New diagnostics authorities, accelerated approval council featured in Senate user fee bill

Regulatory NewsRegulatory News | 31 May 2022 |  By 

The Senate Health, Energy, Labor and Pensions (HELP) committee has introduced its version of the user fee reauthorization bill. Like its sister bill in the House, the proposed legislation would introduce new guardrails around the US Food and Drug Administration’s (FDA) accelerated approval program, though it includes notable departures from the House bill, such as new authorities for FDA to oversee certain diagnostic products.
On 27 May, the HELP committee published the FDA Safety and Landmark Advancements (FDASLA) act that would reauthorize FDA’s prescription drug, generic drug, biosimilar and medical device user fee programs before they expire in September. In most respects, the bill mirrors the legislation being considered in the House.
Notably, the Senate version includes new authorities for FDA to regulate certain in vitro diagnostics, including laboratory developed tests (LDTs) that have traditionally been regulated under the Clinical Laboratory Improvement Amendments (CLIA) by the Centers for Medicare and Medicaid Services (CMS). (RELATED: User fee reauthorization bill advances in the House, Senate eyes different riders, Regulatory Focus 18 May 2022)
While FDA has used regulatory discretion for years to refrain from regulating LDTs, the agency has recently insisted that greater oversight of such tests is needed.
FDA has said that enforcement discretion was appropriate in the past as such tests were typically simple and were for less risky indications. However, over the years LDTs have evolved in complexity, are used to diagnose more serious diseases, and in some cases are being mass manufactured, according to the agency.
At the end of the Obama administration, the FDA developed a framework to regulate LDTs using a risk-based approach but that didn't happen with an administration change that emphasized deregulation. The agency pulled back on the framework and published a white paper on how such tests needed to be regulated. Since then, FDA has lobbied Congress for new authorities to regulate LDTs, and if the provisions in the Senate bill are made into law, it will get exactly that.
While the House version of the user fee reauthorization bill does not include the Verifying Accurate Leading-edge IVCT Development Act (VALID Act), House representatives have already indicated that they plan on adopting the language expanding FDA’s authority during legislative reconciliation.
FDASLA clarifies the definition of what is considered an in vitro diagnostic such as test kits, test systems, certain software and laboratory test protocols.
The bill states that such tests may not be sold without the explicit authorization of FDA except in certain circumstances such as when they are considered low risk. It also says the Department of Health and Human Services (HHS) needs to maintain a list of what is considered low-risk tests so manufacturers are not caught by surprise if FDA decides to regulate their product.
Another notable provision of the Senate bill is the creation of an intra-agency coordinating council that will oversee its drug accelerated approval program. The program recently came under heavy scrutiny after FDA approved Aduhelm, an Alzheimer’s Disease drug, despite a panel of experts recommending against its marketing.
The Senate bill includes language that would increase intra-agency discussion of decisions regarding drugs that go through the accelerated approval pathway by requiring FDA to convene the coordinating council before making a decision.
“The council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval,” the bill states. “[It] shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the [FDA].”
The coordinating council is also tasked with developing guidances and policies for the accelerated program, including training product review teams and advising review divisions.
Another major difference in the Senate bill is that it omits provisions to increase clinical trial diversity, which is a major priority for the Biden administration. However, that may be eventually worked into the package during the legislative reconciliation process.


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