Catalyzing controversy: FDA emails challenge its claims that price plays no role in approvals

Over 200 pages of emails released as a result of litigation against FDA and HHS challenge FDA’s claims that it does not consider price when making approval decisions. The emails pull back the curtain on the agency’s scramble to prevent a drug company from turning an old, cheap medicine into a gold mine.

The docket raises questions about how far FDA can and should stretch its authority to address pricing issues, and whether FDA or Congress should change policies and laws that incentivize companies to obtain marketing approvals for unapproved drugs. ...