Postapproval Study Requirements for Certain Controlled Substances

Floor Speech

Ms. JACKSON LEE. Mr. Speaker, I rise in strong support of H.R. 5811, which amends the Federal Food, Drug, and Cosmetic Act with respect to post approval study requirements for certain controlled substances.

H.R. 5811 allows the 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.

In recent years, many communities have been devastated by the number of overdoses that have been related to the escalating opioid epidemic.

According to U.S. Department of Health and Human Services, illegal substances, deadly synthetics such as fentanyl, and legally available pain relievers accounted for more than 42,000 deaths across the country in 2016.

Further, in the city of Houston, there were 364 drug-related overdose deaths alone that happened in 2016 according to the Treatment Center, a highly respected drug and alcohol addiction treatment service center.

This is a national emergency that deserves immediate action.

H.R. 5811 would expand an existing mandate that requires drug developers to conduct post-approval studies or clinical trials for certain drugs.

FDA will provide doctors and patients the information they need to use medicines wisely.

This will ensure that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

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.

I urge my colleagues to join me in voting to pass H.R. 5811.

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