By Jeffrey N. Wasserstein, Michelle L. Butler, and Jamie K. Wolszon – On December 18, 2008, the Advanced Medical Technology Association (“AdvaMed”) announced the release of a newly revised version of the “Code on Ethics on Interactions with Healthcare Professionals,” which is a voluntary code focusing …
By Kurt R. Karst – Last week, ViroPharma Inc. announced that the company filed a complaint in the U.S. District Court for the District of Columbia alleging that FDA has “wrongfully withheld agency records requested by [ViroPharma] by failing to comply with the statutory time limit for …
By Jamie K. Wolszon – FDA’s recent decision to require a Risk Evaluation and Mitigation Strategy (“REMS”) for two prescription oral sodium phosphate (“OSP”) products raises questions regarding the impact the agency’s evolving application of its new REMS authority will have in instances where both …
By John R. Fleder & Kurt R. Karst – On December 10, 2008, the United States District Court for the Northern District of Illinois in Chicago dismissed a federal False Clams Act qui tam action in U.S. ex rel. Kennedy v. Aventis Pharmaceuticals, Inc. involving allegations of off-label …
By Diane B. McColl & Ricardo Carvajal – FDA has issued “no questions” response letters to the GRAS notices submitted by Cargill and Whole Earth Sweeter Company for rebaudioside A, described as “a highly purified component of the stevia plant.” The letters (available here and here) …
By Riëtte van Laack – On October 21, 2008, the National Resource Defense Council (“NRDC”) petitioned FDA to issue a regulation to prohibit the use of Bisphenol A (“BPA”) as a food additive. Currently, BPA is approved as a chemical for use in the production of …
By Diane B. McColl & Ricardo Carvajal – On December 15, Cargill issued a press release in which it announced a “broad-based national integrated marketing campaign” to promote its sweetener Truvia™ (Truvia™ is Cargill’s preparation of rebiana, or rebaudioside A, one of the sweetening components …
By Ricardo Carvajal & John R. Fleder – At the invitation of the U.S. Supreme Court, the federal government has recently filed a brief as amicus curiae in the case of Albertson’s, Inc. v. Kanter (No. 07-1327) in which the government argues against preemption of California …
The accolades keep rolling on in . . . . USPharmD has named the FDA Law Blog one of the “Top 50 Medical Ethics Blogs.” According to them, we will help you “[s]tay on top of current legal issues in the medical field.” And all …
By Ricardo Carvajal – According to a recently-issued Letter to Manufacturers, FDA “feels it is imperative to remind its constituents that front-of-package symbols can at times constitute nutrient content claims” that are subject to FDA’s regulatory requirements at 21 C.F.R. 101.13 and Subpart D of …
By Kurt R. Karst – Earlier today, by a five-to-four vote, the U.S. Supreme Court ruled against preemption in Altria Group, Inc. Good, the so-called “light cigarette” case. Background on the case is available via the SCOTUS Wiki. The respondents in the case (i.e., Good …
By Kurt R. Karst – We previously reported on concerns as to whether a company submitting an ANDA (or a 505(b)(2) application) containing the results of an in vivo bioequivalence study must certify on Form FDA 3674 that new Public Health Service Act (“PHS Act”) …
By Anne Marie Murphy – We have previously reported on the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) (here, here, and here), which makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). Section 102(a)(1) of the CPSIA …
By Jeffrey N. Wasserstein, Alan M. Kirschenbaum & Bryon F. Powell – On December 10, 2008, the Massachusetts Department of Public Health (Department) issued proposed regulations pursuant to Mass. Gen. L. § 111N, which requires the Department to promulgate regulations that adopt a standard marketing code …
By Cassandra A. Soltis – FDA has posted on its web site two revised draft guidance documents (here and here) concerning the labeling requirements of dietary supplements and over-the-counter (OTC) drugs under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006. That Act …
