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# Cures Law Emphasizes ‘Speed Over Science’: Professors
- URL: https://www.fdaweb.com/cures-law-emphasizes-speed-over-science-professors/
- Published: 2017-01-05T12:00:00.000Z
- Updated: 2026-09-14T21:58:16.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137648

Harvard Medical School professors **Aaron Kesselheim** and **Jerry Avorn** say some provisions in the 21st Century Cures law emphasize speed and ease over science and could end up hurting patients and drug development. Writing in a *Journal of the American Medical Association* Viewpoint [column](http://click.alerts.jamanetwork.com/click/e4qqy-5szll4-1b7d7ve3/?ref=fdaweb.com), Kesselheim and Avorn say that while some problematic provisions were dropped from the final version of the bill, “the version signed into law retained several provisions designed to reduce the amount and rigor of clinical testing required before new drugs and devices can be approved for use. These changes are based on the foundational misconceptions that FDA standards for approval are too demanding and thus keep valuable new treatments from the U.S. public and needlessly increase the cost and duration of drug and device development. In this respect, the law is a solution to a problem that mostly does not exist.”

The two particularly question provisions addressing the types of data that manufacturers will be able to use to gain FDA approval of new products or additional indications for existing products. Thus, they say, one section directs HHS/FDA to qualify drug development tools to facilitate new drug approval such as biomarkers, surrogate measures, other assessments, and “any other method, material, or measure that the \[HHS\] secretary determines aids drug development.” There are also requirements to develop pathways to facilitate submission of “patient experience” information in regulatory decision-making and to establish a program to use “real-world evidence” to support approval of new uses for existing drugs.

The article points out that most of these data elements are already used by FDA, with about half of all new drugs now approved based on biomarkers and other surrogate measures. “Overreliance on such measures has recently led to approval of treatments for muscular dystrophy, tuberculosis, and metastatic breast cancer,” the two write. “When biomarkers used as the basis for drug approval are not rigorously validated, they may not actually predict patient benefit, can mislead physicians about whether a drug works, and have the potential to expose patients to poorly effective treatments or unanticipated adverse effects. These sections of the bill increase the probability that insufficiently tested biomarkers could be ‘qualified’ under orders from the secretary. Remarkably, scientific merit is not a mandatory component.”

Kesselheim and Avorn note that the incoming Trump administration has stated its desire to deregulate as much of the U.S. economy as possible, and the two (unnamed) candidates apparently being considered for the job of FDA commissioner have advocated for less oversight of many aspects of new drug and device approvals. “An antiregulatory ideology of new FDA and HHS leadership coupled with the elements of the 21st Century Cures Act that encourage use of less rigorous data to meet standards for approval are a dangerous combination that could prove risky to patients as well as to the drug development enterprise,” they conclude.