FDA Commissioner Announces Drug Competition Action Plan to Help Lower Drug Prices

FDA Commissioner Scott Gottlieb, MD, has unveiled a new plan to facilitate increased competition in the prescription drug market through approval of more lower-cost, generic medications.
Jackie Syrop
June 22, 2017
The FDA is also going to be examining policy and programmatic changes to address the issues thwarting generic competition. Some may be actions the FDA can take by using their own authorities more forcefully, while other steps might involve collaboration with sister agencies.
 
The Action Plan unveiled by the FDA Commissioner will grow and be updated as initial elements are implemented. The agency intends to broaden access to safe and effective generic drugs that can improve access to medicines and help consumers lower healthcare costs, but will steadfastly maintain FDA’s gold standard for rigorous, science-based regulation, Gottlieb promised.
 
Even though the actions promised by Gottlieb don’t affect branded drug spending until much later in the drug’s lifespan, his plan could be a setback to companies such as Turing Pharmaceuticals and Valeant Pharmaceuticals that specialize in buying up older, off-patent drugs and dramatically raising the prices once they become de facto monopolies. Targeting such “gaming” of the system would be an initial step in the FDA’s efforts to address generic drug markets, Gottlieb implied, and could later involve the Federal Trade Commission.

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