VSongress is considering two measures that modernize the tools the Food and Drug Administration uses to oversee two areas of its broad portfolio: diagnostic tests and cosmetics. Although the stakes are different for each of these industries, the basic premise underlying these measures is the same.
The FDA is currently working from an outdated regulatory manual that has left gaps in its safety and efficacy oversight and made it more difficult to introduce new innovations. The new legislation would strengthen consumer and patient protection for diagnostic tests and cosmetics, and make it easier for manufacturers to introduce better products.
The provisions are seen as political riders to the spending bill that would fund the federal government for the next year. It took nearly two decades of debate and compromise to develop bipartisan proposals for these modernizations that met with the approval of most stakeholders. If these measures are not adopted now, it may take many years, along with many other setbacks and side effects, before there is enough political momentum to bring them so close to the finish line. .
Legislation governing diagnostics, Verifying Accurate Leading-edge IVCT Development Act, or VALID Act (S. 2209 and HR 4128), modernizes the FDA program to oversee diagnostic tests used to screen blood and tissue. Diagnostic technologies have seen tremendous advancements over the past few decades, driven by innovation in areas such as genomics, proteomics and data science. Sophisticated tests that detect genes, proteins, and other markers help doctors make diagnoses that were often unrecognized not long ago, or that would have required far more expensive, riskier, and more invasive to be checked. According to the Centers for Disease Control and Prevention, 70% of healthcare decisions are based on clinical laboratory tests. The potential for the future is even greater, with earlier detection and better treatment advice, and opportunities for new targeted therapies that will be guided by diagnostic markers.
However, existing laws governing the FDA’s regulation of laboratory tests to ensure they produce accurate results and can be used reliably in medical practice have not kept pace with these advances. . The outdated framework has forced the agency to regulate a test based on where it’s made — by a medical device maker, for example, or in a university or clinical lab — rather than its particular complexity or risks potentials. The result is an outdated, bifurcated approach that leaves patients and providers often overestimating the amount of oversight that has been applied to tests that matter to increasingly important clinical decisions, and that leaves test developers faced with both to uncertainty and ineffective regulatory burdens.
The FDA is currently using its former authority over medical devices to regulate tests performed by commercial manufacturers and packaged in kits or distributed outside of the labs that created them. For tests that are made by the lab administering them, however, the agency exercised “enforcement discretion,” due to a previous dispute over whether those tests were a medical device subject to oversight. of the FDA, or a service provided in the practice of laboratory medicine. Although it has been generally agreed for years that lab-developed tests are devices and therefore also subject to FDA regulation, the agency’s stance of enforcement discretion has left it without an effective approach. – and clear mandate – to oversee most of these products.
Because of this bifurcated regulatory regime, the level of regulatory assurance of a test’s quality and reliability depends on where it was developed – a reality that many consumers do not realize. When tests are flawed and unreliable, their results have led to misdiagnoses or poor treatment decisions.
The VALID Act would create a consistent standard for all tests, regardless of the type of facility in which they were developed or manufactured, as well as a modern regulatory framework uniquely designed for recent and emerging technologies used to develop tests. This allows the FDA to provide a consistent and effective level of oversight based on risk and complexity, and how a test is used, rather than where it was manufactured.
The law’s new regulatory approach largely removes testing from the FDA’s existing structure for overseeing medical devices and instead creates a new framework specifically tailored to diagnostics.
Recognizing that test manufacturers often market multiple tests that have much in common and sometimes make frequent changes to existing tests, the FDA would oversee the methods used to develop the test set and certify the thoroughness of this process, rather than regulate each test as a stand-alone product. Under this “enterprise-based” approach, test developers who have a rigorous process to ensure the reliability of their tests would, in many cases, be able to bring new tests to market and update upgrade their existing tests without undergoing the same pre-market review each time. Case. This approach, which applies to moderate-risk testing, would make the introduction of new innovations much more efficient.
The modernizations proposed in the VALID Act would also allow for greater oversight to transition to the post-market framework, if appropriate. Currently, all new tests are automatically considered Class III – posing a high potential risk if inaccurate – and are subject to the FDA’s strictest requirements for seeking pre-approval. commercialization, unless they are reclassified, which can be an arduous process for retesting. navigate. Under the proposed law, the FDA would have more flexibility to adjust its regulatory approach based on risk and down-regulate low-risk tests for moderate or low-risk categories.
Existing lab-developed tests, including those assembled and used by academic medical centers, would be exempted so they would not face new regulatory authorities. New lab-developed tests would have a five-year phase-in period to be placed under FDA oversight. The new framework would also allow laboratories to continue to offer testing for rare diseases without unnecessary new burdens. Laboratories could modify a test or develop a new one for unique or unusual circumstances, or for low-volume use, without seeking FDA clearance. There is also an “accredited person program,” where state regulatory programs can become third-party reviewers that replace the FDA.
Some academic medical centers have raised concerns that VALID could interfere with the way they deliver care, as they often tailor tests to meet the needs of their affiliated providers. We believe VALID’s risk-based framework has taken these concerns to heart and balanced the need to foster innovation and give providers discretion in an effort to protect patients. The VALID framework has many exemptions to ensure that academic medical centers can continue to meet patient needs.
If VALID does not pass now, the FDA has signaled that it will begin to actively regulate all laboratory-developed tests by issuing a rule that declares them subject to the provisions of its existing medical device review process. This unsuitable process would be much less efficient than what VALID prescribes, and the uncertainty of how it would be applied would thwart investment and innovation.
The FDA’s approach to cosmetics is also plagued with some of the same challenges. It was created by a framework adapted to an older generation of products that included less innovation, but also less risk. Today’s cosmetics are more diverse in how they are made and how they work on the body. Many cosmetics contain advanced ingredients that provide consumers with a wider range of options, but may also contain unwanted and sometimes dangerous contaminants.
New cosmetics legislation allows the FDA to recall products containing ingredients that could cause serious harm when companies fail to do so voluntarily. It would also require manufacturers to disclose the ingredients they use and follow good manufacturing practices.
When cosmetic companies are made aware of serious adverse health events, they must report them to the FDA. As with diagnostic tests, consumers likely think their cosmetics already meet these basic requirements and overestimate the reach of existing FDA protections.
Both of these proposals are close to passing, but the opportunity could still be lost. If that window closes, it may take many more reports of poor results, and more evidence of lost innovation due to outdated regulation, to reach a point where these needed reforms are so close to passage.
Scott Gottlieb is a Physician, Senior Fellow at the American Enterprise Institute and served as Commissioner of the Food and Drug Administration from 2017 to 2019. Mark B. McClellan is a Physician, Director of the Duke-Margolis Center for Health Policy at Duke University. , and served as FDA commissioner from 2002 to 2004. Gottlieb serves on the boards of Illumina, Pfizer, and Tempus Labs; McClellan serves on the boards of Alignment Health Care, Cigna and Johnson & Johnson.
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