U.S. federal drug regulators approved 35 drugs in fiscal 2011, a near decade record only beat in 2009, according to a report released Thursday.
The Food and Drug Administration's annual report released Wednesday included several innovations including two breakthroughs in personalized medicine, seven cancer treatment drugs and 10 drugs for rare diseases that typically lack therapies.
Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients, Commissioner of Food and Drugs Margaret Hamburg said in a statement.
Nearly half the drugs came under priority review, a system that pushes approval to within a six-month window, the report stated.
The majority of drugs, two thirds, took a single review before approval without the FDA requiring any additional information.
The accelerated drug approval process stems from The Prescription Drug User Fee Act that Congress passed in 1992.
Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere, said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy.
The law expires on Sept. 30, 2012, however, the FDA released a plan in October to help small entrepreneurs develop drug.
The increased drug approval comes at a time when the entire pharmaceutical industry is on the rise.
Dow Jones U.S. Pharmaceuticals Index increased nearly 13 percent between the beginning of fiscal 2010 and the end of fiscal 2011. The index peaked on Dec. 29, 2000 at 414.57 before plunging in mid-2002, plateauing for much of the decade and reaching a historic low of 179.85 on March 6, 2009. Since then, the index increased 46 percent.