How a Drug gets Approved by the FDA

There have been more than 45,000 incidents of complications submitted by women who have used Bayer Pharmaceutical’s intrauterine birth control device (IUD) Mirena, according to AdverseEvents.com. Additionally, over 40 lawsuits have been lodged against Bayer alleging severe health consequences after using the IUD. These staggering numbers lead many to question how a drug that has caused everything from surgeries to infertility can be approved for use.

According to Wikipedia, President Theodore Roosevelt signed the Food and Drug Act into law in 1906. This act was the basis for the Food, Drug, and Insecticide organization, shortened to the Food and Drug Administration (FDA) a few years later. Since 1938, every new drug has been required to be approved by the FDA before U.S. commercialization.  The FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety.

Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is one of only three IUD’s approved for use in the United States. In 2009, the FDA expanded Mirena’s approval to treat heavy menstrual bleeding in women already using an IUD. According to the FDA’s website (fda.gov), the mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in the United States are safe and effective. CDER does not test drugs, although the Center’s Office of Testing and Research does conduct limited research in the areas of drug quality, safety and effectiveness.
When a company wants to introduce a new drug into the market, it must submit a New Drug Application (NDA). It is the company’s responsibility to test the drug and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists and other scientists reviews the sponsor’s NDA containing the data and proposed labeling. The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body and how it is manufactured, processed and packaged.

Despite this lengthy, time-consuming and expensive process, thousands of women have suffered severe medical problems while or after using Mirena. Women across the country have complained of the following issues:

  • Abscesses
  • Embedment of the IUD in the uterine wall
  • Uterine perforations
  • Infertility
  • Infection
  • Intestinal perforations or obstruction
  • Pelvic Inflammatory Disease
  • Ectopic Pregnancy

There is help if you or someone you know has suffered any harmful side effects following Mirena usage. The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.