Bradley Merrill Thompson Quoted in “Coalition: OMB Caved to Pressure by Shielding Lab-Made Tests from FDA”

FDA Week

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Coalition: OMB Caved to Pressure by Shielding Lab-Made Tests from FDA."

Following is an excerpt:

The Combination Products Coalition -- dismissing the arguments in a laboratory industry-backed citizen petition -- said it is well-established that laboratory developed tests are medical devices and by not regulating them FDA is endangering patient safety and dissuading diagnostic developers from creating more innovative tests. The coalition also points a finger at the White House Office of Management and Budget, which it said is buckling to political pressure by stymieing FDA proposals to regulate LDTs and companion diagnostics.

LDTs and in-vitro diagnostics are indistinguishable and FDA cannot continue to have different regulatory systems for these products, the coalition argues. CPC said FDA should issue guidance laying out how it plans to regulate LDT's and implement general controls within six months. …

CPC counsel Bradley Merrill Thompson said currently IVD companies face the prospect of having their products come to market only to be followed in quick succession by an identical LDT not subject to any regulation. He also said while FDA has issued clear statements in the past indicating its intention to regulate LDTs as medical devices, that move has faced mounting pressure from Congress. …

Thompson said gridlock on the issue is "killing" the IVD industry. Something must be done regarding FDA's regulation of both LDTs and companion diagnostics, he said. …

But Thompson said FDA is not the only agency to blame for the delays. OMB is also refusing to move forward on the issue by releasing FDA proposals to regulate LDT's. The FDA Safety and Innovation Act mandates Congress be notified before any draft or final guidance in LDTs is released and Thompson said OMB might be avoiding a potential political struggle over the issue.