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For people living with a chronic, incurable disease like multiple sclerosis (MS), drug research can’t happen quickly enough.While there are several disease-modifying therapies (DMTs)—a vital group of drugs proven to reduce MS relapses and slow progression— available to treat the disease, they do not cure or prevent MS. In the eagerness to remedy this situation, it is easy to forget that finding new and more advanced medicines takes time…not to mention creativity, diligence, persistence, and a great deal of money. News reports touting “breakthroughs” and imminent cures only increase frustration when the drugs don’t materialize. At the end of the day, managing expectations and excitement from scientific and medical stories can add to the challenge of managing MS.
Here, we explain drug development, an enterprise that begins with ideas, carries on through discoveries and testing, and ends, if all goes well, with a safe and effective new treatment approved by federal regulators. Knowing the process should help people affected by MS balance hope and optimism with a healthy dose of realism.
The Drug Approval Landscape
Perspective is all-important as you read about drug development. Patience comes from understanding the steep odds against a drug concept evolving into a beneficial and approved treatment. Consider these facts and figures about drug development in the United States.
- A drug’s journey from laboratory to pharmacy takes an average of 15 years to complete.
- Out of every 5,000–10,000 compounds that enter the research and development “pipeline,” only 1 ever becomes a new drug.
- Only 5 in 5,000 compounds tested with laboratory and animal studies ever reach the point of testing with people (clinical trials).
- Only 1 in 5 compounds tested in clinical trials ever becomes available to the public.
- The average cost to develop each successful drug is $800 million to $1 billion.
In the United States, drugs are developed by independent laboratories and pharmaceutical companies, university medical centers, and government institutions. From these points of origin, all roads lead to a key federal agency, the Food and Drug Administration (FDA), whose physicians and scientists must grant approval for a drug to enter the marketplace. Of the 15 years typically needed for drug development, clinical trials take about 6–7 years, and the FDA approval process takes up to 2 years.
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