To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office.
About This Bill
Committee
Latest Action · September 13, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
The Medication Affordability and Patent Integrity Act requires pharmaceutical companies to share information consistently between the Food and Drug Administration and the U.S. Patent and Trademark Office when seeking drug approvals and patents. Specifically, companies must certify that data about their drugs submitted to the FDA matches what they told the patent office, and they must share any clinically relevant information with both agencies. The law applies to all new drug applications submitted after its enactment, as well as to future patents on previously approved drugs. If a company fails to comply with these disclosure requirements, the FDA can deny or refuse to approve the drug application, and defendants in patent infringement lawsuits can use non-disclosure as a legal defense. The legislation aims to prevent companies from selectively presenting information to regulators and patent offices in ways that might inflate patent protections or drug approval prospects.
Take Action
Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.