Recently the US government has been enforcing their stand regarding advertising the off-label uses of drugs. But one pharmaceutical company is taking a stand of their own. Allergan, Inc., the company that makes Botox, has filed a legal action against the government regarding this process. The company wants to be able to “share truthful, relevant information” with doctors and health care professionals about the off-label therapeutic uses for some of the drugs that they manufacture.
Sharing this type of information with physicians is not illegal, however pharmaceutical companies are not supposed to push uses for their drugs other than what they have been approved for. Allergan feels that the government’s position regarding off-label use is inconsistent with the Federal Food, Drug and Cosmetic Act as well as a violation of the First Amendment.
The defendants in the case that was filed Thursday include the Food and Drug Administration, its commissioner, Margaret Hamburg, the secretary of Health and Human Services, and the United States. If Allergan wins their point it would be a major coup for pharmaceutical companies across the country.
Basically the process of promoting off-label use of drugs is where a pharmaceutical company provides information to physicians and other health care professionals as to other ways that their approved drugs can be used. Using a drug to treat any other illness or disease other than what it was originally approved for is what the government is working hard to prevent.
But Allergan is not looking to provide false or inaccurate information regarding their drugs and the use of them. The case in point refers to Botox, which has been approved to treat eye spasms. (Botox Cosmetic is another form of Botox that is injected to ease the effects of wrinkles on the face.)
Allergan states that along with its intended use Botox has also been effective in treating spastic conditions of adults after they have suffered from a stroke. It has also been used to treat the spasticity of juveniles who have cerebral palsy. In order to have Botox as well as the other medications on the market that are promoted for off-label use it would take around 10 years to conduct the clinical trials and results that are necessary to get FDA approval.
With the process of providing helpful information regarding alternate uses of Botox that have been proven effective, Allergan feels that their Freedom of Speech is being denied. They are not trying to deceive the medical field or promote their drugs regardless of their effectiveness but they do feel that the process involved in getting approval for a medication that has already been approved is a waste of time that could better be spent treating patients who will benefit from it.
Allergan file their legal action in the U.S. District Court for the District of Columbia. They stand by their belief that the FDA’s actions do not serve the health and well-being of the public.