We recently reported that the FDA would update its laws concerning generic drugs in September 2015. September came and went with no word from federal authorities. Our team of drug injury lawyers confirms that the final rule date has been pushed to July 2016.
The ruling will decide whether or not generic drug manufacturers will be allowed to update safety labels without prior FDA approval. Currently only brand-name manufacturers are allowed to change drug labels at any time, without FDA approval, to reflect new or emerging safety risks.
This is the second time the FDA has delayed its ruling, partly due to major pushback from Big Pharma and certain members of Congress. The controversial rule change was put into effect by a U.S. Supreme Court Decision, PLIVA v. Mensing, which we have written extensively about on this blog (here and here). In sum, the Court decided generic drug companies could not be held liable (that is, open to injury lawsuits) for failing to include new safety information on labels because companies could not do so on their own.
Currently, generic drug makers are required by law to mimic brand-name equivalents exactly, from the formulations to the labeling. Generic companies are not allowed to make any changes to labels unless granted express permission by the FDA. Of course, this leaves little incentive for drug makers to make any changes whatsoever, even if safety risks are clear and present. Only brand name companies are allowed to make label changes independently.
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That 2011 decision created an immense debate over how generics are regulated in our country. More than eight in ten (88%) prescriptions filled are for generic drugs, and consumer groups say generic labels do not adequately warn about the true risks of drugs. Most consumers are completely unaware that their generic drugs may not be warning them of updated, emerging, or newly-discovered side effects of their medications.
Most consumers are also unaware that generic companies are not required to run tests to prove their drugs are actually equivalent to brand names. Millions of people are taking medications assuming they are safe and effective when in fact they are taking something they know very little about. New and very important safety information on drugs emerges almost every day from Actos causing bladder cancer to Viagra leading to melanoma and leaving 88% of Americans left in the dark is not right.
Many are concerned that the FDA will succumb to drug industry pressure. Trade groups for Big Pharma and generic companies have offered their own proposal for labeling changes, which are toothless at best. Drug companies propose the burden for label updates fall wholly on the FDA.
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The dangerous drug lawyers at Pintas & Mullins Law Firm will continue to update this blog on FDA decisions, debates and mass tort actions against Big Pharma. If you or someone you love was seriously injured by a drug, contact our firm for a free case review. We accept clients nationwide.