39 New Drug Approvals by US FDA in 2012, Hit A 16-Year High
The US Food and Drug Administration (US FDA) approved a record number of 39 new drugs in 2012, marking the highest in 16 years. When compared with 39 approvals in 2012, only 30 new drugs were approved in 2011 and just 21 in 2010. In December alone, the FDA approved 8 new drugs, of which Johnson & Johnson's drug Sirturo is the first new treatment for drug-resistant tuberculosis to be released in the market in more than 40 years.
Over the last few years, major US pharmaceutical companies have lost $21 billion dollars in revenue while European businesses about $10 billion because of a recent spate of patent expirations of lucrative medications. So with cheaper generics available at a lower cost, sales of brand drugs drop sharply. However, with the recent run-up of new drug approvals by FDA, the pharmaceutical sectors are back on track and are poised for further growth, thereby making up for loss from generic competition. Analysts forecast that some medicines approved in 2012 can even become multibillion-dollar sellers.
Of the 39 new drug approvals in 2012, about 10 had fast track status that allowed them to be reviewed more quickly. FDA spokeswoman Sandy Walsh said in an e-mailed statement that the FDA could boost the new drug approvals due to the Prescription Drug User Fee Act, whereby pharmaceutical companies pay toward the drug approval process in return for the FDA to meet its regulatory deadlines. She also said, "pipeline of new drugs under development remains strong and is growing."
"The patent exposure will be less going forward, but where there is still a little bit of uncertainty is how much better the pipelines have become and how strong the recently approved products are," said Damien Conover, the director of pharmaceutical research at research firm Morningstar.