FDA Proposed Rule Could Provide Better Drug Safety for Americans

By Peter DePaolis

The American Association of Justice (AAJ) is in support of the US Food and Drug Administration’s (FDA) proposed rule to allow generic drug manufacturers to independently update their warning labels.

The US Supreme Court ruled in Pliva v. Mensing that generic drug manufacturers cannot independently update their warning labels, even when new side-effects are known. This ruling created two systems: one for patients who use name-brand drugs and one for patients who use the generic. As a result, thousands of Americans have had their court cases dismissed merely because they took the generic instead of the brand name drug.

The FDA’s new rulemaking would allow generic drug manufacturers to update their warning labels using the same process that brand name drug companies currently use.

“The FDA’s proposed rule will significantly increase prescription drug safety for American consumers and patients,” stated AAJ President Burton LeBlanc. “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.”

In November 2013, the FDA proposed rulemaking to allow generic drug manufacturers to independently update their warning labels when new side effects are known. Since then, over 20,500 consumers have called on the FDA to enact this rule through an online petition, which we encourage you to sign here.

Harmed by a Generic Drug? Let Our Injury Lawyers Help You Today!

Drug manufacturers must exercise reasonable care in the labeling, manufacturing conditions and dissemination of vital information to medical doctors and pharmacists concerning the risks of their products, whether the drug is generic or not.

If you or a loved one developed a serious injury or condition after taking a pharmaceutical drug, contact our experienced lawyers today. For 30 years we have successfully obtained substantial monetary compensation on behalf of our clients.

Sponsored by William P. Lightfoot.

Koonz’s Did You Know: Currently, over 80 percent of all prescriptions in the US are filled with the generic version of the drug.

Koonz, McKenney, Johnson & DePaolis L.L.P.

Maryland, Washington, D.C. and Virginia Injury Attorneys

Source: http://www.justice.org/cps/rde/xchg/justice/hs.xsl/23016.htm#ContentTop

About the Author
Peter DePaolis joined the firm in 1980 and has since represented a large number of individuals involved in automobile collisions, truck accidents, bus crashes, defective products, and medical malpractice cases. A significant portion of Mr. DePaolis’ practice is devoted to working on behalf of people suffering from asbestosis, mesothelioma, and other asbestos-related cancers. He has led his firm’s fight against the asbestos industry and has recovered over $30 million in damages for asbestos victims and their families.