Good news (or is it?): The average U.S. Food and Drug Administration drug review time is at its lowest point this century.
A handy chart from the California Healthcare Institute and Boston Consulting Group released today at BIO 2014 in San Diego highlights the precipitous drop in the time of review and approval of drugs.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
According to the chart, FDA review times averaged 9.4 months in 2013. That’s a month-and-half faster than the previous year and nearly 66 percent faster than 2008, when it took an average of 23.8 months for an FDA drug review.
What’s more, nearly three-quarters of drugs approved last year got the OK within a year of submission, and hardly anyone had to wait more than two years, according to the chart.
So where’s the rub?
Todd Gillenwater, president and CEO at the California Healthcare Institute, noted that not all therapies are created equal. Cancer treatments easily get the fastest approvals, while central nervous system treatments will take much longer. Without a consistently fast review period, investors will be less likely to make bets on those clinical areas, Gillenwater said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“I do believe the data suggests that managerial and cultural practices differ across the agency and they should be adopted more consistently along the agency,” Gillenwater said.
Here’s another concern: Charts like this could fuel an increasingly vocal concern that drugs and devices are being being approved too quickly. A series of Journal of the American Medical Association reports earlier this year pointed out that 37 percent of drugs were approved on the basis of a single pivotal trial from 2005 to 2012.
Gillenwater said, however: “We do not believe that ‘slower means safer.’ We can, and should, have strong and rigorous science and safety standards AND efficient, consistent and predictable review processes. We believe that the recent review-time improvements are illustrative of FDA’s success in meeting that goal.”
Short answer: We do not believe that “slower means safer.” We can, and should, have strong and rigorous science and safety standards AND efficient, consistent and predictable review processes. We believe that the recent review-time improvements are illustrative of FDA’s success in meeting that goal.
Take a look at the chart and determine whether this good news has a darker lining.
