• where experts go to learn about FDA
    • HHS Secretary Michael Leavitt Wades Into BlogdomOctober 31st, 2007

      Earlier this year, after the success of the Department of Health and Human Services’ Pandemic Flu Leadership Blog (and no doubt also due to the success of FDA Law Blog), Secretary Michael Leavitt decided to test the waters of blogdom with his own blog, aptly …

    • HHS OIG Announces FY 2008 Work Plan; 9 New FDA Studies Identified, Including Clinical Trial Oversight and Off-Label PromotionOctober 30th, 2007

      The Department of Health and Human Services’ (“DHHS”) Office of Inspector General (“OIG”) recently announced its Fiscal Year 2008 Work Plan.  The OIG Work Plan, issued annually, sets forth various projects to be addressed during the coming fiscal year by the Office of Counsel to …

    • Sen. Sanders Introduces Bill to End Market Exclusivity and Create a New “Medical Innovation Prize Fund”October 28th, 2007

      Earlier this month, Senator Bernie Sanders (I-VT) announced the introduction of the “Medical Innovation Prize Act of 2007” (S. 2210).  If enacted, the bill would replace the current patent and non-patent market exclusivity system for drugs that has been in place since the enactment of …

    • FDA Publishes Two Draft Guidance Documents on the Reporting of Serious Adverse Events Associated with OTC Drugs and Dietary SupplementsOctober 26th, 2007

      On October 15, 2007, FDA issued two Federal Register notices announcing the availability of draft guidance documents related to serious adverse event reporting for OTC drugs and dietary supplements.  The first draft guidance is titled “Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed …

    • FDA Issues Request for Notification of Participation in New DTC User Fee ProgramOctober 25th, 2007

      Earlier today, FDA issued a Federal Register notice explaining the new Direct-to-Consumer (“DTC”) user fee program established by the FDA Amendments Act of 2007 (“FDAAA”) and requesting companies to notify the Agency within 30 calendar days whether they intend to participate in the program during …

    • When Safe and Effective Means Neither Safe Nor EffectiveOctober 23rd, 2007

      We previously reported on a May 2007 Proposed Decision Memorandum issued by the Centers for Medicare and Medicaid Services (“CMS”) that would restrict the use of Erythropoiesis Stimulating Agents (“ESAs”) in cancer-related anemia and similar conditions.  The proposed memorandum was finalized in a July 30, …

    • 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 …

    • Another Food Safety Bill Will Likely Join the CrowdOctober 15th, 2007

      Last week we reported on an influx of food safety bills that have been and that are planned for introduction in both the U.S. House of Representatives and the U.S. Senate.  The already crowded field became a little more congested when Representative Rosa DeLauro (D-CT), …

    • FDA Solicits Public Comment on Yet Another 180-Day Generic Drug Exclusivity IssueOctober 12th, 2007

      For the third time in as many weeks, FDA has requested public comment to help resolve 180-day exclusivity issues.  This time FDA’s request concerns the antinauseant and antiemetic drug granisetron HCl, which is marketed by Roche under the tradename KYTRIL.  In late September, FDA solicited …

    • 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 …

    • Congress Set to Consider Multiple Food-Related BillsOctober 7th, 2007

      In response to recent scares over tainted food imports and E.coli outbreaks in produce, several members of the U.S. House of Representatives and Senate have introduced (and plan to introduce) a variety of bills aimed at improving food safety and security.  In late September alone, …

    • Bristol-Myers Squibb Achieves Global Resolution on Array of Historical Drug Pricing and Marketing AllegationsOctober 5th, 2007

      On September 28, 2007, the U.S. Department of Justice announced that Bristol-Myers Squibb (“BMS”) agreed to pay more than $515 Million Dollars to settle off-label promotion, anti-kickback, Average Wholesale Price (“AWP”), and Best Price (“BP”) allegations, and related False Claims Act claims.  The enforcement action …