The FDA Listens. We Can Speak Up.

News
>
Blog|Insiders

We can speak up.FDA Listens.

FDA works better when they hear from patients. FDA wants to hear from us. They want to know how devices and medication work in real life.FDA is big. So they have created processes to channel patient views to the right groups of people in the agency. At first, these can appear formal. But learning about them can make sharing our views more comfortable. Let's look at three of these: guidance, advisory committees, and reporting adverse events.

Guidance

FDA creates guidance documents to help innovators understand how FDA anticipates reviewing a type of care. These give manufacturers direction on how to seek FDA approval. Before publishing them, FDA shares a draft and opens a process to take comments. FDA has used this process for glucose meters, automated insulin delivery, and other regulated diabetes care. Pharma and medical professionals take the opportunity to share their views. We should too. That way FDA will hear a balance.What do they want to hear from us? FDA leaders say they are looking for two general things from patients in comments.

  • They are looking for ways to improve the proposal.
  • They want to hear what patients like about the draft.

We should not assume they know what we like or want; we need to tell them.Things change between the draft and the final guidance. And these can help us. For example initially, FDA had two drafts on automating insulin delivery. They condensed that to one final document that anticipated devices with different abilities, from low glucose suspend, to more advanced automation. It also opened review criteria to allow including endpoints in addition to A1C. These could be things like time in range and reduced burden of care. These changes were the result of comments.

DPAC will help you know when FDA opens a docket that touches life with diabetes. We will make sense of the proposal and give you an easy way to share your views.

Advisory Committees

Often FDA seeks expert advice considering an application for a new device or drug. In these cases, FDA holds a structured advisory committee hearing. FDA assembles an expert board of physicians, researchers. The panel also includes a consumer and patient representative. Board members review detailed documents and FDA questions before the meeting. The meeting opens with the company applying for approval presenting detailed study data supporting their application. FDA gives an equally professional evaluation of the basis of their questions for the committee to consider. This comprehensive examination is critical. However, in the scientific conversations value to patient lives can get lost.FDA advisory committee meetings also have time allotted for public views.The time for each public speaker is short, typically three minutes. However, I have seen a series of public speakers including representatives of professional organizations, academics, physicians, educators, and patients refocus a conversation to include the value a device or drug offers clinicians to consider with their patients. Few people can dedicate a day to give three minutes of comments.Fortunately, FDA also welcomes written submissions before the meeting. Those written comments become part of the review materials that FDA and expert advisors consider before hand.

To make written participation easy, DPAC has shared petition and letters that individuals can sign to increase the impact of public views.

Reporting Adverse Events

Sometimes things don't work right. You can easily tell FDA about a problem. For example, if one of your diabetes tools just didn't work right. FDA wants to hear about it. They would like details of what went wrong including the specific device or medication that caused the problem.FDA has an app for that. It is called MedWatcher, look in your app store or there is a web form to make a report here.

FDA is listening.

We as patients need to be part of the conversation. The easy way to do that is:

[button link="http://act.diabetespac.org/app/register?0&m=59722" color="default" size="large" type="" shape="" target="_blank" title="" gradient_colors="|" gradient_hover_colors="|" accent_color="" accent_hover_color="" bevel_color="" border_width="1px" border_color="" border_hover_color="" shadow="" icon="fa-envelope-o" icon_divider="yes" icon_position="left" modal="" animation_type="0" animation_direction="down" animation_speed="0.1" class="" id=""]Sign Up To Be A DPAC Insider[/button]