FDA Labeling Rules Keep Doctors in the Dark
By Peter J. Pitts
Should the federal government punish companies for telling the truth?
Of course not. But the Food and Drug Administration does it all the time. Consider a recent federal court case involving Amarin, a biopharmaceutical company in New Jersey.
The company hoped to market its fish-oil pill as a way to lower blood fat levels -- a use that is not approved by the FDA. Predictably, the agency objected. But a federal court just ruled that distributing "truthful and non-misleading" information about a product isn't illegal. After all, don't we want pharmaceutical companies to tell the truth about their drugs?
To its credit, the FDA is letting Amarin slide by not contesting the ruling. Federal regulators should side with the truth more often. Suppressing accurate, objective information about prescription drugs is no way to protect patients.
Amarin is defending what's known as off-label drug usage, or the application of an existing drug for a condition not found on the medication's label. The FDA does its best to ensure that such additional uses aren't included in drug marketing materials.
For instance, the agency strictly forbids "misbranding" of drugs, which includes labeling a drug with an off-label use.
At first glance, this appears reasonable. That is, until you consider that doctors prescribe drugs off-label all of the time.
The practice is hardly cause for alarm. In some cases, doctors will recommend off-label usage once they've exhausted all approved treatment options. This can be a valuable last resort for critically ill patients. But the more common reason doctors prescribe off-label is to treat conditions for which approved drugs are either limited or don't exist at all.
For instance, doctors have found that the drug methotrexate, which is approved to treat cancer and arthritis, offers relief to those with Crohn's disease.
Securing FDA approval for these additional uses can be a costly process requiring months of additional trials. So drug companies rarely go to the trouble.
But as effective as off-label prescribing practices can be, a lack of information often leaves doctors grappling in the dark to find the best treatment for a given illness.
This knowledge gap is easy to bridge. Pharmaceutical companies, for instance, continue to collect reams of data about their drugs long after clinical trials have concluded. Other information can be gleaned from insurance claims, patient registries, and electronic medical records.
These kinds of data could make it far easier for doctors to determine whether an off-label prescription is appropriate and, if so, which one.
Unfortunately, the FDA's strict labeling requirements prevent such information from appearing on a drug's label. The agency can address this flaw by relaxing its labeling rules while enforcing several basic principles to ensure that any labeling information is clear and accurate.
For one, companies should be required to provide ample context for any information not found in the FDA-approved label.
Labeling information should also be tailored to the unique needs of various healthcare providers. Depending on a doctor's specialty, he or she may require different amounts of background material on a given medicine in order to make an educated decision.
Drug companies have information that could drastically improve the health of millions. The FDA should stop trying so hard to keep doctors in the dark.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
