New U.S. Food and Drug Administration (FDA) guidelines for oversight of "off-label" drug use — still in draft form and unfinalized — could allow pharmaceutical companies to market more drugs for unapproved uses. The proposed guidelines are a step in the wrong direction according to Dr. Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center. His concern for patient safety was articulated in a recent edition of the New England Journal of Medicine.
While the FDA approves drugs for specific purposes, doctors can use drugs off-label to treat medical conditions that aren’t included in the FDA approval. This is common practice, but what’s known about the use of a drug for one condition may not apply to other situations — the use of antipsychotics for treatment of dementia is one example.
Although Stafford doesn’t criticize the off-label use of medication, he does believe that relying on off-label prescriptions as first-line therapy — which is increasingly occurring — is potentially unsafe for many patients.
Currently, drug makers can’t heavily promote drugs for off-label uses, but they can give doctors educational materials about off-label use of a drug. Generally they do this by circulating published journal articles related to off-label uses. This practice is permitted only if the drug maker submits the articles to FDA for review and is seeking formal FDA approval for the new use. FDA enforcement of these rules is limited, however, according to Dr. Stafford.
The new draft guidelines eliminate both of these requirements and replace remaining polices with only non-binding recommendations.
Public comments on the FDA’s draft guidelines are being accepted through April 21, 2008. Those comments may be submitted by anyone via the Regulations.gov website, using Docket No. FDA-2008-D-0053 in the "Search" window.
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- A study indicating that 80% of hospitalized kids receive medication approved only for adults
- Pharmaceutical residue found in many public drinking water supplies
- Dangerous dietary supplements that promote prostate cancer
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