Millions of consumers take for granted laboratory medical tests to diagnose cancers, analyze blood composition, and ensure pregnancies are going smoothly. If the Food and Drug Administration moves forward with proposed regulations, lab innovation may soon grind to a halt. The FDA is proposing to treat these tests the same way it treats medical devices, ensuring that simple lab tests would have to be cleared in advance by regulators. This would (at the very least) ensure more paperwork and at worst result in an onerous pre-market review process currently applied to medications, pacemakers, and deep-brain simulators. Instead of doubling down on onerous regulations, the FDA should embrace innovation and flexibility.
The road to lab-grown regulation began a half-century ago, when Congress passed the Medical Device Amendments of 1976. These amendments to the Food, Drug, and Cosmetic Act imbued the FDA with the authority to regulate “medical devices,” a category of products ranging from dental floss to computed tomography (CAT) scanners. Depending on what category (or “class”) the products fall into, the agency could demand pre-approval clinical trials or require the maker to analogize the device to a previously approved device. The FDA spared lab tests from this expensive and complicated system, using “enforcement discretion” to keep these products shielded from scrutiny. But, according to the agency, things have changed in recent decades. In its proposed rule, the FDA claims that lab tests “are generally, among other things, used more widely, by a more diverse population, with an increasing reliance on high-tech instrumentation and software, and more frequently for the purpose of guiding critical health care decisions.”
While this is true, it is actually an argument for greater permissiveness. The FDA ignores the role that a light-touch regulatory approach plays in fostering the development of high-tech testing. For example, the biotechnology company Grail recently pioneered a high-tech, multi-cancer early detection test performed via liquid biopsies. While Grail was able to develop its lifesaving technology relatively free from regulatory scrutiny, it is now fighting for its life against an overzealous Federal Trade Commission helmed by Lina Khan. The FTC believes that Grail combining with testing/sequencing company Illumina would cripple the market, despite the efficiency and funding gains that test developers would get from partnering up with sequencers. In waging war against Grail, regulators are sending a message to test providers that attempts to grow their product market will be met with an iron wall of bureaucratic resistance.
Even if providers aren’t deterred from trying to enter the market, the FDA pre-market process ensures that products will be delayed at a high price. For example (in 2022), the FDA rejected a drug called omburtamab, designed to treat a rare pediatric brain cancer. Regulators expressed alarm that the data set provided by the drug’s producer contained some information collected during the 1990s and early 2000s when cancer treatments may have been less effective.
The agency extensively communicated these concerns with its advisory committee, concluding that the FDA “cannot reliably attribute the observed [overall survival] OS difference to omburtamab.” Yet in the same analysis, the FDA reported that it was in fact able to control for patients’ use of other treatments (i.e., radiation therapy, surgery, chemotherapy) and the time period of treatment.
Even after adding the controls, the results appear encouraging for the medication. The data suggest that patients taking omburtamab live seven to 12 months longer than their non-medicated peers. Despite these sustained positive findings, the advisory committee bought into the FDA’s critical briefing and voted to reject the drug. The FDA followed suit and sent Y-mAbs Therapeutics a rejection letter. As the Taxpayers Protection Alliance noted in a 2023 report (analyzing 2022 drug approvals), this risk-averse mentality plagues drug approvals and hampers innovation across the life sciences sector. Patients cannot afford the same approach exported to lab tests.
Laboratory medical tests can save millions more lives, but only if regulators stay out of the way and let innovation win the day.
David Williams is the president of the Taxpayers Protection Alliance.