Consumer Groups Object to FDA Reforms in Cures Bill

By Bronwyn Mixter

May 18 — Thirteen consumer and patient groups May 18 warned members of a Senate committee not to insert proposals in their version of the 21st Century Cures Act that would undermine patient safety and curb access to lifesaving treatments.

The groups sent a letter to the Senate Health, Education, Labor, and Pensions (HELP) Committee requesting that the committee not include sweeping Food and Drug Administration reforms found in the “flawed” bill (H.R. 6) passed by the House in 2015.

The goal of the legislation is to speed the approval of innovative drugs and medical devices. At the moment, there’s not a true companion bill in the Senate. Instead, the HELP Committee in April approved measures that touch on similar areas (67 HCDR, 4/7/16).

The groups said they object to the proposal in the House bill that would require the FDA to speed the review of “breakthrough” medical devices “by restricting the FDA's ability to request new evidence during clinical development.” The groups also said they are concerned about proposals that would lower drug approval standards “by pressuring the FDA to rely more heavily on ‘evidence from clinical experience,' meaning sources other than randomized, controlled clinical trials, the gold standard for medical research.” In addition, they said they object to a provision in the House bill that would delay market entry of generic drugs.

Legislative Process

In their letter, the groups asked HELP Committee Chairman Lamar Alexander (R-Tenn.) and ranking member Patty Murray (D-Wash.) to observe “regular order” during the bill's remaining stages of the legislative process.

“We write to urge that members invested in patient safety, access to affordable medicines, and biomedical innovation observe ‘regular order' as these Senate bills are combined into one package, introduced, and voted on before the full Senate, and potentially conferenced with the much more far-reaching House 21st Century Cures Act,” the letter said.

The groups said “any maneuver resulting in a final legislative package that includes some or all of the dangerous provisions in the House 21st Century Cures Act that were not discussed during the Senate mark-up would constitute an unacceptable end-run around a normal legislative process, exactly the kind of cynical maneuvering feeding public distrust with the workings of the U.S. Congress.”

Alexander said in a May 11 Senate floor speech that he would like to see a floor vote on the legislation this summer (92 HCDR, 5/12/16).

“There's a very important biomedical research bill called the 21st Century Cures Act that I hope we can get to sometime before July,” he said.

The Senate is in session until May 27, when both chambers break for Memorial Day recess. There are then two short sessions in June and July before the long August recess and the national party conventions.

The 13 organizations that signed the letter include the Annie Appleseed Project, Article 25, Breast Cancer Action, Center for Medical Consumers, Knowledge Ecology International, Health GAP, Public Citizen, National Physicians Alliance, Treatment Action Group, Universities Allied for Essential Medicines, the Veterans Health Council, Vietnam Veterans of America and the Young Professionals Chronic Disease Network.

FDA Commissioner's Concerns

On May 5, FDA Commissioner Robert Califf also said he has concerns that if the 21st Century Cures legislation “is not carefully crafted it could pose a significant risk” for the agency and patients because it could cause drugs and devices to be approved too quickly.

“Innovative therapies are not helpful to patients” if they don’t work or they cause harm, Califf said at the Food and Drug Law Institute’s Annual Conference (88 HCDR, 5/6/16).

Califf also said it is important that Congress provide the FDA with an “adequate and stable source of funding” for any mandates in the legislation.

To contact the reporter on this story: Bronwyn Mixter in Washington at

To contact the editor responsible for this story: Brian Broderick at