Amanda’s Absence by Dan Johnson

“Members of the Committee, we appreciate this opportunity to discuss drug safety and the worldwide withdrawal by Merck & Co. of Vioxx. Modern drugs provide significant health benefits. We believe FDA maintains the highest worldwide standards for drug approval.

All drugs pose some level of risk. Unless a new drug’s demonstrated benefits outweigh its known risks for the intended population, FDA will not approve the drug. FDA only grants approval once a sponsor demonstrates through clinical trials that a drug is safe and effective. However, our experience has shown we cannot anticipate all adverse effects of a drug before approval, because not every adverse drug reaction occurs during pre-approval trials.

Occasionally, serious adverse effects are identified after approval, in post-marketing clinical trials or through spontaneous reporting of adverse events. Adverse effects also result from errors in drug prescribing, dispensing or use. FDA has a strong post-market drug safety program designed to uncover adverse events that happen after initial approval. Drug safety staff evaluate and respond to adverse events identified by ongoing clinical trials, or as reported by physicians or patients. Our recent actions concerning the drug Vioxx illustrate the importance of continuing to assess the safety of a product once it is in widespread use.

Detecting and limiting adverse reactions can be challenging. How do we weigh the impact of adverse drug reactions against the benefits of a product to individual patients and the public health? The question is multifaceted and complex, involving scientific as well as public policy issues.”

*Based on the original testimony, which has been modifed for the purposes of this case study.