Need Bloodwork? The FDA Will See You Now

Many cancers are treatable… until they are not. The problem is that some of the deadliest cancers (e.g., colon cancer) develop quietly and are often found too late. Innovators are hard at work developing easy and affordable alternatives to colonoscopies and other intrusive screenings. The Food and Drug Administration (FDA) recently approved a blood test called Shield that can accurately detect DNA shed by troublesome tumors.

However, onerous agency rules spell trouble for other laboratory tests in the works that could save millions of lives. Regulators should embrace flexibility and allow easy patient access to testing. Diseases such as colon cancer don’t need to be a death sentence.

Based on the FDA’s approval of the Shield test and its 2016 approval of a similar test called Epi proColon, it’s tempting to think the FDA has finally ditched its long-held hostility to innovation. Sadly for consumers, this is not the case. In April, the FDA issued a final rule that would treat laboratory developed tests (LDTs) the same way it treats medical devices, ensuring that simple lab tests would have to be cleared in advance by regulators.

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. 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 has had to fight for its life against an overzealous Federal Trade Commission (FTC) 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. And, so far, regulators are winning and consumers are losing. The Fifth Circuit handed the FDA a major win against Grail and Illumina, finding “substantial evidence” for the Commission’s conclusions in a December ruling.

While more recent rulings such as Loper Bright may give companies more legal avenues to challenge onerous regulations, innovators are fighting an uphill battle against government overreach. The FDA can set a new tone by doubling down on test approvals and embracing a more flexible regulatory approach.

Laboratory tests don’t need to be treated like medical devices, and patients with rare diseases need all the help they can get. As Yale School of Medicine Professor Henry Rinder, MD notes, “enforcement by the FDA could put us into a situation where we just have to stop LDTs. Suddenly, clinicians will realize they can’t get an important test anymore or have to wait weeks for results.” It’s time for regulators to ditch this failed approach and work to save patient lives.

David Williams is the president of the Taxpayers Protection Alliance.