The recent ruling by an American Court of Appeal risks "being the first step in the judicial dismantling of the US pharmaceutical regulatory system": three Harvard experts have signed an article in which they express deep concern about the consequences of the decision to allow the promotion off-label medicines by companies
The recent ruling by an American Court of Appeal risks "being the first step in the judicial dismantling of the US pharmaceutical regulatory system": three Harvard experts have signed an article in the Jama journal of the American medical association in which they express deep concern for the consequences of the decision to allow - in the name of free speech - the off-label promotion of medicines by companies. Aaron Kesselheim and colleagues from the Division of Pharmacoepidemiology and Pharmacoeconomics of the Harvard School of Medicine reconstruct the judicial story of Alfred Caronia, who in 2005 was investigated for violating the rules of the Food and drug administration for having - in agreement with the company he worked for - boasted the harmlessness and benefits of a drug even for many unapproved indications, in spite of a specific warning contained in the package insert regarding the lack of safety studies in those subpopulations. The company, Orphan medical, immediately pleaded guilty, while Caronia was convicted while maintaining that he should not be punished for expressing his thoughts, and on this basis he appealed. After various contrary decisions of intermediate courts, last December the line of defense was finally heard by the Court of Appeal. According to the jury (which split in a 2 to 1 vote) limitations on individual freedom of expression are justified only when they serve to directly and concretely defend and promote a public interest, and only to the extent that these limitations are necessary . In essence, according to the judges, the government has other tools (including greater education of doctors and patients to distinguish between science and marketing) to achieve the same results without imposing bans. "The vision that emerges envisages increasingly protecting the freedom of expression of companies too, at a commercial level, and this could prove to be incompatible with the regulation of drug promotion" explain Kesselheim and colleagues, expressing the hope that the higher courts - and ultimately the Supreme Court - realize it: «The current approach to the regulation of drug promotion, refined by an enormous clinical and regulatory experience, is justifiable from a scientific and legal point of view and has produced benefits for decades doctors and patients,” they conclude. "It shouldn't be abandoned now."
