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Drug Companies Set to Fight New FDA Regulations on Generic Drugs

Update Date: Feb 18, 2014 10:37 AM EST
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The United States Food and Drug Administration's (FDA) latest regulations for generic drugs will mandate drug-manufacturing companies to inform consumers of every single known health risk involved with every drug product that they sell. The drug companies are planning on fighting these newly proposed rules stating that they "would be nothing short of catastrophic" and would only "create dangerous confusion."

The new regulations were devised as way to close up the legal loophole created by the Supreme Court. The loophole involves brand-name and generic drugs. Back in 2009, the Supreme Court ruled that drug-manufacturing companies that produce brand-name drugs could be sued if they failed to inform their customers of all the risks involved with taking the particular drug. However, this ruling did not extend to generic drugs, which are lower-priced versions of the brand-name drugs.

Generic drugs are typically made with the same kind of active ingredient, strength and dosage form as the brand-name drugs. These drugs must also have the same route of administration but are not required to contain all of the inactive ingredients found in the brand-name versions. At this time, the court ruled that drug companies that produce generic versions are protected from lawsuits because these companies are not allowed to revise or update their warning labels. Since generic drugs can have the same exact side effects as brand-name drugs, the FDA sought to amend this loophole.

This past November, the FDA proposed new regulations that would require generic drug makers to alter their warning labels when new issues regarding the drug are brought to light. The new regulations would also make generic drug companies liable for any uninformed side effects that consumers might experience.

"In the current marketplace, approximately 80% of drugs dispensed are generic drugs," the agency said according to the Los Angeles Times. "Accordingly, there is a need for [generic drug producers] to able to independently update product labeling to reflect certain newly acquired safety information...[these companies have an] independent responsibility to ensure its product labeling is accurate and up-to-date."

The president of the Generic Pharmaceutical Association, which is an industry trade group, Ralph G. Neas stated that his group would fight these new regulations.

"Our aim is to get the facts out there," Neas said. "This will go for some time. I don't believe this [proposed] rule benefits anyone in the healthcare system."

The FDA is waiting until March before completing the work involved with this proposal. The agency plans on responding to the complaints from these drug-manufacturing companies.

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