Why does the FDA Reauthorization Bill Matter to Patients?
On August 17, 2017, the Food and Drug Administration Reauthorization Act of 2017 (FDARA) became law. FDARA is primarily responsible for funding the Food and Drug Administration (FDA) so that the agency can review and approve drugs and devices in a timely manner. It also contains provisions that provide guidance for manufacturers on how they conduct research on the drugs and devices they are developing.
Why is this important and exciting for people impacted by cancer?
This reauthorization contains an expanded definition of “patient experience data” to include not only physical, but also psychosocial impacts of a condition, therapy or clinical investigation/ trial.
How will this impact people with cancer?
As drugs and devices are developed to monitor or treat people living with or at high risk for cancer, manufacturers are now encouraged to capture not only the physical impacts of the drug/device that is being tested, but also social and emotional issues that impact the patient’s experience of a clinical trial.
Here is an example: If there were two therapies that worked equally as well treating a patient’s cancer, but one required weekly clinic visits and one only required monthly clinic visits, it is likely that the convenience factor may make the patient more likely to favor one therapy over the other. Prior to this expansion of the definition of the patient experience, drug manufacturers only measured the physical reactions to a therapy. Now, they would be encouraged to also measure the psychosocial impacts and would capture other factors that might be important to patients like taking time off of work, finding child care, paying for transportation and parking, etc.
How did this expanded definition get included in FDARA?
Over the past four years, the Cancer Support Community’s Cancer Policy Institute (CPI) has been working closely with Congress, drug manufacturers, and the FDA to build awareness about the need to measure and monitor the psychosocial impacts of therapies so that we can fully understand the patient experience. Through bipartisan, bicameral support and the leadership of Senator Tammy Baldwin (WI), Congressman Leonard Lance (NJ), and Congresswoman Diana DeGette (CO), an amendment was included in FDARA that expanded the definition of patient experience to include the psychosocial impacts. This is a huge win for patients as this is the first time that their psychological well-being is considered as equally important to their physical well-being in clinical research.
As with all policy changes, getting something written into law is just like scoring a touchdown: this does not mean that the game is over. Next steps include ensuring that drug and device manufacturers integrate psychosocial patient experience measures into their clinical trial design and report their findings to the FDA. Ultimately the CPI would like to see patient experience measures reflected on drug labels so that a patient will have a comprehensive understanding of how a certain therapy could positively or negatively impact their complete well-being.
What can you do?
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