Why does the Food and Drug Administration (FDA) exist? The original purpose was for the regulation of selling food and drugs. The Agency’s origins start in 1906 under the name of the Pure Food and Drug Act. It was created to curb manufacturer abuses. In 1930 it was officially named the FDA. The FDA’s duty is to address the risks that can be managed and avoided. The FDA’s regulatory responsibilities is to provide the public with accurate science-based information to ensure the safe and appropriate use of medical products and foods. The benefits of any drug must outweigh the risks and be effective. However it is an accepted fact that both prescription drugs and OTC drugs have side effects also known as adverse events. A side effect is considered serious only if it results in death, life threatening hospitalization, disability or permanent damage or causes birth defects. If you have any side effects you should report them to MedWatch.
The FDA depends on voluntary reporting and a follow up of the drug manufacturers, hospitals, doctors and patients to track side effects or complications stemming from the products, However, the FDA DOES NOT HAVE THE AUTHORITY TO ORDER OR MANDATE A DRUG RECALL. The recall must come from the manufacturer or by a FDA request but it’s up to the manufacturer.
Americans receive as many as 3 billion prescriptions for pharmaceuticals each year and millions receive medical devices such as hip and knee implants. Since the FDA was created thousands of dangerous drugs have entered the market and caused harmful side effects including serious illnesses and wrongful deaths.
Before 2013 drug companies and the FDA could be sued if their drug caused serious adverse side effect injuries, illnesses or death. In 2013 the US Supreme Court made a historic decision: Once the FDA approves a drug individuals are prohibited from suing the FDA or drug manufacturer even if it’s proven that the drug causes harm. However, you can sue the doctor and/or the pharmacist. The FDA has sovereign immunity as a government agency. Government agencies cannot be sued unless they allow it.??
Drug companies seeking to sell a drug must first go through FDA testing requirements. The FDA doesn’t actually do the testing themselves. They have the drug companies do the testing and then the FDA does a limited research for drug safety, quality and effectiveness. The statistical finding for the testing are produced by the drug manufacturer.
Critics and consumer watchdog groups accuse the FDA of being influenced by Big Pharma. This is understandable due to the already mentioned self testing by the same drug manufacturer that is trying to get this product out for sale. Also when the US Supreme Court decided to rule in favor of the FDA and drug companies to stop consumers from suing that allowed the drug producers to apparently get drug into the market with less intense testing for the safety of the patients. Also in 2015 the FDA spent 1.1 billion dollars of which the drug companies provided $769.1 million or over 75%. The cost of this was passed onto the consumers in the form of high prices. Finally there have been a number of FDA scandals concerning the failure of the FDA reporting falsified clinical trials from drug manufacturers. Research found 57 recently published clinical trials that the FDA failed to publish significant drug problems.
Historically there are many other instances of outright abuse and indifference toward the public and for the drug manufacturers. Historically it appears the FDA has leaned toward the drug manufacturers for the quick dispense of medication to the public regardless of patient risk. Of course there is public pressure to have experimental drugs available for patients with serious conditions. Still there must be a balance of benefits to risks. That is the regulatory responsibility of the FDA.