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 …
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Drug Development
- Fifth Circuit Vacates District Court “Second Inspection Ruling” in Compounding Pharmacy CaseFebruary 28th, 2011
- Inmates Sue FDA Over Importation of Death Penalty DrugFebruary 9th, 2011
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 …
- Regenerative Sciences – FDA Struggle ContinuesJanuary 19th, 2011
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”) …
- FDA Amends Informed Consent RegulationsJanuary 10th, 2011
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. § …
- McNeil Petitions the U.S. Supreme Court on OTC Drug Labeling Failure-to-Warn Preemption IssueDecember 7th, 2010
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 …
- Legal Setbacks and Legislative Inaction May Push the FTC to Consider “Plan C” to Address Patent Settlement AgreementsNovember 29th, 2010
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 …
- Rep. Slaughter Tells FDA That Triclosan Should Be Banned From Consumer ProductsNovember 25th, 2010
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 …
- Sandoz Attempts to Clear Up Post-Losartan “Bottleneck” with DJ Action on Disclaimed PatentNovember 22nd, 2010
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 …
- FDA Says There is No Scientific Evidence of Problems in Switching Bioequivalent Anti-epileptic Meds, But Further Study is WarrantedNovember 21st, 2010
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 …
- Accelerate Your Understanding of Accelerated Approvals; Navigating The FDA Accelerated Approval ProcessNovember 19th, 2010
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 …
- District Court Grants FDA Motion to Dismiss in Unapproved Morphine Sulfate LitigationNovember 17th, 2010
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 …
- Senator Cites Ethical “Defect” in Biosimilars Law Exclusivity Provisions; Proposes Legislative FixNovember 4th, 2010
By Kurt R. Karst – Just as FDA was getting started with its two-day public meeting earlier this week on the Approval Pathway for Biosimilar and Interchangeable Biological Products, which occurred a little more than seven months after the enactment of the Biologics Price Competition and …
- FDA Issues Draft Guidance on the Qualification of Drug Development ToolsNovember 3rd, 2010
By Carrie S. Martin – On October 25, 2010, FDA issued a draft guidance entitled “Qualification Process for Drug Development Tools.” This draft guidance describes a new qualification process for drug development tools (“DDTs”), which include, among other things, biomarkers and patient reported outcome instruments. The …
- GAO Report Blasts FDA for Failure to Implement 2008 RecommendationsOctober 31st, 2010
By Jennifer B. Davis – Earlier this week, the Government Accountability Office (“GAO”) publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY – FDA Has Conducted More Foreign Inspections and Begun to Improve Its …
- New Draft Guidance for Industry: INDs – Determining Whether Human Research Studies Can Be Conducted Without an INDOctober 18th, 2010
By Dara Katcher Levy & Diane B. McColl - Last week, FDA issued a draft guidance intended to assist sponsors and investigators with decisions as to whether human research studies can be conducted on products without an investigational new drug application ("IND"). The draft guidance explains …