Patients desperate for medical breakthroughs should never have to sacrifice safety in the name of innovation, but the U.S. House recently passed legislation to do just that.
This bill, known as the “21st Century Cures Act” or simply “Cures,” has several key provisions that would significantly weaken consumer protections and lead to patients being exposed to potentially unsafe or ineffective drugs and medical devices.
The Senate is working on its version of a medical innovation bill now and it’s important that it addresses the flaws of the House bill. We can fix these issues to craft legislation that drives improved treatments that are safe and effective for patients without compromising safety and efficacy standards.
What’s wrong with the House Cures bill?
Weakens the FDA’s ability to ensure safe and effective medicines
The Cures bill would lower the standards the FDA uses to approve antibiotics and antifungals, putting patients at risk for treatment with unsafe or ineffective medicines. The legislation includes a fast track for approving antibiotics based on less rigorous testing. Instead of using Phase III clinical trials — the large, randomized, controlled trials that are the gold standard for testing a drug’s safety and effectiveness — the FDA would be able to approve drugs based on far smaller Phase II studies alone.
Additionally, the legislation includes incentives to prescribe newly developed antibiotics. Hospitals would receive a bonus for using new antibiotics, which could lead to overuse and antibiotic resistance, undermining one of the very problems the legislation is supposed to address. By contrast, Consumers Union thinks hospitals should use new antibiotics only when absolutely necessary, because the more new antibiotics are used, the faster bacteria will become resistant.
Undermines the FDA’s ability to ensure the safety and efficacy of medical devices
Cures would allow the FDA to approve medical devices based on case studies or medical journal articles alone. Medical devices should not be approved based on the results of case studies, which rely on anecdotal examples rather than rigorous testing and evidence-based results backed by data. Medical journal articles often leave out important information because of space limitations or to increase chances of publication. This means that medical devices could be approved and used on patients based on anecdotes and incomplete or cherry picked information, instead of clinical evidence. Under the bill, real world testing would happen only after the device is already on the market and being used by patients. This post-market surveillance relies on human subjects to provide the data to prove the safety and effectiveness of the device, after it has already been approved by the FDA. What’s more, there is no provisions in the bill to fund FDA’s examination of post market data. Currently device makers have a poor record of conducting post market studies and sharing them with the FDA. What’s in the bill that will change this behavior?
Cures would also allow medical device companies to make changes to the highest risk devices, like heart valves and brain stents, without first telling the FDA or proving that the altered device remains safe and effective. Device companies would be allowed to pay a third party to vouch that they have an acceptable quality control system, after which the device company itself would be authorized to decide whether a modified device is still safe and effective. Device companies would be able to select their third party certifier and there would be nothing in place to prevent companies from simply picking the third party that had given them the most positive evaluations.
Undermines the Physician Payment Sunshine Act
Cures would create a huge loophole in the Physician Payment Sunshine Act, which requires medical device and pharmaceutical companies to disclose payments they make to physicians and to teaching hospitals. These types of payments can include large amounts paid to doctors for speaking engagements, or covering large fees for doctors to attend conferences, sometimes in exotic locations. The Sunshine Act was designed to increase the transparency of these transactions in order to discourage physicians from accepting gifts that could potentially influence treatment decisions. If enacted as-is, this provision would completely undermine the Sunshine Act.
Reduces access to generic drugs
Cures would keep certain generic drugs off the market longer, giving pharmaceutical companies extended monopoly power to sell costly, brand name drugs. The House bill gives drug companies an extra six months of patent protection for drugs when a new indication is approved for treatment of a rare disease. This extended patent protection applies to all of a drug’s purposes, not just those related to the rare disease. This would increase drugs costs at a time when Americans are being required to cover more of the their healthcare costs and, ultimately, limit patient access to these drugs.
Is there a better way to address these issues?
Yes, there are better options. For one, the Helping Effective Antibiotics Last (HEAL) Act, sponsored by Representatives DeLauro, Slaughter, and Meng, would protect patient safety in the FDA approval process while encouraging the development of proven and safe new antibiotics.
Isn’t it too late? The Cures bill already passed the House of Representatives.
No! It’s not too late! The Senate will be working on its own version of a medical innovation bill in the coming months. It’s very important that we work to get a bill that supports medical innovation WITHOUT huge drug and device company giveaways that sacrifice important consumer protections.
Go here to tell your Senators you support safe, effective, and affordable cures.