The Changing Regulatory and Policy Environment for Diagnostics: What to Expect in 2015 and Beyond

“What’s past is prologue.” —The Tempest, Shakespeare

If there’s one thing that history teaches us, it’s that history repeats itself. To get a picture of what the regulatory landscape will look like tomorrow, it’s important to understand what it looked like yesterday, and how we got to where we are today. Through this lens, we should examine two current initiatives that could both directly and indirectly affect the regulatory and policy environment of the future: 21st Century Cures, and the proposed Regulatory Framework for In Vitro Clinical Tests.

21st Century Cures Initiative
The 21st Century Cures Act (H.R. 6), currently being discussed in the U.S. House of Representatives, addresses reforms not just for diagnostics, but across all FDA centers. It is a draft legislation created by the House Energy and Commerce Committee’s leadership. Co-sponsored by Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), and released with the support from members of both parties, the bipartisan initiative aims to improve innovation for new treatments and tests, and to streamline approval efforts by the FDA.

Amendments intended to improve innovation in healthcare are not new. First came the Medical Device Amendments, added to the Food, Drug and Cosmetics Act (FD&C) in 1976, but other amendments have followed.

Among them was the Safe Medical Devices Act (SMDA), signed into law by George H.W. Bush in 1990. The SMDA primarily instituted Medical Device Reporting (MDR), which requires safety related issues, both real and potential, to be reported to the U.S. Food and Drug Administration (FDA). Few would argue that the amendment has not improved the safety of devices, but it was not focused on innovation or process improvement.

In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended sections of the FD&C Act relating to the regulation of food, drugs, devices, and biological products. With the passage of FDAMA, Congress enhanced the FDA’s mission, recognizing that the agency “would be operating in a 21st century characterized by increasing technological, trade and public health complexities.”

After the first two user fee-related medical device amendments in 2002 and 2007, a third amendment in 2012, called the FDA Safety and Innovation Act (FDASIA), gave the FDA a powerful drug development tool: Breakthrough Therapy Designation. This designation assists drug developers by expediting FDA review of new drugs that are supported by preliminary clinical evidence indicating the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.

FDASIA also sought to further innovation by including draft guidance on the process for approving applications for medical device clinical investigations. It also permits the FDA to review “direct” (rather than the previously cumbersome “sequential step”) de novo device submissions.  FDASIA also attempted to engage stakeholders more in FDA review and decision-making.

So, how should we view the 21st Century Cures initiative, given this historical perspective? It is safe to say that, once medical issues surface for discussion, the legislature generally has acted for the betterment of public health. True to that historical standard, legislation likely will pass that makes changes for the better, to improve innovation and process.

21st Century Cures also could result in an organizational restructure at the FDA. The legislation, as it currently is written, contains a great number of reforms: Clinical Laboratory Improvement Amendments (CLIA) waiver study design guidance for in vitro diagnostics (IVDs), expediting patient access, notification of marketing of certain Class I devices, priority review for breakthrough devices, telemedicine, FDA advancement of precision medicine, and improving scientific outreach for the agency. Any one of these reforms could open the door to an FDA organizational restructure and, considering the grand scope of the initiative, it is hard to imagine that some sort of organizational restructure won’t occur.

However, 21st Century Cures remains silent on regulation of laboratory developed tests (LDTs). The nature of the FDA’s involvement in oversight of LDTs is a hot topic within the industry, and it will be very interesting, to say the least, if the legislation moves forward without requiring or allowing that oversight.

Regulatory Framework For In Vitro Clinical Tests
The Regulatory Framework for In Vitro Clinical Tests proposal was a creation of the diagnostic industry, rather than government, spearheaded by the membership of AdvaMedDx, the largest group representing this industry. The proposal was developed to potentially replace the existing regulatory structure for all diagnostics (both manufacturer and LDT), regardless of site and entity. Under the proposal, the FDA, the Centers for Medicare and Medicaid Services (CMS), and other stakeholders would engage in any legislative process for statutory changes.

This proposal is related directly to the LDT Framework, merging it with the Transitional In Vitro Diagnostic Test (TIVD) proposal offered to the FDA by industry a few years ago. The TIVD eventually was embraced by Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, and a pilot program currently is underway with multiple manufacturers participating. If this program is successful — and it should be — it could change the way we look at how product approvals should occur in the future.

History dictates that some version of the framework will continue forward as-is. But it remains possible that the FDA’s effort to regulate LDTs could be undermined by  21st Century Cures or something more extreme, such as a lawsuit by the lab community.

What’s Past This Prologue?
Historical knowledge provides precedence that, if we are smart, can guide current and future decision-making to benefit the public health.

Through the lens of historical knowledge, we can see that, once discussion of reform begins, movement generally continues toward action. We also can see that, when all stakeholders are involved and cooperate, public health benefits. Public meetings, agency outreach, and guidance comments are very important in developing fruitful outcomes. Today, cooperation between agency and industry is at its highest level ever. This bodes well for the future and ensures the best possible outcome for all parties.

Robert Di Tullio, Senior Vice President, Global Regulatory Services

Date posted: June 3, 2015

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