By Kurt R. Karst – Speculation was running high that the U.S. Supreme Court would be petitioned on whether a patent settlement agreement (what opponents call “pay-for-delay” agreements or “reverse payments”) involving manufacturers of Ciprofloxacin HCl (CIPRO) is per se lawful under the Sherman Act after …
By Ricardo Carvajal – As required by its Good Guidance Practices regulation, FDA published its annual guidance document agenda and request for comment on “possible topics for future guidance document development or revisions of existing [guidance documents].” Among the food-related topics that caught our eye are new …
By Kurt R. Karst – Does “federal law, which imposes a strict set of labeling requirements on manufacturers of Final Monograph [Over-the-Counter (‘OTC’)] drugs, including mandatory product warnings authored by the FDA, [preempt] state-law product liability actions premised on theories of failure to warn[?]” That is …
Hyman, Phelps & McNamara’s Paul Hyman and Ricardo Carvajal recently published an article in Food Chemical News on the cost of inadequate substantiation of health-related claims made in the labeling and advertising of foods. Although FDA appears reluctant to take an aggressive stance with respect …
By Ricardo Carvajal – In a strongly worded opinion, a federal judge has ordered that genetically modified sugar beet stecklings (seedlings) planted pursuant to permits issued by USDA be pulled from the ground. As we noted in a prior blog posting, USDA/APHIS was found in violation …
By Ricardo Carvajal No sooner had we blogged on Senate passage of the Food Safety Modernization Act than Roll Call reported that the bill might be doomed by a constitutional flaw – namely that § 107 of the bill proposes fees, and Article I, section 7 …
By Karla L. Palmer and Peter M. Jaensch On November 24, 2010, using its emergency authority under section 202 of the Controlled Substances Act (“CSA”) (21 U.S.C. § 812), the U.S. Drug Enforcement Administration (“DEA”) published a Notice of Intent to temporarily place five synthetic cannabinoids in Schedule …
By John A. Gilbert & Karla L. Palmer – The Drug Enforcement Administration (“DEA”) recently published a decision that considers the scope of a pharmacist’s “corresponding responsibility” under 21 C.F.R. § 1306.04(a). East Main Street Pharmacy (Affirmance of Suspension Order) (Docket No. 09-48) (75 Fed. Reg. …
By Ricardo Carvajal - FDA announced that its Food Advisory Committee will meet on March 30 and 31, 2011, “to discuss whether available relevant data demonstrate a link between children’s consumption of synthetic color additives in food and adverse effects on behavior.” Earlier this year, the European …
By Jeffrey K. Shapiro & Carmelina G. Allis – FDA’s review of 510(k) program continues to cause concern in Congress. On November 24, 2010, the Minnesota delegation, including unlikely collaborators Senator Al Franken and Representative Michele Bachmann, sent a letter to Dr. Hamburg asking “FDA to review …
By Ricardo Carvajal – By a vote of 73 to 25 (see the roll call here), the Senate has passed S. 510, the Food Safety Modernization Act. As we noted in a prior posting, the Senate HELP Committee released a compromise agreement in August that would …
Thanks to our faithful readers, we made the list for the annual American Bar Association (“ABA”) Journal Blawg 100 for the second year in a row. The editors of the ABA Journal announced the top 100 best law blogs by lawyers, for lawyers earlier this …
By Kurt R. Karst – Recent judicial setbacks for the Federal Trade Commission (“FTC’) in actions challenging patent settlement agreements (or what opponents call “pay-for-delay” or “reverse payment” agreements) and opposition from both Republicans and Democrats to the inclusion of the Preserve Access to Affordable Generics …
By Susan J. Matthees – Congresswoman Louise Slaughter (D-NY) recently sent a letter to FDA Commissioner Margaret Hamburg requesting that FDA ban the use of triclosan in consumer products. Triclosan is commonly used as an antibacterial agent in topical antiseptic products, such as soaps and hand …
By Ricardo Carvajal – It’s the time of year for holiday food safety alerts. The home kitchen has long been recognized as a significant source of foodborne illness. Reliable data are hard to come by, but a recent survey and study suggest that consumer awareness and …
