Momenta Pharmaceuticals, Inc. (MNTA)

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FDA aims at removing barriers to generic drug competition

In a statement, FDA Commissioner Scott Gottlieb, M.D. says the agency should do more to restrain high drug prices by facilitating more competition via approving lower-cost generic meds.

A public meeting is scheduled for July 18 to solicit input on areas the FDA should focus on to make it more straightforward for generic drug sponsors to get their products approved. Dr. Gottlieb's Drug Competition Action Plan will target agency rules, including standards and procedures, that may create obstacles to patient access to generics.

He cites examples of branded drug makers' behavior that impede the progress and encroachment of generic competition. For instance, they make it difficult for generic drug firms to acquire the amount of branded product needed for comparative testing.

Dr. Gottlieb adds that the FDA will explore ways to coordinate with the Federal Trade Commission in identifying and publicizing practices that the FTC deems anticompetitive.