H.R. 5811, a bill to amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes

On May 9 and May 17, 2018, the House Committee on Energy and Commerce ordered 59 bills to be reported related to the nation’s response to the opioid epidemic. Because of the large number of related bills ordered reported by the Committee, CBO is publishing a single comprehensive document that includes estimates for each piece of legislation.

H.R. 5811, a bill to amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes, would allow the Food and Drug Administration (FDA) to require that pharmaceutical manufacturers study certain drugs after they are approved to assess any potential reduction in those drugs’ effectiveness for the conditions of use prescribed, recommended, or suggested in labeling. CBO anticipates that implementing H.R. 5811 would not significantly affect the FDA’s costs over the 2019-2023 period.

H.R. 5811 would expand an existing mandate that requires drug developers to conduct postapproval studies or clinical trials for certain drugs. Under current law, in certain instances, the FDA can require studies or clinical trials after a drug has been approved. H.R. 5811 would permit the FDA to use that authority if the reduction in a drug’s effectiveness meant that its benefits no longer outweighed its costs. CBO estimates that the incremental cost of the mandate would fall below the annual threshold established in the Unfunded Mandates Reform Act (UMRA) because of the small number of drugs affected and the narrow expansion of the authority that exists under current law.

H.R. 5811 would impose private-sector mandates as defined in UMRA. CBO estimates that the costs of the mandates would not exceed the UMRA threshold for private entities.