Reference no: EM133463329

We look at the Caronia case dealing with a court ruling on the constitutional limitations on off label promotional activities insofar as they pertain to factual statements. In particular, the Court held that commercial free speech protects truthful and not misleading statements made about off label promotional statements about a pharmaceutical product.

Doctors are regulated by state medical boards, not by the FDA, so medical professionals are free to prescribe to patients as they see in the best interest of the patient and based upon available scientific information. Clearly, medical professionals should not be restricted from making any potential treatments available to their patients that they believe will be effective and that the benefits will outweigh the risks.

Summarize the Caronia case.

1. What types of restrictions should be maintained on off-label promotions by pharmaceutical and medical device companies?

2. What are the benefits on having restrictions placed on pharmaceutical and medical device companies with regard to off-label promotion?