What can patients tell the US Food and Drug Administration (FDA) about how products should be regulated? By the agency's own admission, plenty. But in recent years, a large portion of the feedback FDA has sought from patients has concerned the pharmaceutical regulatory process. That dynamic, however, may soon change.
Since the AIDS crisis began in the US during the 1980s, FDA has been steadily increasing the participation of patients into the regulatory process, placing representatives onto Advisory Committee panels and frequently meeting with patient groups to gauge their needs and assessment of how prospective therapies might stand to have a meaningful impact on their quality of life.
In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which for the first time instructed the agency to begin holding dedicated meetings where it could gather feedback from large groups of patients affected by a particular disease with less than adequate treatment options.
That initiative, known as the Patient-Focused Drug Development Initiative (PFDDI), is charged with holding 20 meetings over the next five years, and has already held four (lung cancer, HIV, chronic fatigue syndrome and narcolepsy).
"The human drug and biologic review process could benefit from a more systematic and expansive approach to obtaining input from patients who experience a particular disease or condition," FDA explained in a Federal Register posting announcing the program in September 2012.
The initiative is also meant to work in tandem with a newly launched Patient Network website launched by FDA that is intended to educate patients about FDA's regulatory process so they can, in turn, better engage with regulators in various regulatory forums.
The Patient Preference Initiative
But these initiatives have left patients whose disease may benefit from medical device treatments largely out of the regulatory process-a fact seemingly recognized by FDA on 26 July 2013 when it released an advanced Federal Register notice announcing that it will soon hold a public workshop entitled "The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Process."
Little is known about the Patient Preference Initiative thus far. Its existence was first announced in a speech given by FDA Commissioner Margaret Hamburg in February 2013 in the context of the Center for Devices and Radiological Health (CDRH) working with diabetes patients to develop a guidance document on an artificial pancreas. Hamburg said CDRH had soon thereafter launched the Patient Preference Initiative "because it wants to find new ways to incorporate into its review process the views of patients on the potential risks and benefits of the products they'll be using."
The upcoming meeting is intended to "discuss ways to incorporate patient preferences on the benefit-risk tradeoffs of medical devices into the full spectrum of the Center for Devices and Radiological Health (CDRH) regulatory decision making," FDA explained in the Federal Register notice. That would make it similar in concept to the PFDDI, though with a focus on devices instead of drugs.
The meeting will also reportedly look to "advance the science of measuring treatment preferences of patients, caregivers, and health care providers."
"The information learned from this workshop and public comments will benefit regulators, industry, providers, patients, and device innovators," FDA added.
The meeting will be held over two days (18-19 September 2013) at FDA's White Oak campus in Silver Spring, MD.
Federal Register Notice