Waiting for Guidance
Alexina Fredman, senior consultant with the healthcare professional services firm Falcon Consulting Group, cited FDA inaction to date on closely watched industry rules. The agency has yet to finalize a 2011 draft guidance on responding to unsolicited requests for information—for example, a question about off-label use.
“As soon as there are a few more regulations put into place, whoever takes advantage of that is going to have a good competitive edge over new customers, putting the patients first, having the patients be able to share their experiences with others, and do a bit more word-of-mouth marketing and really utilize social media in the way that other industries have,” Fredman added.
At Eli Lilly, a company-initiated “community conversation” uniting local leaders and people with severe, persistent mental illness resulted in improved access to psychiatric treatment.
“The reason so many people were not accessing their treatment and therefore getting arrested or living on the streets, was there was no bus line to the main community psychiatric center. The only people who could make it there were those who could walk several miles, or those who had transportation,” Michele M. Oshman, director, global advocacy & professional relations with Lilly, told GEN. She could not furnish the municipality’s name at deadline.
Lilly’s engagement also funds the Welcome Back and Reintegration annual awards of the National Council for Community Behavioral Healthcare, whose 2,000 member organizations treat eight million adults and families annually. Winners receive awards of $5,000 to $10,000 that must be donated to nonprofits that assist other patients.
“We will never be aligned on every issue. They have other business interests. But in places where we are aligned, certainly around issues of access to treatment, we’re able to work together in coalitions, and we’re much more powerful together,” Linda Rosenberg, the national council’s CEO, told GEN. “They really put their money into really supporting patients as well as, obviously, making important products.”