Earlier this month, Rep. Frank Pallone, a New Jersey Democrat, introduced a bill that could restrict the Food and Drug Administration’s “accelerated approval” pathway — the program responsible for bringing promising medicines to patients years ahead of schedule.
The accelerated approval pathway is a rare example of government working efficiently. Ensnaring it in red tape is senseless — and could delay patient access to lifesaving treatments.
Under the accelerated approval process, the FDA conditionally approves medications targeting serious or life-threatening diseases. The pathway allows patients to begin taking a medication as soon as it’s proven safe and reasonably likely to improve health outcomes — rather than making patients wait until years of clinical trials definitively demonstrate the anticipated benefit. The process shaves more than three years , on average, off the FDA’s traditional approval process, which typically takes eight years. Some cancer drugs that receive accelerated approval reach patients even quicker — roughly five years sooner than those in the traditional pathway.
That can mean the difference between life and death. For patients with the diseases accelerated-approval drugs typically target, from HIV to cancer, the odds of survival grow slimmer each day they wait for an effective treatment. And drugs given accelerated approval are certainly effective. According to a Health Affairs study , medications cleared via accelerated approval generally provide greater health gains than medicines that go through the traditional approval process.
In total, the accelerated approval pathway has swiftly delivered more than 250 lifesaving medications to patients who need them.
Inserting more bureaucracy in the accelerated approval pathway, as Pallone and some of his fellow Democrats are contemplating, will only lead to the types of delays that hamper other government programs. In this case, those delays could be deadly.
Sally C. Pipes is president, CEO, and Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is False Premise, False Promise: The Disastrous Reality of Medicare for All (Encounter 2020). Follow her on Twitter @sallypipes.