November 29, 2016
The Honorable ________
United States House of Representatives
Washington, DC 20515
Dear Senator/Congressman ____:
The undersigned nonprofit organizations represent members of the Patient, Consumer and Public Health Coalition, which includes more than 6 million healthcare providers, public health experts, and consumer and patient advocates. We are writing to urgently express our strong opposition to the newly revised 21st Century Cures Act, both in terms of the process of trying to pass a bill without adequate time for public debate, and for specific provisions in the bill that would harm patient safety. Passing a complicated health bill in the rush of a lame-duck session is always problematic. Passing a 996-page bill that was negotiated behind closed doors and includes provisions that were never voted on before represents the kind of legislative sausage that Congress should reject.
While the bill includes some positive measures, the most important ones – funding for the National Institutes of Health (NIH) and the Opioid bill that previously passed – are not guaranteed in this legislation. Unlike the earlier version of the 21st Century Cures Act that was passed in 2015, the funding is not mandated in the new version. In exchange for the hope of additional funding, the bill contains dangerous measures that would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA). This would put all patients and consumers at risk.
For example, the bill would allow antibiotics to be approved based on minimal evidence of safety and effectiveness through a “limited population” approval pathway. The bill would not require that the antibiotics be studied on the target population that the new drugs would be approved for. In other words, it is possible that the antibiotics would not meet the urgent need that they are intended for. Unfortunately, these antibiotics could then be widely advertised and used by patients who are not likely to benefit, and could be seriously harmed by them. In the long run, that would contribute to antibiotic resistance. While the Senate version had several restrictions designed to help protect patients, the 21st Century Cures version released this past weekend does not.
The MEDTECH section of the bill would deregulate electronic medical records and decision support software. A study by the National Center of Health Research (NCHR) found that these types of health IT devices can cause life-threatening problems when they miscalculate incorrect drug dosages for chemotherapy drugs and other treatments. The Breakthrough Devices (Sec. 3051) encourages shorter and smaller clinical trials for medical devices. These smaller studies make it impossible to include sufficient numbers of women, men, seniors, and racial and ethnic minorities. Moreover, a recent study of high-risk medical devices found that the median number of participants is currently only 65 patients, which is already too small a cohort to adequately evaluate safety and effectiveness for both men and women, let alone for elderly men and women compared to young adults, or for minority populations.
The bill would also drastically lower standards by allowing companies to provide FDA with summaries of their data, instead of the data itself, as now required, when they want to sell drugs for new indications (treatments). It also encourages the FDA to make approval decisions based on “real world evidence” that is not necessarily scientifically sound. The FDA currently reviews and scrutinizes scientific data provided by companies, which is necessary to make sure the benefits outweigh the risks for any approved indication. Providing summaries would also reduce information about the possible risks to particular demographic groups, such as women or patients over 65.
The Accelerated Approval for Regenerative Advanced Therapies (Sec. 3033), creates an expedited review pathway for ‘regenerative medicine.’ This section has been promoted by extensive campaign contributions, was not in any previous version of the Cures legislation, and should not be rushed through without adequate discussion and debate.
The bill also allows off-label promotion of medical products under certain circumstances, which reduces the incentive for companies to conduct scientific research to prove that their products are safe and effective for new indications.
By lowering standards for approval of drugs and devices, and in some cases eliminating them, the bill would increase the cost of healthcare and pharmaceuticals at a time when such costs have become a grave threat to affordability of health insurance and to the survival of Medicare. The implications for patients’ health and the affordability of medical care can’t be overstated. Researchers at the best medical schools in the country already have shown that many ineffective and unsafe drugs have already been approved by FDA on the basis of the kind of preliminary data encouraged by 21st Century Cures.
This situation would worsen under the bill. For example, the National Center for Health Research assessed the cost of new, ineffective cancer drugs and found that they cost the same or more as cancer drugs that are proven to work. In addition, the bill would continue the existing pediatric priority review voucher program, even though a recent GAO review of the program concluded that the program has questionable benefit. This increases the cost of medications and undermines FDA’s ability to set its work priorities based on public health needs.
The extensive and expensive lobbying efforts in favor of 21st Century Cures have been designed to make every aspect of the bill seem bipartisan and non-controversial. If that were true, however, the bill would not have been negotiated behind closed doors and released during the Thanksgiving holiday weekend. That is why dozens of patient, consumer, physician, labor, and public interest groups, as well as former Members of Congress, have asked the Congress to delay consideration of the bill.
Thank you for your consideration of our views on this legislation. We must ensure that patients can trust their drugs and medical devices to improve their health rather than harm it.
National Center for Health Research
American Medical Student Association
American Medical Women’s Association
Association for Medical Ethics (AME)
Advocating Safety in Healthcare E-Sisters (ASHES)
Breast Cancer Action
Center for Medical Consumers
Connecticut Center for Patient Safety
Mothers Against Medical Errors
MRSA Survivors Network
National Physicians Alliance
National Women’s Health Network
Our Bodies, Ourselves
Quinolone Vigilance Foundation
Treatment Action Group
Union of Concerned Scientists
Washington Advocates for Patient Safety (WAPS)
WomenHeart: The National Coalition for Women with Heart Disease
For more information, please contact Jack Mitchell at email@example.com.