SNOWMASS, COLO. – The jury remains out on ambitious Food and Drug Administration initiatives aimed at renovating the image and improving the performance of the oft-criticized agency. Indeed, many of the major new FDA reform projects are still on the drawing board or just barely underway. But one relatively simple reform that’s been well received by organized medicine concerns the embattled agency’s efforts to improve communication with physicians regarding safety issues.
"FDA communication with physicians has been a huge problem," Dr. Lenore M. Buckley said at a symposium sponsored by the American College of Rheumatology.
That began changing when Dr. Margaret Hamburg was appointed FDA commissioner in 2009. She pledged better communication, organizational transparency, and increased efficiency.
Toward the goal of improved communication with physicians, agency officials reached out to the American Medical Association and asked how they can do a better job. The AMA convened a meeting attended by representatives of the FDA and the major medical specialty organizations, who proceeded to give the FDA an earful.
"The specialty groups vented that the information you give physicians is difficult to read, it’s too technical, it’s too late, it’s not helpful, and we can’t even find it because your Web site is too difficult to navigate," said Dr. Buckley, professor of internal medicine and pediatrics at Virginia Commonwealth University, Richmond.
"And so the FDA decided one of the big changes it was going to make was that it was going to try to communicate safety information through the specialty organizations and let them decide which information is important to their members, and also to let them decide how to deliver the message. That’s actually worked fairly well with the ACR [American College of Rheumatology]", Dr. Buckley noted.
Through the FDA’s cooperation, the ACR Drug Safety Committee and other groups are now able to prioritize which safety message needs to get out to members quickly, and in which format: flash e-mails, the Rheumatology Morning Wire, the Hotline, the Drug Safety Quarterly, articles in the college’s journals, or the FDA-cochaired drug safety session held each year at the annual national ACR meeting.
In the past, because of legal and bureaucratic restrictions, the FDA would often make a public announcement that a drug was being withdrawn without providing access to the data on which the decision was based. The predictable result was chaos and confusion.
"Patients would pour into our offices the next morning asking us questions, and we’d look kind of silly because we didn’t have any more information than they did," the rheumatologist and pediatric rheumatologist recalled.
In the spirit of reform, however, the FDA has agreed to give the ACR and other concerned specialty organizations a heads-up alert 1 or 2 days before releasing important information about a safety issue. It’s not working perfectly, but it is a big improvement over the older method.
As part of the new approach, for example, the FDA notified the ACR shortly before its public announcement that it would be looking into a possible increased risk of lymphoma and solid malignancies in children with rheumatologic diseases treated using anti–tumor necrosis factor agents.
"Those of us who see children could predict this was going to be a big deal. There was a dialogue with the FDA about what they knew, what kinds of patients these were – Crohn’s disease or arthritis," recalled Dr. Buckley, who is on an FDA advisory committee and is also active on drug safety issues within the ACR.
"That dialogue wasn’t perfect. We had a first conversation where we said we didn’t have adequate information and needed to look at the data they were basing their conclusions on. They told us they couldn’t give us any more information, they went public, and there was a lot of backlash from parents. But there was a continuing dialogue between the FDA and ACR in which we said we need more, and the FDA actually came around to the ACR annual meeting and released some data they’d been reluctant to release prior to that, and it gave us a way to take a harder look at the data."
For years the FDA has been plagued by unrest, with frequent staffing turnover and whistle-blowing over cozy relationships with industry. Criticism of the agency has come from every quarter: physicians, industry, public advocacy groups, patient organizations, and especially Congress. In September 2006, an Institute of Medicine report to Congress blasted the agency for its feeble postmarketing safety follow-up, inconsistent leadership, and poor communication.
The IOM report was instrumental in the passage a year later of the FDA Amendments Act, in which Congress granted the agency clear new regulatory authority, along with an additional $225 million over 5 years, for drug safety, and instructed the agency to create an active postmarketing data surveillance system.