Drug company 'shenanigans' to block generics come under federal scrutiny

FDA Commissioner Scott Gottlieb said recently that drug makers must "end the shenanigans" that prevent competing products from reaching the market.

FDA Commissioner Scott Gottlieb said recently that drug makers must "end the shenanigans" that prevent competing products from reaching the market. The Trump administration is targeting pharmaceutical companies that refuse to provide samples of their products to generic drug companies, making it impossible to create inexpensive generic copies of a brand-name medicine. he maneuvers by brand-name drug firms, Gottlieb said, "frustrate the ability of generic firms to purchase the doses of a branded drug that they need to run their studies." The Federal Trade Commission is investigating the practice, which it says can forestall generic competition and "potentially preserve a brand firm’s monopoly indefinitely." Legislation to ensure access to drug samples for generic drug manufacturers has broad support in Congress from both parties. Brand-name drug companies say such legislation is not needed. FDA approved 1,027 generic drugs last year, a record number, and nearly 90% of prescriptions are filled with generic medicines, suggesting that generic manufacturers have generally been able to obtain the samples they need, the brand-name companies say.