Pass VALID Act Now: Former Commissioners
Former FDA commissioners Scott Gottlieb and Mark McClellan say Congress should act promptly to approve the Verfiying Accurate Leading-edge IVCT Development Act (VALID Act) and modernize FDA’s regulatory framework for overseeing diagnostic tests that are used to screen blood and tissue. Writing in an online Stat News opinion column, the two say the agency “is currently working from an outdated regulatory playbook that has left gaps in its oversight of safety and effectiveness and makes it more difficult to introduce new innovations. The new legislation would strengthen protections for consumers and patients for both diagnostic tests and cosmetics, and make it easier for manufacturers to introduce better products.” (The article discusses a modernized regulatory approach to both diagnostic tests and cosmetics.)
Gottlieb and McClellan say it has taken almost 20 years of debate and compromise to reach bipartisan proposals for regulatory modernization that have met the approval of most stakeholders. “If these measures don’t pass now,” they caution, “it may take many years, along with many more setbacks and side effects, before there’s enough political momentum to get them this close to the finish line.” They say the proposals are being considered as policy riders to the spending bill that would fund the government for next year.
After reviewing FDA’s current regulatory approach to diagnostic tests and the bill’s major provisions, the article says the VALID Act “would create a consistent standard for all tests, regardless of the kind of facility they were developed or made in, as well as a modern regulatory framework that’s uniquely designed for the recent and emerging technologies being used to develop tests. It allows FDA to provide a consistent and efficient level of oversight that’s based on risk and complexity, and how a test is being used, rather than where it was manufactured. The act’s novel regulatory approach largely takes the tests out of FDA’s existing structure for overseeing medical devices, and instead creates a new framework uniquely tailored to diagnostics.”
Gottlieb and McClellan say that under VALID, FDA would oversee the methods test makers use to develop a set of tests and certify the rigor of that process, rather than regulate each test as a standalone product. “Under this firm-based approach,” they write, “test developers that have a thorough process for ensuring the reliability of their tests would, in many cases, be able to market new tests and update their existing tests without undergoing the same premarket review in every case. This approach, which applies to moderate-risk tests, would make introduction of new innovations far more efficient.”
The authors acknowledge that some academic medical centers have raised concerns that VALID could interfere with how they deliver care because they often tailor tests to meet the needs of their affiliated providers. Gottlieb and McClellan say they believe that VALID’s risk-based framework has taken such concerns to heart and has balanced the need to foster innovation and give providers discretion with the goal of protecting patients. “The VALID framework has many exemptions to ensure academic medical centers can continue to meet patient needs,” they conclude.
If VALID doesn’t pass, the article says, FDA has signaled it would start actively regulating all laboratory-developed tests by issuing a regulation that would declare them subject to the provisions of its existing medical device review process. “This ill-fitted process would be far less efficient than what VALID prescribes,” it says, “and the uncertainty about how it would be applied would thwart investment and innovation.”