By John R. Fleder & Anne K. Walsh – Perhaps Yogi Berra's most famous quote was: "This is like déjà vu all over again." Recently proposed amendments to the Sentencing Guidelines applicable to U.S. courts suggest that companies and their executives regulated by FDA may be …
By Karla L. Palmer & Larry K. Houck – Consistent with its November 24, 2010 Notice of Intent, the Drug Enforcement Administration (“DEA”) published its Final Order temporarily placing five synthetic cannabinoids into Schedule I under the Federal Controlled Substances Act (“CSA”) to avoid imminent hazard to …
By Kurt R. Karst – FDA’s Unapproved Drugs Initiative, which began in June 2006 when the Agency issued its final version of “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100,” took a major step with the Agency’s March 2, 2011 announcement that FDA plans to …
By Kurt R. Karst – Midnight, March 4, 2011 – that’s the time and date on which the federal government will close for business if Congress fails to approve a spending bill, or a short-term/stopgap funding measure that would likely just delay a shutdown for a …
By Susan J. Matthees – In an interesting twist in a developing story on the importation of thiopental, a drug used to administer the death penalty by lethal injection, the attorney for Georgia death row inmate Andrew Grant DeYoung sent Attorney General Eric Holder a …
By Carrie S. Martin – In a draft guidance issued on February 28, 2011, called “Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Services (REMS),” FDA proposes: (1) to implement a procedure that allows applicants with a REMS to request eliminating a …
By David B. Clissold – In a federal lawsuit filed on Friday, February 25, 2011 in the District of Columbia, Lorillard, Inc., Lorillard Tobacco Company, and R.J. Reynolds Tobacco Company sued the FDA, DHHS, Kathleen Sebelius, Margaret Hamburg, and Lawrence Deyton for declaratory and injunctive relief …
By Kurt R. Karst – In a win for compounding pharmacies and a loss for FDA, the U.S. Court of Appeals for the Fifth Circuit ruled last week in Med. Ctr. Pharmacy v. Holder that the U.S. District Court for the Western District of Texas violated …
By Ricardo Carvajal – FDA denied a citizen petition filed on behalf of OVOS Natural Health, Inc. (“OVOS”) that asked the agency to issue a regulation under FDC Act § 201(ff)(3)(B) or § 301(ll) acknowledging that marketing of homotaurine as a dietary ingredient in dietary supplements …
By Kurt R. Karst – It was just yesterday that we commented on how folks in the Hatch-Waxman community have been patiently awaiting FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic …
By Ricardo Carvajal – In a letter directed to Attorney General Eric Holder, Senator Patrick Leahy (D-VT) asked the U.S. Department of Justice (“DOJ”) for an update on its investigation of the Peanut Corporation of America (“PCA”) and its president, Stewart Parnell. According to the letter, FDA …
By Kurt R. Karst – As folks in the Hatch-Waxman community patiently await FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic version of XYZAL (levocetirizine dihydrochloride) with skinny labeling that omits, via …
By Peter M. Jaensch – United States Senator Charles Schumer (D-NY) recently introduced legislation that is intended to prevent sales of recalled biologics, drugs, medical devices, infant formula, and foods. However, if that legislation is enacted it may actually dissuade companies from undertaking voluntary recalls. On February …
By Kurt R. Karst – Last week, substantively identical legislation was introduced in both the U.S. House of Representatives and in the U.S. Senate to amend the FDC Act to prohibit the manufacture, marketing, sale, or distribution of an authorized generic version of an NDA-approved drug …
By Riëtte van Laack – As previously reported, on Dec. 8, 2010, FDA published a proposal to amend the interim final rule ("IFR") governing health claims concerning the risk of cardiovascular heart disease and consumption of phytosterols (see 21 C.F.R. § 101.83). FDA stated that, as …
