November 10, 2016
The Honorable _________
United States Senate
Washington, DC 20510
Dear Senator __________:
The USA Patient Network respectfully urges 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, but instead wait for when you have more time to carefully weigh each aspect of the bills in 2017.
As patients and patient advocates, we strongly support additional funding for the National Institutes of Health (NIH). There are other provisions in the House and Senate bills that we also support. However, too many sections in the House and Senate versions of the bills would compromise patients’ health and safety because they lower the standards for drugs and medical devices at the Food and Drug Administration (FDA). And, unfortunately, once a product is approved by the FDA, many years can pass before patients are informed about new risk information based on postmarket studies or surveillance. Meanwhile, patients’ lives are at risk.
Some experts have pointed out that the bills allow standards to be changed and possibly lowered but don’t usually require that they be lowered. We disagree with that distinction We do not know who will be in the leadership at the FDA in the years to come, or even after January, but we do know that when Congress passes legislation pushing the FDA to approve medical products more quickly on the basis of smaller and shorter-term studies, patients have been harmed. This is especially likely for women, people of color, patients over 65, because smaller studies do not take into account what works best for specific demographic groups. In addition, a study of 60 patients or fewer, for example, which is already quite common for device studies, is likely to be too small to determine if a new product has life-threatening side effects for less than 5-10% of patients. If that product is then used on tens of thousands of patients, thousands of patients could be seriously harmed or even killed.
The USA Patient Network is a new nonprofit group that does not accept funding from pharmaceutical or Medtech companies, and we have been trained to understand the FDA approval process as well as the importance of well-designed clinical trials. Our members are from all over the country, and new members are added daily. Some of our members have been terribly harmed by unsafe medical products, and others are hoping that new safe and effective treatments will be developed soon. Based on our own experiences and our solid understanding of the approval process, we strongly urge you to delay passing any legislation during the rush of a lame-duck session, and instead consider our perspectives when you take up these issues in 2017.
For example, the MEDTECH Act, in both the Senate and House (Section 2241) bills, would put patients like us at risk. Currently, medical providers must inform the FDA of flaws in electronic medical records and decision support software that put patients at risk, and the FDA can then work with the companies to determine if a recall is necessary. Under the MEDTECH Act, neither the FDA nor any other entity would have that responsibility. A study by the National Center of Health Research found that these types of health IT devices can miscalculate chemotherapy doses and other medical treatments, with results that have sometimes been fatal.
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. As previously mentioned, these smaller studies make it impossible to include enough women, men, seniors, and racial and ethnic minorities to determine if the product is safe or effective for them. The House Cures bill is even worse, since Section 2221would permit companies that manufacture cardiac implants and other life-saving devices to make changes to the design or materials without the new devices being reviewed for safety by the FDA. In addition, the Cures bill would allow anecdotal and easily manipulated health data to be used to approve new drugs (Section 2121). It would eliminate the requirement that clinical trials be conducted to prove safety and efficacy for new medical uses. This measure also would result in the widespread use of medications for uses that are not approved by FDA, which is also harmful to patients (Section 2012).
The PATH Act, in both the House and Senate versions, would allow antibiotics to be approved based on tiny studies. Unfortunately, these antibiotics could then be widely advertised to all patients, not just the ones that the drugs were supposed to be intended for. It is likely that antibiotics approved under those circumstances would be much less safe or effective than older, less expensive antibiotics. The House bill is much worse than the Senate bill, because it extends this loophole pathway to antifungals and other medical products in addition to antibiotics.
The bills would also extend patent exclusivity provisions, which is adding to the skyrocketing cost of prescription drugs. For example, the Senate’s Advancing Hope Act, would continue the existing pediatric priority review voucher program through 2022, even though the concluded that the program has questionable benefits to children (but considerable benefit to companies).
The House version of the bill also weakens reporting requirements for the Physician Payments Sunshine Act. We understand that many physicians who accept gifts from pharmaceutical and device companies do not like that information to be public, so they are pushing to weaken the Sunshine Act. As patients and patient advocates, however, we think that information should be publicly available to all of us.
Finally, we are very disappointed that neither the House nor Senate bills do anything to lower drug prices. In fact, several provisions in these bills would have the opposite impact. Many new drugs would be sold without clear evidence that they are safe and effective for most patients, and yet new drugs always cost more than older treatments, even when the older treatments are superior.
Sincerely,
USA Patient Network