Cruz or FDA: Who do you trust with your health?

Sen. Ted Cruz (R-Texas) not only wants to be your president; he wants to decide what medicines you can get. On Dec. 10, Cruz and Sen. Mike Lee (R-Utah) introduced legislation intended to speed up Food and Drug Administration review of drugs and devices that have been approved in certain foreign countries. The Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act would require FDA to approve or reject within 30 days of application any drug or device that has been approved in a “trusted” foreign country — specifically, Canada, Australia, Israel, Japan, and the European Union members. Should the FDA reject an application, Congress can override the agency. 

The proposed legislation raises several red flags. For one, the FDA is the global gold standard for review of new drugs and devices. Outsourcing review to the nations selected by Cruz and Lee effectively invites pharmaceutical and device companies to shop for the least onerous regulatory process, knowing that they will nevertheless be able to sell their products in the United States, the world’s largest and wealthiest medical market. At the same time, outsourcing review of new drugs and devices means handing over to other nations the power to influence what new products enter the U.S., regardless of the fact that American health concerns and priorities may not be the same as those elsewhere. 

{mosads}Another concern is that Cruz and Lee apparently believe Congress to be a more qualified and trustworthy arbiter than the FDA, an agency comprising impartial scientists whose sole mission is to protect Americans’ health by ensuring the safety and efficacy of medical products. Whereas the FDA relies on scientific evidence and expert assessment, pharmaceutical and biotech dollars are often the lifeblood of Congress members and senators. For example, Cruz has received nearly $100,000 in contributions from drug companies, the most of any of the GOP presidential candidates. Congress would need to manage a mountain of conflicts of interest to supplant the FDA as the regulator of your medicines. 

Cruz and Lee also appear to be uninformed about FDA approval rates and speeds. Last year saw a record number of new drugs approved by the FDA, and 2015 has had even more approvals. And FDA approval times are quicker than in many of the “trusted” countries. If the bill’s sponsors don’t know this, how can they be trusted to overhaul the FDA?  

According to Cruz, the impetus for the RESULT Act is patients failing to get access to lifesaving drugs because of FDA red tape. He fails to understand that determining safety — not to mention efficacy — is a process that necessarily takes time. In the late 1950s, the developers of thalidomide in Germany, a country included on the RESULT Act’s list of trusted regulators, believed their product to be safe, but FDA medical officer Frances Kelsey took the time to take a closer look and deemed the drug unsafe for use here, thereby limiting the severe birth defects that stemmed from thalidomide use by pregnant women. This is just one famous example; there are many others. 

Do we really want Cruz and Lee — two lawyers turned politicians — and their colleagues to be in the position of overturning a decision like Frances Kelsey’s? In a political system where money talks and advertising is considered constitutionally protected speech, there needs to be one independent entity that relies on science to safeguard the public’s health. Even if one believes that FDA approvals take too long, or that, as Cruz alleges, the government is a roadblock to medical innovation, the solution is not to take oversight of our health out of the hands of medical and pharmaceutical experts and place it in the hands of a group so identified with gridlock and partisanship.  

Cruz believes that it is time to “unleash life-saving drugs and devices in the United States.” We fear instead that the bill will unleash harmful products that are not up to U.S. standards, in response to either backroom deals cut by lobbyists who don’t have the best interests of either current or future patients in mind or to well-intentioned pressure from patients groups. 

There is an old adage that sometimes the treatment is worse than the disease. Bearing that warning in mind, we find that there is little to trust and much to fear about the RESULT Act.

Kearns is a research associate at the NYU Langone Medical Center Division of Medical Ethics. Bateman-House is a Rudin Postdoctoral fellow at the NYULMC Division of Medical Ethics. Caplan is the founding director of the NYULMC Division of Medical Ethics.