Thu October 29th, 2020
Sponsor: Rep. Doris Matsui — D — CA
Allows the Secretary of Health and Human Services to require label updates for certain generic drugs once the reference drug’s patents and exclusivities expire, new information is available, and the Secretary determines that the public health would benefit from the updated label. Under current law, labels on generic drugs must match those of their corresponding reference brand drug. The bill also would require the Secretary to report to the Congress every four years on the number and types of such determinations made and on the number of times manufacturers disagreed with those determinations.
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