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Senate Releases FDA Discussion Draft With Reforms for Diagnostic Testing

May 18, 2022 by Alexa Hornbeck
An FDA microbiologist prepares to conduct tests for high risk pathogens in a biosafety laboratory. (FDA Flickr)

WASHINGTON — Members from the Senate Health, Education, Labor and Pensions Committee released a draft of the legislative package to reauthorize user fee agreements for the U.S. Food and Drug Administration on Tuesday, which are set to end on Oct. 1, 2022. 

“This bipartisan draft strengthens FDA’s foundation to ensure our review and approval process is ready for the next generation of innovative products. It also includes key measurements to ensure the agency meets its commitments and modernizes our diagnostic testing framework to bring certainty to test developers and give Americans confidence in their health care decisions,” said Sen. Richard Burr, R-N.C., who serves as ranking member of the Senate HELP Committee, in a press release on Tuesday.

The discussion draft of the FDA Safety and Landmark Advancements Act, released by Burr and Sen. Patty Murray, D-Wash., who serves as committee chair of the Senate HELP Committee, would reauthorize the FDA’s prescription drug, generic drug, biosimilar and medical device user fee agreements.

The 409-page draft document was developed after the committee hearings with FDA officials and stakeholders last month. According to Burr, the mark up for the final version of the legislation will be released in the coming weeks.

The Subcommittee on Health of the Committee on Energy and Commerce released a draft version of the bill on May 4, and met to mark it up on May 11. 

The Senate draft of the FDA reauthorization legislation package released on Tuesday includes new oversight of cosmetics and dietary supplements, reauthorizes important programs for medical product development and aims to modernize diagnostic test regulation.

“The latest discussion draft from the reauthorization from the committee includes a discussion of the VALID act,” said Liz Richardson, project director of Health Care Products at Pew Charitable Trusts, during a phone call with The Well News.

The VALID Act, also known as the Verifying Accurate, Leading-edge IVCT Development Act, would establish a regulatory category called in vitro clinical tests, including current laboratory developed test services.

Richardson said the VALID Act would increase oversight of the FDA for in vitro diagnostics tests, which are tests which use human samples like blood or tissue to help clinicians diagnose and treat health conditions ranging from cancers, to suspected drug abuse, to lead poisoning.

“Many tests are just not reviewed by the FDA before they are used in clinical care, based on one regulatory decision made 40 years ago,” said Richardson.

“[The current] policy is no longer a good fit for the market. In order to adequately protect public health and drive decision making, we need to update the regulatory framework,” continued Richardson.

Richardson said concerns about how IVD tests are regulated has been on the FDA’s radar since the 1990s, but talks of the VALID Act have only been happening on the Hill for about six years. 

Richardson said that around 2014 the discussion for how the framework for diagnostics and laboratory developed tests would be reformed shifted to the legislator. 

The FDA released a discussion draft in 2016 called the Diagnostic Accuracy and Innovation Act following substantial input from the diagnostics and laboratory industry. This led to the first draft of the VALID Act in December 2018, which was a revision of the DAIA bill.

Richardson said most of the current FDA regulatory framework focuses on commercially manufactured tests, where clear authority is given to FDA to review.

“But for lab tests, for any tests developed or used in the same lab, as long as it never leaves the foreign walls of that lab, the FDA is not reviewing it, because of that policy enforcement discretion,” said Richardson.

Richardson said that part of the challenge with laboratory developed tests is that they are poorly tracked and highly fragmented. 

“Nobody knows how many are out there,” said Richardson.

“What we do know is there are a lot of LDTs in-use in certain fields—oncology, infectious disease, prenatal testing, and toxicology,” said Richardson.

Richardson said the lack of consistency in testing, especially in high-risk settings can be harmful to patients.

“If you sent a tumor sample to three different labs you would potentially get three different results, that’s why it’s a problem for patients,” said Richardson.

Richardson said that she and her research team have plans to submit a comment letter to the discussion draft released on Tuesday by the Senate HELP Committee. 

“The dynamics are complicated. I don’t know what will happen over the next month. Over the next couple weeks, lots of stakeholders will weigh in on VALID and try to get their changes into the bill,” said Richardson.

Not all members from the research community support the VALID Act, as some say it will hinder innovation. 

This is the position of The American Association for Clinical Chemistry, a global scientific and medical professional organization dedicated to clinical laboratory science and its application to health care, which has advocated against FDA regulations of LDTs since their first position statement on the issue in 2016. 

“The VALID Act would formalize FDA oversight of LDTs in addition to CMS oversight. As a result, many labs would be forced to stop developing LDTs, as they would not have the resources to meet these new, duplicative regulatory requirements. This in turn would hinder our ability to respond to emerging threats to health, such as new drugs of abuse,” Dr. Stephen R. Master, AACC president, chief, Division of Laboratory Medicine at Children’s Hospital of Philadelphia, associate professor, Pathology and Laboratory Medicine at the University of Pennsylvania Perelman School of Medicine, in an email to The Well News.

Master said that public health advocates and organizations have been debating LDT regulation ever since FDA first proposed bringing LDTs under its oversight in 2010.

The draft bill from the Senate HELP Committee would create a new user fee program that can be applied to laboratories performing LDTS, but Master said that there is an alternative approach — to modernize Clinical Laboratory Improvement Amendments, or CLIA.

Clinical laboratories are currently regulated by the Centers for Medicare and Medicaid Services under the CLIA.

The AACC position calls for modernizing CLIA and harnessing CMS’s already existing authority to ensure that laboratory developed tests are effective and safe, without introducing dual FDA-CMS oversight.

“We are confident that modernizing CLIA will effectively address concerns about LDTs … by hindering labs’ ability to perform LDTs, the VALID Act would ultimately stifle the field’s ability to progress,” said Master.

Alexa can be reached at alexa@thewellnews.com

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