Upcoming meeting matches sleep patients with regulators

WASHINGTON - For several years, Congress and patient advocates have demanded that patients have a greater voice in the U.S. Food and Drug Administration's product review process.

Now, a June 8 meeting has been set that will bring together sleep apnea patients, industry stakeholders and FDA officials to discuss the impact of the disease.

“The intent of the patient engagement movement is to ensure that the FDA understands the perspectives of patients,” said Adam Amdur, chief patient officer for the American Sleep Apnea Association. “These patients are impacted by a disease or condition and the FDA keeps those in mind when reviewing prospective treatments, as well as the safety of treatments on the market.”

In the weeks leading up to the meeting, ASAA will collect patient and caregiver experiences through its AWAKE Sleep Apnea initiative via an online survey. The initiative allows patients to share their experiences as they relate to diagnosis and treatment, symptom management and impact on daily life.

Regulators won't fully understand what patients deal with until they hear it directly from the source, says Theresa Shumard, patient advocate.

“We want the FDA to better understand the complete sleep apnea patient journey and possibly foster the development and delivery of better care,” she said. “It's important to be proactive, and research of this kind can benefit the patient of today and in the future.”

Insurance issues present the largest barrier to care for patients, says Shumard.

“They may have difficulties with high deductibles or they are shut out of insurance completely for whatever reason,” she said. “Sometimes they just can't afford another sleep study.”