FDA Post-Marketing Surveillance Funding

The US Food and Drug Administration has no system in place to dealuniformly with adverse event reporting and related matters, according to FDA Lead Deputy Commissioner Michael Friedman, and it needs a really efficient and effective agency-wide system. The public and Congress need to learn how immensely valuable this would be, he told a seminar organized by the Center for Drug Evaluation and Research.

During talks with pharmaceutical manufacturers about the Prescription Drug User Fee Act, the FDA had tried to secure funding for expanded post-marketing surveillance, but the companies were completely unsympathetic to the idea of their providing the funding. They thought PMS would be a good idea, but suggested that the FDA pay for it, he said.

FDA appropriations remain at 1992 levels under the initial PDUFA agreement, giving the agency a functional $30 million loss per year. Within that level budgetary authority is a constant erosion from inflation and salaries that rise; the FDA is very salary-intensive. It is about 10% smaller now than four or five years ago, and the trends are likely to continue. While its resources are decreasing, its responsibilities are growing, with more New Drug Applications and generic drug applications. It is not just that the numbers have increased, he noted, but some are much more complex and deal with new science and new sorts of mechanisms of action, toxicities and labeling claims. These are very challenging concerns, he said.