As part of its effort to be more transparent and loop patients into its processes and policies, the U.S. Food and Drug Administration this week launched a new website called FDA Patient Network.
It’s meant to be an educational resource for patients, patient advocates and consumers to learn about drug and device approval, off-label use of products and clinical trials. It’s also intended to be a place to ask questions of FDA officials, comment on decision-making and become involved in the decision-making process, the FDA says.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
“When patients better understand the intricacies of how medical products are studied, reviewed, assessed and brought to market, their input will be that much more focused and valuable,” Commissioner Margaret Hamburg wrote in a blog post. “We hope, with the launch of this new website, to expand the role of patients beyond the select group of patient representatives and to engage a wider audience of patients in new and broader ways.”
She noted that it will open new channels of communication with the public, including live chats with senior agency officials. The FDA has worked with patients and patient advocates since the 1980s, but under the Food and Drug Safety and Innovation Act signed into law in 2012, it’s been charged with upping patient participation in medical product regulation. Last year, it inaugurated an annual Patient Network Meeting as part of that effort.
It’s nice to see the FDA making these efforts. In general, I sense frustration among patients (excluding the ones who are very plugged-in to the conversation around their condition, e.g. the ones who are probably reading this) when they hear about a new drug or device that could help them, but don’t understand what trials and reviews need to be done — and why they need to be done — before that product can be sold.
I am continually reminded of this when I (still) get comments and emails from people inquiring about a bloodless glucometer I wrote about last July. The general sense of the comments and emails is: I hate pricking my finger every day. Why can I not find this anywhere? When can I get this? I want this — help!
It’s understandable, of course, and it’s discouraging writing replies. At the time the story was published, the company had just raised a small Series B and seemed to be moving pretty slowly. I’ve reached out to the company since then for an update, but without response, so I really have nothing new to share with these patients.
Anyway, the FDA is headed in the right direction with this, but it’s just a start. I hope the agency will become more proactive in helping patients understand its processes and include them in the conversation.
[Screen cap from FDA Patient Network]
