The Supreme Court has ruled that drug labeling laws normally applied to brand-name medications don’t extend to generic prescription drugs. Any newly observed side-effects or adverse reactions to generic prescription drugs do not have to be disclosed on the label.
Federal and state laws conflict
A Supreme Court case has resulted in a 5 to 4 ruling in favor of generic prescription drugmakers being exempt from certain laws governing drug labeling. The case Pliva v. Mensing resulted in the high court ruling that generic prescription drugmakers do not have to continually update drug labels in case of newly observed side effects or adverse drug reactions, according to the Los Angeles Times. Brand-name drugmakers must update drug warning labels whenever new side effects or adverse drug reactions occur. Justice Clarence Thomas wrote the decision for the majority, who held that because federal and state laws conflict on labeling laws and liability, generic drugmakers that following federal rules cannot be sued for violating state labeling laws. The Food and Drug Administration has to approve any and all label changes.
Generics make up bulk of prescriptions
Generic drugs, according to CNN, account for at least 70 percent of filled prescriptions every year. The court ruled in 2009 on a similar matter, according to Reuters, when it found that pharmaceutical companies can be held liable under state law in drug labeling suits, but the company in this case was using the same labels as the brand-name version of the drug involved. The drug in question was an acid reflux and heartburn medication called metoclopramide, which in brand-name form is Wyeth Pharmaceutical’s drug Reglan. Generic versions are made by the PLIVA pharmaceutical group and Avactis, among others. Two women took generic versions from PLIVA and Avactis and developed tardive dyskinesia, a motor-neuron disease that causes people to have involuntary muscle movements. Both plaintiffs sued the respective companies for not disclosing the side effect, which had been observed in other patients.
Laws treat companies differently
In essence, drug companies can be sued for improper or inadequate labeling in state courts in states that have “failure-to-warn” laws that mandate drug companies warn people about possible side effects. However, according to the San Francisco Chronicle, generic drug companies usually copy warning labels from brand-name drugs, a legal practice under FDA regulations. If a person had an adverse reaction to a drug, that specific generic drugmaker would have to change its label, which would conflict with FDA guidelines and federal law, as the brand-name maker would have to change the label as well. Both the majority and minority in the Supreme Court acknowledged that drug labeling laws and regulations do not treat generic and brand name drugs the same, but the majority found that complying with state and federal laws would have been impossible.
Los Angeles Times: http://www.latimes.com/health/sc-dc-0624-court-drugs-20110623,0,293021.story
San Francisco Chronicle: http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2011/06/22/bloomberg1376-LN8YCT6JIJUO01-59R62RVQMS1E3FDO745OOJ47GP.DTL
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