Drug Companies Less Innovative, Spend More Money, GAO Finds
Pharmaceutical companies are submitting fewer drug applications to FDA while spending more money to develop new drugs, according to a report released Tuesday by the Government Accountability Office, the Washington Post reports.
The report found that the pharmaceutical industry's annual research and development spending increased by 147% to $60 billion from 1993 through 2004. During the same period, the number of drug applications to FDA increased by 38%, the study found.
The report also found that the number of applications by drug companies to FDA generally has been declining since 1999. In addition, about two-thirds of new drug applications submitted to FDA represented modifications of existing drugs, while 32% of applications represented innovative medications, GAO said.
Investigators identified several reasons for a reduction in the number and types of new drugs -- including a growing difficulty in translating basic research into effective medicines; a shortage of physician-scientists who have both medical and research expertise; and an emphasis on developing "blockbuster" drugs that bring in substantial profits, which has reduced the amount and types of new products. GAO also found that the pharmaceutical industry increasingly has been trying to develop treatments for complex diseases such as cancer, which have higher failure rates.
"Over the past several years it has become widely recognized throughout the industry that the productivity of its research and development expenditures has been declining," the report stated, adding, "That is, the number of new drugs being produced has generally declined while research and development expenditures have been steadily increasing."
The three Democratic lawmakers who requested the report -- Rep. Henry Waxman (Calif.) and Sens. Richard Durbin (Ill.) and Edward Kennedy (Mass.) -- said the findings indicate that the drug development process should be re-examined.
Durbin in a statement said the findings "raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market. Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs."
Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said the report confirms that creating effective new drugs has become more difficult and more expensive. Johnson added that 300 new drugs have entered the market in the past 10 years and that 2,000 others currently are in development.
Johnson in a statement said, "There should be no doubt that recent biopharmaceutical advances mean new hope for patients suffering from life-threatening diseases so that they can live longer, healthier lives" (Lee, Washington Post, 12/20). An abstract of the report is available online.