By Kurt R. Karst – FDA’s Sixth Annual Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience during Fiscal Year 2013 (“FY 2013”) with citizen petitions subject to FDC Act § 505(q), though largely repetitive of reports filed for previous fiscal years …
By Jennifer M. Thomas – Last month, the U.S. District Court for the District of Utah dealt a significant blow to the Federal Trade Commission (“FTC”) when it denied FTC’s motion summary judgment in a case against Basic Research, LLC (“Basic Research”). The Court’s decision marks …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2013) – Agreements Filed with the Federal Trade Commission under the …
By Anne Marie Murphy – On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act ("DSCSA") prior to May 2015. The guidance, states in relevant part: FDA recognizes that …
By Ricardo Carvajal – In an opinion piece recently published in the Journal of the American Medical Association, a trio of Colorado physicians examine the implications of legalization of marijuana in their home state. The authors summarize “expected” effects, including increased use of health care services in …
By Jeffrey K. Shapiro – FDA has always allowed companies to transfer 510(k) clearances without obtaining new clearance. Indeed, this blogger provided a short primer on the topic 15 years ago. However, this administrative practice has long been shrouded in mystery, because FDA has never published …
By Kurt R. Karst & Michelle L. Butler – Ever since FDA withdrew a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, to the U.S. Court of Appeals for the District of Columbia Circuit (see …
By Ricardo Carvajal - The Weston A. Price Foundation sued FDA to compel a response to the Foundation’s 2008 citizen petition (Docket No. FDA-2008-P-0452) asking FDA to revoke its regulation authorizing heart health claims for soy protein, which the Foundation claims is “not soy in its natural form.” …
By Kurt R. Karst – Queue up the dueling banjo scene from the film Deliverance. . . . Early last month we saw an interesting press release from Veloxis Pharmaceuticals, Inc. (“Veloxis”) announcing FDA’s October 30, 2014 tentative approval of the company’s 505(b)(2) NDA 206406 for ENVARSUS …
By James E. Valentine* & Anne Marie Murphy – As we previously reported, last month the National Institutes of Health (“NIH”) published a Notice of Proposed Rulemaking on clinical trials registration and results submission (“NPRM”), and is requesting public comment by February 19, 2015. The NPRM generally …
By Kurt R. Karst – December 16th was a good day for Hyman, Phelps & McNamara, P.C. We learned that the U.S. Court of Appeals for the Fourth Circuit handed our client, Mylan Pharmaceuticals, Inc. (“Mylan”), a significant victory. In a 3-0 panel decision (Circuit Judges …
By Karla L. Palmer – The Senate passed a bill last Thursday, December 11, 2014, that will prohibit the use of certain designer anabolic steroids. H.R. 4771, titled the Designer Anabolic Steroid Control Act (“DASCA”), adds 25 specific over-the-counter designer substances to the category of "anabolic …
By Karla L. Palmer – On December 4, 2014, in the United States District Court for the District of Tennessee, Main Street Family Pharmacy, LLC and its co-owner David Newbaker each pled guilty to a misdemeanor criminal violation of the Federal Food, Drug, & Cosmetic Act …
By Jeffrey N. Gibbs & Allyson B. Mullen – A new article published on Medical Device and Diagnostic Industry’s (MDDI) website by Hyman, Phelps & McNamara, P.C.’s Jeff Gibbs, Allyson Mullen, and Graematter, Inc’s Melissa Walker, shows that there is more to 510(k) review time statistics …
By Jamie K. Wolszon & Jeffrey N. Gibbs – The House Energy & Commerce Committee, which has jurisdiction over FDA, has issued a “white paper” announcing that as part of its efforts to prepare a draft discussion legislative package in early 2015 related to the overall …
