By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By JP Ellison – Virtually all of the mainstream and trade press outlets have covered the recent Abbott resolution with the U.S. Department of Justice regarding allegations of off-label promotion of Abbott’s drug Depakote. Undoubtedly, the $1.5B price tag and that coverage have made most readers …
By Riëtte van Laack – On May 21, 2012, the FTC posted the 345-page Administrative Law Judge’s ("ALJ’s") Initial Decision in In the Matter of POM Wonderful LLC et al. ("POM") (FTC Docket No. 9344). The ALJ upheld the FTC’s Complaint insofar as the FTC asserted …
Hyman, Phelps & McNamara P.C. invites you to register for our webinar, “Garbage Runs, Fake Identities, and Surprise Home Visits: Strategies to Deal With FDA's Nontraditional Investigative Tools,” which is scheduled to take place on Wednesday, June 20, 2012 from 12:30 – 2:00 p.m. ET. From …
By John R. Fleder & Jennifer M.Thomas— As previously reported here, on April 13, 2012 ViroPharma Incorporated (“ViroPharma” sued FDA to challenge the agency’s April 9, 2012 approval of three Abbreviated New Drug Applications (“ANDAs”) for generic versions of the company’s antibiotic drug Vancocin® (vancomycin hydrochloride). …
By Ricardo Carvajal – Warning letters issued by FDA since late February provide an indication of the types of violations that could trigger reinspection fees under the authority provided by the Food Safety Modernization Act (“FSMA”). As we noted in a prior blog posting, FSMA authorized …
By Kurt R. Karst – In a decision and accompanying Order handed down on March 27, 2012, Judge Richard J. Leon of the U.S. District Court for the District of Columbia ordered that FDA “immediately notify any and all state correctional departments which it has reason …
By JP Ellison – We previously reported on the oral arguments in the Supreme Court case Sackett v. EPA that raised the question of when agency action was sufficiently final to allow a party to seek review in federal court. Earlier this week the Supreme Court …
By Ricardo Carvajal – In a letter that includes fun facts about the function of the epiglottis, FDA has warned Breathable Foods, Inc. that its AeroShot product is misbranded. The product’s labeling is alleged to be false and misleading because it contains contradictory statements regarding whether …
By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food and dietary supplements unless they are supported by two well-controlled clinical studies, the industry has been …
By Kurt R. Karst – Among the Warning Letters FDA posted on its website this week, one in particular caught our attention – a February 17, 2012 Warning Letter to Merck Sharp and Dohme Corp. (“Merck”) citing a violatation of FDC Act § 505(o)(3). FDA’s enforcement …
By Kurt R. Karst – Following a long court battle in which a three-judge panel of the U.S. Court of Appeals for the Tenth Circuit affirmed a November 2010 decision from the U.S. District Court for the District of Wyoming granting FDA’s Motion to Dismiss a …
By JP Ellison – An important issue relating to when an action by an administrative agency can be challenged in court was argued before the Supreme Court last week. The case involved administrative enforcement activities of the U.S. Environmental Protection Agency (“EPA”). The case, Sackett v. …
By Susan J. Matthees – Earlier this week, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the U.S. District Court for the District of Columbia’s decision granting FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear …
By JP Ellison – We have previously posted both on FDA’s renewed focus on misdemeanor prosecutions of “responsible corporate officers” under the Park doctrine generally, and on the use of that doctrine against four Synthes executives (see here, here, here, here, and here). Two recent opinions …
