Inside Health Policy recently reported on the writings of several professors who opined on courts’ deference to the FDA. The writings discussed in the Inside Health Policy piece were from the July 2008 Cornell Law Review, which devoted an entire issue to “Symposium: U.S. Food …
On October 2, 2008, the Consumer Product Safety Commission (“CPSC”) held a public meeting on the testing and certification requirements imposed by the recently enacted Consumer Product Safety Improvement Act (“CPSIA”). A similar meeting was held on September 4, 2008 and several others are planned …
BNA, a leading provider of expert information and analysis, is holding a one-day, information-packed conference, titled “Pharmaceutical Patent Laws: A prescription for Success in Challenging Times.” Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be on a panel discussion of Non-Patent Marketing Exclusivity with …
First introduced in September 2007 as S. 2029 by Senator Charles Grassley (R-IA), the ranking member of the Committee on Finance, and Senator Herb Kohl (D-WI), the Chair of the Special Committee on Aging, the Physician Payment Sunshine Act is progressing through Congress. Representatives Peter …
On October 7, 2008, the U.S. Court of Appeals for the Eleventh Circuit, in Hi-Tech Pharmaceuticals v. Lester M. Crawford, affirmed a district court decision finding that: (1) FDA complied with the Administrative Procedure Act (“APA”) in promulgating its final rule banning dietary supplements that …
In a surprising and likely controversial decision regarding so-called “Section 340B covered entities,” the U.S. Court of Appeals for the Ninth Circuit in County of Santa Clara v. Astra U.S.A., Inc. recently reversed the U.S. District Court for the Northern District of California’s dismissal of …
More than one might guess. On September 26, 2008, the Government Accountability Office (“GAO”) released a report, titled "Food Safety: Improvements Needed in FDA Oversight of Fresh Produce." As the title suggests, the report is somewhat critical in tone, although it does acknowledge FDA’s efforts …
Earlier this week, Senator Sherrod Brown (D-OH) announced the introduction of S. 3633, the “Transparency in Drug Labeling Act.” The bill, also know as the “COOL Pharmaceutical Bill,” would amend the FDC Act to require Country-Of-Origin (“COO”) labeling on prescription and Over-The-Counter (“OTC”) drug products. …
