By Caitlin Carmody, Communications Officer
In an article published today on Inside Health Policy, journalists investigated how the largest medical device lobbying group worked with officials at the Food and Drug Administration (FDA) to author key provisions of the 21st Century Cures legislation. This legislation recently passed in the House and a companion bill is expected soon in the Senate.
Supporters of the optimistically-named 21st Century Cures Act say it will help bring new medical technologies and treatments to the marketplace. It is being promoted as a regulatory update in response to technological innovation and medical advancement. But the truth is that this industry-friendly bill is a give-away to Pharma and Biotech that would reduce standards of safety and efficacy necessary to protect patients.
According to internal emails and documents obtained by Inside Health Policy through the Freedom of Information Act, “FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version.”
While it’s common for industry to lobby hard on legislation that will heavily impact their business, this level of cooperation between an industry and the agency tasked with regulating that very industry is alarming and unethical. Diana Zuckerman, president of the National Center for Health Research, says in the article: “I worked in the House and Senate for a decade, and this would never have been considered acceptable. For years, there was a revolving door between CDRH leadership and the device industry, but this is even worse than a revolving door: It is a partnership that excludes public health and consumer advocates who do not have close ties to industry.”
We will continue to oppose this legislation in its current form and will keep you updated on opportunities to take action.
You can read the full article here.