So you open up a bottle of a prescription drug your doctor prescribed to make you better. But as you’re about to pop that pill you hear yourself saying, “You should not take this drug if you are not able to stand up for 30 minutes. Call your doctor immediately if you feel dizzy, have new or worsening heart burn, severe headache, difficulty swallowing, have diarrhea, shortness of breath, or develop chest pain.”
Oh, and don’t operate machinery either.
The U.S. Food and Drug Administration (FDA) is tasked with protecting the public health by assuring the safety and security of human drugs, biological products, medical devices, and our nation’s food supply. Their website also states they are responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.
In FDA speak that’s Uncle Sam telling us to be careful and exercise caution, just as warning labels on prescriptions remind us of a long list of potential hazards. But is Uncle Sam going too far and not letting new medicines that could have potential lifesaving effects for millions get past the hurdles of FDA approval?
Some people believe the FDA imposes increasingly onerous trials on new drugs to insulate themselves from critics if something eventually goes wrong with the drug. These laborious trials, they say, prevent some promising therapies from being developed.
But precaution is their job and we feel they are doing it well, protecting us from potential deadly effects if the drugs weren’t made to go through intense scrutiny before being mass marketed.
It’s easy to have our heartstrings pulled when we hear of a child – or anyone – facing a terrible and painful disease for which there is currently no cure. It makes it worse when we hear there are drugs currently being developed to help, yet aren’t approved by the FDA. However, any drug that is powerful enough to make a difference in patients’ lives is also powerful enough to do something that we don’t want it to do and didn’t expect it to do. This is particularly important for medications that treat chronic problems. You don’t want to damage your liver while treating longstanding problems with your joints.
There should be an agency out there – hence the FDA – looking out for us. After all, no amount of gut-feelings nor internet searching can produce effective do-it-yourself research into new drugs.
We need the caution of the organization and approvals for new drugs in the U.S. come faster than in Europe or Canada. According to Forbes, 77 percent of drugs are approved in the U.S. the first time around and review times here are shorter than in Europe.
So the FDA is saying yes to new drugs at a rapid clip and studies into the drugs are needed to ensure our safety. It may take time, often just 6 months or less, but it is much-needed time to perform rigorous reviews and weigh the benefits and potential hazards of something new. We consider it a good thing for the FDA to temper enthusiastic companies with billions of dollars riding on its product against the health of the American people.
While we always want everyone to be as healthy and pain-free as possible, rather than thinking of the FDA as a big speed bump in marketing new drugs, think of the organization as the people who make it their business to realize there are lives at stake on both ends of the drug-approval process.