The FDA is Issuing Four Guidances to Improve Patient Engagement in Their Processes

The Bio Patient and Health Advocacy Summit of 2019 was recently held in Washington D.C. One of the panels addressed patient engagement with the FDA and how patients, advocates, families, and organizations can get involved.

In a world that has slowly but surely been opening its doors to the patient voice, its easier than its ever been to become a part of the process. But just because its easier than in the past, doesn’t mean it can’t still be difficult.

 “It’s about empowering people to step through those doors.”

The more that patients are involved in the drug development process, the better outcomes will be for everyone. If the patient is not consulted, there is no way to ensure that what is most important to the patient is being researched, let alone discovered.

Four Guidances

To increase patient involvement in the process, the Patient Focus Drug Development Program within the FDA has helped to establish four different guidances. These guidances serve as a framework for how the organization collects patient input.

  1. Establishes the best sampling methods for collecting patient opinions
  2. Outlines best practices for determining what is most important to patients
  3. Works to create potential study instruments based off what patients view as important
  4. Will focus on the proper methods for collecting and storing patient opinion data

A public workshop for the fourth guidance will be held on December 6, 2019.

Not all of the guidelines have been published yet but the FDA is working to complete them as soon as possible. Then, they will disseminate their recommendations.

The FDA assures patients that every comment received is read and taken note of. They know it takes a collaborative effort to improve outcomes.

For Rare Diseases

There are special rare disease listening sessions being held by the FDA in order to ensure that rare diseases are given the attention they deserve. These sessions are being put on in collaboration with NORD. They will take place in 2020. If you would like to participate, simply fill out this form. If you aren’t able to participate, you can stay up to date on the sessions by reading the summaries that will be posted online after each one.

The hope is that these programs will help the FDA design better clinical trials, better considering patient needs and desires.


So what is the FDA to do with the patient data once its gathered? Of course it will impact their own future directions and choices, but they also plan to ensure that the patient opinions get to other researchers who could use it.

Likewise, other organizations on the same mission are also sharing their findings with the FDA and one another. This field should not be a competition between groups, it should be a collaborative effort to ensure that everything possible is being done for the patient. Thankfully, we’re making progress.

You can read more about this effort here.

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