The Food and Drug Administration has halved its approval time for new drugs since 2009, as illustrated in a colorful new infographic from the California Life Sciences Association and Boston Consulting Group.
Indeed, in 2009 the typical drug approval time was 21 months. Last year, it was 10 months. Not surprisingly, the fastest approvals go to drugs in the oncology, infectious disease and rare disease spaces. However, drugs treating diseases of the endocrine, gastrointestinal and central nervous systems are still in need of faster approval times.
The reason for the overall speeding of drug sanctions? The impact of the “Breakthrough Therapy Designation” that stems from 2012’s FDASIA, which allows for review timelines to be shortened to 60 days for certain submissions. Most breakthrough therapies are, of course, in the oncology, infectious disease and rare disease spaces. Here’s a breakdown of the breakthroughs:
Cancer drugs are most commonly submitted for review to the FDA – and the most quickly reviewed, the report says. Cardiovascular drugs are, a bit surprisingly, a bit less common. Here’s the breakdown:
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.
