FDA Approving Drugs Too Quickly
Typically, when a drug has Food and Drug Administration, or FDA, approval, it is taken as a mark of safety. If a medication has been approved by the FDA, it is completely safe and will not have any unexpected side effects, right? Wrong. The FDA is a preliminary means of getting a drug product into the general public; it is usually not known what effects the drug will have until it has been on the market and used by a large number of people. In recent years, the FDA has been reported to have been rushed into introducing new drugs into the market, which can lead to compromised safety protocol and an increase in major safety issues caused by these drugs. If you or a loved one has been adversely affected by drugs that were approved by the FDA to quickly and then withdrawn for safety issues, it is imperative that you seek legal counsel.
Scientific and technological advances are causing a steady increase in drugs that can be used to treat a variety of illnesses and defects. This is good news considering the drugs that have come into existence for issues with relation to physical and mental disorders that have not had a remedy until now. However, many of these drugs are getting pushed into the market much more quickly than they should, and the results can be worse than the problems they were manufactured to treat. According to Kaiser Health News, 71 of 222 drugs that were approved by the FDA in the first decade of the millennium have been withdrawn or required safety announcements to the public. It took about four years for these problems to come to light, at which point the people who had been taking these drugs all this time would have been negatively affected. The FDA has been cutting corners to push quicker approval: “Drugs ushered through the FDA’s accelerated approval process were among those that had higher rates of safety interventions. These approvals typically rely on surrogate endpoints, meaning that researchers measured something other than survival, such as tumor size, to determine whether the drugs worked”. The FDA is using research to meet enough criteria for the drug to be distributed to the public, but not researching what is pertinent to retaining the health of those clients relying on the drugs. This behavior is more than questionable and is a danger to society.
There is a reason for the FDA behaving this way: people who suffer from illnesses are constantly seeking the newest and most advanced medical breakthroughs to fight the illnesses. The FDA faces pressure to get these drugs onto the market as quickly as possible. Yet, we must ask ourselves if it is worth getting the newest medical breakthrough medications if our health may be compromised by a product that did not receive the appropriate research prior to being released. In an attempt to get promising drugs in the market as quickly as possible, the FDA has adopted the “Expedited Drug Development Pathway” which is a program that “allows the agency to do a variety of things to speed the approval process such as beginning the review process before all the clinical trials are completed or giving the drug a high priority to allow it to be reviewed in less than six months.” according to Forbes. This fact is very disturbing. The FDA is developing programs that allow them to release drugs onto the market that is not at all proven to be safe for consumption. The demand for newer and better drugs does not validate this behavior and the harm that it will inevitably cause to the human population.
Expediting for the approval of drugs can allow all kinds of horrible side effects into the population of people who take them. Additionally, drug expedition raises concern about new products and whether they are even any different from or better than their predecessors. Specialty Pharmacy Times writes that the exceptions to the rules of FDA approvals are seeming to become the rules themselves. The FDA allows exceptions that are used to expedite the drugs, and they seem to be abused as of late so that new drugs can be pushed onto the market faster with less research. “These early approvals and developments are controversial because they often rely on information gathered from early-stage trials that are mostly small in size.” said in an article written by Specialty Pharmacy. This protocol allows faulty products into the market and an increase of products that are no better than the drugs that came before them.
The FDA is acting negligently by allowing dangerous drugs to be sold to the general public. There will always be a huge demand for new drugs that follow the most groundbreaking medical developments, but that does not allow the FDA to cut corners and make decisions that will undoubtedly compromise the health of the public. The FDA needs to be a program that people can trust. FDA approval must come with extensive research and heavy safety precautions, and cannot be viewed as a stamp on a product that is still potentially dangerous. It is important that we have medical programs in place that have the best interest of the public in mind.
Victims of drugs that were expedited and then withdrawn by the FDA should know their rights. An attorney is standing by to aid you in your pursuit of recovering for sustained injury and monetary loss. To provide the best possible chance of total loss recovery, it is crucial that an attorney is contacted immediately after you have been injured or wronged.
The Kentucky and Ohio dangerous and defective products attorneys at Schachter, Hendy, and Johnson can represent victims immediately after a dispute has arisen. Call today at 859-578-4444 or contact us online (This is where a link would go for a form on your site) to schedule a free consultation.