Industry group voices 'extreme' concern with PROTECT Act

Opposition to the PROTECT Act continues to mount--this time, in the form of a letter signed by 12 health organizations.

In a Feb. 14 letter to Senator Tom Harkin (D-Iowa), Chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), a coalition of influential patient groups expressed their concerns about the proposed legislation that would limit the U.S. Food and Drug Administration's regulatory authority.

"As members of the Patient, Consumer and Public Health Coalition, we strongly oppose the PROTECT Act of 2014. The Act, as drafted, would have the harmful consequence of exempting so-called 'health software' and 'clinical software' devices from FDA oversight," states the letter signed by 12 organizations, including the American Medical Women's Association, the Jacobs Institute of Women's Health, National Consumers League, National Physicians Alliance, National Research Center for Women & Families and the National Women's Health Network. 

Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced the PROTECT Act bill in the Senate on Feb. 10 in a legislative effort to amend the Federal Food, Drug and Cosmetic Act and to ensure that clinical and health software would not be subject to regulation. According to the coalition's letter, medical devices are "clearly defined" in the Federal Food, Drug and Cosmetic Act while the PROTECT Act only "muddles" the definition of a device by creating new categories of products that would be exempt from FDA oversight.

"We are extremely concerned that this bill will deregulate a broad swath of medical devices that rely on software and will create opportunities for rampant 'gaming' to avoid regulation," asserts the letter. "For example, MRIs and CT scanners, or heart monitoring devices, might no longer be regulated by the FDA. This would put the health of millions of Americans at risk."

The Patient, Consumer and Public Health Coalition isn't the only industry group to voice these concerns. In a Feb. 12 position paper, the CDS Coalition and mHealth Regulatory Coalition made a similar case that the proposed legislation would remove from FDA regulation high-risk clinical decision support software, mobile medical apps and other medical device functionality currently under the oversight of the regulatory agency.   

"Healthcare providers and patients rely on the FDA to establish that a device is reasonably safe and effective," argues the letter from Patient, Consumer, and Public Health Coalition. "Without FDA to carefully scrutinize the risks and benefits of a device, patients' health may be seriously harmed. Even if the device itself is not harmful, if it is not proven effective, then patients could be harmed by inaccurate results that are either anxiety-producing or erroneously reassuring; these outcomes could result either in unnecessary testing or serious illness or death."

The PROTECT Act would also make the National Institute of Standards and Technology the federal agency with oversight responsibility for technical standards used by clinical software--a provision opposed by the coalition.

"We adamantly disagree with the Act's finding that the National Institute of Standards and Technology should be the Federal agency that has oversight on standards used by clinical software," states the letter. "NIST's mission is to promote U.S. innovation and industrial competitiveness, whereas the FDA's mission is to protect the public's health by assuring the safety and efficacy of drugs, biological products, and medical devices."

To learn more:
- read the letter to Sen. Harkin