By Susan J. Matthees – FDA is extending the deadline for comments to the proposed rule on menu labeling from June 6 to July 5, 2011 (see our previous post here). FDA states in a notice to be published in the Federal Register on May 24th …
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Hyman Phelps McNamara
- FDA Extends Comment Period for Proposed Rule on Menu LabelingMay 23rd, 2011
- To Implement Health Reform Orphan Drug Exclusion, HRSA Issues First-Ever Proposed Regulation on 340B Drug Discount ProgramMay 20th, 2011
By Alan M. Kirschenbaum – Today the Office of Pharmacy Affairs (“OPA”) of the Health Resources Services Administration (“HRSA”) published in the Federal Register its first proposed regulation under the 340B Drug Discount Program since the Program was established in 1992. This Program, authorized under section …
- GAO Issues Critical Seafood Safety Report (and Domestic Catfish Farmers Rejoice)May 19th, 2011
By Ricardo Carvajal – In a report titled “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” GAO found fault with many aspects of FDA’s imported seafood safety program. GAO set the stage for its review by noting that more …
- Consolidation of Seizure and Forfeiture Regulations under CAFRA – DEA Proposed RulemakingMay 18th, 2011
By John A. Gilbert & Karla L. Palmer – On May 9, 2011, the Drug Enforcement Administration ("DEA") published a proposed rulemaking addressing the “Consolidation of Seizure and Forfeiture Regulations” to conform with the Civil Asset Forfeiture Reform Act ("CAFRA") of 2000. When finalized, the rule will …
- Do State Laws on Methamphetamine Precursors Burden Practitioners and Patients?May 17th, 2011
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Associate Peter M. Jaensch examines the increasing legislative efforts by states to require prescriptions for products containing methamphetamine precursors (such as pseudoephedrine and ephedrine), and to list them as Controlled Substances. Mr. …
- ISTA Sues FDA Over Generic XIBROM Approval, Says ANDA Approval Should Disappear in the Blink of An EyeMay 17th, 2011
By Kurt R. Karst – Last Friday, ISTA Pharmaceuticals, Inc. (“ISTA”) filed a Complaint and a Motion for a Temporary Restraining Order and a Preliminary Injunction in the U.S. District Court for the District of Columbia seeking to vacate FDA’s May 11, 2011 approval of Coastal …
- FTC Alleges Companies Were Asleep At the Wheel When They Failed to Report Settlement Agreements on AMBIEN CR; Commission Uses the Opportunity to Provide Industry Guidance – And a WarningMay 15th, 2011
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced that the Commission’s Bureau of Competition (“Bureau”) sent letters (here, here, and here) to Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V. notifying them that the Bureau believes the companies violated …
- FDA’s Warning Letter “Close-Out” Process Is Not WorkingMay 11th, 2011
By Robert A. Dormer – In an August 2009 speech to the Food and Drug Law Institute, FDA Commissioner Margaret A. Hamburg, M.D., emphasized the importance of enforcement (see our previous post here). Among other actions announced by Dr. Hamburg was a warning letter “close-out” process. …
- Congressional Leaders Request FDA to Issue Voluntary Recall of Brazilian Blowout and Other Hair Smoothing Products Containing FormaldehydeMay 11th, 2011
By Cassandra A. Soltis – In a May 6, 2011, letter to Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration (“FDA” or “the Agency”), 10 congressional leaders requested the Agency to “take immediate action” against Brazilian Blowout Solution, Acai Professional Smoothing Solution, and …
- HP&M Director to Moderate at FDLI REMS ConferenceMay 11th, 2011
Hyman, Phelps & McNamara, P.C., Director Josephine M. Torrente will be moderating a session at the Food and Drug Law Institute’s (“FDLI’s”) upcoming 1-day conference on Risk Evaluation and Mitigation Strategies (“REMS”), which were created under the 2007 FDA Amendments Act. The FDLI conference, for …
- Social Media: Why Bother Issuing Guidance When You Can Issue Untitled Letters?May 10th, 2011
By Jeffrey N. Wasserstein – As aficionados of all things social media (see our prior postings here, here, here, and here) (other than kitten videos, enough with those already!) we couldn’t help but notice a recent Untitled Letter to Warner Chilcott, LLC, relating to a YouTube video. A …
- D.C. District Court Grants FDA Motion for Summary Judgment in Spat Over Generic ALDARA CreamMay 10th, 2011
By Kurt R. Karst – On May 10th, the U.S. District Court for the District of Columbia ruled in FDA’s favor in a case filed last July by Graceway Pharmaceuticals, LLC (“Graceway”) stemming from the Agency’s January 2010 denial of a Graceway citizen petition and approval …
- FDA Gets the Ball Rolling on Biosimilar/Interchangeable Biological Product User Fee Program; Proposal Gives a Hat Tip to PDUFA While Acknowledging the Nascent State of the IndustryMay 9th, 2011
By Kurt R. Karst – On May 9th, FDA announced the May 10th publication of a Federal Register notice proposing and requesting comment on the structure of a user fee program for applications for biosimilar and interchangeable biological products submitted under section 351(k) of the Public …
- Device Company Seeks D.C. Circuit Review of FDA 510(k) Rescission OrderMay 9th, 2011
By Jamie K. Wolszon – ReGen Biologics, Inc. (“ReGen”) has petitioned the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) to review the Center for Devices and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a …
- The FTC’s Latest Patent Settlement Report Will Serve as Fodder for the Commission’s Crusade Against Patent Settlement AgreementsMay 8th, 2011
By Kurt R. Karst – While we were at the American Conference Institute’s conference on Paragraph IV Disputes last week, the Federal Trade Commission (“FTC”) announced the publication of its annual summary of agreements filed with the Commission during Fiscal Year 2010 – “Agreements Filed with …