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Amarin Lawsuit Against FDA Victory

About 20% of all prescriptions in the United States are for off-labeled use. Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects [1]. This same reasoning is now being applied to pharmaceutical industries themselves. Any product that is used not in the way that was originally approved by the FDA must be proven through research and evaluation for doctors to use. Originally, this rule was applied by the FDA, now drug companies can advertise their product with claims of their adaptability because of a new court ruling.

What does this mean for the FDA?

The United States Court ruled that the FDA cannot bar a company from promotional methods for off label use because of first amendment rights. The fish-oil capsules, Vascepa was the drug that began this debate because of the company’s research and evaluations that proved the variety of ways the drug can be used for treatment. Vascepa is a treatment for people with extremely high levels of triglycerides. Triglycerides are blood fats that can cause cardiovascular disease, therefore the higher the reading, the higher the risk. The Irish pharmaceutical company Amarin wanted the drug to be marketed for people with lower, but still very high, levels of triglycerides as well as the aforementioned treatment, however, the FDA blocked this possibility.

For Amarin, a small pharmaceutical company with only Vascepa, this disapproval of off-label patenting put its potential market of 35 million patients to a low of its current approval for four million. The company then decided to initiate a rare constitutional challenge, arguing the FDA’s stifling of its efforts to communicate truthful information to doctors breached the company’s first Amendment right to free speech. Many feel as though, this could potentially cause significant implication for the agency’s ability to regulate drug marketing. Using drugs in ways for conditions not specifically approved by the FDA can ultimately be dangerous and cause defective drugs to go haywire- although there is nothing to stop doctors prescribing off-label.

However, the president and CEO of Amarin said that the lawsuit is based on the principle that better informed physicians will make better-quality treatment decisions for their patients. The company can give doctors valid information about unapproved uses of its fish-oil product, despite the objections of U.S. regulators seeking to limit how drug makers promote their products. The fear from the FDA is that the success for Amarin has the potential to establish precedent that would return the country to the pre-1963 era when companies were not required to prove that their drugs were safe and effective for their intended uses. Nevertheless, the judge overseeing the case stated, “Although recognizing that the FDA’s policies advanced a substantial government interest in requiring manufacturers to submit supplemental applications, the restrictions on such a speech were more extensive than necessary and thus breached the first amendment” Therefore, it is not surprising that the FDA and Amarin came to an agreement on March 9th, allowing the company to distribute journals about unapproved uses for the drug [2].

Proven Results

Overall, pharmaceutical companies who have proven results for other uses of drugs should be able to share this information with doctors to give patients the best potential of the drug they are using for treatment. Doctors have the knowledge and expertise to know if a drug will be useful for their patients. If physicians specifically request it, the ruling allows pharmaceutical companies to hand out the information more widely. Patients always trust that their doctor is competent enough to eradicate any problem they may have with treatments prescribed by said doctor. Unfortunately that is not always the case. Medical malpractice is a serious problem, falling behind only heart disease and cancer as the leading cause of death in the United States.  The average annual number of suits filed each year is about 85,000, with the actual number of medical injuries estimated to be about one million per year. Without the regulations from the FDA, this number could possibly increase [3]. Do not be a part of the injured statistics.

Sibley Dolman Gipe Accident Injury Lawyers, PA

If you or anyone you know has been severely affected by a bad drug or irresponsible doctor, please call the personal injury attorneys at Sibley Dolman Gipe Accident Injury Lawyers, PA to combat these issues. Call (833) 606-DRUG [3784] today for a free consultation and evaluation.

Sibley Dolman Gipe Accident Injury Lawyers, PA
800 North Belcher Road
Clearwater, FL 33765
(833) 606-DRUG [3784]



[1] https://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know
[2] https://www.upi.com/Health_News/2016/03/09/FDA-allows-Amarin-to-market-off-label-use-of-Vascepa/1121457535374/
[3] https://oig.hhs.gov/publications/docs/hcfac/FY2014-hcfac.pdf