By: Attorney William Hawal
The U.S. Food and Drug Administration (the FDA) is finally initiating a long-needed change to its regulations which would place the same safety protections on generic drugs as currently exist for their brand-name counterparts. For many years the FDA has required the pharmaceutical industry to add label warnings and precautions as soon as the drug manufacturers became aware of new risks or side effects. This information is so important to consumers that medical proof establishing that the drug caused the side-effect isn’t even necessary to initiate a labeling change.Also, FDA approval of these new or expanded warnings is not required before taking action to add the new warnings.
However, in June 2011, the U.S. Supreme Court held in a case called Mensing v. Pliva that the manufacturers of generic drugs could not be held accountable to patients for failing to similarly update their drug labels.
Given the fact that approximately 80% of patients take generic versions of prescription drugs, some members of Congress, members of the medical community, and consumer groups have been urging the FDA to correct this inconsistent treatment created by the Mensing decision. On November 13, 2013, the FDA submitted a proposed change to its drug labeling regulations which would, if adopted, permit generic drug manufacturers to initiate labeling changes (regardless of the labeling on their brand-name equivalents) to warn prescribing doctors and patients of new drug safety risks.
Permitting generic drug manufacturers to include these important side-effect warnings is very important to ensure the safety of those who take generic medications. The FDA will be accepting comments from the public regarding this proposed regulatory change for a period of 60 days. Hopefully, the regulation will become effective after the comment period is over. Those who wish to submit a comment may do so at: www.regulations.gov.
