Marc Rodwin, Edmond J. Safra Lab Fellow and Professor of Law at Suffolk University Law School, presented his research at the Lab seminar on December 7. His presentation, “Reforming Pharmaceutical Policy and the Pharmaceutical Industry: Some Modest Proposals,” outlined some of the major issues within the pharmaceutical industry, and suggested some possible reforms.
In their discussion, seminar participants particularly focused on three areas of potential reform: pharma funding and control of clinical trials used in new drug applications to the FDA; lack of information and funding for post-marketing drug evaluation; and off-label drug use.
In reference to the pharmaceutical industry’s control and funding of clinical trials, Rodwin suggested that reform options could include revising regulations to require that phase 3 clinical trials used to support new drug applications be designed and conducted by an independent entity. The drug firms would pay for the trial but not be able to determine the design or researchers. Some seminar participants noted that, historically, academic physicians tended to be the ones who designed and implemented such independent trials, and wondered whether there might be a way to “re-empower” them to take on that role once again, though such a course may be complicated by the number of academics who also have financial ties to pharmaceutical companies.
Rodwin also noted the importance of continued evaluation of drugs even after they are marketed, since it is only at that point that some risks become apparent. Unfortunately, there is little information or funding for post-marketing drug evaluation. While drug companies will often purchase data, including specific information about the doctors who prescribe their drugs, and the patients they prescribe them to, that information is not widely available. To address this issue, Rodwin proposed that drug firms be required to share with government agencies any data that they possess or purchase on drug uses. Some participants pointed out that many physicians underreport side effects, and wondered whether there might be ways to incentivize reporting in order to improve the data on drugs after they’ve gone on the market.
Participants also debated the issue of off-label prescriptions. While drug firms are not allowed to promote off-label uses, physicians are allowed to prescribe medications for any use. As Rodwin pointed out, drug firms have incentives to encourage off-label use, as they earn income regardless of why a physician chooses to prescribe a particular medication. In response, participants pointed out that off-label use is not always a bad thing, as there are some off-label uses that have been found to be quite effective. As a possible reform option, Rodwin proposed that drug firms be reimbursed for off-label sales only at the marginal cost of pill production rather than the usual sale price. The difference would then be used to pay for testing of drugs for off- label uses by independent researchers.