Medications are designed to help people with their illnesses and conditions. Patients put their trust in these drugs, the companies that formulate them and the Food and Drug Administration (FDA) in ensuring they are safe.
However, there are times when the FDA expedites drug approvals. There are various reasons for this and those justifications might supersede the in-depth testing and approval process that is usually used. People should be aware of key points about accelerated approvals.
The accelerated approval process is under scrutiny
When the FDA approves a drug via an accelerated process, it does so because of its preliminary data. The manufacturer must continue to conduct studies to ensure that the medication performs as it is supposed to. If the study finds issues, the drug can be removed from the market. This puts the onus on the manufacturer to complete the necessary studies, but some have failed to keep up. This leaves medical professionals and their patients taking the risk of using the medication without all the necessary precautions having been taken.
According to NPR, 42% of these studies were not completed or had not even begun for over a year after the drug was approved through the accelerated process. Of those, 19 did not start for at least three years after there was an accelerated approval. With four, they did not start for at least 10 years.
In many cases, people are not even fully aware that the drugs they are being given were part of an accelerated process for approval by the FDA. In the past, doctors gave a disclosure that drugs were subject to accelerated approval. This is not required and it does not happen today. To make the process more troubling, more drugs are being sent to market through accelerated approval. In 2020, for example, 49 drugs were approved in this way.
If people suffer from medication-related issues, understanding the approval process is key
Since many drugs can have side effects that are not known until they have been in use for an extended time, the failure to conduct extensive testing in the interest of getting the drugs to market in an expedited way could be damaging. Those who have been harmed or lost a loved one should consider this when they are thinking about their legal options for defective drugs. The drug, its use, its testing procedures and what side effects were known and unknown must be assessed. Having experienced help can be essential when holding drug makers accountable.