Under current law, labels on generic drugs must match those of their corresponding reference brand drug. H.R. 5668 would allow 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. 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.
CBO expects that over the 2021-2025 period, implementing H.R. 5668 would require the work of less than one full-time staff member of the Food and Drug Administration. CBO estimates the cost would fall below $500,000 over the 2021-2025 period, although the amount could be higher if the Secretary determines that a significant number of labels require updates. Any spending would be subject to the availability of appropriated funds.
H.R. 5668 would impose a private-sector mandate as defined in the Unfunded Mandates Reform Act (UMRA) by requiring manufacturers of certain drugs to update product labels. Because this requirement is not expected to apply to a large number of products in the first few years, CBO estimates that the aggregate cost would fall below the private-sector threshold established in UMRA ($168 million in 2020, adjusted annually for inflation).
