Off label drugs are medications that are prescribed by doctors for purposes other than what they were originally intended or received approval for. The practice of prescribing off label medications is far more wide spread and common than most people believe and as an increasing number of people are experiencing adverse effects of medications that were rushed to market, the question of who has the responsibility and oversight of regulating these forms of prescriptions becomes more prevalent. You may be alarmed or even angry once you understand the answer to this question and the manner in which big pharmaceutical companies get away with marketing medications that are harmful or deadly while making enormous profits off of the infirm without a care in the world about the repercussions.
How are Off Label Medications Prescribed?
The nagging question that most people have concerning medications that are prescribed for reasons other than they were designed or intended is how or why doctors are allowed to place patients on the meds in the first place. In truth, the process of gaining approval by the Food and Drug Administration and subsequent oversight over the prescribing and administration of medications is so full of loop holes that it may require a complete overhaul for the sake of the average person’s wellbeing.
Once a pharmaceutical company has created a new drug, the company is required to conduct its own research and trials— the results of which are submitted to the FDA. It is the information that is provided by the drug companies that influences the FDA’s decision to approve or deny the marketing of the medication and the FDA does not conduct any research of its own or demand independent research to confirm the conclusions that are presented by the pharma company peddling the new medication. This makes it far too easy for drug manufacturers to omit, fabricate or misrepresent data when submitting trials.
Once a medication has been approved, doctors are given the discretion to prescribe the medication for any purpose that they feel will benefit their patients. Where things often go awry is that pharmaceutical companies will then make erroneous claims about how the medications may be used or the associated risks. In some cases, doctors will even be enticed with kickbacks or other incentives for prescribing certain medications.
How common are Off Label Prescriptions?
Almost twenty percent of prescriptions written in the United States are for off label medications and there is absolutely no oversight or regulations that disallow doctors to continue this practice. The FDA does not govern the practice of medicine and is only responsible for preventing hazardous drugs and substances from reaching the market and removing those that are already on the market. Your doctor has full discretion to place you on the medication that he or she feels will best address your symptoms or condition and the majority of the information influencing his or her decisions in this regard is provided by the pharmaceutical companies, which have a growing track record of concealing, omitting or denying risks that are associated with their medications.
What is more alarming is that children are exposed to far more off label prescriptions than adults and are treated as test subjects in the process. One study showed that 38% of patients under the age of sixteen were prescribed medications for off label purposes and in as many as 84% of cases, the medications were prescribed with very little or no scientific support for their use.
Off Label Medications and Pregnancy
The FDA has designated a specific category system for the rating of medications prescribed for pregnant or nursing women. There are five categories with varying degrees of risk and providing different forms of advice to doctors who are considering prescribing a medication to pregnant women. These classifications range from being considered completely safe to warning of specific risks and severe harm that may be caused to the unborn child. The key flaw in the category system, however, is that the FDA relies on data submitted by the pharmaceutical companies rather than independent researchers— this is how Zofran was prescribed off label for decades despite its manufacturer knowing of the potential risks, for example.
Who is at Fault When Off Label Prescriptions Cause Adverse Effects?
It can be argued that doctors have the largest burden of ensuring the safety of their patients and that they should know better than to prescribe medications that are harmful or deadly. However, doctors must rely on the information that is provided to them and often weigh the benefits and risks of every medication before writing prescriptions. They cannot be blamed in many cases for making decisions based on information that was inaccurate or erroneous but in some cases, they should know better than to place patients on medications that lack specific data to support their benefits and safety.
The pharmaceutical companies carry far more of the blame for the consistent practice of circumventing the process of acquiring FDA approval for the use of medications to treat specific conditions and constantly finding loopholes that allow them to profit off of the harm of other people. Aside from pushing to amend the laws and requiring more oversight, the only method left of obtaining justice for this gross lack of concern for our safety when creating and marketing medications is to take the matters before a civil court. The Rosenfeld Injury Lawyers LLC are a leading group of pharmaceutical complication attorneys who are dedicated to holding these mega corporations to account for their sins and if you have been harmed through the use of a medication issued in such a manner, we’d love to have the opportunity to defend your interests.
Contact us today to arrange a free consultation where you can speak with an attorney about any pending litigation involving cases similar to your own and how it may impact the value and outcome of your case as well as to learn about your rights and legal options and to launch an investigation into your matter to determine your best course of action. Our lawyers are dedicated to serving your interests above all else and we only receive compensation when our clients do. If we cannot assist you or fail to collect compensation on your behalf, our services are free.