Patient Engagement Mainstreams

One Tuesday morning early in October in 1988, a large group of protestors appeared in front of the building that housed the Food and Drug Administration and effectively shut the agency down. There were hundreds of protesters present, organized by ACT-UP (the AIDS Coalition to Unleash Power) and scores were arrested by glove wearing policemen who told many FDA staffers coming to work to turn around and go home. Said one protester, “[w]e are here for all the people with AIDS but we are also here for all the other people with life-threatening illnesses who need drugs now.” The demands of the protesters were numerous, but chief among them was a greater say in the way clinical trials were conducted and the speed with which drugs were approved.

As a result, the approach to drug approvals changed and mechanisms formally introduced into the process that significantly cut down on the time that it took to get candidate therapies reviewed by the agency. AIDS activism – demanding a greater say – changed the system. The mold of patient advocacy changed shape.

Over the years, those pathways have been refined – Fast Track, Accelerated Approval and the like. But the bottom line is that the involvement of patients into the process changed the status quo and most would argue, for the better.

Patient engagement can mean many things. It can mean that when in a doctor’s office, a patient is engaged with his or her physician to ask important questions. Or it can mean that patients are in a position to have some input into the development of treatments for their conditions. This is about the latter.

In the fall of 2015, FDA formally embarked on the development of a new advisory committee – the Patient Engagement Advisory Committee – by announcing its formation in September and soliciting nominations for membership. According to the Federal Register notice, the agency said that the committee would provide input for FDA related to the development of guidance and policy documents, clinical trial registries, patient preference study design and other aspects related to medical devices. Last week FDA published notice that the committee would be formally added to the roster of Advisory Committees.

That is what is happening with devices. With respect to the development of medicines, FDA has been involved in a five year initiative to get patient input related to drug development though a series of public meetings and a list of the topics and meetings can be found here.

Times have changed from 1988. But a generation following the protest of that Tuesday in October, it would appear that there are more ways and more opportunities for patients to have direct input into the development of treatments. And though the list of demands from that day have yet to be fully addressed, formalizing pathways for greater patient involvement is a start. And it’s not just for patients with life-threatening illnesses, it is for all of us.

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