The Food and Drug Administration wants to regulate Internet search.
At the least, searches that are mediated by regulated medical companies, and tie disease keywords to specific, regulated medical products.
The issue has come to the fore in a warning letter that FDA recently sent to Medical Doctors Research (MDR), a Florida-based researcher and manufacturer of nutritional supplements.
In the January 29th letter, FDA alleges a number of problems with MDR’s manufacturing and promotional activities. But the one that’s catching attention is the FDA’s beef with MDR’s website.
These issues were first spotted in an excellent article by Alex Gaffney of Regulatory Focus, a must-read publication for the drug regulation crowd. (You can follow Gaffney on Twitter: @AlecGaffney)
FDA says that MDR’swebsite has search capabilities on its web site that allow users to search for a particular terms. The results of these keywords, it said, bring up specific products associated with the search entries, including disease terms.
“Typing the key word ‘cancer’ or ‘diabetes’ into MDR’s product search field located on its website” brings up a number of products, FDA observed. Because those products are associated with that particular search term, the company is thus “implying that its products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases,” FDA said.
As Gaffney notes, enforcement of keyword association could prove difficult for FDA. Unlike visible words, metadata sits in the source code and HTML of a page, and is largely invisible to the untrained eye. Other associations, such as those hard-coded into a search engine (as opposed to a static link), may be difficult to find without spending a considerable amount of time on a page. “Still, the warning letter indicates that regulatory officials are intent on targeting those associations when they’re able to be found,” he says.
Deloitte has executed a Global Health Care Professional(HCP) Transparency Study to provide insights into countries’ current and anticipated regulatory requirements for tracking payments and transfers of value that life sciences companies make to health care professionals and organizations (HCP/O).
While U.S. pharmaceutical manufacturers have been dealing with the federal Sunshine Act and state-level transparency laws for some time, new and pending legislation such as France’s disclosure law, Loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé, which was passed in December 2011 and the European Federation of Pharmaceutical Industries and Associations’ (EFPHA) draft Code on Disclosure of Transfers of Value from Pharmaceutical Companies to HCP and HCO, which is scheduled to go into effect in 2014, are the latest in a series of transparency related legislation and industry codes being instituted around the globe (Figure 1 in attached PDF). In fact, we estimate that over 70 percent of pharmaceutical sales will occur in countries which have HCP Transparency regulations in place by 2015.
Study finds that 'Big Pharma' fails at self-policing ED drug advertising
The pharmaceutical industry's efforts to self-regulate its direct-to-consumer (DTC) advertising are "an industry-sponsored ruse," intended to deflect criticism and collectively block new Federal regulation, a study released today in the Journal of Health Politics, Policy and Law found.
The paper, "The Politics and Strategy of Industry Self-Regulation: The Pharmaceutical Industry's Principles for Ethical Direct-to-Consumer Advertising as a Deceptive Blocking Strategy," was written by Denis Arnold, Associate Professor of Management and Surtman Distinguished Scholar in Business Ethics in the Belk College of Business at UNC Charlotte, with Jim Oakley, Associate Professor of Marketing at Montana State University.
Arnold and Oakley studied the marketing campaigns for erectile dysfunction (ED) drugs over a four-year period, 2006 to 2010. These products include sildenafil citrate, manufactured and marketed as Viagra in the U.S. by Pfizer; tadalafil, manufactured and marketed as Cialis in the U.S. by Eli Lilly; and vardenafil HCI, manufactured by Bayer Healthcare and jointly marketed as Levitra in the U.S. by Bayer Healthcare, GlaxoSmithKline and Merck.
All of these companies have certified compliance with the "PhRMA Guiding Principles," developed by the Pharmaceutical Research and Manufacturers of America trade organization and first introduced in 2005. Under these guidelines, a company must commit to internal processes to ensure compliance with the principles, complete an annual certification of compliance, and submit a document to PhRMA signed by the CEO and chief compliance officer attesting to compliance.
"The Guiding Principles were introduced, as least in part, to preclude the need for additional federal regulation of broadcast drug advertising," Arnold said. "In this regard they have been largely successful."
Arnold and Oakley's analysis found that rather than a serious effort to facilitate the education of consumers, the Guiding Principles were often ignored, putting consumers at possible risk and exposing children to inappropriate content.
"Cumulatively, our data shows that ED marketing campaigns fail to responsibly educate consumers about health conditions and appropriate treatments," Arnold said. "Instead of facilitating a balancing of interests between company profits and public health, the illusion of industry self-regulation is primarily serving the interest of pharmaceutical companies at the expense of the public's interest in genuine health education and welfare."