Will the LDT Rule Make it Easier for Sports Dopers to Go Undetected?

June 7, 2024By Jeffrey N. Gibbs & Allyson B. Mullen

The FDA’s new rule for laboratory developed tests (LDTs), unless overturned through litigation (see here), by legislation, or the election, is going to have profound effects on the U.S. health care system.  At this point, nobody knows all the impacts the rule will have.  But even FDA acknowledges that some labs will go out of business, some tests will be discontinued, there will be some consolidation of the industry, and costs will be higher.  It is absolutely foreseeable that the LDT rule will reduce innovation for new tests, make it harder for labs to modify tests, and make it much less likely that patients with rare diseases or conditions will be correctly diagnosed.

There is another foreseeable impact: sports doping will be harder to detect.  In the preamble to the rule, FDA has maintained an exemption for forensic tests, which it states is exclusively for “law enforcement.”  As the rationale for this limited exemption, the preamble says, “[t]ests used in the law enforcement setting are subject to protections and requirements associated with the judicial process that mitigate risk related to test accuracy and sample collection.”  FDA makes it crystal clear that this exemption does not apply to sports testing.  See 89 Fed. Reg. 37286, 37298 (May 6, 2024) (here).  In other words, labs that offer tests to catch cheaters will need to comply with the full panoply of device requirements.

As a threshold matter, FDA’s approach fails to recognize that sports testing, as now conducted, does involve numerous safeguards.  FDA’s exemption for forensic testing is based on the checks and balances that the judicial system provides.  While major sports leagues do not have a judicial process, there are significant technical and procedural safeguards in place, with processes negotiated with unions.  The U.S. Anti-Doping Agency (USADA) also follows extensive policies and procedures to try to ensure accuracy of test results.  For example, in the recent suspension of swimmer Kensey McMahon (announcement here), the USADA press release explained that an independent arbiter had rendered a decision after an evidentiary hearing where both the athlete and USADA were provided a full opportunity to present their case and witnesses.  FDA’s preamble completely ignores these types of measures, which differentiate sports testing from other settings for drug testing.

The world of performance enhancing drugs (PEDs) has been characterized by innovation.  Over the years, many new drugs have become available to would-be cheaters.  Historically, PEDs were thought of as steroids alone, but in recent years new types of PEDs, including experimental peptides like BPC-157 have entered the market.  See here. News outlets have also reported that with the emergence of artificial intelligence, it is possible for would-be cheaters to develop new PEDs to evade outdated drug tests.  See here.  LDTs, because they can be rapidly developed, validated, and deployed, are well‑equipped to identify these new PEDs.

Conversely, speed and flexibility are not hallmarks of the device regulatory system.  New PEDs can emerge quickly.  While an LDT can be rapidly introduced to address these new products or any variations to them, FDA-regulated diagnostics cannot.  Barring a complete overhaul in FDA’s approach, the comprehensive testing that would be needed before a marketing application can be submitted for a new PED and the extensive FDA review process, means that new 510(k)s simply can’t quickly be obtained.  Moreover, the high regulatory costs and niche market may mean these tests are uneconomical for manufacturers, barring significant subsidies from customers such as sports leagues or the U.S. Olympic Committee.

While overlooked now, this issue may get more visibility with the upcoming Paris Olympics, new stories about cheating in sports (see, e.g. here), and the run-up to the 2028 Olympics in Los Angeles.  If the current FDA approach remains in place, it is difficult to see how the USADA (or World Anti-Doping Agency) will be able to keep up in the race with sports dopers.  Without LDTs, U.S. companies will not be able to provide comprehensive panels that include the newest PEDs.  Setting up satellite facilities in other countries to run the tests for the LA Olympics might be feasible, although embarrassing and less efficient.

Maintaining integrity in sports has become increasingly challenging.  FDA’s rule adds one more hurdle to those who are trying to catch cheaters.  Because FDA’s LDT rule is short on specifics, the agency could easily decide to extend enforcement discretion to sports testing.  If it does not, then the bodies responsible for trying to hold sports doping in check are going to face new obstacles as they try to detect and punish cheaters.