May 24, 2017
As members of the Patient, Consumer and Public Health Coalition, we are writing to strongly urge you to oppose S. 951, the Regulatory Accountability Act of 2017 (RAA). This legislation, which covers guidance documents and well as rule-making, has dangerous implications for the health of all Americans. The current rule-making process is much too slow as well as unduly influenced by the special interests and court challenges of regulated industries. The RAA will make this situation worse, jeopardizing public health by threatening the safeguards needed to ensure clear air and water, safe workplaces, untainted food and effective medical products, and safe toys and consumer goods.
Rather than improve the current regulatory process, the legislation would instead weaken regulations that protect the public. While we can all agree that rules should be cost-effective, that term can be defined in many different ways. Years of litigation would result. Unfortunately, the bill’s “savings clause” does not clarify who authorizing statutes would be affected by the bill’s many requirements, and so is likely to result in years of wasteful litigation.
The RAA reintroduces “formal rule-making” which involves the use of adversarial, trial-type hearings to resolve complex policy questions. Any individual could petition an agency to hold a hearing on any “genuinely disputed “scientific or factual conclusions underlying the proposed rule. This would obviously not be in the public interest. The bill would also expand the scope of judicial review. While federal agencies have technical and scientific expertise, judges who are generalists would lack the expertise required to fully understand the need for or impact of a rule. Against, years of litigation are the likely result.
We are particularly concerned that agency guidance documents would be weakened and delayed under the RAA. For example, FDA guidance documents are often needed to keep up with innovations in medical treatment. Under RAA, these guidance documents would be greatly delayed, resulting in uncertainty for companies trying to get their medical products approved, and potentially putting patients’ health or lives at risk.
In conclusion, the RAA would do more harm than good by undermining life-saving safeguards that protect the public. We strongly urge you to consider the impact on your constituent and oppose the Regulatory Accountability Act of 2017.
Association for Medical Ethics
American Medical Women’s Association (AMWA)
Connecticut Center for Patient Safety
Kids in Danger
MRSA Survivors’ Network
National Center for Health Research
National Consumers League
National Organization for Women
National Women’s Health Network
Our Bodies, Our Selves
Washington Advocates for patient Safety (WAPS)
The Patient, Consumer, and Public Health Coalition is an informal coalition of nonprofit organizations representing the interests of millions of patients, consumers, health-care professionals, scientists, and public health experts. The coalition can be reached through Paul Brown at (202) 223-4000 or at email@example.com.