The Food and Drug Administration (FDA) wants to know your opinion. More specifically, it wants to know how it can better regulate drugs and medical devices. The Agency is creating a public forum for commentary on its activities under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. With this public docket FDA intends to gather input from stakeholders, and the public at large, on how it can more effectively (1) obtain the views of patients during the medical product development process, and (2) consider patient perspectives during regulatory discussions.
FDASIA was signed into law on July 9, 2012. The Act is designed to strengthen FDA’s ability to safeguard and advance public health by increasing involvement in the regulatory process. FDASIA directs the Secretary of Health and Human Services 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 discussions.” The Act also reauthorizes the Medical Device User Fee Act providing FDA with resources that impact the regulatory processes involved in bringing medical devices to market. Additionally, FDASIA reauthorizes of the Prescription Drug User Fee Act for regulation of human drug and biological products.
The [November 2014] notice provides background on patient engagement activities, so that stakeholders can consider both current and new activities that involve patient participation and perspectives during medical product regulatory discussions.
According to the November 4th notice, FDA is “opening a docket for 30 days to provide an opportunity for interested stakeholders to submit comments on ‘strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions’ under section 1137 of FDASIA.” Comments should be submitted by December 4, 2014. Electronic comments should be submitted to http://www.regulations.gov and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The FDA’s November 4, 2014 notice can be found here.