Ennis & Ennis, P.A. Supports Petition to FDA to Revise Generic Drug Warning Label Regulations

Consumer Advocacy Group Calls for Accountability and Stricter Warning Label Regulations on Generic Drugs

Online PR News – 30-August-2011 – – Ennis & Ennis, P.A. strongly supports consumer advocacy group’s, Public Citizen, petition dated August 29, 2011 urging the U.S. Food and Drug Administration (FDA) to require manufacturers of generic drugs to promptly update warning labels when they learn of new side effects (http://www.citizen.org/documents/Citizen-Petition-8-26.pdf).

Currently, generic drug manufacturers are precluded from updating their warning labels unless they have FDA approval, or unless the brand name maker has updated the label first. Public Citizen argued that this outdated regulation only hurts consumers because generic drug sales have skyrocketed and their manufacturers have a wealth of information about issues related to effectiveness and safety. “Since generic makers are currently selling most of the products, the generic makers are hearing about issues regarding the side effects and effectiveness first,” said Allison Zieve, direct or Public Citizen’s Litigation Group. In fact, the group noted that 90% of prescriptions for drugs with generic equivalents were filled with generics rather than brand-name drugs.

“After the June ruling in PLIVA v. Mensing, where potential claimants are now precluded from filing claims against generic drug manufacturers for side effects suffered that are not listed on the warning label, it only make sense to require generic drug manufacturers to warn of side effects of which they have knowledge,” said Attorney David Ennis. Ennis further commented “There needs to be some accountability.”

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. Ennis & Ennis, P.A. specializes in mass torts and represents individuals against pharmaceutical companies worldwide as well as medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills.

Remember the law limits the time in which you can file a claim so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com.

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