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  • Drug Development

    • Mass. Court Permits Pharmacy Mailing Program, But Requires Disclosure of ProfitsOctober 22nd, 2007

      Many pharmacies send letters to consumers advising them about refill or alternative products.  Generally, these “refill reminders” are paid for by pharmaceutical manufacturers.  A recent decision, however, will require more specific disclosure about the funding of such letters in the future.  The Superior Court of …

    • Congress Requires Action on FDA’s Proposed Toll-Free Number Adverse Event Reporting Labeling RuleOctober 19th, 2007

      Buried in Title V of the recently-enacted FDA Amendments Act ("FDAAA") is a provision requiring FDA, with certain limitations, to either publish final regulations to provide for the addition of a toll-free number to product labeling to report adverse events, or to make the Agency’s …

    • HPM Issues Detailed FDAAA Summary and AnalysisOctober 11th, 2007

      Earlier today, Hyman, Phelps & McNamara, P.C. issued its detailed summary and analysis of the recently-enacted FDA Amendments Act (“FDAAA”).  A copy of the summary and analysis is available here.  FDAAA reauthorizes several user fee and pediatric-related laws, and includes a host of new provisions, …

    • OIG Report Critical of FDA’s Clinical Trial OversightOctober 9th, 2007

      The U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a report critical of FDA’s clinical trial oversight along with recommendations to improve such oversight.  Congress requested the OIG report after a series of news articles published in 2005 highlighted …

    • FDA Will Meet to Address Possible Behind-The-Counter Drug AvailabilityOctober 8th, 2007

      On October 4, 2007, FDA issued a Federal Register notice announcing that the Agency will hold a public meeting to address the possible creation of a third category of drugs for the U.S. market – so-called Behind-the-Counter (“BTC”) drugs.  Such drugs would be available without …

    • FDA Announces New Generic Drug InitiativeOctober 4th, 2007

      Earlier today, FDA announced a new initiative, called the Generic Initiative for Value and Efficiency (“GIVE”), which is intended to increase the number and variety of generic drug products.  According to Gary Buehler, R.Ph., Director of FDA’s Office of Generic Drugs (“OGD”): GIVE is an initiative …

    • WLF Asks Supreme Court to Hear Abigail Alliance Case on Access to Experimental DrugsOctober 1st, 2007

      On September 28, 2007, the Washington Legal Foundation (“WLF”) asked the Supreme Court to review the U.S. Court of Appeals for the District of Columbia Circuit’s recent ruling in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach concerning access to experimental therapies.  …

    • Supreme Court Agrees to Hear Warner-Lambert Preemption CaseSeptember 26th, 2007

      We previously reported on several cases involving FDA-regulated products and certain preemption of state law issues.  Yesterday the Supreme Court agreed to hear (i.e., granted Cert. [see page 5]) in one of those cases – Warner-Lambert v. Kent.  The case concerns Warner-Lambert’s REZULIN (troglitazone), certain …

    • Senate Passes Omnibus FDA Reform LegislationSeptember 20th, 2007

      Late today, the U.S. Senate passed FDA reform legislation by unanimous consent.  The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007.  Earlier in the day there was some concern that the Senate vote on the …

    • An Agreement Has Been Reached – House and Senate Staff Negotiators Release “Staff Agreement” on Omnibus FDA Reform Legislation; a Vote is Expected SoonSeptember 19th, 2007

      House and Senate staff have reportedly reached an agreement on omnibus FDA reform legislation that would, among several other things, reauthorize the Prescription Drug User Fee Act (“PDUFA”) through fiscal year 2012.  Earlier today, a “staff agreement” (427 pages) and summary of the legislation was …

    • Senators Kohl and Grassley Introduce Bill Targeting Industry Gifts to PhysiciansSeptember 19th, 2007

      Many pharmaceutical manufacturers are already struggling under the regulatory burden associated with the various requirements of state gift reporting statutes.  That burden may soon be made heavier.  Earlier this month, Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) introduced legislation that would require drug, biologic, …

    • WLF “Legal Opinion Letter” Decries Proposed DTC Legislation as UnconstitutionalSeptember 10th, 2007

      In a September 7, 2007 “Legal Opinion Letter” published by the Washington Legal Foundation, attorneys Arnold I. Friede and John F. Kamp criticize legislation introduced earlier this year that would disallow a tax deduction for certain Direct-To-Consumer (“DTC”) prescription drug advertisements.  The bill, H.R. 2823, …

    • Preemption Cases Involving FDA-Regulated Products are Increasing – Third Circuit Rules that FDA Approval Preempts State False Labeling Claims & Supreme Court Petitioned to Review REZULIN CaseSeptember 4th, 2007

      Over the summer we posted on several preemption cases involving FDA-regulated products.  In July, we reported that the Supreme Court agreed to hear Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant …

    • FDA Proposes Monograph for OTC Sunscreens Addressing Protection Against UVA and UVB LightAugust 29th, 2007

      On August 27, 2007, FDA published its long-awaited proposed rule to amend the final monograph for Over-the-Counter (“OTC”) sunscreen drug products.  The rule, if finalized, would set standards for formulating, testing, and labeling OTC sunscreen drug products with Ultraviolet A (“UVA”) light and Ultraviolet B …

    • Is FDA Poised to Withdraw the First Subpart H Approval?August 9th, 2007

      In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly …