FDA confronts its limits in push on drug pricing image

Biopharmadive, August 27, 2018
Ned Pagliarulo, quoting Rachel Sachs (Academic Fellow Alumna)

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From the article: 

Drugmakers like AbbVie, which makes the best-selling biologic Humira (adalimumab), have reached settlement deals with makers of approved biosimilars to push off market entry. In the case of Humira, a low-cost option likely won't be available until 2023, despite two biosimilars already approved.

Elsewhere, Johnson & Johnson, the maker of branded Remicade in the U.S., has used rebates and contracts with payers to blunt the immediate effect of biosimilar copies from Pfizer and Merck & Co.

Neither examples are areas in which the FDA has authority.

"[Gottlieb] has been quite explicit about some of the gaming tactics that innovator pharmaceutical companies are engaged in that delay generic competition," said Rachel Sachs, an associate professor of law at the Washington University School of Law. "But his ability to crack down on them isn't as complete as he might like."

Still, the FDA appears to be exploring how it might work with other agencies that can. In his July remarks on biosimilars, Gottlieb said the agency was taking efforts to coordinate with the Federal Trade Commission to address "anti-competitive behavior."

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