The FDA’s Accelerated Approval pathway has assisted America’s biotech industry in making remarkable advances over the last 30 years—but it has come under political attack, putting potential cures at risk, according to experts in a Vital Health podcast episode recorded during the BIO International Convention.
What is Accelerated Approval?
Accelerated Approval, which was established in the 1990s to boost R&D for HIV/AIDS, expedites FDA approval for medications that address critical illnesses with no therapies.
“50% of all therapies created over the last 10 years originated in small US biotech companies—thanks to policies like Accelerated Approval,” said podcast host Duane Schulthess, CEO of Vital Transformation, which studies the economic effect of treatment pathways and biopharma innovation.
Why we need Accelerated Approval
The problem? Centers for Medicare and Medicaid Services (CMS) decided earlier this year to severely limit coverage for a new Alzheimer’s drug, going against the FDA and long-standing precedent.
CMS “found the Accelerated Approval process a convenient objective whipping boy” to blame for budgetary problems caused by the pandemic and other structural challenges, said John A. Murphy, III, Chief Policy Officer and Deputy Counsel for the Biotechnology Innovation Organization (BIO).
Vital Transformation presented research at the BIO International Convention that showed if the pipeline was blocked, many therapies that save lives might never get to patients.
The Accelerated Approval pathway supports a robust U.S. biotech industry—which exists “due to policy that rewards innovation,” said Nick Shipley, BIO EVP and Chief Advocacy Officer. “It’s a strategic advantage. It is a healthcare asset that is of great benefit to this country.”