By Rachel Sachs
On Thursday, Senators Ted Cruz and Mike Lee introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text), which would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada. The Act would require the FDA to grant such “reciprocal marketing approval” within 30 days, unless the FDA makes affirmative determinations about the drug or device’s lack of safety and efficacy. If the FDA declines to grant reciprocal marketing approval, the Act would also permit Congress to override the FDA’s decision through a majority vote via a joint resolution.
Zachary Brennan at RAPS has already provided a helpful explanation of the problems with this proposal, and in particular the problems created if Congress were permitted to override FDA denials of approval. In this post, I want to focus primarily on the Act’s premise. Senators Cruz and Lee argue that this bill would speed approval of drugs and devices “which are currently saving lives in other developed countries, but have not been approved in the U.S. because of FDA red tape.” The implication is two-fold: 1) that drugs are often left languishing at the FDA while they enjoy approval in other countries, and 2) that the FDA has no grounds for failing to approve these drugs. The first argument, about the speed of FDA approval, is made quite frequently by legislators who seek to weaken the FDA’s gatekeeping authority over new drugs and devices in the United States. Unfortunately, it hasn’t really been true for decades. The second argument ignores the historical context of the FDA’s decision-making authority.