New drugs cleared by the Food and Drug Administration (FDA) last year kept pace with 2008 and the number of “black box” warnings decreased, suggesting that the tougher approach to preclinical and clinical drug safety has not slowed approvals.
In the past year, the FDA also increased its use of “early communications,” a sign that the Agency is acting more quickly to address drug safety concerns. Under the current “more transparent” policy, initiated in 2007, the FDA issues warnings to the public when it first begins looking at potential side effects with a drug, even if no direct link has been established.
The Agency has increased staff and is operating within its goal of taking 10 months to review regular drug applications and 6 months for review of priority applications. Priority review is reserved for drugs that offer a major medical advancement or treat diseases with few alternate therapies. FDA’s John Jenkins, the Office of New Drugs director, told executives at an industry conference last month that the FDA is reviewing roughly 85 percent of drug applications on time.