Tuesday, May 21, 2013

FDA brings patient engagement to drug, device approval process | EHRintelligence.com

FDA brings patient engagement to drug, device approval process | EHRintelligence.com

FDA brings patient engagement to drug, device approval process

Author Name Jennifer Bresnick   |   Date May 20, 2013   |  

Physicians aren’t the only ones placing an emphasis on getting patients engaged in their own care to encourage healthy choices and preventative medicine.  While the Food and Drug Administration (FDA) doesn’t have to worry about Stage 2 meaningful use requirements demanding a 5% engagement rate, the agency does play a critical role in patient care, and is working on allowing the public to be more involved with drug approval, medical device development, and regulatory processes before products ever hit the shelves.  With the launch of its new Patient Network website, the FDA invites patients to learn about the approval process, ask questions of senior administrators, and provide feedback on research and regulation processes from the comfort of their own keyboard.
The FDA has recruited and involved patient advocates for years, allowing them to attend meetings and learn about the development of pharmaceutical products and medical monitoring devices to focus their input and provide an important real-world perspective for the agency during its review procedures.  The new Patient Network site is intended to be an interactive tool to foster engagement, and “brings together, in one place, information that is important to patients, making it easier for them to find what they are looking for and to understand the significance of their findings.”
“This web site will open new channels of communication with the public,” says Dr. Margaret A. Hamburg in a blog post announcing the site launch.  “It will help patients and consumers better understand the process for determining whether medical products are safe and effective and encourage them to contribute their ideas and concerns about the development and regulation of these products.”
As the FDA plans to take a greater role in the regulation of mobile health devices and medical equipment, input from patients will become increasingly valuable as mHealth products and applications continue to skyrocket in popularity.  The agency plans to regulate high-risk apps used in conjunction with standard devices, and has been wrangling with opponents about a 2.3% excise tax on devices for more than two years.  Final guidance about the FDA’s involvement in mHealth regulation is expected soon.
The website will help give patients a voice by allowing them to comment on ongoing regulatory decisions, live chat with senior officials, become a patient representative, and submit questions or comments online.  The site “provides a new model for FDA to follow in making its inner workings transparent to the public,” Hamburg says. “It ushers in a new era of access and input for patients and consumers that will evolve with the needs of both communities.”

No comments:

Post a Comment