By James E. Valentine* & James C. Shehan –
On November 4, 2014, FDA’s Office of Health and Constituent Affairs and an Agency-wide working group posted a notice requesting comments generally on all its various patient engagement activities and specifically on FDASIA Section 1137— the provision on Patient Participation in Medical Product Discussions.
Section 1137 directs 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 discussions, including by—(1) fostering participation of a patient representative who may serve as a special government employee in appropriate agency meetings with medical product sponsors and investigators; and (2) exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry.”
The FDA Patient Representative Program allows patients and caregivers to become Special Government Employees (SGEs) and thereby participate in advisory committee meetings about medical products and serve as consultants to review divisions to provide input at FDA-sponsor meetings during the clinical development process. The Program’s genesis was the HIV/AIDS activism movement in the 1980’s and it was expanded and made formal by President Clinton’s cancer initiative in the 1990’s. According to Heidi Marchand, Pharm.D., FDA Assistant Commissioner for Health and Constituent Affairs, whose office administers the Patient Representative Program, since 2012, Patient Representatives have served on advisory committee meetings for over 150 medical products and participated in 22 FDA-sponsor product development meetings.
This notice comes on the heels of a flurry of recent activity in the arena of patient advocacy in medical product development and review, albeit not activity specifically focused on Sec 1137. In October alone, FasterCures, BIO, NORD, and DIA hosted meetings and workshops to discuss the role of patient engagement with industry and FDA. CTTI has embarked on a project to understand best practices for effective engagement with patient groups around clinical trials (see here). Meanwhile, on Capitol Hill, the proposed 21st Century Cures legislation continues to contemplate expanding the role of patients in the medical product development process (see our previous post here). In addition, FDA has spent the last couple of years piloting new initiatives to more systematically collect patient input (i.e., CDER/CBER Patient-Focused Drug Development, CDRH Patient Preferences Initiative). Each of these efforts seeks to find ways for the patient voice to be better heard.
FDA’s Federal Register notice is worded broadly and seeks input on all of its patient engagement activities, not just those specified in Section 1137, recognizing that all the tools for obtaining the patient perspective collectively contribute to FDA’s understanding of the patient perspective.
While not its exclusive focus, the newly established public docket represents an opportunity to weigh in on FDA’s implementation of Section 1137 via the Patient Representative Program. For those interested in providing comments, this public docket (here) is open until December 4, 2014.
MassBIO is hosting a Patient Advocacy Summit on November 10th (agenda here) where HP&M’s Jim Shehan will be participating in a panel on access issues.
*Not admitted to practice law. Working under the supervision of the Firm’s attorneys.