The Impacts of FDA Regulations on Diagnostics in Oncology

Scott Gottlieb, MD, resident fellow at the American Enterprise Institute; Michael A. Kolodziej, MD, national medical director of oncology strategy at Aetna; Bruce Quinn, MD, PhD, MBA, senior director at FaegreBD Consulting; and Joy Larsen Haidle, MS, CGC, 2015 president of the National Society of Genetic Counselors, discussed the impacts of FDA regulation on diagnostics in oncology during The American Journal of Managed Care’s 4th Annual Patient-Centered Oncology Care Meeting. The panel discussion was moderated by Dennis P. Scanlon, professor of health policy and administrator and director of the Center for Health Care and Policy Research at The Pennsylvania State University.

Whether or not the FDA should regulate diagnostics in cancer care has been an ongoing discussion for the past decade, but, according to Gottlieb, one of the biggest concerns circulating this space is whether the regulation would impact innovation. He explained that the FDA has made a clear distinction in that it would regulate for clinical validity and not clinical utility. In other words, the FDA would regulate for how well the diagnostics test for what they claim to be testing for, instead of regulating for the decisions physicians make based on the results of the tests.

“I think a lot of people, including myself, who have concerns around seeing the FDA step in to regulate this space, don’t feel that they should be trying to regulate to ensure the clinical utility of these tests,” Gottlieb said. That’s something that should be left up to the practice of medicine. The tests should accurately read out what they purport to read out. Everyone wants the tests to be accurate.”

Haidle emphasized the importance of validity among these diagnostic tests, as the accuracy of the tests and their results not only impact the provider, who is relied upon to accurately take the results into account in the patient’s care, but also directly impacts the patients and their family members, as in the case of genetics.

Kolodziej added: “Whether the FDA is the right agency or the wrong agency or whether government is here to help you or not, I’m apolitical. I actually don’t care. But somebody has to do it. So let’s just think a little bit about the customers and who’s in a position to do it. When an oncologist orders the test, in fact by and large, they have no idea where the test is going and therefore they have no idea about whether the test is being done well. Patients would be horrified by that statement. They presume their doctor is trying to send the test to the best possible place to make the decision making accurate.”

Where the government may not be stepping in, many organizations and professional societies are putting together their own sorts of regulations, Quinn added. He said that even the doctors and payers are moving in this direction, of taking measures to ensure quality, whereas the FDA is only in the talks of doing so.