A coalition of over 80 groups, including manufacturers, providers, laboratories and patient advocates, sent a letter Wednesday (May 9) to key members of Congress attempting to create momentum around passing legislation in 2018 revising government oversight of diagnostics, including laboratory developed tests (LDTs).

The unified call for congressional movement comes as FDA is providing technical assistance on a yet-to-be-released revised piece of legislation, which was introduced as a discussion draft last year, according to the letter. While stakeholders see legislation as an answer to solving conflicting standards between FDA and CMS, how exactly the legislation will tackle the issue is unclear, given stakeholders have not seen final language and FDA is expected to “make significant edits” to the bill.

“As we’re in the middle of this Congress, we just think time is of the essence. We wanted to send a unified message that this is a high priority for us,” Mark Fleury, a principal for policy development and emerging science for American Cancer Society Cancer Action Network (ACS CAN), told Inside Health Policy.

The letter, which was addressed to the chairs and ranking members of the Senate health committee and the House Energy & Commerce Committee, was signed by AdvaMedDx, Johnson & Johnson, the Biotechnology Innovation Organization and the American Clinical Laboratory Association, among others.

“Stakeholders have never been more aligned on the need for diagnostics reform than we are now,” read the letter. “With leadership provided by you, your fellow committee members, and the administration, we believe the goal of a new statutory framework is within reach.”

The letter calls out the Diagnostic Accuracy and Innovation Act (DAIA), which was released by Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) in 2017. However, it stops short of endorsing that legislation, which appears to still be in flux.

The bill, Fleury says, would do the diagnostics space a great service by installing a uniform, risk-based framework for regulating LDTs. ASC CAN says “conflicting regulatory standards and oversight between FDA and [CMS] have significantly slowed progress in bringing new, ground-breaking diagnostic tests to market.”

The bill, Fleury said, would remedy that situation. “The basic concept of the draft is that diagnostic tests would be regulated in the same way, regardless of how or where they’re performed,” he said.

Fleury added that ASC CAN and other stakeholders submitted comments about the bill and made suggestions during listening sessions led by Congress, but he’s unsure how significantly the sponsors changed the bill in response to stakeholder feedback.

FDA is now reviewing “an amended discussion draft,” the letter said, but Fleury has not seen that amended draft. Nevertheless, he expected FDA would make significant tweaks to the bill.

“I would suspect they will make significant edits to the bill according to what they would like to see,” he said. “The fact that they’re providing input at all is something we’ve been waiting on for the better part of a year,” he added.

To further show consensus on the issue, the letter refers to FDA Commissioner Scott Gottlieb having made “repeated public comments that comprehensive legislative reform of clinical laboratory diagnostics is timely and appropriate.” As IHP previously reported, Gottlieb has been forthcoming in his belief that Congress should legislate on this issue.

“I think Congress needs to legislate. And I think that there are more opportunities here for Congress to think about doing something comprehensive. Because you’ve seen the stakeholders in this community start to align around some common principles in a way that they might not have been aligned certainly 10 years ago but even five years ago. So, I think that the opportunity to see some comprehensive legislation that would address some of the real concerns that different parties have are there,” Gottlieb said last September at a Friends of Cancer Research event.

Fleury said the hard work of ironing out the details of the bill will start once FDA has completed its review. Until then, he hopes the letter will also encourage the Senate to pick up the House’s discussion draft once FDA has completed its review.

https://insidehealthpolicy.com/daily-news/stakeholders-urge-congress-ta…