EVENTS

Date:	Thursday, March 13, 2008 - Friday, March 14, 2008
Location:	Wohlstetter Conference Center, Twelfth Floor, AEI 1150 Seventeenth Street, N.W., Washington, D.C. 20036

 

FDA's Regulatory Changes Will Be Science-Based, Commissioner Says

 

 

WASHINGTON, MARCH 14, 2008 -- The Food and Drug Administration (FDA) must change to respond to innovations in cancer therapies, FDA commissioner Dr. Andrew C. von Eschenbach said at AEI on Thursday. But he cautioned that regulators must maintain safeguards on drug approval. Much of the recent public scrutiny of the FDA has concerned the agency's handling of drug safety, but too little attention has been given to the apparent decrease in the number of innovative new cancer therapies being brought to market in the past several years due to the higher regulatory burdens being placed on new cancer products.

Von Eschenbach spoke at an AEI/University of Chicago Law School conference at which academics, medical researchers, and former FDA commissioners evaluated and critiqued the FDA review process for cancer drugs. In a talk imbued with the theme of "change," he offered the agency's perspective on the institutional changes he is making to better address growing challenges, such as developing better scientific tools for evaluating new drugs, improving the agency's ability to recruit and retain scientific staff, and taking new steps to give better assurances that the products FDA approves are safe.

"We have to address the fact that in order to change the process of cancer we may need to change the process of how we go about discovery, development and delivery," he said. "And those changes in that process include changes that have to occur within the regulatory framework."

Although oncology drugs often receive "accelerated approval" and "orphan drug" designations to accelerate their entries into the market, U.S. clinical development took one and a half times longer on average for oncology drugs than other drugs approved from 1990 to 2005, according to data presented at the conference. Only 8 percent of oncology drugs that enter the first phase of review are actually approved, compared to 20 percent for drugs in other therapeutic categories.

Conference speakers attributed these trends to regulatory shortcomings, such as the use of outdated statistical methods in clinical trials, a reluctance to use measures of tumor progression rather than measures of survival (which often require clinical trials to be longer and to enroll many more patients), too few patients willing to enter clinical trials, and the FDA's movement away from making more robust use of accelerated approval, which enabled products to come to the market more quickly in the past.

Von Eschenbach stated that although there may be some advantages to using progression-free survival as an "endpoint"--that is, a particular target in clinical trials--the science must be developed to ensure that the endpoints are meaningful, not arbitrary. He said that the regulatory process does not need to be a "retardant" to progress and the development of safe and effective new products--as long as regulators rely on good scientific tools for evaluating new products. He affirmed the FDA's "openness to examine new endpoints, new ways of arriving at those endpoints, and new scientific tools that will give us the certainty that's required to make a regulatory decision."

"Where science leads us will be what we will do," he added. The commissioner said the FDA will take other steps to make its regulatory approach more efficient and risk based:

• Increase the FDA's involvement in post-market surveillance and efforts surrounding "pharmacovigilance." He noted that the agency should expand its role in the "total life cycle" of the products that it regulates.
• Increase and rebuild FDA's workforce through new initiatives such as the launch of a credentialed FDA fellowship program that will train more than two thousand fellows in two years with curriculums in FDA law, science, policy, and practice. The FDA hopes to recruit up to 20 percent of these fellows to remain in careers at FDA.
• Spend $250 million to modernize the agency's information technology infrastructure, including its programs and systems.
• Open FDA offices in foreign countries that import large volume of products into the United States, an initiative aimed at encouraging more cooperation between nations for the oversight of products being marketing worldwide.

--KRISTY HAWLEY

For video, audio, and more information about this conference, visit www.aei.org/event1666/.

AEI's Scott Gottlieb and John E. Calfee research the FDA's structure and performance, particularly FDA oversight of oncology drug development.

• Gottlieb has written about the FDA's efforts to "manage" drug risks.
• Calfee has examined the FDA's drug safety oversight process.

For more information about AEI's Health Policy Studies program, visit www.aei.org/health/ or contact Kristy Hawley at kristy.hawley@aei.org or 202.8625920.

For media inquiries, contact Véronique Rodman at vrodman@aei.org or 202.862.4870.

###