ClickCease FDA's New Proposed Rule Would Change Label Rules
03/28/14   |   By

In Wake of Pilva V. Mensing, an Uproar: FDA’s New Proposed Rule Would Let Generic Drug Makers Update Their Warning Labels |

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In 2012, the U.S. Supreme Court ruled in the case of Pilva, Inc. v. Mensing that the makers of generic pharmaceuticals cannot update their warning labels independently. This proscription holds, even when new, dangerous side effects of a medication are found. Drug makers cannot add those dangers to their labels by themselves.

Pilva v. Mensing was an interesting, subtle case, but critics argue that the SCOTUS ruling created a loophole that put thousands of Americans at risk and unfairly limited their legal recourse. They say it created a de facto “two tiered” system — one set of rules for updating warning labels on brand drugs and another set of rules for updating labels on generics. This system needlessly confuses people and lacks accountability.

Consider this fact: 80% of prescriptions filled in the United States are generic. That’s four out of every five prescriptions filled. Since Pilva, thousands of people hurt by side effects of generic drugs have been unable to have their day at court.

Recognizing this insanity, in November 2013, the FDA proposed a new rule to let generic drug makers revise warning labels when new side effects are discovered. This amendment to the process would effective end the annoying and unfair de facto “two tiered” system.

The American Association for Justice (AAJ) supports the FDA’s proposed guidelines. AAJ president, Burton LeBlanc, noted that “the proposed rule takes account of both the need for accurate warnings and the need for the sameness and proposes regulatory changes that will [further] both of those goals… [It] will make consumer safety information work accessible and available sooner… In addition, the proposed rule will ensure that generic pharmaceutical manufacturers are responsible, if they fail to warn the public of a known safety hazard associated with their products.”

Consumer advocates want the FDA to push this rule through, ASAP, and they’ve created an online petition to get the FDA to act. This petition already has over 20,500 signatures.

The proposed rule changes would constitute a good start towards cleaning up the regulatory environment and making systems less complex for consumers and doctors. However, tons of work still needs to be done. Regulatory authorities are often shamefully slow to react the dangerous, careless, and negligent behavior of drug makers and pharmaceutical companies. Their sluggishness can leave injured consumers confused, overwhelmed, and sick — forcing them to engage in lengthy, fractious, expensive legal processes to get justice.

If you or someone you love was hurt by a generic pharmaceutical drug, the Washington D.C. personal injury lawyers at Regan Zambri & Long would be happy to provide a free and confidential consultation about your case. Call us now at (202) 463-3030 for much needed strategic insight.

Regan Zambri Long
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