What’s the harm in more drugs getting “accelerated” FDA approval?

On Behalf of | Mar 16, 2022 | Product Liability |

Most Americans have always felt some reassurance that before the U.S. Food and Drug Administration (FDA) allows a drug to be prescribed to patients, it has to go through rigorous testing and be proven safe and effective in multiple clinical trials. As one professor of medicine and public health says, “I think people generally assume that when the FDA has approved something, there’s overwhelming evidence it is safe and effective.”

Only drugs that are intended for people who have no other effective treatment options for a serious or terminal condition have gotten what’s known as “accelerated approval.” However, in recent years, the FDA has granted accelerated approval to more drugs – 14 in 2021 alone. That was over a quarter of the total drugs approved last year – compared to 7% in 2018. 

Where is the pressure coming from?

Why the change? Some blame pressure from patient groups, politicians and the pharmaceutical industry who each have their own reasons for getting drugs to market as quickly as possible.

Some in the medical field are concerned that the lack of evidence and scrutiny that comes with accelerated approval “is causing huge amounts of real harm,” as a former professor of medicine put it. 

Several well-known drugs for Alzheimer’s disease, muscular dystrophy and prevention of premature birth have caused serious side effects and limited effectiveness among those who have used them, despite their high price tags. Further, patients don’t have to be told that a drug they’re being described has gone through an accelerated approval process.

These drugs are rarely recalled after their approval

The FDA has the authority to get drugs off the market if there are problems after their initial approval. However, the regulatory agency seldom does that.

If you or a loved one has been harmed by prescribed medication, it’s wise to find out what your options are for seeking justice and compensation. Having experienced legal guidance can help.