There is an article in the Wall Street Journal covering a recent bill that just passed in the House of Representatives regarding medical research, and specifically the monitoring of medical devices. The bill is referred to as the 21st Century Cures Act. The intention of the Act is to “bring our health care innovative infrastructure into the 21st Century, delivering hope for patients and loved ones and providing necessary resources to researchers to continue their efforts to uncover the next generation of cures and treatments,” according to the House’s Energy & Commerce Committee. The House passed the Act back on July 10th.
An important part of the Act includes an amendment that “unique device identifiers” of medical devices should be included in electronic health records and that the devices and patient injuries could thus be tracked more closely. The WSJ article mentions that the FDA issued a rule back in 2013 requiring labels of medical devices to include “unique device identifiers” and that they were supposed to phase in a system tracking that over several years.
The article goes on to explain that Rep. Mike Fitzpatrick pushed this amendment because he was troubled by the defective medical devices, morcellators, and the issues that have now been brought to light about these FDA approved devices. Rep. Fitzpatrick also wanted to add an amendment that would have required the Government Accountability Office to investigate FDA medical device safety reporting regulations, specifically focusing on power morcellators, but it was not approved.
However, there have been some interesting op-eds written regarding this bill. In an op-ed from the New York Times written by Rita F. Redberg and Sanket S. Dhruva, cardiologists, they discuss how they believe this legislation weakens, not strengthens, the FDA’s regulatory process of medical devices. The Act would allow for companies to provide evidence of safety and effectiveness of devices based on sources other than clinical trials. They also mention how there would be a new and faster process for “breakthrough technologies” which are only believed (not proven) to offer better advantages over existing technologies. According to the op-ed authors the Act would allow for an even lower standard of evidence then currently used. Drs. Redberg and Dhruva claim that there needs to be “stricter evidence standards” and increased federal funding for the FDA in order to ensure that new medical devices lead to better health for all.
There was a separate op-ed in the New York Times about the bill as well. In this op-ed the author claims the legislation is “loaded with bad provisions.” It goes back to the idea that the FDA’s current regulation system is failing and this new legislation weakens it. The author does point out some benefits of the bill including making experimental drugs available more quickly to patients whose illnesses cannot be cured. The author notes that the bill increases funding for the National Institutes of Health by $8.75 billion over the next five years.
The FDA approval process with medical devices like morcellators is very troubling, and the steps to cure this process are important. The government should not be making it easier for defective medical devices or bad drugs to get on the market. Only time will tell if this Act is effective. The Senate is due to take up a similar bill later this year.