Last week, we reported on a January 16, 2008 proposed rule issued by FDA that would “reaffirm [the Agency’s] longstanding position that” labeling changes for approved drugs, biologics, and medical devices made by Changes Being Effected Supplements (“CBE Supplements”) may only be made to show …
North Dakota-based food and dietary supplement manufacturer Swanson Health Products, Inc. (“Swanson”) filed a Citizen Petition with FDA dated January 18, 2008, requesting the Agency to “take all appropriate steps to prevent California’s Safe Drinking Water and toxic Enforcement Act (‘Proposition 65’) from being applied …
The Food and Drug Law Institute is scheduled to hold its 6th Annual Conference on Enforcement and Litigation on February 19-20, 2008. Among other topics of discussion slated for the conference are the U.S. Sentencing Commission’s proposed guidelines that would greatly enhance the criminal penalties …
On January 16, 2008, FDA issued a proposed rule that would “reaffirm [the Agency’s] longstanding position that” labeling changes for approved drugs, biologics, and medical devices may only be made to show newly acquired information or to “add or strengthen a contraindication, warning, precaution, or …
We previously reported on FDA’s request for public comment to help resolve 180-day exclusivity issues concerning a generic version of the antinauseant and antiemetic drug KYTRIL (granisetron HCl) Injection. Specifically, in October 2007, FDA established a public docket in response to a letter from Teva …
On January 14, 2008, Nu-Pharm Inc., a Canadian drug company formerly owned by Apotex, Inc., filed a complaint in the U.S. District Court for the District of Columbia against FDA seeking declaratory and injunctive relief with respect to the company’s Abbreviated New Drug Application (“ANDA”) …
On January 31, 2008, the New York State Bar Association will hold its annual meeting of the Food, Drug, and Cosmetic Law Section. Some of the topics slated for discussion are the current political and regulatory landscape in the wake of the enactment of the …
We previously reported on the new voluntary Direct-To-Consumer (“DTC”) television ad user fee program established by the FDA Amendments Act (“FDAAA”) and FDA’s establishment of Fiscal Year 2008 DTC television ad user fee rates. Due to inadequate funding by Congress, however, the new program will …
The United States Sentencing Commission (“Commission”), which sets the guidelines that are usually followed by federal judges sentencing defendants convicted of federal crimes, has issued proposed Sentencing Guidelines (“Guidelines”) that would likely greatly enhance the criminal penalties applied to some criminal violations of the Federal …
On January 8, 2008, the District of Columbia Council passed the SafeRx Act of 2007 (“Act”), which requires pharmaceutical detailers to be licensed by the Board of Pharmacy. The Act will be presented to Mayor Adrian Fenty for his signature and then to Congress if …
Earlier today, The Plain Dealer, a Cleveland newspaper, reported that Senator Sherrod Brown (D-OH) submitted a request to the Congressional Research Service (“CRS”) requesting information on FDA’s “Fast Track” designation program. CRS provides policy and legal analysis to committees and to Members of both the …
On February 8, 2008, Hyman, Phelps & McNamara, P.C. (“HPM”) is sponsoring a Medical Device Seminar in Newport Beach, California. The topic of this seminar will be “Striving for Regulatory Success in a Changing Environment.” Scheduled speakers for the seminar are Jeff Gibbs, Brian Donato, …
We previously reported on FDA’s plans to take enforcement action with respect to firms manufacturing and distributing unapproved drugs containing hydrocodone. According to the October 1, 2007 FDA Federal Register notice: Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than …
Last week, the United States Court of Appeals for the Seventh Circuit concluded that the Federal Trade Commission Act (“FTC Act”) does not require placebo-controlled, double-blind testing for consumer products. The ruling, issued in Federal Trade Commission v. QT Inc., upheld a decision by the …
Title VIII of the recently-enacted FDA Amendments Act (“FDAAA”) requires the responsible party of an applicable clinical trial (for both drugs and devices) to certify that the new requirements of Public Health Service Act (“PHS Act”) § 402(j) have been met. Under PHS Act § …
