Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
Bay Area Reporter - December 28, 2006
Bob Roehr
The General Accountability Office reached that conclusion in a report, "New Drug Development." It analyzed data from all 1,264 new drug applications filed with the Food and Drug Administration from 1993 through 2004. And the GAO spoke with numerous experts in the field. The report was released December 19.
It found that industry increased spending on research by 147 percent, to nearly $40 billion a year, but the number of new molecular entities increased by only 7 percent. Those are the new categories of drugs that often represent the greatest advance in treatment.
This was particularly troubling, the report stated, because it came during a period when completion of the human genome, advances in imaging technology, and the ability to synthesize and screen thousands of compounds for activity "created expectations that the pharmaceutical industry would soon be producing an increasing number of new and innovative drugs to more effectively treat disease."
Interestingly, the one field that showed major advances was the treatment of HIV. During that period the protease inhibitor class of drugs, as well as the fusion inhibitor Fuzeon were introduced. CCR5 inhibitor and integrase inhibitor classes of drugs are in advanced development.
The FDA approved roughly 80 percent of the drugs submitted to it. The average time to review a standard application declined form 669 days (1993) to 442 days (2002), while drugs for which there is an urgent need were submitted under accelerated approval and were reviewed within six months.
Part of the explanation as to why it is taking longer and costing more money to develop innovative new drugs is that there already are good therapies for many of the infectious diseases of the industrialized world, and pharmaceutical companies have turned to chronic diseases. These diseases often are more complex, less well understood, and it takes much longer to evaluate what, if any, impact a drug may have on them.
The report also cited business policies such as the aversion to risk, mergers within the industry, and the quest for blockbuster drugs that have the potential for sales of at least $1 billion a year as helping to drive decisions on drug development.
"This new GAO study refutes many of the pharmaceutical industry's myths about the drug development process," said Representative Henry Waxman (D-California). "Most prominently, it indicates that the link between high research expenditures - which the industry claims must be driven by high prices - and new drug development is unclear at best."
Senator Ted Kennedy (D-Massachusetts) said, "The report shows that much drug industry research doesn't translate into real breakthroughs for patients." The two congressmen asked the GAO to conduct the study.
Waxman said that many aspects of the drug development process need to be examined "to determine how to encourage research that focuses on breakthrough treatments rather than drug industry profits."
Reauthorization of the FDA is scheduled for consideration in 2007. Kennedy already has introduced his version of such a bill and both he and Waxman will play important roles in that process.
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