FDA Should Not Approve Off Label Marketing By BigPharma

The FDA has issued a draft proposal which would permit BigPharma to market their drugs for off label use by physicians. The proposal would permit drug manufacturers to distribute peer reviewed scientific articles touting their products for uses for which the companies had never sought FDA approval or even been denied such approval.

Not that the companies don’t market off label anyway. Pfizer, for instance, paid enormous fines for marketing its drug Neurontin for a panoply of off label uses that proved to be ineffective if not outright dangerous. And BigPharma has long promoted the use of antidepressants by children even though no study has demonstrated that such drugs are either effective or safe for use by anyone but adults. In fact, the estimates are that more than 20% of all prescriptions are for uses not approved by the FDA and not indicated in the labeling the companies supply with their products.

Such a proposal can only lead to harm to consumers. As the New England Journal of Medicine recently uncovered, drug companies generally publish only the results of clinical trials which successfully show their products’ effectiveness while burying the results of trials that show otherwise. The plain fact is that if a product is safe and effective for a particular use, the FDA will approve such a use. That is the agency’s very purpose. And if approval is not sought or even withheld, one can surmise a good reason exists for that state of affairs and the company should not be allowed to bypass the approval process through off label marketing.

Alan Milstein