Hyman Phelps McNamara

By Alan M. Kirschenbaum – Individuals may have their tax cuts extended, but a new tax on the drug industry is about to begin in 2011, and the IRS has issued a notice to implement it.  As we explained in our summary of the Patient Protection …

This week, the Republican Steering Committee selected Congressman Fred Upton (R-MI) to succeed Congressman Henry Waxman (D-CA) as Chair of the House Energy and Commerce Committee in the next Congress.  In August 2008, at the Democratic National Convention in Denver, Hyman, Phelps & McNamara’s Frank …

By Ricardo Carvajal – The D.C. Circuit Court of Appeals upheld the D.C. District Court’s grant of an injunction that bars FDA's regulation of e-cigarettes as drug/device products absent claims of intended use to that effect (for our prior posting on the district court decision, see …

The Washington Legal Foundation recently published an article written by HPM attorneys, Ricardo Carvajal and Nisha P. Shah, on the February 2010 Government Accountability Office ("GAO") report that criticized FDA's general oversight of uses of ingredients that are generally recognized as safe (“GRAS”) and the agency's …

By William T. Koustas – The Red Flags Rule (“the Rule”) requires entities covered by it to establish and implement an identity theft prevention program.  We have been following this issue for some time now and have previously reported that the FTC last delayed enforcement of …

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 …