In July, we posted a blog about patients who suffered vision loss after receiving injections of the drug Avastin. The defective injections were being used to treat a condition for which Avastin was not designed. Avastin is a drug designed for cancer patients. That sort of situation is common in the medical field and is known as off-label use. Drug makers are now pushing for the FDA to reduce the restrictions placed on them regarding advertising these off-label uses.
Several members of the Pharmaceutical Manufacturers Association have filed suit to attempt to force the FDA to allow them to market their drugs for off-label uses. They claim that it is a violation of the First Amendment to restrict them to advertise the ways in which their product can be used. The FDA maintains those restrictions to differentiate treatments that have been tested and deemed safe and effective from those that have not. While off-label uses are supposed to be safe, they are not subjected to the same rigorous testing to ensure that they actually work.
The drug makers are concerned about the length of time it takes to do the proper research to prove a drug is effective. Formal FDA approval is a slow process. Their concern is naturally over the money they lose, and not on the safety of the patients being treated. These manufacturers have extensive resources and lobbyists on their side. Patient and safety advocacy groups are at a disadvantage when battling a drug company.
Attempting to limit the exposure of the public to potentially unsound off-label treatments is something the FDA should have the power to do. Until a drug is proven safe and effective in treating a specific condition, the FDA should have the right to restrict how drug companies market it.
Source: Today’s News-Herald, “FDA’s off-label rule under attack,” 10 November 2011