State & Federal Policy
The rising costs of prescription drugs and events such as the Vioxx disaster have incresed public scrutiny of the nexus between pharmaceutical marketing and medicine. In some states disclosure laws have been enacted, requiring the pharmaceutical and medical device intustries to report their financial relationships with prescribers. A federal bill to this effect has also been introduced in Congress.
Other legislative efforts have been focused on the creation of alternate prescriber education progams, or "academic detailing", to counterbalance the information provided to doctors by industry sales representatives. The pages under this section contain an overview of current federal, state and organization initiatives to examine and regulate pharmaceutical marketing and promte appropriate prescribing.
For further information on legislative activity and action, please use the links below:
FDA licensing and Modafinil case study
Of the course of the last 3 years, AMSA has sought to investigate the case study of Provigil and Nuvigil (Modafinil and Armodafinil respectively). This investigation aims to identify the growing body of knowledge suggesting that Modafinil (and it’s newer relative Armodafinil) should re-examined for use within healthy individuals, based on recent findings highlighting its safety and efficacy within healthy (non-sleep deprived) individuals, depression and ADHD. In keeping with AMSA’s access to medicines and interest in science-based medicine, this initiative has detailed the rising popularity of online Modafinil pharmacies, offering cheap “off-label” generic Modafinil to consumers, where their doctor has refused to offer the medicine via prescription for non-approved symptoms. This blatant disregard for patients well being and general quality of life should be addressed, and re-examined by the FDA in light of recent scientific information.