Make sure drugs granted accelerated approval actually work, Congressman says

A US lawmaker has introduced a bill to improve the Food and Drug Administration’s (FDA) accelerated approval program.

Energy and Commerce Committee Chairman Frank Pallone Junior’s proposed Accelerated Approval Integrity Act would enhance the FDA’s ability to ensure that drugs that receive accelerated approval are providing a proven clinical benefit to patients.

"Patients deserve to know that the drugs they are taking are safe and effective"He said: “The Accelerated Approval Program allows patients to access innovative new drugs while the manufacturer and FDA conduct additional studies to confirm the product’s clinical benefit.