GAO: FLAWED DRUG DEVELOPMENT SYSTEM NEEDS CHANGES
A new congressional report has concluded that the drug industry's increasing investment in R&D is not resulting in sufficient increases in the new drug pipeline and structural changes are necessary to fix a "stagnant" system.
While drug companies are spending more on R&D, the number of new drug applications (NDAs) submitted to and approved by the FDA has "not been commensurate with these investments," the Government Accountability Office (GAO) said in the Dec. 19 report.
The industry increased its R&D spending from $16 billion in 1993 to nearly $40 billion in 2004, a 147 percent increase, the report found. However, the number of NDAs submitted to the agency increased by just 38 percent during this time. Furthermore, the number of applications for new molecular entities (NMEs) increased by only 7 percent during this time. The report also found that most NDAs were for non-innovative drugs, also known as "me-too drugs."
"These submission trends indicate that the productivity of research and development investments has declined," the report, "New Drug Development: Science, Business, Regulatory and Intellectual Property Issues Cited as Hampering Drug Development Efforts," said.
Democratic lawmakers are using the report to criticize the drug industry. Sens. Dick Durbin (D-Ill.) and Edward Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.), who requested the study, argue that the report contradicts industry's basis for rising drug costs.
Kennedy used the report to support his call for the FDA's Critical Path Initiative, which is focused on improving drug development.
But HHS differed with these findings on two points. The agency disagreed with the report's premise that a product with an NME was more innovative than products not containing NMEs. Such a characterization is "misleading," the agency said in an Oct. 20 letter to the GAO. "Being an NME in and of itself does not mean innovation." Many times, an NME is just a minor modification to an existing product, the agency said.
HHS also concluded that statutory changes would be necessary to implement the recommendations on changing the FDA's regulatory process. Allowing drug approvals using fewer numbers of patients would probably "require statutory change," the agency said.
Industry officials said they were unable to respond to requests for comment.
The GAO report is available at www.gao.gov/new.items/d0749.pdf (http://www.gao.gov/new.items/d0749.pdf).