Letter to House Members Opposing Language Added to the Appropriations Bill that Lowers the FDA’s Safety and Efficacy Standards for Drugs and Devices

U.S. House of Representatives

Washington, DC 20515

Dear Representative _______

The National Center for Health Research strongly opposes language added at the last minute to the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for fiscal year 2017.  The language lowers the FDA’s safety and efficacy standards for approving drugs and medical devices and will put the public health at risk. These are the same provisions that members of the Patient, Consumer, and Public Health Coalition have previously opposed.  We urge you to oppose including in the appropriations bill language that lowers FDA’s standards for drugs and devices. Our specific concerns are listed below.

We strongly oppose Section 2001. This section requires the FDA to establish processes where patient experience data may be used in the risk-benefit assessment of a new drug.  While the FDA already considers patients’ experiences as part of the approval process, this language would pressure the FDA to allow anecdotal evidence collected by patients, caregivers and others to replace scientific evidence.   The experiences of a small number of patients is often very different from the experiences of thousands of patients, because those small numbers of patients cannot adequately represent women, men, people of color, or patients over 60 years of age.  That is why the law currently requires scientific evidence.  If you or a loved one was considering a new medication, would you rather have one that 2 patients said was very beneficial, or one that was found to be more beneficial than placebo for 100 patients?    The history of the FDA is a history of strengthening legislative safeguards in response to tragedies liked thalidomide, diethylstilbestrol (DES), and the Dalkon Shield IUD. Those tragedies resulted in requirements that drugs and devices be evaluated in scientific studies, and that is why FDA approval is the gold standard worldwide. Section 2001 would drastically undermine the meaning of FDA approval.

We strongly oppose Sections 2061 and 2062.  These sections lower the FDA’s gold standard of randomized, double-blind clinical trials and urges the FDA to rely on other types of evidence such as preclinical studies (such as rat studies and test tube research), case histories (anecdotes about individual patients), clinical experience (anecdotal information from small numbers of patients), and “alternative” statistical methods.  It also tells FDA reviewers what types of research designs and statistical analyses to require.  Unless you are a statistician, I hope you’ll agree that those decisions are best left to unbiased experts, rather than Congress and the President.

We also strongly oppose Section 2201 (Priority Review for Breakthrough Devices).  Approximately 99% of all regulated medical devices are cleared by the FDA through the 510(k) process, and the FDA reviews 90% of 510(k) applications within 90 days.[1] That’s an amazing track record which would be undermined by the legislation.  Under current law, new medical devices such as hips, spinal implants, and even many cardiac devices are almost never required to be proven safe or effective in clinical trials. And yet, this section would lower FDA standards for the 1% of the highest-risk devices – devices that patients’ lives depend on.  Patients want safe and effective devices cleared in a timely manner—and doctors want to know that the devices they put in patients’ bodies will help and not harm them.

In addition, we strongly oppose language that was added to the appropriations bill that will delay the FDA’s ability to issue its LDT (Lab Developed Tests) guidance.  Currently, lab-developed tests are not required to be proven accurate.  When they aren’t, inaccurate results lead to unnecessary and expensive testing and medical treatments, or to patients being erroneously assured that they are healthy when they are not.  Inaccurate LDTs lead to unnecessary injuries or deaths. FDA regulation would assure the public that these tests are accurate.  Your constituents and your loved ones deserve that.


We ask that you to stand up for patients and consumers by opposing language inserted into the bill that weakens FDA’s standards for approving drugs and medical devices.   Well-respected researchers from Harvard, Yale, UCSF and elsewhere and public health and consumer advocates have raised alarms that these sections (already included in the 21st Century Cures Act) would drastically lower FDA safety and efficacy standards. Once again, we urge you to oppose including the above provisions in the appropriations bill and report.

National Center for Health Research

The National Center for Health Research can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org

  1. Food and Drug Administration (2011) Analysis of Premarket Review Times Under the 510(k) Program. Retrieved from http://www.fda.gov/downloads/aboutfda/centersoffices/cdrh/cdrhreports/ucm263386.pdf