Regulate or self-regulate?

The New York Times last week highlighted a proposed bill which would require pharma and device companies “to report publicly nearly all payments and gifts to doctors under legislation introduced Thursday in the Senate.”  Reports indicate that this federal bill is more comprehensive than other related bills that have passed in different states including Minnesota and Vermont.

“Companies with at least $100 million in annual revenues would have to make quarterly disclosures of gifts or payments that exceed $25, and the reports would be posted on a Web site. Companies failing to make the disclosures — and many have not complied with the laws in Minnesota and Vermont — would be fined at least $10,000 per infraction.”

Some of the areas which companies would need to be report include free meals, consulting payments, financing for continuing medical education (CME).  According to the Accreditation Council for CME,  CME revenues represented $2.4B in 2006. Almost half or $1.2B was from commercial support.  This amount pales in comparison to other pharma promotional activities to physicians which are excluded from this bill such as free drug samples which represents $18.4B and financing for clinical trials.

At the same time, some of the largest pharma companies are voluntarily providing greater transparency of their CME and grant making activities as described in Medical Marketing & Media.  These companies say that “openness is needed to counter misperceptions that CME funding is a tool for promotion.” Eli Lilly was one of the early leaders in the industry in opening its CME registry earlier this year “which disclosed $11.8 million in grants given to 495 organizations during the first three months of the year. The firm pledged to update data on a quarterly basis.” Other organizations including Pfizer, Wyeth, Novartis, and Shire have said that they intend to go public too. 

Self-regulation seems much more appropriate than federal regulation.  It is reminiscent of the PhRMA DTC guidelines which represented $4B in 2005.  However self-regulation sometimes may only occur based upon the threat of regulation.

September 14, 2007

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