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# Coalition Opposes Senate FDA Reform Bills
- URL: https://www.fdaweb.com/coalition-opposes-senate-fda-reform-bills/
- Published: 2016-03-11T12:00:00.000Z
- Updated: 2026-09-15T02:43:07.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5135059

> A coalition made of 15 public health and patient advocate groups have written Senate lawmakers opposing seven bills that were reported out of the Senate HELP Committee 3/9 ([see earlier story](https://www.fdaweb.com/help-committee-votes-out-seven-biomedical-innovation-bills/)). The groups say they are “concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure they are safe and effective. Whether creating a new breakthrough pathway for devices (which already are approved based on much lower standards than drugs) or deregulating health IT software, for example, patients will be at risk.”  
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> The groups say they strongly oppose the Advancing Breakthrough Devices for Patients Act (S 1077) “because it sets a low bar to qualify for ‘breakthrough’ status, micromanages the FDA, lowers standards for safety and effectiveness, and uses a promotional term that misleads the public. In order to qualify for breakthrough status, a device simply must be ‘in the best interest of patients...’ Such a vague criterion will encourage many device companies to apply for ‘breakthrough’ status, overwhelming the resources of the FDA.”  
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> The coalition also says the bill undermines FDA’s professional judgment by telling it what type of statistics it should use (Bayesian), recommending the “adoption of shorter or smaller clinical trials,” stating who should be on device review teams, and requiring the agency to agree to a legally binding clinical trial plan in writing at the outset. “This is particularly problematic because new safety information is often learned during the development process, requiring study modifications to avoid harming patients,” it says.  
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> Additionally, the coalition objects to the MEDTECH Act (S 1101) because it would remove potentially life-saving and life-threatening health IT software entirely from FDA’s regulatory oversight. “If this bill becomes law, the FDA would no longer gather adverse event reports and it would not issue recalls for IT devices that have life-threatening flaws,” it says.  
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> And the coalition opposes the Combination Product Regulatory Fairness Act (S 1767) because it requires FDA to review more combination products as devices rather than as drugs. “It does this by requiring that jurisdiction as drugs or biologics not be assigned ‘solely because’ of chemical action in the human body,” it says. “Devices are held to a much lower standard for approval than drugs, so this shortchanges patient safeguards. In addition, the bill requires the FDA and sponsor to develop a binding clinical trial plan early in the development process. This would restrict the FDA’s ability to later seek additional clinical data if it discovers new information related to safety and effectiveness. That is dangerous for patients.”