FDA takes action to speed safety information updates on generic drugs

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© KentWeakleyI was watching the Today Show last week and was SHOCKED by a story they aired regarding generic drugs. Generic drugmakers can’t be sued because, under current FDA rules, only name-brand drugmakers are responsible for safety warnings. So if you take a drug that was the generic brand and the label was misleading and inaccurate and you ended up getting sick and injured, too bad – you have no legal recourse…

BUT there may be hope that this will not always be the case…apparently there is a new FDA proposal which would change all of that. Recently the agency announced a proposed rule that would allow generic drugmakers to update labels with new information, just like brand manufacturers, and potentially open them up to liability. With more than 80 percent of the prescriptions in the U.S. filled with generic drugs, the FDA said it is important for generic manufacturers to be actively involved in making sure drug labels are up-to-date and accurate.

Currently, generic manufacturers must wait to update product safety information until the corresponding brand name product has received approval to update its safety information. Brand drug manufacturers are allowed to independently update and promptly distribute updated safety information by submitting a œchanges being effected (CBE-0) supplement to FDA. Generic manufacturers must notify the FDA of new safety information, and wait for the FDA and the brand manufacturer to determine the updated labeling, which may result in a delay in getting new information to health care professionals and patients.
Under current law, generic and brand drug manufacturers are required to promptly review safety information about their drugs and comply with the FDA’s reporting and recordkeeping requirements. When new information becomes available that causes the product labeling to be inaccurate, all drug manufacturers must take steps to update the labeling.

As would be expected, the Generic Pharmaceutical Association does not see the benefit of this proposed role. In fact, they think the change in rules would create unnecessary confusion and could drive up costs.

The proposed change will now go through a public comment period before it can be finalized. The FDA also announced that it plans to create a new web page where safety-related changes proposed by all manufacturers would be made available.
Of course, when your doctor writes you a prescription, be sure to ask about all the side effects. And when you pick it up from the pharmacy, find out if it’s the name brand or a generic.

 

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