Congressional Statement On Vioxx And Drug Safety

BACKGROUND ON DRUG SAFETY

Modern drugs provide unmistakable and significant health benefits. It is well recognized that FDA's drug review is a gold standard.   Indeed, we believe that FDA maintains the highest worldwide standards for drug approval. FDA grants approval to drugs after a sponsor demonstrates that they are safe and effective.  Experience has shown that the full magnitude of some potential risks do not always emerge during the mandatory clinical trials conducted before approval to evaluate these products for safety and effectiveness. Occasionally, serious adverse effects are identified after approval either in post-marketing clinical trials or through spontaneous reporting of adverse events. 

That is why Congress has supported and FDA has created a strong post-market drug safety program designed to assess adverse events identified after approval for all of the medical products it regulates as a complement to the pre-market safety reviews required for approval of prescription drugs in the United States. 

Monitoring the drug safety of marketed products requires close collaboration between our clinical reviewers and drug safety staff to evaluate and respond to adverse events identified in ongoing clinical trials or reported to us by physicians and their patients.  The most recent actions concerning the drug Vioxx (rofecoxib) illustrates the vital importance of the ongoing assessment of the safety of a product once it is in widespread use.

It is important to understand that all approved drugs pose some level of risk, such as the risks that are identified in clinical trials and listed on the labeling of the product.  Unless a new drug's demonstrated benefit outweighs its known risk for an intended population, FDA will not approve the drug.  However, we cannot anticipate all possible effects of a drug during the clinical trials that precede approval.  An adverse drug reaction can range from a minor, unpleasant response to a drug product, to a response that is sometimes life-threatening or deadly.  

Such adverse drug reactions may be expected (because clinical trial results indicate such possibilities) or unexpected (because the reaction was not evident in clinical trials).   It may also result from errors in drug prescribing, dispensing or use.   The issue of how to detect and limit adverse reactions can be challenging; how to weigh the impact of these adverse drug reactions against the benefits of these products on individual patients and the public health is multifaceted and complex, involving scientific as well as public policy issues.

CONCLUSION

In summary, FDA worked actively and vigorously with Merck to inform public health professionals of what was known regarding CV risk with Vioxx, and to pursue further definitive investigations to better define and quantify this risk.   FDA also reviewed and remained current on new epidemiologic studies that appeared in the literature.   Indeed, the recent study findings disclosed by Merck, leading to its decision to voluntarily withdraw Vioxx from the marketplace, resulted from FDA's vigilance in requiring these long-term outcome trials to address our concerns.

Detecting, assessing, managing and communicating the risks and benefits of prescription and over-the-counter drugs is a highly complex and demanding task.   FDA is determined to meet this challenge by employing cutting-edge science, transparent policy, and sound decisions based on the advice of the best experts in and out of the agency.   We are confident that the additional activities discussed above will strengthen the agency's program to greater ensure the safety of medical products that make a major contribution to the health and quality of life of millions of Americans.   Medicines that receive FDA approval are among the safest in the world, and the measures we are taking are designed to strengthen this quality, as well as consumer confidence that FDA's processes ensure the highest protection of the public health.

Reference for Vioxx Article

U.S. Food and Drug Administration

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