Off-Label Drug Promotion, the First Amendment and FDA

Off-Label Drug Promotion, the First Amendment and FDA

Ever wondered that speaking the truth can violate the law? Yet, this is the stand of Food and Drug Administration, commonly known as FDA, which states that when it approves a drug, its other uses are banned to be promoted by the manufacturer even if those statements are the truth. FDA’s authority to regulate off-label promotional speech has been called into question through the case of United States vs Caronia.

What is Off-Label Promotion?

Off-label promotion means when a company wishes to promote a drug or medical device for a use which is not yet approved by the FDA. Drug manufacturers in order to increase sale, push doctors to prescribe the medicine for some off-label uses which have been clinically tested and proven. Conflict arises between government power and safeguards provided by First Amendment due to FDA’S regulation.

FDA and the First Amendment

People must be able to speak what they wish to and raise their voice is rightly recognized by the first amendment. Although doctors can prescribe off-label uses of any drug as they are not answerable to FDA directly but, what is good for health may not be constitutional. FDA rather than suppressing promotional speech can directly regulate off-label uses if it wishes to restrict them in some way. The question arises, if it is safe and clinically tested to use the drug for purposes other than prescribed, why then the FDA restrict them to be known to general public. The answer remains equivocal even after cases like Central Hudson v. Pub.Serv.Comm’n of N.Y and Sorrell v. IMS Health Inc.

FDA’S Defence

The FDA states that the companies cannot be prosecuted simply for discussing their drug’s off-label use instead they can be for the sale of same. Truthful and non-misleading information about the off-label use is protected by the First Amendment.

Statements made by one who seeks to generate sales and earn maximum profit through the health of general public must not go public before going through proper scrutiny of the appropriate authority.

Originally posted 2017-11-07 20:23:34.


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