This week, U.S. PIRG joined several pro-patient, pro-safe, pro low-cost drug organizations -- the Prescription Project and the Prescription Access Litigation LLC coalition (both out of Community Catalyst) and the National Physicians Alliance -- in detailed comments opposing a wrong-headed FDA proposal that would allow greater dissemination to doctors of "truthful" but not "misleading" medical journal articles promoting off-label uses for drugs. From our submission:

This Draft Guidance lowers the threshold for the promotion of off-label uses through the distribution of published studies, thereby reducing industry incentive to conduct more conclusive trials.

Currently, FDA approval is a major incentive for companies to test and evaluate their products. Once a medication is approved for any use, drug companies have incentive to study that product for use in additional indications.

Creating a pathway to more off-label marketing reduces the incentive to obtain FDA approval for new indications.

Under the Draft Guidance, a company would be able to disseminate a trial that finds positive data for any unapproved use, thus reducing the incentive to conduct more detailed research that might contradict the initial finding...In conclusion, the Prescription Project and other organizations listed above urge the FDA
not to issue the Draft Guidance in its current form, which would encourage the pharmaceutical industry to expand marketing practices which have been found to be illegal by government fraud investigations and successful litigation by government and consumers. We urge the FDA to hold public hearings to consider under what circumstances, if any, the industry should be allowed to market products for off-label indications.