The FDA’s accelerated approval pathway has a potentially prominent champion — Robert Califf, the scientist President Biden has nominated to lead the FDA.
This pathway opens the door to earlier approval of drugs aimed at serious conditions that fill an unmet medical need based on a surrogate endpoint, which can considerably shorten the time required to submit data to the FDA and expedite the agency’s review process.
At his confirmation hearing in December, Califf said he is “a fan of accelerated approval for the right conditions.”
Six weeks later, Senator Ron Wyden (D-Ore.), who chairs the U.S. Senate’s Committee on Finance, sent Califf a letter asking him to clarify his position on accelerated approval. He asked Califf five important questions:
- What standard will you use to determine whether a company has failed to comply with confirmatory evidence requirements?
- How do you expect to hold laggard companies accountable? Which of the existing FDA authorities will you use?
- How will you measure compliance with clear enforcement standards?
- If these actions do not lead to success, will you request additional authorities from Congress?
- How will you use your position to prioritize policy reforms that use existing authority to fix the problems for drugs with accelerated approval when they have yet to provide evidence for confirming their effect?