FDA Launches Lab Test Broadside

We can’t let the agency get away with its latest power-grab that will jeopardize your health. Action Alert!

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THE TOPLINE

• The FDA released its final rule that extends the agency’s power over laboratory developed tests (LDTs).
• This rule adds a bevy of new regulations on LDTs over which the FDA has questionable jurisdiction.
• This rule will slow innovation and compromise patient health.

Do you and your healthcare provider rely on a wide array of lab tests to help you monitor and manage your health?

The FDA has just thrown a massive wrench in the works of laboratory developed tests (LDTs), coming good on years of effort to extend its regulatory power over these products. With the release of its final rule earlier this month, the FDA is adding a bunch of new regulatory requirements that LDTs must meet, including, in some cases, pre-market review. This will reduce the testing options available to you and make it more difficult for companies to develop new and innovative tests. Most importantly, we believe this rule will compromise patient health.

LDTs are important tools used by healthcare providers to diagnose and manage a wide range of conditions. They are widely used—thousands of different LDTs are available—and include genetic tests, heavy metal tests, tests for rare conditions, nutritional status tests, and hormone tests. They can be tailored to meet specific patient needs and can be used to respond rapidly to emerging threats like COVID-19.

Over the years, the FDA has tried every trick in the book to extend its power over LDTs, which are currently regulated by the Centers for Medicare and Medicaid Services. About a decade ago, the agency issued a guidance document take control over LDTs. Congress pushed back, and eventually the FDA withdrew the guidance. During this time, Representative Michael Burgess (R-TX) said in a statement that the FDA’s regulatory approach to LDTs is “redundant, will stifle innovation, and will require additional taxpayer funding for the FDA.”

There are also legal questions as to whether the FDA has jurisdiction over LDTs, and indeed, it seems a legal challenge to this rule is very likely. Senator Rand Paul (R-KY) has introduced a resolution opposing the FDA’s rule.

The new requirements contained in the rule will come into effect in stages over the next four years. Tests currently on the market will be exempt from pre-market review and some other requirements, but will have to comply with other rules. While the FDA is saying that, as of now, certain tests are exempted from some requirements under a policy of enforcement discretion, that policy can easily change to bring more tests under the FDA’s thumb.

The FDA states rather openly that, in its view, LDTs are, and always have been illegal, and it has only been through the FDA’s benevolence that they have remained on the market. It’s a situation similar to what we’ve seen with homeopathy. All homeopathic drugs are technically illegal, but the FDA will allow certain products to skate by—for now, or until the agency changes its mind. This is not exactly solid ground on which to build a business or invest in new and innovative products!

It’s a familiar story: the agency wants to add a bevy of new requirements and regulations to LDTs that will make it exponentially harder for smaller labs to innovate and compete. It’s this kind of red tape that prevented the rapid distribution of COVID tests at the start of the pandemic that could have saved many lives.

Action Alert! Write to Congress and the White House and tell them to block this terrible rule. Please send your message immediately.