Last week, the US Food and Drug Administration issued a press release lauding its approval of 35 new prescription medications in FY2001. According to the release 2011 was a banner year for drug approvals; being only surpassed in FY2009 when 37 new medicines garnered regulatory approval.
FDA detailed its accomplishments in a report entitled “FY2011, Innovative Drug Approvals” which touted faster approval times in the United States as compared with the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.
Among this year’s highlights:
- Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
- Seven of the new medicines provide major advances in cancer treatment;
- Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
- Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
- Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
- Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
- Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program
- Thirty-four of 35 were approved on or before the review time targets agreed to with industry under The Prescription Drug User Fee Act (PDUFA), including three cancer drugs that FDA approved in less than six months.
PDUFA was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012.
Maybe the agency can keep its streak alive before PDUFA expires next year!
Until next time...
Good Luck and Good Job Hunting!!!!!