Colorado Rep. Diana DeGette (D) is urging the Food and Drug Administration (FDA) to recognize the importance of Internet communication in drug research. Her efforts are being joined by drug companies and medical experts, and the FDA says it is listening and trying to improve.
DeGette explained the important role social media can play when researching diseases and treatments in a July 2014 congressional health subcommittee meeting, telling the story of a family with a child who had the rare NGYL1 disease. The father was a computer professor at the University of Utah and searched the Internet for others who suffer from the ailment. The father was able to identify patients who were suffering with NGYL1 around the world, which led to the formation of a research group to study the disease and a paper scheduled for publication.
“Social media are particularly important in helping patient populations with rare diseases,” said Matt Inzeo, communications director for DeGette. “In the past, if you had a one-in-million disease, odds are you were quite disconnected. Thanks to social media, these are people who have the ability to connect and interact and in some cases, working together to pool medical data that researchers can use.”
“What the digitally connected world offers is some possibilities [for] pulling patient groups together and using that connectivity to target research and design more therapeutic treatments,” Inzeo said.
Drug Information Restricted
The Pharmaceutical Research and Manufacturers of America (PhRMA), a nonprofit association representing the country’s leading pharmaceutical research and biotechnology companies, has identified several ways the FDA prevents drug companies from sharing information on research.
“Unfortunately, the FDA’s regulations regarding companies’ ability to share truthful, non-misleading medical and scientific information are outdated,” PhRMA stated in a June 2014 report. “These regulations do not even mention the Internet, much less facilitate or allow robust use of social media in a manner akin to the FDA’s own use of such communication tools.”
The FDA approves what appears in the drug’s “package insert,” which lists warnings, including potential adverse reactions and dosages for a drug.
Dr. Gregory Schimizzi, a rheumatologist and member of the Coalition of State Rheumatology Organizations (CSRO), said the FDA should allow drug companies to share more of the wealth of information they have compiled on their drugs.
He told the House Energy and Commerce Subcommittee on Health in July his understanding was the FDA didn’t allow drug companies to distribute any key information unless it is explicitly referenced in the package insert.
“By limiting the sharing of information, physicians are hampered in their ability to access all available sound medical evidence and firm scientific rationale necessary to treat patients with difficult problems,” Schimizzi said. “Congress and the FDA should be encouraging the exchange of scientific information, not hampering it,” he added.
FDA Reviewing Regulations
FDA spokesperson Andrea Fischer said the agency is performing a comprehensive review of its regulations and guidelines, sparked by emerging case law involving the First and Fifth Amendments.
“FDA continually strives to provide regulatory oversight to protect the public health—the fundamental interest underlying FDA’s mission and statutory framework—while harmonizing this goal with First Amendment interests in the dissemination of truthful, accurate, and non-misleading information regarding medical products,” Fischer said in an email.
Fischer said the FDA has already issued draft guidance regarding unsolicited requests for off-label information about prescription drugs and medical device practices and the distribution of scientific and medical texts. The FDA also released two draft guidances regarding the use of social media.
“These two proposed draft guidances for industry contain recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices,” Fischer said.
“FDA plans to issue guidance that addresses unsolicited requests, distributing scientific and medical information on unapproved new uses, and manufacturer discussions regarding scientific information more generally,” she added.
Tom Gantert ([email protected]) writes for Michigan Capitol Confidential.