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 …
By Kurt R. Karst – Now that the dust from 2015 has settled, we’re able to take a look at and evaluate the year that was in orphan drug designations and approvals. Our annual review has become quite popular. We often see the numbers we provide …
In November 2013, the Drug Quality and Security Act (“DQSA”) was signed into law in an effort to increase the quality of the United States drug supply. The law contains two separate acts: the Compounding Quality Act (Title I), and the Drug Supply Chain Security …
By Kurt R. Karst – The ink from President Obama’s signature on Public Law No. 114-89, the “Improving Regulatory Transparency for New Medical Therapies Act” (or “IRTNMTA”), was hardly dry when the company that led the charge to change the law, Eisai Inc. (“Eisai”), asked the …
By Kurt R. Karst – Those folks who have been following this blog for several years have a good sense about the depths of this blogger’s passion for the Orange Book. There’s the license plate (“ORNGBUK”), the trip to the summit of Mt. Kilimanjaro with the …
By Kurt R. Karst – Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or challenging FDA’s denial of New Chemical Entity (“NCE”) exclusivity for VASCEPA (icosapent ethyl) Capsules (NDA …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2014) – Agreements Filed with the Federal Trade Commission under the Medicare …
By James E. Valentine – On January 13, 2015, CDER’s Clinical Outcome Assessments Staff (formerly Study Endpoints and Labeling Development (SEALD)) announced the launch of Stage 1, or the pilot stage, of its Clinical Outcomes Assessment (COA) Compendium. A COA measures patients’ symptoms, overall mental state, or …
