Drug company ‘shenanigans’ to block generics come under federal scrutiny

New York Times

14 April 2018 - Trump administration officials, seeking ways to lower drug costs, are 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.

Dr. Scott Gottlieb, the commissioner of the FDA, said recently that drug makers must “end the shenanigans” that prevent competing products from reaching the market.

Generic drug developers need samples of brand-name drugs to show that a generic copy is equivalent to the original. The manoeuvres by brand-name drug firms, Dr. Gottlieb said, “frustrate the ability of generic firms to purchase the doses of a branded drug that they need to run their studies.”

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Michael Wonder

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Michael Wonder