Ted Cruz proposes controversial plan to expedite drug approvals through 'reciprocity'
- Proposed by presidential candidate Senator Ted Cruz (R-TX), the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act would mandate approval of a drug within 30 days if it has already been approved in a "developed and trustworthy" country.
- The bill (S. 2388) would also allow Congress to override FDA decisions.
- Proponents suggest this bill will not only save lives by making life-saving medications available more quickly, but will also foster greater innovation in the biopharma industry.
The RESULT bill is an attempt to expedite and streamline drug approvals—a key part of the broader 21st Century Cures Act. It provides for reciprocal approval of drugs, as well as devices and biologics, between developed countries and the United States. A drug approved in one jurisdiction would be available in the others.
This would streamline the regulatory process by eliminating the need for multiple countries to replicate the approval process for the same drug. Patients in need of a certain medication would not need to wait for the approval process to run its course in their home country in order to obtain treatment.
Cruz sets out to define which countries are "developed and trustworthy," including in the list E.U. countries, Israel, Australia, Canada and Japan. But his suggestion fails to recognize the large variability between drug-approval laws in different countries, as well as challenges that have continually come up around medical devices in Europe.
Device manufacturers often seek approval for devices in an E.U. country with lower standards in order to expedite the product to market. With a reciprocal approval, drug and device makers could broaden their attempts to arbitrage regulatory systems.
In addition, establishing a mechanism for Congress to overrule the FDA challenges the agency's regulatory authority, essentially disempowering it. It is worth noting the pace of drug approvals by the FDA has increased, with a record number of approvals this year. The FDA also has a priority review designation, speeding up its ability to get groundbreaking deals approved quickly.