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

CBI’s Pharmaceutical Congress on Paragraph IV Disputes
Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of FDALawBlog.net) will be speaking at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes, October 15 - 16, 2008, at…
“Male Enhancement” Dietary Supplement Distributor Gets Sentencing Enhancement -- 25 Years for Fraud
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…
FTC Announces Workshop and Study on Follow-On Biologic Patent and Non-Patent Exclusivity Issues
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…
DEA Actions Upheld by D.C. Court of Appeals
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…
District Court Rules on Jurisdiction and Non-Final Agency Action
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…
On Tuna, Methylmercury, and Preemption, FDA’s Net Comes up Empty
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…
FDA Clarifies that 3-Year Exclusivity can be Granted for the Removal of Labeling Information
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…
New Agreement Between OND and OSE for Management of Significant Safety Issues
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…
Notable Recent Third Circuit Decision in Appeal from FDC Act Conviction
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…
Traditional Diet Advocates Take a Swing at Soy Protein
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…