Bugs in the Drug Approval Process

The Washington Times (Washington, DC), April 13, 2003 | Go to article overview

Bugs in the Drug Approval Process


Byline: THE WASHINGTON TIMES

There's never been a greater need for new pharmaceuticals. The SARS outbreak is still burning and strains of known pathogens continue to develop resistance to conventional antibiotics. Above that hangs the terrible potential embodied by a terrorist armed with a vial of anthrax or smallpox.

Yet, countering such potential catastrophes has rarely been more problematic, since the flow of new drugs to the market has become so sluggish. According to Dr. Mark McClellan, the commissioner of the Food and Drug Administration (FDA), the agency's approval of new medicines is at its lowest level in a decade it gave approval to only 21 new drugs last year, less than half of what it approved in 1996. The FDA only approved 12 new biological licenses last year 27 were approved in 1998.

One particularly alarming area that this slowdown has showed up in is in the development of antibiotics. Only two new classes of antibiotics have emerged in the last 30 years, and resistance to one class had developed before the drug was formally approved, according to a recently published study from the National Academy of Sciences, "Microbial Threats to Health: Emergence, Detection and Response." The study also pointed out only four companies with extensive antibiotic development programs remained in existence in 2002, and there are exactly zero new classes of antibiotics currently in advanced development.

As worrisome is the fact that many of the existent countermeasures to bioterrorism are based on old technology. The smallpox vaccine hasn't been improved in decades, and Dr. McClellan noted in a recent speech that the "currently-available antitoxin to botulism is based on a technology available when the FDA came into existence in 1906."

Money is a major reason. Research by the Tufts Center for the Study of Drug Development (CSDD) showed that bringing a new drug to the marketplace costs about $802 million and takes between 10 and 15 years. While biomedical advances have been phenomenal over the last years, they have not made for a more certain drug discovery process the Tufts study determined that, on average, only one of every 1,000 potential medicines make it to clinical trials. Typically, only one of the five finalists will make it into medicine cabinet. …

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