With so many new drugs arriving on the market each year, it may seem like the process of developing these medicines is quick and easy.
But the truth is for every new medicine that makes it onto a pharmacy’s shelves, there are thousands of others that don’t. Only .01 percent of drugs that scientists start work on will ever become a real, Food and Drug Administration (FDA)-approved medication, according to the Pharmaceutical Research and Manufacturers of America (PhRMA).
And the process for making these drugs isn’t cheap. The estimated cost of bringing just one medication to market is $1.2 billion.
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The evolution of a drug
That high price tag isn’t surprising when you consider how much time and energy it takes to develop a new treatment.
The process starts with research. Scientists generally spend between three and six years combing through 5,000 to 10,000 compounds to find the one that looks most promising as a drug therapy.
Once a compound is identified, it begins the journey toward development.
Researchers also spend time running tests on the compound in the laboratory until they decide it’s ready to test on actual patients who volunteer to be subjects in clinical trials. But that’s only if the FDA agrees that the drug is worthwhile and safe enough to test on people.
Multi-stage clinical trials
The most expensive part of the drug development process is testing the drug in clinical trials, which run in three different parts or phases, a process that can take another six or seven years.
Phase I of these trials is designed to make sure the medication is safe. Testing is done only on a small group of 20 to 100 people, according to PhRMA.
If the medication makes it past this initial phase, it moves on to Phase II. Researchers will test the medication on a larger group, typically ranging from 100 to 500 people, to see if it works well and to determine the best dosage.
After Phase II, the medication must pass a final hurdle, a large trial involving thousands of patients, to definitively gauge the drug’s safety. This is known as Phase III.
Even if a drug does well in trials, it still isn’t ready for market until the FDA gives it a stamp of approval. The U.S. drug approval process is considered one of the world’s toughest, according to PhRMA.
FDA experts typically pore through piles of scientific data and evidence before deciding whether the medication is safe and effective.
On average, only about 60 percent of drugs that apply get FDA approval. In 2012, 43 new medicines gained FDA approval — one of the highest numbers in recent history.
FDA review can take up to two years, but the agency may speed things up if the treatment is poised to be a breakthrough or can provide hope to patients suffering from serious conditions.
Even after a drug is approved for sale, the work doesn’t stop then. Biopharmaceutical companies still have to continue to monitor how well the medication is performing and to ensure that no safety issues crop up in the years after it goes into widespread use.
While this review process can be arduous, it hasn’t deterred progress. The number of medications in the pipeline has increased by 40 percent since 2005, according to PhRMA, and there are now 5,400 medicines in development globally.
And for many Americans this lengthy process pays off with new treatments and the potential for better health.