White House Calls to Expedite Review of 2nd or 3rd Classes of New Molecular Entities image

Regulatory Focus, February 09, 2018
Zachary Brennan, quoting Rachel Sachs (Academic Fellow Alumna)


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From the article:

The White House's Council of Economic Advisers on Friday released a report on drug pricing, suggesting changes to the Medicare and Medicaid programs and reforming the US Food and Drug Administration (FDA) could encourage more robust price competition.

On the FDA front, the report calls for expedited reviews of new molecular entities that are "second or third in a class, or second or third for a given indication for which there are no generics.

Rachel Sachs, associate professor of law at Washington University School of Law, told Focus: "We've seen many examples where more branded drugs on the market has not led to a decrease in prices," but actually to "lock-step increases."

Sachs noted: "There is a lot of rhetoric in this report about things like over-pricing and under-pricing, suggesting that there is a 'right price' but no where do they say what that is."

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