Firms Reveal Secrets to Working With the FDA on Electronic Projects

Recognizing that the FDA is understaffed and underbudgeted is the first step in forging an effective working relationship with the agency in trying to launch electronic initiatives, company officials tell PIR.

“You have to make it easy for them,” said Michelle Snyder, vice president of marketing with Epocrates.

She has worked with the agency for about five years to find ways to use her company’s physician alert and information sharing product to provide better, faster recalls and other information coming out of the agency.

More than one in four U.S. physicians, students at every U.S. medical school and hundreds of thousands of other allied healthcare professionals use Epocrates mobile and online clinical reference and support solutions daily, according to the company.

“They knew it was a good idea,” Snyder said. “The FDA knew they had to do more to push their information out there.”

Show a Problem and an Answer

But Snyder and her team succeeded in making their pitch to the agency because they demonstrated a need and also a relatively easy way to fill it. “You have to recognize that the FDA is a large bureaucracy with a lot of turnover,” Snyder said. “You have to be able to show them clearly that you come [bearing] a solution.”

It is also important to be very clear about what is expected of the agency, she added. Firms should recognize that although the FDA is open to using new technology, “it is hard for them to internally get things done.” Snyder stressed that companies have to come to the FDA with systems that are ready to work.

Regular meetings are also important. Snyder and her team do regular updates and check-ins with the agency, and have one slated for the end of this month to talk about expanding Epocrates use in MEDWATCH and perhaps in some other agency centers, she said.

More FDA Kudos

“We found the FDA to be very open and collegial,” said Saul Shiffman, chief scientist at Invivodata, a firm that specializes in electronic patient recorded outcomes (ePRO). Invivodata combines behavioral science, information technology and clinical expertise to capture ePRO data in clinical research.

The Invivodata solution, which includes DiaryPRO for real-time PRO data collection and SitePRO for site-based PRO data collection, is based on patented compliance methods that include a patient management system that gives researchers and sponsors visibility into study progress, the company said.

The FDA has regularly invited Invivodata to educate the agency and its inspectors on its technology, said Jean Paty, senior vice president of scientific, quality and regulatory affairs.

The FDA makes a solid effort to train inspectors in new technologies, Shiffman said. “We’ve participated in many training sessions with them, helping them to understand ediaries and how to audit them properly,” he told PIR.

He says part of the FDA’s challenge is that it must balance the advancement of technology with a mandate to ensure that it is implemented properly and preserves the integrity of the edata. “It is always a balancing act” for the agency, he said.

And when the FDA gets enthusiastic it can be creative, too, Snyder said. Her firm has just added some capabilities to its black box warnings at the request of the agency. “They pushed us for a new upgrade,” she said. — Michael Causey