More research money doesn't mean more new drugs

A government report finds that pharmaceutical development is stagnating despite billions being spent.

By Victoria Stagg Elliott, AMNews staff. Jan. 29, 2007.

The amount of money spent by the pharmaceutical industry to research and develop medications has increased dramatically, but the number of novel treatments put forward for Food and Drug Administration approval has grown at a far slower rate. This circumstance is particularly true if the product is not related to one already on the market, according to a Government Accountability Office report published in November and distributed in December 2006.

Specifically, the report found that, from 1993 to 2004, R&D funding increased 147% while new drug applications went up 38%. The growth for new molecular entities was only 7%. These numbers lead some experts to express concern that business priorities and the regulatory environment are supporting development of drugs similar to what is already on the market at the expense of therapies that fill a more urgent need.

"Me-too drugs are safer bets. There's a blockbuster mentality that does divert resources from innovation," said David Korn, MD, senior vice president of biomedical and health sciences research at the Assn. of American Medical Colleges. He was a member of the expert panel convened by the National Academy of Sciences for this project.

This report is the latest of several in recent years from government agencies and medical societies finding that the process to develop novel therapies is stagnant. The AAMC issued findings in conjunction with the FDA in January 2005 and blamed several factors. For instance, easier drug targets have been dealt with and remaining ones are more complicated to tackle -- requiring more time and investment before payoff.