Koski Comments on Prospects for Prescription Drug Legislation

Partner Katy Koski was quoted in a Pharmaceutical Technology article, “CREATES Act Dropped But May Still See Progress,” about the chances that legislation aimed at lowering the costs of prescription drugs will be taken up by Congress this year.

The legislation, formally known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, would prevent companies making branded drugs from refusing to sell samples to firms producing lower-cost generic and biosimilar versions, who need access to branded drugs to conduct the comparative testing required to get their own versions approved.

Koski said the focus on the sample-access issue has increased significantly with the introduction of biosimilars, whose manufacturers need to buy multiple batches of branded drugs from various manufacturing lots.