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# Concerns About FDA Approvals Under Cures Act
- URL: https://www.fdaweb.com/concerns-about-fda-approvals-under-cures-act/
- Published: 2017-02-15T12:00:00.000Z
- Updated: 2026-09-14T22:06:44.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137987

Yale Law School professor **Gregory Curfman** and student **Deborah Mazer** say that while there are positive elements in the recently-approved 21st Century Cures Act, subtle changes to the approval procedures for new drugs and medical devices included in the law “could weaken FDA’s regulatory oversight as could a provision that permits off-label promotion of healthcare economic information.” Writing in a detailed *Health Affairs* blog [post](http://healthaffairs.org/blog/2017/02/14/21st-century-cures-act-lowers-confidence-in-fda-approved-drugs-and-devices/?utm%5Fcontent=buffer7a56e&utm%5Fmedium=social&utm%5Fsource=twitter.com&utm%5Fcampaign=buffer), the two say that while changes to the standards of evidence required for drug and device approval are often discretionary, they may have the result of weakening the traditional standards required by FDA, with an unpredictable long-term effect on drug safety and efficacy.

“Bringing new medical products to market efficiently is a laudable goal,” the post says, “but the government must carefully walk the fine line between speed of drug approval and the rigor of the approval process. The next FDA commissioner, along with HHS secretary Price, will have a large role in interpreting the language on drug and device regulation in the 21st Century Cures Act, and President Trump’s choice of commissioner will therefore have an especially great impact on the regulatory process.”

The post details potential modifications to standards of evidence for drug approval, steps toward simpler and easier approval for medical devices, and off-label promotion of healthcare economic information.

The authors say that President Trump’s 1/30 executive order requiring federal agencies to eliminate two regulations for each new regulation the agencies introduce and offset the incremental cost of new regulations introduced another variable into the mix. “This executive order may seriously hinder the implementation of portions of the 21st Century Cures Act—much of the act directs FDA to create new review pathways for drugs and devices, and FDA would effectuate this mandate by promulgating new regulations,” they conclude.