The FDA and Unsafe Drugs The U.S. Food and Drug Administration was created to make certain that the foods we eat and the medicines we use are safe, or as close to it as possible- all drugs carry some risk to everyone. What are the procedures for reporting an unsafe drug, and how does the FDA determine whether to investigate claims against a drug or drug maker? Number of Patient/Consumer Reports The FDA will not investigate a drug or drug maker on only one or even one hundred people’s claims. There is a time-consuming and involved reporting process, where you either are directed to the FDA website to fill in several pages of forms, to include your name and personal information, or you can mail in a written form to them. They generally will not investigate a claim until 1500 or more people have the same or similar complaints and those are sent to the FDA. Inspections The FDA is required to inspect all drug plants, name brand and generic, every two years. Some of the violations found in American and Canadian generic drug plants recently have been appalling. Drugs were not up to standard on dosage - being cut with fillers, rather than being the full strength drug patients expect. Drugs were manufactured in unsanitary conditions, meaning consumers could be made ill by a bacterial infection or a virus because of environmental conditions at the plants. Overseas Drug Plants Conditions at overseas plants controlled by US drug makers are even worse. For example, most heparin supplies - an anti-clotting agent given to people with certain liver diseases and other problems - is made in Chinese plants. The FDA says it doesn’t have enough money or people to inspect overseas plants, and leaves most inspections to the drug makers. In 2008, this allowed fake heparin into the American supply chain, which killed several people before the drug was recalled. The violation was willful - the workers at the Chinese plant decided that certain parts of pigs would do to make heparin for their similarity to heparin, because the pig parts were much cheaper than the active ingredient in heparin. If You’ve Been Injured by an Unsafe Drug If you’ve been injured by an unsafe drug, contact a board certified attorney to learn how you can hold the responsible parties accountable for their mistakes. We have represented many clients who were harmed by defective drugs and defective products. Contact our office at 888-526-7616 for a free case review.
Kennedy Hodges, LLP helps individuals who have suffered serious injury due to prescription and pharmacy errors across the country, including distributing wrong medications, administering the wrong dosage, and failure to provide medication warnings and instructions.
