FDA drug approval at lowest rate Since Vioxx withdrawal, only 37 treatments received federal OK

The Star Ledger, New Jersey
BY GEORGE E. JORDAN
Star-Ledger Staff
Thursday, January 04, 2007
http://www.nj.com/business/ledger/in...140.xml&coll=1

As the American pharmaceutical industry grapples with layoffs and spending cuts, newly released statistics show drugmakers continue to struggle with the discovery of blockbuster medicines.

The Food and Drug Administration approved only 17 new drugs last year, matching the lowest number of newly approved compounds since the peak of 53 approvals a decade ago.

The latest figures mean the FDA has approved only 37 drugs in the two years since the 2004 withdrawal of Vioxx. That compares with 36 approvals the year Merck pulled the painkiller from the market and an average of 28 new drug approvals annually in the years before Vioxx.

The dearth of new medicines, which pushed drugmakers in recent years to spend a record $40 billion annually on research and development, has left many of the big pharmaceutical companies whipsawed by flat sales and earnings and fierce generic competition for older medicines.

"The industry is still suffering from very significant pipeline problems. The short-term future does not look tremendously promising for the pharma industry," said Kenneth Kaitin, director of Tufts University's Center for the Study of Drug Development.

Despite the industry's woes, the Tufts center yesterday released an optimistic report that forecasts FDA approvals will rebound sharply by 2010 as some of the 2,000 drug candidates in early clinical trials -- one in five of them discovered by small biotechnology companies -- come up for final FDA approval.

In a desperate hunt for new products, hardly a week passes that New Jersey's prescription drug icons -- including Pfizer, Schering-Plough, Merck and Johnson & Johnson -- do not announce a merger or co-agreement with an upstart biopharmaceutical company that has discovered what is billed as the latest and greatest new product.

Merck, based in Whitehouse Station, was the only drugmaker to win FDA approval of two compounds, cancer therapy Zolinza and diabetes pill Januvia.

The Pharmaceutical Research and Manufacturers of America, the industry's leading trade group, said the drought of FDA approvals was cyclical and drugs under development include 646 new treatments for cancer, 146 for heart disease and stroke, 77 for HIV/AIDS and 56 for diabetes.

"There would be a much greater concern if there were a few number of compounds going into trials," said Alan Goldhammer, a deputy vice president at PhRMA.

In recent years, several high-profile treatments have proven ineffective or dangerous in large-scale, late-stage clinical trials. The arduous process costs upward of $1.5 billion per medicine and takes as long as 15 years to bring a compound to market.

No recent failure was more stunning than torcetrapib, a heart pill abandoned by Pfizer last month after it was linked to deaths and other cardiovascular problems. Pfizer, which billed the drug as a revolutionary new treatment for diabetes and heart disease, had planned to seek FDA approval of the tablet this summer. The company spent $800 million just on clinical trials.

Some industry observers say one reason for the low number of new drug approvals is that the FDA has tightened the reins since the Vioxx debacle.

But consumer advocate Sid Wolfe, director of Public Citizen's Health Research Group, said the FDA has not cracked down so much as large pharmaceutical drug discovery has floundered.

"The number of real innovations for diseases that never had a treatment before or drugs that are really better, there is just not much there," Wolfe said. "There just are not a lot of innovations lately."

George E. Jordan may be reached at gjordan@starledger.com or (973) 392-1801.

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Prescription Drugs: FDA Approved 17 New Prescription Drugs in 2006,
Lowest Approval Rate Since New Drug Approvals Peaked at 53 a Decade Ago
Kaiser Daily Health Policy Report
Thursday, January 04, 2007
http://www.kaisernetwork.org/daily_r...41936&dr_cat=3

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