By Alexander J. Varond – FDA’s breakthrough therapy designation (BTD) program has been, by all accounts, a popular program. Sponsors, looking to gain extra support from the Agency, shorten review times, and signal to investors that FDA views their preliminary clinical evidence favorably, have submitted over …
By Larry K. Houck – The Centers for Disease Control and Prevention (“CDC”) has released its final guidelines for prescribing opioids for chronic pain. CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016, Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Mar. …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Columbia (Judge Rudolph Contreras) issued a 33-page Memorandum Opinion in a case stemming from a Complaint filed in June 2015 by Ferring Pharmaceuticals Inc. (“Ferring”) against FDA challenging the Agency’s …
By James C. Shehan & Kurt R. Karst – On March 10, 2016, FDA released a draft guidance interpreting the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). This provision, at BPCIA § 7002(e)(4), is one of a …
By James C. Shehan – More than one commentator predicted that the Federal Circuit’s decision in Amgen v. Sandoz interpreting the patent dance provisions of the Biologics Price Competition Innovation Act ("BPCIA") would be a fertile source of new litigation rather than a definitive decision laying …
By David C. Gibbons & John R. Fleder – On March 8, 2016, Amarin Pharma, Inc. (“Amarin” or “the Company”) and FDA filed a proposed Stipulation And Order Of Settlement (“Proposed Settlement Order”) with Judge Paul Engelmayer in the U.S. District Court for the Southern District of …
By Kurt R. Karst – The ongoing controversy over drug pricing has raised debate on many aspects of drug approval, and, in particular, on the approval of generic drugs. Over the past several months, there have been numerous letters from Members of Congress to FDA – …
By Alexander J. Varond – On March 2, 2016, GAO released its report, “RARE DISEASES – Too Early to Gauge Effectiveness of FDA’s Pediatric Voucher Program.” While the report nicely summarizes the history of the program, it contains little new information. Highlights from the report include: FDA …
By Kurt R. Karst – Earlier this week at the Generic Pharmaceutical Association’s (“GPhA”) annual meeting in Orlando, Florida, Dr. Kathleen (“Cook”) Uhl, Director of the Office of Generic Drugs (“OGD”), gave the keynote address, providing the generic drug industry with a much-anticipated lowdown on FDA’s …
By Mark I. Schwartz – Unlike solid oral dosage form drugs that don’t require sterilization, generally, parenteral drug products must be sterilized and, due to their nature, many parenteral drug products cannot be terminally sterilized. This leaves aseptic manufacturing. In the aseptic process, the drug product and …
By Kurt R. Karst – Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating [Public Health Service Act (“PHS Act”) § 351(l)(8)(A) (42 U.S.C. § 262(l)(8)(A))] as a standalone requirement and creating an injunctive remedy that delays …
By James E. Valentine – Last month, the U.S. Government Accountability Office (GAO), the independent, nonpartisan agency that provides auditing, evaluation, and investigative services to Congress, publicly released the findings of a report on FDA’s handling of drug postmarket safety oversight. As reflected in the title of the …
By Kurt R. Karst – Question: When was the first time FDA approved an ANDA containing a Paragraph IV certification to a patent listed in the Orange Book for DIPRIVAN (propofol) Injection, 10 mg/mL, approved under NDA 019627, and granted a period of 180-day exclusivity? Buehler, Buehler? If …
By Mark I. Schwartz – [1] According to our calculations, 2015 was a banner year, from CDER’s perspective, for foreign drug facilities receiving cGMP Warning Letters citing data integrity issues. While the overall number of cGMP Warning Letters issued by CDER was only 23 (compared, for …
By Kurt R. Karst – We love precedents – particularly unusual precedents that are wrapped up in drug approval histories. A couple of years ago we learned about a new precedent concerning the “date of approval” of a drug product. That term is defined in an …
