- Last Friday, Bernie Sanders announced that he would oppose the nomination of Robert Califf, MD, as commissioner of the FDA.
- The Democratic presidential candidate and ardent pharma industry critic has ripped Califf for not being willing to push back against high drug prices.
- Dr. Califf, founder of the Duke Clinical Research Organization (DRCI), helped design and execute many clinical trials for medications and devices, with the explicit goal of determining whether they were safe and effective.
Ask anyone at the FDA about the agency's primary directive, and that person will speak to the goal of determining whether a drug is safe and effective--not determining whether it is too expensive. The DRCI is one organization that has helped the FDA accomplish its primary mission, and much of the research conducted there has been funded by pharmaceutical companies, In fact, the DRCI often found that drugs or devices they tested were either ineffective, unsafe or sometimes both, in which case the pharma company stopped the trials.
While the drug price issue is an important campaign issue for Sen. Sanders, as well as Democratic frontrunner Hlliary Clinton, the issue is not one that the FDA should be concerned about or has purview over. Rather, the agency should focus on its core mission and allow others to address the pricing issue.