By Kurt R. Karst – FDA’s Office of Orphan Products Development (“OOPD”) surpassed the 2,000 orphan drug designation mark in 2009 and designated a near-record 160 products for orphan (i.e., rare) diseases and conditions. FDA also approved 17 orphan products in 2009, according to data …
By Kurt R. Karst – Massachusetts-based The Medicines Company (“TMC”) has lost its latest battle with the U.S. Patent and Trademark Office (“PTO”) for a Patent Term Extension for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), a drug product FDA first …
Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be speaking at FDLI’s upcoming Introduction to Food Law and Regulation: A Program on Understanding How the Government Regulates the Food Industry. Mr. Carvajal will be presenting on food safety and unintended components/contaminants in food. The conference …
By Peter M. Jaensch – On January 14, 2010, the U.S. Attorney’s Office for the District of Massachusetts issued a statement announcing the charging of Doctor Scott Reuben, a former Chief of Acute Pain at Bay State Hospital in Springfield, Massachusetts, with one count of …
By Ricardo Carvajal – While calling for further research on bisphenol A ("BPA"), a chemical used in the manufacture of some plastics, FDA has acknowledged that it has "some concern about the safety of BPA:" At this interim stage, FDA shares the perspective of the …
By Susan J. Matthees – In July 2008, we blogged about the U.S. District Court for the Central District of California’s decision that found Purely Juice, Inc. liable under the Lanham Act for false advertising related to its pomegranate juice product. Last month, the U.S. Court …
By Susan J. Matthees & Anne Marie Murphy – On January 13, FDA announced the availability of a new draft guidance document titled, Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval. Pursuant to FDA regulations 21 C.F.R. §§ 56.108(a) and …
By Peter M. Jaensch – On January 14, 2010, the United States District Court for the District of Columbia issued a decision in Smoking Everywhere, Inc. and Sottera, Inc. d/b/a NJOY v. United States Food and Drug Administration, et al., in which the court granted …
By Kurt R. Karst – As we reported yesterday, the Federal Trade Commission (“FTC”) held a press conference on January 13, 2010 announcing the release of a report, titled “Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions,” on the effects of pay-for-delay deals in the …
By Cassandra A. Soltis – The Federal Trade Commission ("FTC") made clear in a recent opinion that the Federal Food, Drug, and Cosmetic Act ("FDC Act") is not binding on the Commission in its enforcement of Sections 5 and 12 of the Federal Trade Commission Act …
By Kurt R. Karst – Over the past several weeks, proponents of a ban on so-called pay-for-delay settlements have put a full-court press on Congressional leaders to include provisions in the final Health Care Bill. The House bill includes a provision (§ 2573) sponsored by …
By Ricardo Carvajal – Californians won’t have to contend with this warning in their grocery stores – for now. A California appellate court has upheld a lower court’s ruling that the Federal Meat Inspection Act (FMIA) preempts Proposition 65 point-of-sale warning requirements for meat. The suit …
By Peter M. Jaensch – On January 4, 2010, the Washington Legal Foundation (“WLF”) filed an amicus curiae brief in support of Ortho Biotech Products’ petition for a writ of certiorari in the Supreme Court of the United States, urging review of the decision in …
By Dara Katcher Levy – On December 23, 2009, FDA filed a Motion To Dismiss the First Fishery import matter that we previously blogged about back in late October. In short, First Fishery had filed suit seeking declaratory judgment and injunctive relief with regard to its …
By William T. Koustas – In yet another twist in the debate regarding FDA’s use of Risk Evaluation and Mitigation Strategies (“REMS”), Kaiser Permanente (“Kaiser”), which is the largest private integrated health care delivery system in the U.S., submitted a citizen petition on December 22, …
