Missouri Dangerous Drug Attorney

How Does a Drug Reach the Market?

According to Drugs.com, over $12.6 billion is spent in the United States in researching and developing new drugs each year, and in order for a drug to reach the shelves, it must undergo a rigorous approval process. On average, the number of drugs that actually gain the approval of the U.S. Food and Drug Administration (FDA) for testing on humans is 1 in 1,000. Furthermore, the time spent to get the drug onto a shelf in a pharmacy takes approximately 12 years.

Prior to filing an application for human testing, prospective drugs must be tested extensively for nearly three years by their respective manufacturers in a laboratory. If the application is approved, a high degree of safety and effectiveness must be documented in three separate clinical trials.

Problems Facing the FDA Approval Process

According to an article published in Newsweek, there are several weak links in the approval process. Reportedly, there have been times when the FDA was aware of potentially deadly side effects, but still allowed a drug to reach the market. One instance involved a popular drug, named Tamiflu, which was hailed as one of the most effective anti-influenza drugs in existence.

This perspective quickly changed when investigators discovered that the makers of Tamiflu had hidden negative test results from over 70 different clinical trials. To make things worse, it was later revealed that the FDA was fully aware of Tamiflu’s potential side effects. This information was only revealed after the drug was distributed globally and reports of delirium, bipolar disorder, depression, and psychosis were documented in South Korea, the United States and Japan. Tamiflu’s manufacturer had also failed to publish over 100,000 pages of data. 

Clinical Studies and “Publication Bias”

In some cases, manufacturers may attempt to keep data from trials private so that negative aspects of the drug are not revealed. When manufacturers only release positive data, the action is known as publication bias. Over time, critics have pointed out that other important regulatory agencies do not have access to the same testing information as the FDA and pharmaceutical companies, despite all of the rigorous testing requirements for drugs. This may mean that patients do not have the whole picture concerning the drugs they are prescribed.

Fines and Penalties for Unethical Behavior

According to Natural News, in order to curb unethical behavior, the FDA imposes a variety of penalties and fines on drug companies each year. These cases included the antipsychotic drug Seroquel, which was illegally promoted for off-label use by its maker, AstraZeneca. The company was fined $520 million.  In 2011, after also being used for illegal off-label purposes, which were promoted by its maker, the drug Vioxx was linked to over 60,000 deaths caused by heart attacks. Its maker, Merck, was fined $950 million.

In a landmark case, GlaxoSmithKline, the makers of the antidepressants, Wellbutrin and Paxil, incurred a $3 billion fine for promoting the drugs for off-label uses. To date, this is the largest fine against a pharmaceutical company in American history. Other companies were penalized for deliberately making unproven claims in order to mislead the public and for refusing to publish studies that produced negative or inconclusive results. In all, pharmaceutical companies paid out over $7 billion in lawsuits, fines, and penalties between 2004 and 2010.