Researchers Say FDA Should Consider Allowing Reciprocal Approval for Generic Drugs
The FDA could offset drug price spikes or shortages by allowing reciprocal approvals for certain generic drugs with limited competition, according to joint research from Johns Hopkins, Yale, Harvard and the Council on Foreign Relations, published in BMJ.
The research team identified 170 novel branded drugs whose patent protection has expired in the U.S. and have up to three generics on the market. They found that thirty-nine percent could have four or more approved manufacturers if the agency were to allow reciprocal approval for drugs cleared by any of seven international drug regulators.
“The most noteworthy — and surprising — finding is that there are a substantial proportion of off-patent drugs that could have additional manufacturers if a system of reciprocal approval were developed,” said Ravi Gupta of Johns Hopkins School of Medicine, lead author of the study report.