FDA Official Explains the Prescription Drug Ad Regulatory Process

Posted on June 5, 2013

They’re so prevalent that they’ve become the target of numerous jokes that you might see on late night television:  prescription drug ads that feature a voice explaining the potential side effects of a drug as quickly as possible.  But while some might scoff about such promotional materials, it’s important to realize that warnings about drugs are essential to ensuring the safety of consumers.

That’s where the Food and Drug Administration’s Office of Prescription Drug Promotion comes in.  You have them to thank for the myriad warnings you see alongside any promotion of a prescription drug.  A recent interview finds the director of that office explaining the duties of the agency and explaining why such regulation is necessary for consumer safety.

Reviewers receive as much as 8,000 promotional materials every month from prescription drug companies.  When under review, members of the office are on the lookout for claims that can’t be backed up by scientific research or misleading statements that could downplay side effects and risks.

If an advertisement is deemed to be misleading in any way, the drug company could find itself on the receiving end of a warning letter from the FDA asking them to cease running the promotion in question.  Noncompliance could trigger legal action from the Justice Department.

For more information about the OPDP and its regulatory efforts in the age of social media, follow the link above.

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