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2) Improve health outcomes for patients through increased access and compliance

3) Reduce the costs of these products that can cost hundreds of thousands of dollars per patient per year.

Without generic competition, prices will continue to place these miracle medicines out of reach for consumers.

All parties in this debate agree that only safe products should be allowed on the market. The FDA has testified that it has the scientific expertise to review these products but currently lacks the authority to approve them. Further, the “interchangeability” or substitutability of biologic products would only be determined by the FDA if its scientists conclude it to be safe for the patient.

The biotech drug lobby claims that biogenerics legislation could undermine innovation.

Drug manufacturers said the same thing 20 years ago when a pathway for traditional generics was created. Since then, innovation has flourished. According to Dr. Scott Gottlieb, former FDA director of Medical Policy Development Commissioner for Medical and Scientific Affairs, biogenerics legislation will actually speed up progress. In short, the time is now for biogenerics legislation.


President and CEO

Pharmaceutical Care

Management Association