On May 17, the House Energy and Commerce Committee advanced its comprehensive legislative package to reauthorize the Food and Drug Administration (FDA) user fee agreements, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA).
The Association for Clinical Oncology (ASCO) submitted comments earlier this year to the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor, and Pensions (HELP), outlining ASCO’s policy priorities for reauthorization of the user fee agreements.
ASCO is pleased that the House package includes many of these policy priorities. The House package would:
- Strengthen the accelerated approval process by giving FDA additional authority to ensure products that receive accelerated approval are providing a clinical benefit to patients in a timely manner
- Increase the diversity of clinical trials through improved clinical trial access and enrollment of diverse patient populations
- Expand the use of real-world evidence and real-world data to supplement clinical trial data and establish real-world effectiveness and toxicity
- Ensure the safety and efficacy of medical products by providing FDA with new tools and processes to allow the agency to better carry out reviews and inspections
- Bolster FDA’s oversight of drug manufacturers to prevent drug shortages
Also on May 17, leaders of the Senate HELP Committee released a draft version of their FDA reauthorization package. While the Senate package does not include the above provisions supported by ASCO, it does include the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 4128/S. 2209), another ASCO priority. The VALID Act would create a distinct regulatory framework for in vitro diagnostics and lab-developed tests (LDTs, known collectively in the draft legislation as in vitro clinical tests (IVCTs).
ASCO believes that reforming the regulatory framework for clinical laboratory diagnostics is essential to protect patients and ensure access to innovative and high-quality testing, however, the current version of the VALID Act is imperfect. ASCO has provided recommendations to the HELP Committee to help them strengthen the bill. Recommendations include:
- Give FDA sufficient and explicit post-market authority, including the authority to remove tests from the market or put additional safeguards in place to mitigate risks when a test demonstrates it is not delivering accurate and reliable information to providers and their patients.
- Create clearer definitions for risk categories to help better clarify which test will require each new level of pre-market review.
- Require transparency at of the test's level of regulatory review to ensure labels clearly show whether a test has been reviewed by the FDA and which risk category the test falls under.
- Authorize the necessary resources beyond the industry user fees to effectively implement this regulatory framework for LDTs and IVDs.
ASCO is encouraged that the House and Senate appear poised to act on so many of the Association’s FDA advocacy priorities and urges the relevant House and Senate committees to work together to reconcile the two packages and pass a bill that includes policies that ensure all patients have access to safe and effective therapies, including through clinical trials.
ASCO members should use the ACT Network to urge their lawmakers to swiftly pass FDA reauthorization legislation that includes ASCO’s priorities.
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