Study Shows One Third of Drugs Approved by FDA Have Major Safety Concerns

Pharmaceutical drugs can save lives and offer relief from medical conditions for millions of people in this country. All drug companies must go through an approval process with the Food and Drug Administration (FDA) in order to sell a prescription drug. The process requires laboratory and animal testing and studies using humans. The pharmaceutical company then submits an application to the FDA showing all test results, manufacturing information on the drug and the labeling information for the drug. The FDA considers this information in determining if drug is safe for use and if the benefits of the drug outweigh the risks or side-effects.

Pharmaceutical companies and patients and now many politicians complain that FDA approval process is often lengthy and complex. The Obama Administration signed legislation to speed drug approvals in 2016, and now there is growing pressure from the Trump administration on the FDA to approve new drugs more quickly and with fewer obstacles. However, researchers at the Yale School of Medicine just published an article in JAMA that found that 32% of all drugs approved by the FDA from 2001 to 2010 had major safety issues after the drug reached the general marketplace. Specifically 71 or 222 drugs required a withdrawal from the market, a “black box” warning on side-effects or the issuance of a public safety announcement. Oftentimes these safety issues did not become known for many years after the drug become available. The median time for safety concerns to be discovered was 4.2 years.

Previous research by the Yale School of Medicine showed that the FDA actually approves drug faster than the European Medicines Agency (EMA) – the FDA’s European counterpart. Additionally, Yale researches determined that the majority of trials conducted by drug companies and other researchers include less than 1,000 patients and last less than six months.

While the FDA drug approval process can certainly be improved, it is important to consider this research and other product safety information that illustrates the frequency of safety issues that accompanying many pharmaceutical medicines and medical devices. Research also shows that safety issues and health concerns may not become evident for many years, so clinical testing that takes place over a short period of time with a limited number of participants may not adequately exhibit the risks of certain drugs or medical devices.

Currently our firm is concerned with health risks associated with a number of pharmaceutical drugs and medical devices, including: