I received a copy of a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the Combination Products Coalition (CPC), an association of drug, biologic, medical device, and IVD manufacturers dedicated to working with FDA to improve the regulation of combination products. In this letter, the attorneys discussed the regulation of laboratory-developed tests (LDT) and made the argument for “creating a single regulatory framework for IVDs and LDTs.”

According to the letter, FDA received a citizen petition in June 2013 from the American Clinical Laboratory Association (ACLA), which asked the agency to refrain permanently from regulating LDTs. In November 2013, FDA responded that it “has been unable to reach a decision on the petition because it raises issues requiring further review and analysis by agency officials.” Since then, FDA has still not responded to the petition.

“The issue, whether or not FDA should regulate LDTs, has been under review by the agency since the 1976 Medical Device Amendments were enacted and clarified FDA’s authority over IVDs,” said Thompson and Boiani. “Further, the same question has been raised time and again by various stakeholders. Respectfully, after nearly 40 years of review, and in the interest of public health, it is time for a decision.”

Read: Breaking Down the Regulation of LDTs: FDA Jurisdiction

The letter stated that FDA must act now because the dual system of regulation for IVDs and LDTs does a disservice to patients. If a more restrictive FDA-type system is needed to assure the safety and effectiveness of IVDs, the agency’s failure to regulate LDTs is putting patients at risk. Conversely, if CLIA regulation alone is sufficient, FDA is making IVD manufacturers waste billions of dollars each year complying with unnecessary requirements. Manufacturers could spend this money instead on developing new tests under a CLIA system without FDA oversight.

“FDA has not only the authority but also the obligation, to create a single regulatory framework for IVDs, one where regulations depend on the risks and benefits of the test and not who makes them or where they are made,” said Thompson and Boiani. “To this end, CPC asks FDA and the rest of the Obama Administration to put patients first by creating a single regulatory framework for IVDs and LDTs.”

The letter also stated that CPC finds common ground with ACLA in its implicit recognition that FDA regulation needs improvement. Over the years, FDA regulatory burdens on IVD manufacturers have increased dramatically. It is therefore fair to ask if the agency’s current approach establishes the proper balance between protecting the public from unsafe and ineffective IVDs, and improving the public health by promoting innovation. Even FDA acknowledges that this balance needs to be improved in favor of innovation, and has been working on developing pathways to bring emerging IVDs to market more quickly. While this work should continue as equality is brought to the regulations, it should not delay the move toward a single regulatory system.

“Although this petition is addressed to FDA, and it is FDA action that is needed, we recognize that decisions regarding LDT regulation are not FDA’s alone,” said Thompson and Boiani. “Other agencies within the executive branch have been playing a significant role in the decision to maintain the status quo. Therefore, we also ask that the rest of the Obama administration – the Office of Management and Budget, the Centers for Medicare and Medicaid Services, the Department of Health and Human Services, and others – all offer their support for equal regulation either by endorsing this effort, or not standing in the way of addressing this problem. Unequal regulation has existed for far too long.”

Read: Breaking Down the Regulation of LDTs: FDA Authority

Regulating Labs and IVD Manufacturers Equally
“ACLA’s petition asks FDA to refrain from regulating LDTs,” said Thompson and Boiani. “Respectfully, this request misses the real issue, which is whether FDA should regulate LDTs and IVDs equally. To answer that question, we consider whether FDA has the authority to regulate LDTs; whether it should use this authority; and assuming the agency would prefer to keep the current dual system in place, whether it would nonetheless be compelled by law to regulate LDTs and IVDs equally.”

Assuming FDA has discretion to continue giving preferential treatment to clinical laboratories and LDTs, the agency needs to ask itself whether the public health is served by the dual regulatory system it has created. The answer is no for the following reasons.

“First, the IVD and LDT regulatory systems cannot both be right,” said Thompson and Boiani. “There is no way that the two systems can provide equivalent benefits to the public health. If extensive FDA regulation is necessary to ensure the safety and effectiveness of IVDs, then FDA must regulate LDTs. On the other hand, if FDA regulation is unnecessary, the amount of waste caused by compliance with unnecessary FDA requirements is harming the public health by limiting resources for innovation.”

Second, the letter stated that most major FDA-related legislation, from the 1906 Pure Food and Drugs Act to the 2013 Compounding Quality Act, has been prompted by tragedy. In light of this history and FDA’s previous determination that LDTs can pose serious risks, the agency has only two reasonable options: impose IVD requirements on LDTs, or explain why it was wrong about the risks posed by LDTs and move to deregulate IVDs.

Read: Breaking Down the Regulation of LDTs: Public Health, First Amendment, and Innovation

“Third, in the absence of direct LDT regulation, FDA has tried to indirectly control how laboratories manufacture their tests by restricting the speech of IVD manufacturers that supply them with LDT components, and imposing other requirements,” said Thompson and Boiani. “FDA may see this as a way to control or limit the proliferation of LDTs, but the harm it does far outweighs the good. In addition to limiting the exchange of expertise that could result in safer and more effective tests, the restrictions run afoul of the First Amendment."

Fourth, the letter also stated that innovation is harmed by the dual regulatory system. The ACLA petition presented arguments for why the LDT enforcement discretion policy helps innovation. With regard to lab innovation, it probably does. However, the analysis misses the larger picture: the current system excludes IVD innovators, which hinders innovation. In addition, FDA pathways do exist to address partly the concerns that ACLA has raised regarding access to IVDs. Improving these pathways further should accompany any effort to bring LDTs within the current FDA regulatory framework.

“Must FDA regulate LDTs and IVDs equally? The answer is yes,” said Thompson and Boiani. “As a matter of law, FDA must treat similarly situated products (e.g., IVDs and LDTs) and parties (e.g., non-labs and labs) in similar ways. Yet over 38 years, seven Presidential administrations and 11 FDA commissioners have allowed FDA to treat test manufacturers differently based on who they are (a lab or a non-lab) as opposed to what they make, imposing two very different standards on these similarly situated products and parties. This is the very definition of arbitrary and capricious, and it must end.”

Read: Breaking Down the Regulation of LDTs: Access to Innovative IVDs

In the coming weeks, I’ll present how the attorneys expanded on each of the points above and proposed actions FDA should take to move toward equal regulation. I’ll also present how they explain why FDA can, should, and must create a single regulatory system that treats manufacturers equally, whether they call themselves a lab, an IVD company, or something else.

Read: Breaking Down the Regulation of LDTs: Moving Forward