WASHINGTON — The Senate on Tuesday approved a proposal from Sen. Kay Hagan, D-N.C., that will speed the approval process for drugs intended to treat patients with rare diseases. WASHINGTON — The Senate on Tuesday approved a proposal from Sen.
WASHINGTON — The Senate on Tuesday approved a proposal from Sen. Kay Hagan, D-N.C., that will speed the approval process for drugs intended to treat patients with rare diseases.
The provision passed the Senate as part of a wider bill that updates and reworks the user fees paid by drug companies that are seeking Food and Drug Administration approval for their products.
The FDA Safety and Innovation Act passed the Senate 92-4; it’s already cleared the House of Representatives and now moves to President Barack Obama for his signature.
Hagan originally proposed her provision as a standalone piece of legislation in February. It’s intended to expedite the review of treatments for patients who have certain serious or life-threatening diseases.
The provision is significant for patients suffering from diseases that don’t have adequate treatment options or might have no treatment options at all, Hagan said Tuesday in a conference call. She said the provision would enhance the uniformity and consistency of the FDA’s accelerated-approval system; since 1992, the agency has allowed faster approval for drugs that treat certain serious illnesses.
The wider FDA bill revises and extends user fees that pay for the prescription-drug and medical-device approval process; it also creates user-fee programs for generic drugs and biopharmaceutical products. The drug and medical device industries have paid such fees for FDA reviews since 1992.
Public Citizen, a consumer advocacy group that’s often critical of the drug industry and the FDA, opposes the user-fee law and the new approval process Hagan proposed.
“The problem with the accelerated approval process is that it does set a lower bar for bringing things to market,” said Dr. Michael Carome, the deputy director of Public Citizen’s Health Research Group. In addition, Carome said, user fees create a conflict of interest for the FDA and the drug and medical device industries.
“We’ve long opposed user fees because we believe it sets up and alters the balance and relationship between the regulator and the industry that’s regulated in a way that’s not good for consumers,” he said. “This tilts the agency toward making decisions in favor of the industry.”
