SUCCESS IN REGULATORY ADVOCACY A SMALL GROUP OF ADVOCATES MAKING A DIFFERENCE
A small group of advocates can make a difference. In January 2014 the FDA Cardiovascular and Renal Advisory Committee held a public hearing to consider approval of a drug to treat multiple system atrophy. A coalition of advocacy organizations in combination with physicians and dozens of patients suffering from the condition provided comments on the lack of benefit most patients experience from the only FDA-approved drug to treat this condition. Collectively, they told their stories and urged the FDA to recommend the new drug for approval.
At the end of the hearing, the committee voted recommended approval by a vote of 16-1. Committee comments made clear that the patient testimony played an important role in the vote. Thanks to advocacy by a small group of patients, more patients will have access to a new treatment option. To learn more about this success, visit: www.multiplesystematrophy.org
CONCLUSION
Healthcare is a highly regulated industry, spanning from drug development, hospitalizations, individual insurance, medical tests, outpatient care, lab tests, treatment, disease prevention, prescribed medications, and more. Thus, advocacy, as it relates to healthcare delivery, is vitally important. Regulation plays a major role within healthcare delivery, ensuring patients have access to the healthcare they need, and that that care is delivered with the utmost quality. Compliance with laws and regulations is critical to the delivery of high quality healthcare. It is important to stay on top of new regulations and policies as they relate to
healthcare and engage and comment where appropriate. Advocacy through engagement with both your state and federal regulators will help them to better understand issues important to patients. Your actions will help ensure that laws are implemented in the manner intended.
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