By Roger C. Thies – On March 30, 2011, FDA publicly announced that it would not take enforcement action under certain conditions against pharmacies that compound hydroxyprogesterone caproate for injection for the reduction of the risk of certain preterm births in women who have had at …
By Roger C. Thies – FDA announced on March 30, 2011 that it “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or …
By Nisha P. Shah & Alan M. Kirschenbaum – In an unusual step, the State of California’s Department of Insurance intervened in a qui tam lawsuit brought against Bristol-Myers Squibb (“BMS”) by three former employees, including a former member of the L.A. Lakers. In The People …
By JP Ellison – The criminal prosecution of Lauren Stevens, the former in-house counsel for GSK, took another twist yesterday when Judge Titus dismissed her indictment without prejudice. We have previously reported on this prosecution here and here. Judge Titus found that the prosecutors' explanation to …
By Kurt R. Karst – Last week, Judge Richard Leon of the U.S. District Court for the District of Columbia granted FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear candle advocates after the Agency issued about 15 Warning Letters …
By Peter M. Jaensch & John R. Fleder – On January 18, 2011, the President issued a significant Order entitled a “Memorandum for the Heads of Executive Departments and Agencies.” The Memorandum directs “agencies with broad regulatory compliance and administrative enforcement responsibilities” to, within 120 days, …
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 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 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 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 Riëtte van Laack – Over the past two years, we have noted several joint or coordinated actions by FDA and FTC. The agencies issued their own warning letters to the same manufacturers at the same time (here and here), and, on several occasions, FDA and …
By Anne K. Walsh – Eleven months after telling Senator Grassley (in a letter available here) that “[c]riteria now have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor …
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Associate Peter M. Jaensch discusses the increasing use of the False Claims Act ("FCA") to privately prosecute what are actually violations of the FDC Act, and examines the allegations underlying the recent GlaxoSmithKline …
By Ricardo Carvajal – Senator Patrick Leahy (D-VT) reintroduced legislation to strengthen criminal penalties for food safety violators in the form of the Food Safety Accountability Act of 2011. As with the version of the bill introduced last year, the current version would amend Title 18 …
By Kurt R. Karst – In a notice slated for publication in the January 7th Federal Register, FDA is seeking to end the continued marketing of many unapproved oral prescription drugs for the relief of cough, cold, or allergy. The action will likely affect hundreds of …
