Senate Finance Committee Should Reject CREATES Act Amendments To CHIP Reauthorization
The Senate Finance Committee is expected to soon consider legislation reauthorizing the Children’s Health Insurance Program (CHIP).
As the Committee moves forward, it is possible that there will be amendments calling to modify the FDA’s Risk Evaluation and Mitigation Strategies (REMS), a regulatory structure that applies to a small set of potentially dangerous drugs.
Specifically, lawmakers may consider S.974, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.”
Senators should vote NO on any effort to implement the CREATES Act via the Committee amendment process.
While the CREATES Act is an honest attempt to increase access to medicines, this proposal risks undermining intellectual property protection, open the door to unjustified litigation, endanger patient and researcher safety, and suppress innovation.
The existing REMS regulatory structure is carefully balanced to promote safety, innovation, and access. The CREATES Act would threaten that balance. As such, members of the Finance Committee should reject this legislation.
REMs is a special regulatory process that affects a small set of about 40 highly advanced, yet potentially dangerous drugs. This process is necessary because of the volatile nature of these medicines, and ensure they are efficiently developed and administered in a way that carefully balances property rights, safety, and access.
S.974 modifies this system by allowing generics to bypass FDA procedures that exist to ensure REMS medicines are safely developed. Under the proposal, a generic manufacturer is not required to include adequate safeguards for patients and researchers as a condition of authorization, and FDA is limited in its ability to deny or modify an authorization request. This lack of safety undermines the entire rationale for the REMS regulatory process.
Additionally, patent exclusivity for medical development has been carefully and deliberately legislated to ensure that creativity, innovation, and medical growth are protected. Although the CREATES Act aims to ensure bad actors do not abuse the regulatory system, the litigation system could create a system where innovators are forced to hand over their IP through the threat of litigation.
If enacted into law, the CREATES Act would open the door to bad actors in the industry launching petty and unjustified legislation. This would be a handout to trial lawyers at the expense of innovators, consumers, and the healthcare system.
While the CREATES Act may be a well-meaning attempt to increase efficiency, it is a flawed proposal. This proposal is bad policy and should be rejected by Senators.