertise and a registrant’s heavy burden in overturning final action by the Drug Enforcement Administration (“DEA”) absent a “flagrant departure from …

    • District Court Rules on Jurisdiction and Non-Final Agency ActionAugust 26th, 2008

      In Novelty Distributors, Inc. v. Leonhart, the U.S. District Court for the District of Columbia recently confronted the issue of whether district courts have jurisdiction over a challenge to an agency action that is admittedly not final.    Novelty Distributors, Inc. (“Novelty”), a distributor of controlled …

    • On Tuna, Methylmercury, and Preemption, FDA’s Net Comes up EmptyAugust 25th, 2008

      In recent years, FDA has studiously avoided taking any broad regulatory action on the issue of whether, and under what circumstances, the presence of methylmercury in fish renders that fish adulterated.  FDA recognized that the scientific evidence that addresses the potential risks posed by methylmercury …

    • FDA Clarifies that 3-Year Exclusivity can be Granted for the Removal of Labeling InformationAugust 24th, 2008

      Under the FDC Act and FDA’s implementing regulations, a sponsor may qualify for a 3-year period of market exclusivity for a “change” to an approved drug product if the application contains: (1) “reports of new clinical investigations (other than bioavailability studies);” (2) that were “essential …

    • New Agreement Between OND and OSE for Management of Significant Safety IssuesAugust 21st, 2008

      FDA released a Memorandum of Agreement Between the Office of New Drugs (“OND”) and the Office of Surveillance and Epidemiology (“OSE”) in the Center for Drug Evaluation and Research (“CDER”) “on the management of significant safety issues associated with pending and approved drug products.”  The …

    • Notable Recent Third Circuit Decision in Appeal from FDC Act ConvictionAugust 20th, 2008

      On August 8, 2008, the U.S. Court of Appeals for the Third Circuit issued an opinion in an appeal from a conviction under, among other provisions, the criminal provisions of the Federal Food Drug and Cosmetic Act (“FDC Act”).  A jury convicted Eric Goldberg of …

    • Traditional Diet Advocates Take a Swing at Soy ProteinAugust 19th, 2008

      The Weston A. Price Foundation has submitted a citizen petition asking FDA to revoke its regulation approving a health claim for soy protein and coronary heart disease.  According to the petition, in light of studies published since the regulation was issued in 1999, “[t]he totality …

    • FDA Issues Comments Concerning Midodrine HCl Exclusivity Issues; Threatens to Withdraw First Subpart H ApprovalAugust 18th, 2008

      As we previously reported, in August 2007, FDA issued a letter and started a docket requesting public comment on a variety of 3-year exclusivity issues concerning generic versions of Shire U.S. Inc.’s PROAMATINE (midodrine hydrochloride) Tablets.  FDA approved PROAMATINE in September 1996 under the Agency’s …

    • 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 …

    • What Does “May Contain Peanuts” Mean, and When is it False or Potentially Misleading?August 17th, 2008

      When Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 to require source declaration for ingredients derived from major food allergens, Congress chose not to include any requirements with respect to so-called advisory labeling (e.g., “may contain peanuts,” or “processed in a …

    • 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 …

    • Ignoring the NAD Can Be CostlyAugust 14th, 2008

      A recent Federal Trade Commission (“FTC”) action serves as a reminder that the agency takes seriously cases referred to it by the National Advertising Division of the Council of the Better Business Bureaus (“NAD”).  In a press release issued earlier this week, the FTC announced …

    • The Check is in the Mail – Please Return to Sender; PDUFA User Fee Waivers and ReductionsAugust 13th, 2008

      Now that FDA has set the Fiscal Year 2009 Prescription Drug User Fee Act (“PDUFA”) user fee rates and is preparing invoices for delivery (payable by October 1, 2008), a quick review of the options available to companies to request user fee waivers and reductions …

    Page 1 of 212