Cancer Drug Supply

I commend Dr. Emanuel for highlighting the importance of generic drugs in assuring cost-effective access to quality health care. He recognizes that his approach may slightly increase prices for generic oncology drugs, to stimulate production in times of shortage. Fortunately, the federal government could recoup these costs several times over.
First, Congress should enact legislation that would put an end to anticompetitive “pay for delay” agreements. Branded-drug manufacturers are paying their generic competitors to stay off the market, making consumers wait years for less expensive generic alternatives. Stopping these sweetheart deals could save as much as $3.5 billion a year.
Second, Congress should amend the rules governing drugs, including oncology treatments, subject to “restricted distribution” safety controls. Some branded companies appear to be exploiting the safety rules by denying research samples to would-be generic competitors, who are blocked at the Food and Drug Administration’s entry gate because they cannot conduct bioequivalence studies.
Facilitating this additional generic competition would reap substantial savings — potentially billions of dollars — which would more than compensate for cost increases triggered by Dr. Emanuel’s proposal and help reduce the budget deficit.