New Drugs Are Taking Longer to Bring to Market in the U.S., According to Tufts Center for the Study of Drug Development

Longer clinical times are extending the time it takes to bring new prescription drugs to market in the United States, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.

The study found that new medicines which win approval from the U.S. Food and Drug Administration (FDA) required an average of 8.5 years to move through the clinical and approval phases in the 2002-2004 period.

This contrasts with a steady decline in combined clinical and phase times since passage of the Prescription Drug User Fee Act of 1992 (PDUFA) — from a high of 9.4 years in 1990-1992 to 7.2 years in 1999-2001, according to the Tufts CSDD analysis.

Tufts CSDD Director Kenneth I Kaitin said lengthening average clinical phase times had offset the gains made by shorter approval phase times since passage of PDUFA.

He added that the number of new drug approvals by the FDA has fallen and that average clinical times for priority drugs are at their longest since before enactment of PDUFA.

“As drug development becomes more complex and expensive, developers tend to concentrate available resources on fewer projects,” said Kaitin. “Fewer development projects, in turn, lead to fewer new drug approvals.”

PDUFA, which generally has been considered a success, allows the FDA to collect fees from drug companies to be used, in part, to hire additional reviewers and improve the drug review process. PDUFA was reauthorized in 1997 and again in 2002.

            AVERAGE CLINICAL AND APPROVAL TIMES FOR NEW DRUGS                  APPROVED FOR SALE IN THE U.S. (Years)           1984-86  1987-89  1990-92  1993-95  1996-98  1999-01  2002-04 Clinical   Phase     6.0      6.3      6.8      7.2      6.4      5.8      7.0 Approval   Phase     3.0      2.9      2.6      2.0      1.4      1.4      1.5  TOTAL TIME 9.0      9.2      9.4      9.2      7.8      7.2      8.5   The Tufts CSDD analysis, summarized in the November/December Tufts CSDD Impact Report, also found that:      — After a spike in new drug approvals in 1996-1998, due in part        to the FDA’s clearing its backlog of applications, total         approvals dropped 47% through 2002-2004.     —  Clinical phase times have increased for most therapeutic areas        between 1999-2001 and 2002-2004.     —  In recent years, drugs for neuropharmacologic diseases have        taken the longest to develop and bring to market. 

About the Tufts Center for the Study of Drug Development

The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter providing analysis and insight into critical drug development issues.