November 8, 2016
United States Senate
Washington, DC 20510
Dear Senator _____:
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 respectfully urge you to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame duck session of Congress. While the House version of the legislation provides additional funding for the National Institutes of Health (NIH), both the House and the Senate versions contain more controversial measures which would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA).
A number of leading medical experts, including a former Commissioner of the FDA, Dr. David A. Kessler, believe that the bill “could lead to the approval of drugs and devices that are less safe or effective than existing criteria could permit”. We believe that the far-reaching measures described below will significantly impact public health and safety and should therefore not be rushed into law in the final brief weeks of this Congress.
For example, the PATH Act, in both the House and Senate versions, would allow antibiotics to be approved based on minimal evidence of safety and effectiveness through a “limited population” approval pathway. Unfortunately, these antibiotics could then be widely advertised in order to increase sales, even though they may be much less safe or effective than older, less expensive antibiotics.
The MEDTECH Act, also in both Senate and House (Section 2241) versions, would prevent the FDA from collecting adverse events caused by flawed electronic medical records and decision support software. A study by the National Center of Health Research found that these types of health IT devices can cause like-threatening problems when they miscalculate incorrect drug dosages for chemotherapy drugs and other treatments.
The Advancing Breakthrough Devices for Patients Act, versions of which are in both House and Senate bills, would encourage 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 to adequately evaluate safety and effectiveness for both men and women, let alone for elderly men and women compared to young adults, or for people of color. The House bill is even worse; for example, Section 2221 would permit companies that manufacture life-saving devices such as heart valves and stents, to be modified without submitting the new devices for FDA approval, as is now required.
Alarmingly, the bill in its current form also allows anecdotal and easily manipulated sources of health data to be used to approve new drugs (Section 2121). It effectively would eliminate clinical trial drug testing for new medical uses (called “indications’ in the bill). This measure also would result in the widespread use of medications for uses that are not approved by FDA, causing inevitable patient harm. (Section 2012: Facilitating responsible communication of scientific and medical development).
In addition to the extensive dilatory effects on FDA’s ability to protect the public health, the bill also extends exclusivity provisions for the pharmaceutical industry, discouraging the use of cheaper generic drugs, and having the practical effect of increasing or maintaining higher drug prices, at a time when the vast majority of Americans are frustrated with and angered by rapidly increasing drug prices. For example, the Advancing Hope Act, passed by the Senate, would continue the existing pediatric priority review voucher program through 2022. A recent GAO review of the program concluded that the program has questionable benefit. And, by allowing drug makers to buy a priority review, the bill undermines FDA’s ability to set its work priorities based on public health needs.
There also is serious concern concerning whether the additional $550 million dollars allocated to FDA by the House version of the bill would be sufficient to carry out the extensive mandates outlined by the legislation. FDA already is severely under-funded and cannot absorb unfunded mandates without dire consequences to its regulatory effectiveness and ability to protect public health.
The House version of the bill also weakens reporting requirements for the bipartisan Physician Payments Sunshine Act (“Sunshine”), a medical payments disclosure measure which is being successfully administered by the Centers for Medicare and Medicaid (CMS). The Sunshine Internet data base has provided the public with a useful and readily accessible transparency tool that can be used to discover which physicians and surgeons are accepting payments from the pharmaceutical and medical device industry, how much, and for what purpose.
Until the Sunshine data base was established a few years ago, doctors were accepting hundreds of millions of dollars annually in undisclosed payments from industry, much of which was intended to influence drug prescribing practices and the physicians’ brand choice of medical devices. The Sunshine Act does not prohibit or discourage these payments, merely makes them part of the public record, and allows patients and consumers to decide whether such payments influence their own medical treatment and choice of physicians.
In addition to weakening safeguards for patients and increasing the availability of treatments that are not proven either safe or effective, neither the House nor Senate bills include provisions to lower drug prices. A recent study by a researcher at the National Cancer Institute found that most cancer drugs approved during a recent 5-year period are not proven to improve the health of cancer patients. The National Center for Health Research assessed the cost of those ineffective drugs and found that they cost the same or more as cancer drugs that are proven to work. A recent letter to Congress by a coalition of more than a dozen labor and public interest groups asked the Congress to delay consideration of the Cures/Innovation bills until there are measures included to lower drug prices. We agree, but we also point out that several provisions in these bills would have the opposite impact, since many new drugs would be sold without clear evidence of efficacy, and yet those new drugs will inevitably cost more than older, more effective and less expensive treatments.
National Center for Health Research
American Medical Student Association
American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Breast Cancer Coalition
Center for Medical Consumers
Connecticut Center for Patient Safety
Institute for Safe Medication Practices
Jacobs Institute of Women’s Health
Mothers Against Medical Error
MRSA Survivors Network
National Physicians Alliance
National Women’s Health Network
Our Bodies Ourselves
Quinolone Vigilance Foundation
Washington Advocates for Patient Safety
For more information, please contact Jack Mitchell at email@example.com.