Appeals Court Reverses Conviction Of Drug Sales Rep Who Talked About Off-Label Uses
The federal judges said the conviction violates the salesman's right to free speech.
The New York Times: Ruling Is Victory For Drug Companies In Promoting Medicine For Other Uses
In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative's freedom of speech (Thomas, 12/3).
Reuters: U.S. Court Voids Drug Rep's Conviction, Cites Free Speech
A divided federal appeals court on Monday threw out the conviction of a sales representative for promoting off-label use of a prescription drug, a ruling that could make it harder for the government to police how drugs are marketed and sold. The 2nd U.S. Circuit Court of Appeals in New York found that the sales representative's free speech rights under the First Amendment had been violated (Stempel, 12/3).
Meanwhile, the FDA promised to help fund the new effort to evaluate medical devices.
Modern Healthcare: Consortium Aims To Speed Device Reviews
The Food and Drug Administration has joined a public-private partnership to fund new evaluation tools and methods for assessing medical devices, according to a news release. The agency will provide an indeterminate amount of funding to the not-for-profit Medical Device Innovation Consortium, which was created by a biomedical science trade association. The group of industry, government and other not-for-profit organizations aims to fund projects that simplify the medical device design and approval process. The funded projects would include new "tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products." … The FDA's support for the initiative may extend to its staff collaborating on partnership-supported research (Daly, 12/3).
Medscape: First-Ever Group Aims To Speed Medical Devices To Market
The US Food and Drug Administration (FDA) today unveiled a new, nonprofit, public-private partnership that aims to speed safe medical devices to market, in part by encouraging otherwise competing manufacturers to pool their knowledge about product testing. … The new partnership, called the Medical Device Innovation Consortium (MDIC), was created by LifeScience Alley, a biomedical science trade association. Founding MDIC members include the FDA, the Centers for Medicare & Medicaid Services, LifeScience Alley, Medtronic, Boston Scientific, the Pew Charitable Trust, and the National Organization for Rare Disorders. Organizers envision bringing aboard leaders of academia as well as industry and government. (Lowes, 12/3).