- U.S. Food and Drug Administration Approved 30% More Drugs in 2012

NEW YORK, NY (Marketwire) 02/08/13 A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index (IBB), the SPDR S&P Biotech ETF (XBI) and the First Trust Amex Biotechnology Index ETF (FBT) have all gained over 20 percent in the past year, outperforming the broader markets by a good margin. Research Driven Investing examines investing opportunities in the Biotech Industry and provides equity research on Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) and Santarus, Inc. (NASDAQ: SNTS).
Access to the full company reports can be found at:
www.RDInvesting.com/OPTR
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Bloomberg recently reported drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago. Oncology drugs lead the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.
The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman, Sandy Walsh. "These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of FDA's drug review staff."

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FDA Urged to Speed Approval of Drugs

LIFE & CULTURESeptember 25, 2012, 7:06 p.m. ET 

By THOMAS M. BURTON

A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.

The President's Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called "special medical use" approvals.

The advisory report gave few details of what new laws or regulations might be required to limit a new drug's use to such populations. Historically, the FDA doesn't attempt to police how doctors use drugs, though companies' marketing is restricted to the conditions specified on the label.

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