Skip to Content

Tufts Center says increased demand on FDA may stretch drug approval times

BOSTON, MASS., Jan. 13, 2003 -- Despite a recent drop in the time required to obtain approval to market new medicines in the U.S., drug companies may see approval times lengthen as they compete for attention from the FDA, according to the Tufts Center for the Study of Drug Development.

Facing a growing list of demands on its limited resources, the FDA will be hard pressed to meet all of them in a timely manner, said Tufts Center Director Kenneth I Kaitin.

"In addition to meeting demands for faster drug application reviews and providing greater oversight of post-approval safety data, the FDA will provide closer scrutiny to the ethical conduct of clinical trials," Kaitin said.

"The new commissioner will have the difficult task of managing the proposed transfer of oversight for biotechnology products from the Center for Biologics Evaluation and Review to the Center for Drugs Evaluation and Review, while at the same time addressing the threat of bioterrorism."

Kaitin made his comments in connection with the Tufts Center's newly released Outlook 2003 briefing on major expected, near-term pharmaceutical industry trends.

He added that the FDA faces several critical issues which will test the new commissioner's ability to respond to legislative initiatives aimed at ensuring safe drug development practices, improving the agency's internal systems, and retaining staff.

"This would constitute a full plate of activities for anyone at any time," said Kaitin.

According to the Tufts Center's Outlook 2003 report:

  • Commissioner Mark McClellan will need to focus on retaining technical staff and maintaining morale in the face of regulatory challenges stemming from pharmacogenetic/genomic information technology, drug-device combinations, and the need for improved safety and quality in clinical trials.
  • Industry advocates and critics will follow the development of a new, de facto post-approval phase of the R&D process, called the peri-approval phase, which includes post-marketing safety surveillance.
  • The FDA, as well as the EMEA in Europe, the MHLW in Japan, and the TPP in Canada, will benefit from the July 1 implementation of the Common Technical Document (CTD) guideline.

Based in Boston, Mass., and affiliated with Tufts University, the Tufts Center for the Study of Drug Development ( provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. The Tufts Center conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics.

Source: Tufts Center

Posted: January 2003