Free Consultation: 617.261.0040 Tap Here To Call Us

Articles Tagged with First Amendment

Does Constitution Prevent FDA from Regulating Off-Label Promotion?

November 23, 2010 | Greene LLP

First Amendment challenges to the FDA’s off-label promotion ban are hardly novel, however case law in this area remains relatively unsettled. Drug makers initially rejoiced with the ruling in Washington Legal Foundation, however the case was later vacated. Case law now appears to be more settled in the wake of Caronia.

First amendment contests are usually brought as either defenses to off-label prosecutions (as in Caronia) or by advocacy groups and drug companies seeking injunctive relief (Washington Legal Foundation). Continue reading ›

First Amendment Protection and Off-Label Promotion: What Drug Companies Can and Can’t Say

November 18, 2010 | Greene LLP

The First Amendment of the United States Constitution protects the freedom of speech. Not all forms of speech, however, receive total protection, such as yelling “fire” in a crowded theater if doing so is likely to cause injury. So-called “commercial speech” is a category of speech afforded partial, but not total, protection by the country’s courts. Regarding the First Amendment debate, the FDA faces a conflict: to balance the need for neutral and candid research within the medical community concerning off-label uses against the self interest of drug makers, who stand to profit if their drugs may be sold for more medical conditions. Continue reading ›