July 5, 2016
As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our views as consumers, physicians, scientists, and public health experts regarding the Senate’s biomedical bills (21st Century Cures companion legislation).
We want all Americans to have the best possible medical treatments but we are concerned that the primary 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 expedited 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.
We are very concerned about unintended consequences of expedited approvals. If drugs are approved based on preliminary evidence and then later found to be ineffective or unsafe, potentially billions of dollars could be wasted by Medicare (taxpayers) and private insurers. Consumers are worried about skyrocketing drug prices. A Bloomberg analysis found that 30 of 39 drugs they reviewed had price increases more than double the rate of inflation from 2009 to 2015, even after discounts were factored in.Innovative new drugs and devices will do nothing to improve health or save lives if they don’t work or if most Americans can’t afford them.
The Food and Drug Administration’s (FDA) primary mission is to protect the public health by “assuring the safety, efficacy and security” of drugs, biological products, and medical devices. As a Senator, it is critical that any legislation you support advances the FDA’s role in protecting public health. Below are bills that we urge you to oppose followed by bills we would like you to support.
We urge you to oppose:
The MEDTECH Act (S. 1101)
The MEDTECH Act removes health IT software from FDA’s regulatory oversight. If this bill becomes law, the FDA would no longer gather information about life-threatening flaws in medical software and no longer have the authority to recall those deadly devices. Dangerous flaws are commonly caused by glitches in software design but can also result if the software is easily hacked. A National Center for Health Research study found that if medical software is removed from FDA regulatory oversight, millions of patients would be at risk from defective software. For example, oncology electronic medical record systems were recalled in the past because they calculated and recorded incorrect drug dosages. Clinical decision support systems used during surgery were recalled because they erroneously switched patient data and failed to warn physicians about dangerous drug reactions.
Advancing Breakthrough Devices for Patients Act (S. 1077)
The Advancing Breakthrough Devices for Patients Act lowers standards for safety and effectiveness for devices. Only 3% of all medical devices are studied in clinical trials, and most are already small. This bill would encourage even smaller clinical trials, which would inevitably have fewer women, people of color, and patients over age 65 (often too few to ensure that the device is safe and effective for those groups). The bill would also push FDA to rely on post-market studies rather than ensuring safety and effectiveness before hospitals and patients pay for the devices. Remember that these are already the riskiest 3% of medical devices! As a result, public and private insurers will spend billions on medical devices that might later be found to be unsafe or ineffective.
The PATH Act (S. 185)
While the amended version that was voted out of the HELP Committee was greatly improved over the 21st Century Cures version, we do not support the concept of a limited population approval pathway for antibiotics. Antibiotics approved via a pathway such as this will have minimal evidence of safety and effectiveness but will inevitably become widely prescribed to more general populations with less severe infections. As a result, resistance will develop and a potentially promising drug will become ineffective.
The Advancing Hope Act (S. 1878)
The ability of the Advancing Hope Act to stimulate innovation through the issuance of priority review vouchers is questionable and it does not efficiently use FDA resources to benefit public health. The priority review vouchers have so far been used for drugs already under development in the U.S. or already licensed in other countries.Furthermore, by allowing sponsors to buy a priority review, the bill removes FDA’s ability to set its work priorities and resource allocations based on the public health merit of the project. In a time of dangerous threats like Zika and Ebola virus, we expect our government agencies to be able to prioritize public health, not to be bound by priority review vouchers that were sold to the highest corporate bidder.
The Combination Product Regulatory Fairness Act (S. 1767)
We strongly oppose the Combination Product Regulatory Fairness Act because it would result in more combination products being classified as devices and thus reviewed with less scientific evidence when it would be better for patients if the FDA used the more rigorous drug review process. This bill also restricts the FDA’s ability to later seek additional clinical data if it discovers new information related to safety and effectiveness. This is dangerous for patients.
The REGROW Act (S. 2689)
While not included in the bills voted out of the Senate HELP Committee, the REGROW Act has been mentioned as a priority by the Republican leadership for inclusion in the Senate biomedical bills. This bill would allow complex biologic therapies to be conditionally approved based on very preliminary evidence and then prescribed to patients without proof that the new therapy actually works or is safe. Notably, the Alliance for Regenerative Medicine (ARM), which includes many of the best regenerative medicine researchers, does NOT support the REGROW Act. If passed, this Act could lead to CMS wasting billions of dollars on medications that were approved by the FDA but do more harm than good. Although strongly criticized by researchers and ethicists, this bill has support from a billionaire who has donated $2 million to a Senate super-PAC.
We urge you to support:
The Preventing Superbugs and Protecting Patients Act (S. 2503)
Drug-resistant infections from contaminated duodenoscopes and other reusable devices have hurt and killed many people throughout the United States. This legislation and the safety recommendations in the recent HELP minority staff report will help prevent this from happening in the future. We strongly urge you to support this legislation that will reduce and eliminate these deadly infections.
The Advancing Research for Neurological Diseases Act (S. 849)
The bill would provide a foundation for the Department of Health and Human Services (HHS) to learn more about the many factors involved in neurological diseases, such as geographic clusters of diagnoses, variances in the gender ratio, disease burden, and changes in health care practices. This could truly be a game-changer for people suffering from neurological diseases and provide critical information to researchers as they work on new treatments and cures.
As you consider combining only the best of these bills into a comprehensive legislative package, it is essential to provide additional mandatory funding for the NIH and FDA so that there are no unfunded mandates in the legislation and there is sufficient support to develop and monitor safe and effective medical treatments. We particularly urge substantial new funding for the NIH to develop new antibiotics targeted to resistant bacteria, as well as to FDA and CDC to ensure stewardship of antibiotics already on the market. We must ensure that these institutions remain at the forefront of science and medicine for years to come and that patients can trust their drugs and medical devices to improve their health rather than harm it.
Breast Cancer Action
Mothers Against Medical Error
MRSA Survivors Network
National Center for Health Research
National Consumers League
National Women’s Health Network
Quinolone Vigilance Foundation
The TMJ Association
Washington Advocates for Patient Safety
 Langreth R, Keller M, Cannon C (June 29, 2016). Decoding Big Pharma’s Secret Drug Pricing Practices. Bloomberg. Available at: http://www.bloomberg.com/graphics/2016-drug-prices/.
 Food and Drug Administration. FDA Mission from the agency’s Web site. Accessed March 3,2016.http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/budgetreports/ucm298331.pdf.
 Branswell H (November 28, 2015). How a system to help treat rare diseases broke down,STAT.http://www.statnews.com/2015/11/28/priority-review-vouchers-rare-diseases/.
 McCaughan M (October 6, 2015). Priority Review Vouchers: FDA Has “Concerns,” Pharma & Medtech Business Intelligence.