Drug Safety - Institute of Medicine Issues Report on "The Future of Drug Safety"

Drug safety was thrust into the media spotlight two years ago with the removal of Vioxx (rofecoxib) from the pharmaceutical market. Patients who were taking the arthritis medication were left feeling unsure about what they should take in place of Vioxx and about drug safety in general. A new report from the Institute of Medicine (IOM), called The Future of Drug Safety: Promoting and Protecting the Health of the Public, outlines suggestions to ensure drug safety and makes recommendations for improving the authority of the FDA (U.S. Food and Drug Administration) .

The report points to an imbalance in regulatory attention and resources available between pre-drug approval and post-drug approval. Well-defined regulatory authority diminishes after a drug is marketed. The IOM report suggests:

• More attention be given to a drug after it is marketed
• New medications should have a designation on their label for two years after being marketed to indicate not all is known about risks and benefits of a drug
• Five years after a drug is marketed, the FDA should conduct a formal review of information regarding risks and benefits
• A possible moratorium on direct-to-consumer advertising during the initial two year period

Other suggestions were to help the FDA improve on:

• The lack of clear authority
• Underfunding
• Organizational problems

It is a huge misconception that once a drug is FDA-approved it carries a guarantee about safety. Not the case. If time were taken to work out all uncertainties, it would delay getting new drugs to patients who need them.

Related Resources:

• More About Arthritis Medications
• Arthritis Drugs: What Are My Options?
• Test Your Knowledge: Arthritis Medications
• Prescription Drug Information Package Inserts Get New Design

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