Botox Lawsuit

Allergan, the maker of Botox, has filed a lawsuit against the FDA and the Justice Department for restricting their marketing efforts and violating their First Amendment rights to free speech. At issue in the lawsuit is a pharmaceutical company’s ability to market their products for so-called off-label uses, something which is currently prohibited by FDA regulations.
While other pharmaceutical companies have not joined the lawsuit, they are watching it closely. The outcome will likely affect the manner in which they conduct their marketing efforts for years to come. Botox is currently approved by the FDA to treat crossed eyes, eyelid spasms, excessive sweating, and wrinkles. Doctors are free to prescribe Botox for any off-label use they deem appropriate. The FDA restriction only prohibits pharmaceutical companies such as Allergan from marketing their products such as Botox for off-label uses.
In their lawsuit, Allergan contends that this restriction unfairly limits them from educating healthcare professionals on other uses of Botox. The FDA has not allowed such off-label marketing because the so-called off-label uses have not been subject to the same scrutiny as for those for which the drug has been approved. This is really a consumer protection issue. If drug companies are allowed to market their products for unapproved uses, it makes the FDA’s regulatory powers irrelevant and places the average consumer at risk.
Botox has received stricter labeling requirements from the FDA after dangerous side effects had been reported. Such adverse effects include difficulty swallowing and breathing problems. To date, sixteen people who had received Botox injections have died as a result of the side effects as a result of dosage and prescription errors.