FDA Law Blog
This blog covers topics of interest to FDA-regulated companies, fellow food and drug and health-care lawyers and regulatory personnel, as well as people just generally interested in FDA law. The blog provides timely updates on FDA enforcement actions, proposed rules, personnel changes, new and improved policies, along with related issues such as health-care fraud and abuse, drug and device reimbursement, HIPAA, and other topics of interest.
Author: Kurt R. Karst is an associate and Jeffrey N. Wasserstein is a partner at Hyman, Phelps & McNamara in Washington, D.C.
Blawg Related Categories: Administrative Law • Health Law • Tort Law • Product Liability Law • Associate • Partner
Recent Posts from FDA Law Blog
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IOM Releases Report and Priorities for Comparative Effectiveness
By Susan J. Matthees – The Institute of Medicine (“IOM”) has released a report and a list of priorities for comparative effectiveness research to be funded by The American Recovery and Reinvestment Act of 2009…
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August 1, 2009 - FTC’s New Identity Theft Rule Probably Requires You To Comply
By William T. Koustas & John R. Fleder – FDA-regulated businesses are certainly closely regulated by FDA and other federal agencies. However, one area that many of these businesses erroneously believe does not affect them…
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Implementation of the Family Smoking Prevention and Tobacco Control Act: FDA Wants to Hear From You
By David B. Clissold & Ricardo Carvajal – In an unusually open-ended request, FDA is asking “all interested parties to provide information and share views” on FDA’s implementation of the Family Smoking Prevention and Tobacco…
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FDA Firms Up Implementation Date for the Reportable Food Registry
By Ricardo Carvajal – FDA has announced public workshops on the Reportable Food Registry intended to “explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a…
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Teva Sues FDA Over Generic COZAAR and HYZAAR 180-Day Exclusivity Forfeiture and Patent Delisting Rule
By Kurt R. Karst – Teva Pharmaceuticals USA, Inc. (“Teva”) recently filed a Complaint and a Motion for Preliminary Injunctive Relief (and a memorandum supporting the company’s motion) in the U.S. District Court for the…
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The FTC Issues Interim Report on Authorized Generics; Report Examines the Short-Term Effects of Authorized Generics During 180-Day Exclusivity
By Kurt R. Karst – The Federal Trade Commission (“FTC”) announced the publication of an interim report on authorized generic drugs. The report, titled “Authorized Generics: An Interim Report,” presents the first set of results…
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Sen. Nelson Introduces Bill to Amend ANDA “First Applicant” Definition that Would Effectively Gut 180-Day Exclusivity; “Reverse Payments” Also Back in the News
By Kurt R. Karst – On June 22nd, Senator Bill Nelson (D-FL) introduced S. 1315, the “Drug Price Competition Act of 2009.” (At this point we have a copy of the discussion draft; however, we…
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BPCA Section 11 and Pediatric Labeling; Revised Labeling Carve-Out Citizen Petition Scorecard
By Kurt R. Karst – Section 11 of the Best Pharmaceuticals for Children Act (“BPCA”) of 2002 amended the FDC Act to add a new provision, which was reauthorized under the FDA Amendments Act of…
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The United States Files Criminal Charges Against Orthopedic Device Manufacturers and Four Executives
By Carmelina G. Allis – We previously reported that the State of New Jersey had entered into an agreement with Synthes, Inc. to settle allegations that the company failed to disclose financial conflicts of interest…
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Pet Food Business Owners Plea to FDC Act Misdemeanors in Connection with Pet Food Scandal
JP Ellison – The U.S. Attorney's Office for the Western District of Missouri announced three guilty pleas to misdemeanor violations of the FDC Act in connection with the "nationwide recall of pet food and the…