The study reported that while most physicians favoured the FDA's drug approval process, which recently has been expedited to bring new drugs quickly into the market, they also mentioned that off label promotions could make clinical decisions worse.

Kesselheim AS, et al. - About one-third of new drugs are approved by the Food and Drug Administration (FDA) on the basis of a single randomized trial and they often rely on results from nonrandomized studies as well, so researchers surveyed a national sample of primary care internists, endocrinologists, and cardiologists to characterize physicians’ attitudes on FDA approval standards.

Investigators created and pretested a novel 25-question survey evaluating viewpoints about off-label drug promotion, FDA approval standards, and relationships between drug evaluation and pricing.

1. While a majority of physicians viewed the FDA’s drug approval regulations favorably, most (78%) preferred that drugs be tested in two prospective randomized trials.
2. More physicians thought that off-label promotion would make clinical decisions worse (42%) vs rather than better (30%).
3. According to findings, over half of surveyed physicians felt that manufacturers do not need to charge less for drugs used off-label; 70% supported comparable pricing, whether FDA approval was based on surrogate or patient results.

The views of practitioners should inform evolving FDA policies on standards for drug approval and off-label promotion.