By Jennifer D. Newberger – One of the tasks of the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) is to make recommendations that will result in cost savings and/or improvements in program efficiency and effectiveness. Unfortunately, as we are …
By Nisha P. Shah – Effective March 28, 2011, sponsors and investigators of human drug and biological products subject to either an investigational new drug application ("IND") or bioavailability ("BA") or bioequivalence ("BE") studies exempt from IND requirements will have revised safety reporting requirements under the …
By Kurt R. Karst – Midnight, March 4, 2011 – that’s the time and date on which the federal government will close for business if Congress fails to approve a spending bill, or a short-term/stopgap funding measure that would likely just delay a shutdown for a …
By Carrie S. Martin – In a draft guidance issued on February 28, 2011, called “Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Services (REMS),” FDA proposes: (1) to implement a procedure that allows applicants with a REMS to request eliminating a …
By Kurt R. Karst – In a win for compounding pharmacies and a loss for FDA, the U.S. Court of Appeals for the Fifth Circuit ruled last week in Med. Ctr. Pharmacy v. Holder that the U.S. District Court for the Western District of Texas violated …
By Susan J. Matthees – Six inmates on death row in three different states sued FDA in the U.S. District Court for the District of Columbia over the importation of thiopental sodium, one of the drugs used by some states to administer a lethal injection. The …
By William T. Koustas – We previously reported on the struggle between FDA and Regenerative Sciences, Inc. (“Regenerative”) in which Regenerative challenged FDA’s claim that the company’s stem cell procedure is subject to FDA jurisdiction and regulation under the Federal Food, Drug, and Cosmetic Act (“FDCA”) …
By Susan J. Matthees – Last week, FDA announced that the Agency has adopted final amended informed consent regulations. As we noted last year, the Food and Drug Administration Amendments Act ("FDAAA") § 801(b)(3)(A) required that FDA amend the informed consent regulations set forth at 21 C.F.R. § …
By Kurt R. Karst – Does “federal law, which imposes a strict set of labeling requirements on manufacturers of Final Monograph [Over-the-Counter (‘OTC’)] drugs, including mandatory product warnings authored by the FDA, [preempt] state-law product liability actions premised on theories of failure to warn[?]” That is …
By Kurt R. Karst – Recent judicial setbacks for the Federal Trade Commission (“FTC’) in actions challenging patent settlement agreements (or what opponents call “pay-for-delay” or “reverse payment” agreements) and opposition from both Republicans and Democrats to the inclusion of the Preserve Access to Affordable Generics …
By Susan J. Matthees – Congresswoman Louise Slaughter (D-NY) recently sent a letter to FDA Commissioner Margaret Hamburg requesting that FDA ban the use of triclosan in consumer products. Triclosan is commonly used as an antibacterial agent in topical antiseptic products, such as soaps and hand …
By Kurt R. Karst – Sandoz Inc.’s recent Complaint filed in the U.S. District Court for the District of Columbia concerning Orange Book-listed U.S. Patent No. 7,429,602 (“the ‘602 patent”) covering ELESTAT (epinastine HCl) Ophthalmic Solution, could, if successful, serve as a model for future cases …
By Kurt R. Karst – Last month FDA responded to an August 25, 2010 request from New Jersey State Senator Joseph F. Vitale (D) concerning pending legislation – Assembly Bill 1995 (the State Senate version of which is Senate Bill 961) – that, if enacted, would …
On December 9, 2010, Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will speak at a webinar on accelerated drug and biologic approvals. In 1992, FDA published final regulations providing for the “accelerated approval” of applications for certain new drugs and biologics. Section 506 of the …
By Kurt R. Karst – In a November 16th decision that might not mark the end to the dispute between Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) and FDA over marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products, Judge Alan Johnson from the …
