Prohibition against off-label drug promotion challenged

Prohibition against off-label drug promotion challenged.

Off-Label Drug Information

drug into interstate commerce unless the FDA has approved the drug and its label.2 A second provision prohibits manufacturers from introducing misbrandeddrugs into interstate commerce.2 Misbranding is considered to occur if drug labeling contains information that describes unapproved uses or is misleading or insufficient to support safe use for approved indications.2 Materials are considered pa...

Do Off-Label Drug Practices Argue Against FDA Efficacy

The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug's efficacy. The act requires efficacy certification for the drug's initial (" on-label ") uses, but does not require certification before physicians may prescribe for subsequent (" off-label ") uses. Are there good reasons for this inconsistency? Using a sequential online surve...

Off-Label Promotion, On-Target Sales

For prescription drugs, demonstrated benefits define the parameters of acceptable risks. For example, liver toxicity may be acceptable in a drug approved for cancer, but unacceptable in a drug approved for acne. Government regulatory bodies review laboratory, animal, and human data to confirm that a drug has the claimed efficacy and safety prior to approving its release in the market for specif...

Off-label drug promotion and the ephemeral line between marketing and education

Fueled by massive settlements and concerns about pharmaceutical company influence over medical practice, the fight over off-label promotion has become a rancorous one with little middle ground. For some, off-label restrictions are both bad law and bad medicine, violating the First Amendment while denying physicians access to crucial information. For others, the battle pits the very soul of the ...