Compliance Management

Would Ted Cruz's Plan "Marginalize" the FDA?

Source: Vox

Dec 16, 2015

Republican presidential candidate Sen. Ted Cruz and Sen. Mike Lee have introduced a new bill designed to completely overhaul the FDA, with the main goal of expediting approvals for lifesaving drugs.

The Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (RESULTS) would allow for "reciprocal approval of drugs, devices and biologics" from "trusted, developed countries" -- meaning Americans would have access to drugs approved in other countries. The bill would also push the FDA to speed up drug approvals by giving them a 30-day window, give the Health and Human Services secretary power to approve a drug, and give Congress the power to overrule FDA decisions on certain drug approvals.

However, regulatory and medical experts are concerned with the drug review process and standards in countries outside the U.S. "This would completely marginalize the FDA," said Aaron Kesselheim, Harvard Medical School professor of medicine, in a Vox article, giving other countries the power to make decisions affecting the U.S. drug market. Additionally, as Vox points out, health professionals and scientists comprise fewer than 10 percent of U.S. Congress members -- begging the question of why these lawmakers would be given the power to make medical regulatory decisions.

Read the Vox article 

Read the RAPS article