Current versions of both the House and Senate stimulus bills call for new reporting mechanisms to require drug manufacturers and active pharmaceutical ingredient (API) manufacturers to report on their supply chain. This would include reporting on where material is made, and the amount of drug or API being manufactured.
The House Democrats' stimulus bill released last night would require drug manufacturers and active pharmaceutical ingredient manufacturers to report quarterly on the volume of drugs they manufacture, prepare, propagate, compound, or process for commercial distribution prior to being imported or offered for import into the United States. Section 70534 of the House bill is available here.
The House version of the bill would also require drug manufacturers to give the government more information when their supplies are interrupted, including details about active pharmaceutical ingredients. The bill also requires drug companies to maintain contingency plans to ensure backup supply of products and to provide information about drug volume.
Both the Senate and House bills also contain funding to support U.S. drug research and development to support U.S. sourced supply chains of vaccines, therapeutics, and active pharmaceutical ingredients. Additional funds are also allocated for stockpiling pharmaceuticals, personal protective equipment, and medical supplies.
We expect further details to become available once final legislation is passed.
Should you have any questions concerning these developments, please contact one of the trade professionals listed here.
Draft Stimulus Bills Call for New Drug Reporting Requirements