The Pharmaceutical and Biotechnology industry is one of the most highly regulated industries in the United States. The Food and Drug Administration (FDA) is responsible for the approval of all drugs before they go to market. Often times this means that as soon as a new piece of information is garnered the FDA will force drug companies to act upon it. Other times though companies must act upon their own to remove drugs from the market place. All in all people’s well being and health are often decided by the ethical actions of companies.
One such example of the FDA forcing ethical action is the British company AstraZeneca and their drug Seroquel. The FDA requested that a new drug label be printed that included a warning about using Seroquel in conjunction with other drugs as a precaution for doctors. Despite the fact that the FDA admits that when taken properly the drugs should cause no negative interactions. In a case like this the ethical decision of whether to include the additional warning was taken out of the company’s hands by the FDA.
As mentioned in previous posts a major decision was just handed down by the Supreme Court regarding generic drugs in the case of Pliva v. Mensing. The makers of the generic drug metoclopramide, sold under the name Reglan, were unable to change the warning label on their drug due to federal law stating that the generic drug must carry the same label as the brand name drug. This put the company (Shwarz Pharma) in a bind. On the one hand, as was ultimately ruled, federal law superseded state law in not allowing them to change the warning label on the drug. As Justice Sotomayor stated in her dissenting opinion that did mean the drug companies should be allowed to sit idly by and do nothing. In this case the company made the unethical decision of not attempting to get the FDA to help allow for proper warning labels and while in the end it was determined to be a legal decision it was only determined to be so by the slim margin of 5-4 and next time they might not be so lucky.
An example of a drug company taking ethical action on its own can be seen with Pfizer and their drug 3-Nitro also known as Roxarsone. Pfizer’s studies of the drug, which was approved in 1944 and is used to kill parasites and promote growth in chickens, found that the drug was not harmful to humans. In February of this year though a more recent study conducted by the FDA showed trace amounts of poisonous inorganic arsenic. While the FDA said that the amounts found in chickens do not pose harm to humans and can continue to be sold. In response Pfizer decided that until a complete scientific study can be conducted and all issues with the FDA squared away they suspended the sale of Roxarsone. As the FDA indicates on their website Pfizer voluntarily took steps to suspend the sale of the drug. After 30 days from the announcement Pfizer suspended all sales of the drug. The drug was given another 30 days of life so that farmers had time to find a suitable replacement in the mean time.
http://www.nytimes.com/2011/07/19/health/19drug.html?ref=drugspharmaceuticals
http://www.nytimes.com/2011/06/09/business/09arsenic.html?ref=drugspharmaceuticals
http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm258313.htm
The portion of the your post about Pfizer was especially interesting to me. When you think about ethical dilemmas, it's been brought up by guest speakers to think about consequences. Companies may weigh the costs/benefits before making the 'right' or 'wrong' decision. Pfizer made a good decision in suspending the drug regardless of FDA's approval; it not only prevents potential law-suits or a damaged reputation, but actually boosts their credibility within their market.
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