The flurry of paper trailing down Capitol Hill to various folks working in and regulating the pharmaceutical industry continues. Recently members of both the House and the Senate have sent letters to manufacturers of treatments that have lately been in the news for reasons of efficacy and safety to question company practices with respect to marketing in general and direct-to-consumer advertising in particular.
On March 31, Senator Charles Grassley sent a letter to Merck and to Schering Plough regarding the timing of the release of the ENHANCE study this past week at the meeting of the American College of Cardiology (ACC). The study, as is well known by now, threw into question the efficacy of Vytorin. He is questioning why the companies waited so long to release the data while at the same time, marketing the combination drug aggressively with, among other methods, a very effective DTC campaign. He has also sent a letter to the ACC requesting information about contributions and financial support for the ACC from the two companies involved with the marketing of Vytorin.
On the House side of things, Congressmen Dingell and Stupak have written letters to Amgen and Johnson & Johnson seeking details regarding the marketing of ESAs. The letter to J&J seeks a great deal of detailed information regarding DTC campaigns both in print and on air.
This scrutiny of DTC probably provides some insight into another spoke of the great wheel of FDA reform that is going to roll through the election cycle. Watch closely the outcomes to discern what shape that might take.