FDA Label Requirements Fail Consumers Harmed by Generic Defective Drugs

Generic Drug Manufacturers Should Have a Duty to Warn Consumers of New Safety Concerns

Generic drugs account for seventy-five percent of filled prescriptions. Buying generic saves money and, often, the drug is just as effective as its name brand counterpart.

However, a 2011 Supreme Court decision Pliva v. Mensing has resulted in a negative consequence for people taking generics. If you or someone you love is injured while taking a generic version of a brand name drug, Pliva v. Mensing could prevent you from holding the manufacturer accountable in the court system.

Before this ruling, the law was unclear about who was responsible for warning consumers about the dangers of defective drugs – the original brand manufacturer or the generic brand manufacturer. Because of this, the Firm was able to help people who were seriously injured while taking generic drugs. Not anymore. This ruling clarified the issue, but came down on the wrong side for consumers.

Because FDA regulations require that generic labels must mirror their brand name counterparts, the court ruled generic drug manufacturers can’t be held responsible when someone is seriously injured while taking a generic version of a defective drug.

Ensuring that generic drugs and their name brand counterparts have the same labels is a legitimate concern. However, no one ever considered what to do if those labels were outdated or if the company was not being completely straightforward about the drug’s actual side effects.

Because of the way the FDA regulations are written, generic drug manufactures are unable to revise their labels until the brand name labels are changed. Most often, name brand drug manufacturers don’t want to change their label since doing so could result in fewer people buying their drug. As a result, there is little motivation for brand manufacturers to voluntarily change a label. While those who take name brand drugs still have legal recourse for an inadequate label, this type of foot dragging by the brand manufacturer regarding label changes leaves those injured while on generics without a similar remedy.

Despite their decision, some of the supreme court justices involved in the Pliva v. Mensingdecision acknowledged that the current regulatory state is extremely unfair for users of generic drugs and urged consumers to impress upon Congress the need for a change.

Thankfully, Congress is taking steps to safeguard consumers taking generic drugs. On April 18, Senator Patrick Leahy (D-VT) and six co-sponsors introduced the “Patient Safety & Generic Labeling Improvement Act of 2012”.  A companion bill, the “Patient Safety and Drug Labeling Act,” was introduced in the U.S. House of Representatives by Reps. Bruce Braley (D-IA) and Chris Van Hollen (D-MD). In addition, Leahy joined Senators Tom Harkin and Al Franken in writing a letter to Dr. Margaret Hamburg of the FDA urging them to amend the label requirements to better protect consumers.

I applaud the Senators for their efforts and hope the FDA will take steps to ensure that all drug makers, including generics, have the ability to take appropriate steps to provide updated warnings to doctors and consumers. Doing this will restore the original intent of the FDA label requirements to keep consumers safe. It will also allow thousands of people harmed by defective drugs, through no fault of their own, to hold those responsible for their injuries accountable.

Simmons Support Team
Simmons Hanly ConroyWritten by:

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