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With the first baby boomers turning 60 this year, there will be an increased demand for new, innovative medicines.
According to the Centers for Disease Control and Prevention (CDC ), 90 million Americans suffer from chronic diseases such as cancer, diabetes, Parkinson's, arthritis, stroke and congestive heart failure. Such chronic diseases account for seven out of 10 deaths in the U.S.
Fortunately, more than 2,700 potential new medicines are in various stages of clinical development today in the U.S. However, on average, only one out of every 250 potential new medicines will be approved for patient use. The current drug development, review and approval process for each new medicine requires 10 to 15 years, multiple clinical trials, thousands of patient volunteers and hundreds of millions of dollars.
"It's taking too long for new medicines to reach patients suffering from chronic diseases. With Parkinson's, for example, it has been 40 years since a breakthrough therapy came to market. Even with considerable interest and investment in the field, we still don't have a drug or device that slows or stops the progression of this unrelenting disease. Patients do not have time to wait," said Mary Richards, director of government relations for the Parkinson's Action Network. "Clearly, the drug development and approval process must be improved and modernized to meet the country's growing health care needs."
In an attempt to begin to address this challenge, the Food and Drug Administration (FDA) has launched the Critical Path Initiative (CPI), a multiyear program to modernize the scientific process through which a newly discovered drug or medical device gets to the pharmacy shelf. Recently, the leading pharmaceutical companies have endorsed the CPI and begun partnering with the FDA on implementing the initiative.
"The Critical Path Initiative is a step in the right direction to ensuring that medicines, medical devices and other treatments are approved as quickly and safely as possible to help people better manage their health," said Richards. "Critical Path holds great promise for the millions of Americans with chronic disease."
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