The Importance of Patient’s Involvement in FDA New Drug Development

Hi, everyone,

It you are interested in this topic, kee on reading the copied message from FDA.

“Dear Colleagues:

The U.S. Congress recently passed the Food & Drug Administration Safety and Innovation Act (“FDASIA”). President Obama signed the legislation on July 9, 2012 (Public Law 112-144). FDASIA reauthorized the Prescription Drug User Fee Act (“PDUFA”) and the Medical Device User Fee Act (“MDUFA”) for five years. Two new user fees were also established in the legislation: the Generic Drug User Fee (“GDUFA”) and the Biosimilars User Fee (“BsUFA”).

Along with the user fee reauthorizations, the legislation contained several changes to the Food, Drug & Cosmetic Act (FD&C Act), which is the primary law that establishes FDA’s regulatory authority, and also several other policy “riders” (additional changes in the legislation that affect FDA policy). One of these riders is located at Section 1137 of FDASIA – Patient Participation in Medical Product Discussions. This provision was originally proposed by the American Cancer Society and was later incorporated into the bill.

The provision requires the Secretary of Health and Human Services (and FDA) to “develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory decisions….” The law states that FDA shall include in those strategies ways for patients to provide perspective in “appropriate agency meetings with medical product sponsors and investigators.” This is an exciting part of the legislation that will further increase patient involvement in the regulatory process.

The Office of Special Health Issues will be working to implement this part of the law. As we move forward, OSHI will provide updates on our progress.

God bless.