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.
First, recent studies demonstrate that a majority – in many years a large majority – of all new drugs are approved first in the US, and the FDA consistently has the speediest review times of the major drug regulatory agencies. A 2012 New England Journal of Medicine article by Downing, Ross, and colleagues concluded that of 190 drugs approved from 2001-2010 by both the FDA and EMA, 63.7% were approved first in the US. Of the 154 drugs approved in the same time period by both the FDA and Health Canada, 85.7% were approved first in the US. The authors also concluded that the median time from submission to approval was shortest in the US, at 322 days, compared to 366 at the EMA and 409 days in Canada. A 2014 Centre for Innovation in Regulatory Science report concluded that 76% of drugs approved in the US, EU, and Japan between 2009 and 2013 were approved first by the FDA. Other studies are consistent with the conclusions reached in these reports. Essentially, even if in the 1980s and 1990s the FDA largely lagged behind the rest of the world in terms of drug approval speed, today the FDA is often the speediest drug approval agency.
Second, even where the FDA has been slow to approve products, that slowness has often been viewed as a virtue, not a vice. The paradigm example is of course thalidomide, which was widely marketed in Europe before it was submitted to the FDA in 1960. Dr. Frances Kelsey famously refused to grant a license to thalidomide’s manufacturer due to her concerns about the drug’s safety profile, and her persistence in the face of pressure from industry and other government officials was rightfully praised, not criticized. Examples from the past decade, including Acomplia and Thelin, have repeated this same story. As such, even if there are a small number of drugs approved first in other countries, the FDA often has good reasons for taking its time with their approval here. The RESULT Act – particularly the provision permitting Congress to override the FDA’s denial of approval – takes a fundamentally different view of the purpose of the FDA, one that could have significant negative consequences for public health.