By Kurt R. Karst – As the U.S. Senate Committee on Appropriations begins its markup and consideration of appropriations bills for Fiscal Year (“FY”) 2011, and in particular the Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill (S. 3606), rare and neglected disease …
In the May/June 2010 edition of FDLI Update, HP&M Director John R. Fleder published his latest article on enforcement matters. This article is entitled “Whistleblowers: Treat Them With Kid Gloves.” The article addresses various issues that companies face when they are confronted with employees who …
By Peter M. Jaensch – On July 14, 2010, the Federal Trade Commission (“FTC”) announced an agreement with Nestle HealthCare Nutrition, Inc. (“Nestle”) to settle an FTC investigation with regard to alleged false and misleading health claims. The FTC's Complaint arose from claims made by …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Diane B. McColl has been elected to the U.S. Pharmacopeial Convention’s (“USP’s”) Expert Committee for the Food Chemicals Codex (Monographs – Food Ingredients) for the 2010-2015 cycle. The committee develops new monographs and revises …
On July 14th, the FTC announced the settlement of a significant false advertising case against Iovate Health Sciences U.S.A. and Canadian affiliates for false weight loss, cold, flu and allergy claims relating to 5 of the company's products. The settlement includes $5.5M for refunds to …
By Kurt R. Karst – Although it took a little longer than we expected, late last week, Graceway Pharmaceuticals, LLC (“Graceway”) sued FDA in the U.S. District Court for the District of Columbia requesting declaratory and injunctive relief with respect to the Agency’s January 2010 denial …
By William T. Koustas – FDA recently released a draft of it class-wide opioid REMS in preparation for an advisory committee meeting on the issue. The Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory …
By John R. Fleder – It is hardly a secret that FDA’s favorite regulated industry is certainly not the businesses that compound pharmaceutical products. For years FDA has struggled to establish an enforcement mechanism that passes muster with Congress and the courts. Two compounding pharmacies have …
By Jeffrey N. Wasserstein – On July 8, 2010, the Office for Civil Rights of the U.S. Department of Health and Human Services announced the issuance of its long-awaited proposed rule (in prepublication form) relating to the modification to the HIPAA Privacy, Security and Enforcement Rules under …
By Kurt R. Karst – With all of the hubbub over Patent Use Codes (“PUCs”) since the U.S. Court of Appeals for the Federal Circuit issued its April 2010 decision in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. addressing whether the patent delisting counterclaim …
By Kurt R. Karst – Earlier today, a 3-judge panel (Judges Tatel, Griffith, and Kavanaugh) of the U.S. Court of Appeals for the District of Columbia Circuit issued a 2-page per curiam judgment (without memorandum) affirming the U.S. District Court for the District of …
By Alexander J. Varond* & Kurt R. Karst – Recently, the U.S. District Court for the District of Columbia dismissed a case brought by the Coalition for Mercury-Free Drugs (“Coalition”). Judge Reggie B. Walton ruled that the Coalition lacked standing to ask the court to ban …
By Kurt R. Karst – Late Thursday, the U.S. House of Representatives passed a package of amendments (beginning on page 74) to the War Funding Bill (H.R. 4899) that included the “Preserve Access to Affordable Generics Act,” which is intended to curb patent settlement …
By Ricardo Carvajal – The Supreme Court overturned a district court decision, affirmed by the 9th Circuit Court of Appeals, that enjoined the USDA Animal and Plant Health Inspection Service ("APHIS") from partially deregulating Roundup Ready Alfalfa ("RRA") and prohibited the planting of RRA until …
