The federal authorities have for years increasingly formulated measures and regulations to help prevent the illegal promotion, distribution and sale of off label drugs. However, cases of unethical and unprofessional promotion of off-label drugs has been a menace for the industry pacing the patient population in a precarious state as they are subjected to unapproved drugs. Pharmaceutical industries have over the years been accused of engaging in illegal promotion of off-label drugs through collaboration with physicians and doctors so that they increasingly prescribe these drugs and maximize revenues. Major cases of fraud activities that have been alleged for instance in the GlaxoSmithKline is the unscrupulous deals where marketers are trained to promote these off label drugs by indicating a drug for diseases or conditions beyond which they have been approved (TheHealthRanger, 2012).
In these cases the training as alleged in the GlaxoSmithKline is a coded mechanism where physician and marketers develop catching phrases to induce the physicians to prescribe the off-label drugs for other conditions than those they have been approved. A particular case is the sale of Wellbutrin which was initially indicated and approved for depression. However, this coded mechanism enabled the marketing of this drug as a drug for weight loss, sexual dysfunction and for pediatrics (CBS News, 2011). The phrase coined in that case was the happy horny skinny drug and this was known to the management of GlaxoSmithKline and since their focus was on maximizing the volume of those drugs, there was no self-regulation in those cases and the physicians who prescribed these medications were compensated or bribed for their role in prescribing the medication for these un-indicated conditions (TheHealthRanger, 2012).
The legal authorities and regulatory agencies despite the available frameworks that guide the prescription of off-label drugs recognize that physicians have the discretion of prescribing off label drugs. In the event that the FDA has approved the marketing of a product, the gap exists where there are no follow-up mechanism to indicate whether the markets in the field adhere to the set out guidelines and market this product for the condition for which it has been tested and approved. The Wellbutrin case is a perfect example of how these gaps facilitate bribery, and coercion of physicians by the companies. This implies that physicians can prescribe a drug for conditions or dosages to within the approved label. On the other hand the other loophole in the regulation is that the omission of approval for off-label by the FDA does not imply that it is unsafe or ineffective, rather it implies that the FDA has not tested the drug for safety and effectiveness (CBS News, 2011). Apparently, this means that in the current setting, the care providers are the determiners of the appropriateness of off-label drugs to the patient population despite the requirement that for a drug to be labeled safe and effective it has to be subjected to a thorough research process to determine its suitability. However, even in the enactment of any new stringent policies and regulations, the ultimate solution is to seek methods of self-regulation of pharmaceutical industries and how they operate in the market, a lacking element at GlaxoSmithKline as evidenced by the poor follow-up and action on individuals and parties that had been reported as having engaged in these misdeeds (TheHealthRanger, 2012).
Reflection
Pharmaceutical industries have to recognize the ethical and professional responsibility they hold in relation to the health of the population and as key stakeholders in a delicate healthcare system it is their role to uphold the corporate socio-ethical responsibility to the population. the quality of prescribing and the process of approval of off-label has to be designed in such a way that the federal authorities constantly monitor the off-label drugs in the market and publish information on these drugs. The challenge for the healthcare industry is that most pharmaceutical industries are commercially string and can negotiate their way even within these regulations by colluding with rogue officials and this is enabled by the extremely bureaucratic audit process. It is important that the audit process is formulated to enable public participation and openness devoid of bureaucratic dealings that expose the population to unsafe and ineffective products.
References
CBS News. (2011). Bad Medicine: The Glaxo Case. Retrieved from https://www.youtube.com/watch?v=NJh9o-MCPXw
TheHealthRanger. (2012). GlaxoSmithKline whistleblower speaks out about bribery of doctors, off-label marketing of drugs. Retrieved from https://www.youtube.com/watch?v=y_RJ9QPG70U
