Senators introduce bill to complement PDUFA reauthorization

Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) introduced the PATIENTS' FDA Act to improve the transparency, accountability and efficiency of FDA's decision-making process for drugs and devices. The Senators said S. 2292 is designed to complement the proposed PDUFA reauthorization agreement negotiated between FDA and industry. PDUFA expires Sept. 30. Also on Wednesday, the U.S. Senate and House of Representatives released drafts of PDUFA reauthorization legislation (see above).

Under the bill, FDA would be required to provide detailed reports on all drug and device decisions, including the scientific and regulatory rationale behind a decision. The bill contains language stating that the agency's review and approval process should be "recalibrated" to better ensure patients have the opportunity themselves to weigh possible risks against the probable benefit of a particular drug or device. ...