Congress Considers Regulation of Lab-Developed Tests – Roll Call

Precision for Medicine’s Karen M. Becker, PhD, Managing Director, Translational and Regulatory Science, is quoted in an article regarding the upcoming Food and Drug Administration’s guidance on how it plans to oversee lab-developed tests used to diagnose conditions. Read the full article below:

By Andrew Siddons

As the Food and Drug Administration moves closer to issuing guidance on how it plans to oversee lab-developed tests used to diagnose conditions, House Republicans and Democrats seem to find themselves in a rare moment of agreement on the need for more regulation.

While it might be surprising for Republicans to be calling for more regulation, the action on lab-developed tests represents their advocacy on behalf of the tests’ developers, who crave a more certain regulatory framework. The FDA’s proposed guidance on lab-developed tests says all the tests would be subject to regulation, but also says the FDA would only enforce the regulations on a case- by-case basis.

Congressional consensus is emerging that the issue needs more than just FDA guidance, which would be nonbinding, subject to legal challenges by companies and could be overturned in court. Draft legislation is being circulated by the House Energy and Commerce Subcommittee on Health that would give the FDA the legal authority to regulate the tests.

“I do not believe that imposing a new regulatory reality on an increasingly important component of our healthcare system via guidance is the best way to address these issues,” Rep. Joe Pitts, R-PA, the subcommittee’s chairman, said at a Tuesday hearing on the subject. “These products warrant a regulatory system with them in mind.”

The FDA has regulated medical devices since the 1970s, but the agency took a more hands-off approach with lab-developed tests because they usually stayed within labs and the FDA considered them simple. But with advances in medical science, the tests are now much more complex, and the FDA has begun to question their efficacy.

The congressional movement on lab-developed tests comes as the FDA begins to scrutinize the practices of Theranos, a high-profile Silicon Valley company that makes diagnostic blood tests. The FDA has expressed skepticism over effectiveness and quality control of the tests manufactured by Theranos.

At his Senate confirmation hearing this week, the nominee to lead the FDA, Robert Califf, said the agency was committed to work with companies that make these tests to set standards and determine their clinical validity.

“This has become a big industry, with major implications for patients, especially with precision medicine, where you have a test, and it tells you what therapy to give,” Califf said. “That can be really good or really bad, depending on whether it’s right.”

On Monday, the FDA published a report offering case studies in when lab-developed tests have been wrong. For example, the report said, some tests associated with the diagnosis of Lyme disease too frequently provide false positives, leading otherwise-healthy people to undergo unnecessary treatment for Lyme that can have side effects such as nausea and allergic reactions.

“It’s an important public health issue. The FDA has a point,” Karen Becker, the director of translational and regulatory science at Precision for Medicine, said in an interview. “But the process needs to be clear and it needs to be thoughtful. Otherwise, it will have serious unintended consequences.”

Potential Legislation

The discourse on lab-developed tests speaks to a larger congressional distaste for nonbinding FDA guidance in various under-regulated corners of the medical product industry.

“FDA continues to try and regulate parties more often through guidance letters than through rulemaking, which shuts out the open comment period, and has confusing effects,” Sen. Johnny Isakson, R-Ga., said at Califf’s confirmation hearing.

The draft legislation aims to establish more consistency. Currently, any oversight of lab-developed tests is handled by the FDA’s Center for Devices and Radiological Health. The legislation would establish a new center that would handle the premarket approvals for lab-developed tests.

If draft legislation is passed in a Republican-controlled Congress, however, it’s possible that the FDA’s authority could be watered down to a level that would make consumer advocates uncomfortable.

But legislation could enhance the likelihood of more money. While the draft version doesn’t address funding, if it advances, either new appropriations or new user fees could be on the table.

If the FDA engages in more widespread premarket approval of lab-developed tests, some question whether the agency can handle a new surge in applications, especially if Congress doesn’t provide the agency more resources.

“I’m concerned that FDA would not have the staff to take one what would be some very complicated submissions,” said Jeffrey Gibbs, an attorney at the law firm Hyman, Phelps & McNamara who specializes in the regulation of medical devices.

Democrats on the Energy and Commerce subcommittee on Health signaled their optimism about the discussion draft. At the hearing Tuesday, the full committee ranking member, Frank Pallone, D-N.J., and the subcommittee chairman, Gene Green, D-Texas, voiced tentative support.

“Legislation is both appropriate and necessary to modernize clinical laboratory diagnostics oversight,” Green said.

No matter how more oversight of lab-developed tests develops, many in the public health sphere would welcome it.

AdvaMed, a medical device industry group, issued a statement this week backing FDA regulation of these tests. Last week, 42 patient advocacy and other groups, including the American Heart Association, the Leukemia and Lymphoma Society, and the National Physicians Alliance send a letter to House Energy and Commerce leaders, saying the FDA has an important role to play in regulating lab-developed tests.

“FDA involvement does not mean a threat to patient access,” they wrote. “The FDA can provide the assurance that when tests are performed they lead to the proper use of associated treatments, a step that’s necessary to improve the public health.