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Should generic drug labels include off-label uses?

Written by Diane Archer

A new bipartisan Senate bill would allow generic drug labels to include off-label uses, Nicholas Florko reports for StatNews. With an FDA finding of sufficient evidence, the bill empowers generic drugmakers to market drugs for particular conditions even though those drugs have not been scientifically proven to treat those particular conditions. It is hard to believe this helps anyone other than the drugmakers.

Senators Orrin Hatch (R-UT) and Michael Bennett (D-CO) introduced the legislation that would lift marketing restrictions on generic pharmaceutical companies. Today, generic drug companies need approval from the FDA to change a drug’s label. Only then can they market a drug as a treatment for a new condition or a new drug dose. And, that takes time and money.

Generic drug companies also do not have the right to set in place the process for marketing a drug for off-label use–a different treatment or a different dosage from what was originally intended. Brand-name drug companies only have that right. But, if the brand-name product is pulled from the market, the brand-name drug company that had promoted the drug for a particular use has no incentive to promote the drug for another use. So, the drug labels rarely change.

The Hatch-Bennett bill would give the FDA authority to review data on generic drugs for off-label use when there is no brand-name competitor. If the FDA finds that there is enough evidence for it to be sold for those uses, the FDA can require a label change. But, the bill is silent as to what evidence would constitute sufficient evidence to require a label change on the generic drug.

This bill appears to give a lot of power to the FDA and the generic drug makers without adequately protecting individuals. No clinical trials showing the clinical benefits of the off-label use of the drug are required to determine safety issues.  And, doctors can already prescribe drugs for whatever use they please. A label change is not required for doctors to prescribe a drug for off-label use.

The label change simply expands the drug companies’ ability to market a drug for a new use. Who is really benefiting here?

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