Company websites, news websites, other content-based websites, and microblogging sites such as Twitter, are important vehicles of communication for disseminating information. A challenge for stakeholders in the pharmaceutical industry—the public at large, patients, medical personnel, drug companies, and regulators—is to have a mechanism for how that information can be effectively and responsibly communicated. Last year, the US Food and Drug Administration held public hearings to gain input from the public and other stakeholders as part of the agency’s evaluation on how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer media technologies. The Pharmaceutical Research and Manufacturers of America (PhRMA) weighed in on this debate by participating in those public meetings. This week PhRMA further detailed its proposals for regulation and standards for communication of online medical-product information.
PhRMA issued a statement and held a conference call with the media on Mar. 9 to explain the association’s position, which includes support of further guidance from FDA on how drug companies can use the Internet and social media. “PhRMA is proposing that the Food and Drug Administration issue new guidance detailing how biopharmaceutical research companies may use social media to help patients and to improve public health; the guidance eventually could be adopted as regulations,” said PhRMA Senior Vice-President David E. Wheadon in the statement. “… At a time when more than half of adults first turn to the Internet to find health information, the extraordinary volume of dangerous and inaccurate information about medicines on the Web makes the FDA’s leadership on this topic all the more essential.”
PhRMA detailed its proposal to FDA in a 16-page letter dated Feb. 26, 2010. The proposal includes three major recommendations, as outlined in PhRMA’s press statement: the adoption of a universal symbol to indicate a direct link to FDA-regulated risk information online; the allowance of introductory drug-warning information in sponsored search results and similar media with direct links to risk–benefit information; and permitting drug companies to microblog newsworthy regulatory and scientific events for medical products.
PhRMA is seeking the adoption of a universal symbol that could be used in space-constrained media to indicate a direct link to FDA-regulated risk and benefit information. “The use of the FDA’s own logo or other FDA-approved symbol would shine a brighter spotlight on official Web sites of FDA-approved medical products containing reliable and comprehensive information and medicines’ benefits and risks,” said PhRMA in its statement.
PhRMA is also seeking to have introductory warning information in sponsored search results and similar media with direct links to comprehensive risk and benefit information. “The FDA should allow manufacturers to present brief introductions to health information in electronic formats, just as the FDA now does it own tweets,” said PhRMA in its statement. PhRMA recommended that postings in space-constrained media such as sponsored search results would include a standard universal warning that would be approved by FDA such as: “All drugs have risks. Click here for more information from the manufacturer.” The link would then take consumers to more product-specific risk and benefit information.
PhRMA also is looking for FDA to adopt standards for microblogging as done through social media sites such as Twitter, a communication tool that the industry wants to be able to use more fully once appropriate standards are specified. “Given space constraints and consistent with FDA’s own use of such media, the Agency should allow biopharmaceutical manufacturers to serve as responsible stewards of newsworthy information about their products and should permit manufacturers to microblog about significant scientific and regulatory events,” said PhRMA in its statement, emphasizing that such exchange of scientific information should not be advertising-related or promotional.
In expanding its use of online information tools, PhRMA is also seeking protection against erroneous, inaccurate, or misleading content about a company’s products. PhRMA is proposing that a biopharmaceutical manufacturer only be accountable for a website or other content that it controls (i.e., as the manufacturer or through it agents), for which it can add or delete content, or which is funded by the manufacturer or its agents.
PhRMA’s proposals are reasonable and are a good step forward to close a large gap in current federal regulation for online health information. Such standards would at least set a framework of regulation that would recognize the need to keep pace with the fast-changing development and adoption of newer media technologies and tools.
The adoption of these proposals or other standards, however, leads to an equally difficult issue: enforcement. How FDA, other federal agencies such as the Federal Trade Commission, search-engine companies, media companies, drug companies, and other stakeholders tackle the jurisdictional, administrative and operational tasks and responsibilities for effective enforcement, including ways to fund increased regulatory oversight, are additional challenges that will need to be addressed as FDA considers this issue.