US drugmakers say the introduction of a Food and Drug Administration internet logo would assure consumers that drug information provided on-line has been approved by the agency.
The proposal was made yesterday by the Pharmaceutical Research and Manufacturers of America (PhRMA), o
n the first morning of a two-day public hearing held by the FDA to gather ideas as to how it should regulate the promotion of drugs, devices and biologics using the internet and social media tools.
FDA needs to “facilitate the appropriate use of on-line media by America’s pharmaceutical r
esearch and biotechnology companies to provide FDA-regulated information on medicines,” given the unprecedented growth of the internet as a source of health information, said PhRMA senior vice president Ken Johnson, before the hearing began.
Currently, drugmakers are not among the big spend
ers on on-line advertising, with PricewaterhouseCoopers estimating that they accounted for just 4% of the $10.9 billion spent on such advertising in the first half of this year. Observers point out that agency regulation here is currently not clear, and the agency acknowledged, when announcing the h
earings, that it might be required to provide additional guidance in order to deal with emerging technologies.
PhRMA says it needs regulatory guidance that outlines clear standards to help patients access truthful, reliable information on the internet. It points out that, already, biopharmace
utical companies provide the only FDA-regulated promotional information about medicines on-line. and that, according to recent research, 61% of American adults now look online for health information, while 42% say they or someone they know has been helped by health information found on the internet.
It points out that not only the FDA but also the White House and the Centers for Disease Control and Prevention (CDC) are already using new media technologies such as blogs and Twitter to communicate important health information directly to patients and their doctors, and calls on the agency to “promote the responsible use of the internet to benefit patients by shining a brighter spotlight on legitimate, FDA-regulated health communication. One way the FDA could accomplish that aim would be to adopt a single, easily-recognisable logo to help guide patients and healthcare providers to FDA-regulated information about medical products, including manufacturer websites.”
Leveraging the FDA’s logo – or a universal FDA-approved graphic symbol – in search results and throughout the Web would inform patients, at a glance, that they are visiting a legitimate site that contains comprehensive FDA-regulated benefit and risk information, it says, and suggests that such a symbol could be combined with a universal warning statement to provide an indication of risk when there is little space (eg, a search result or tweet), it says.
Millions of Internet users are already accustomed to viewing pop-ups, mouse roll-over text, hyperlinks and other new media communication tools, and the FDA should follow the lead of the Federal Trade Commission (FTC) in recognizing the space limitations of certain formats and the flexibility of the internet in communicating warnings, the group recommends.
The agency should facilitate biopharma companies’ use of internet technologies that emphasise brevity such as blog entries and Twitter to communicate abbreviated benefit and risk information, provided there is easy access to longer, comprehensive warnings through a prominently labeled hyperlink, adds PhRMA. For example, it could help manufacturers combine brief “introductions” to a health topic with prominent and clearly marked links that would provide access to the prescription medicine’s full indication and comprehensive risk information; this could also be provided using roll-over or pop-up technology.
– 59 speakers were due to address the two days of hearings, including representatives of individual drugmakers such as Eli Lilly, Johnson & Johnson, Pfizer and Sanofi-Aventis.
