April 12, 2006

Despite the push to implement a personalized approach to developing new medicines, the FDA faces numerous obstacles to doing so, including privacy concerns, financial limits and regulatory roadblocks, HHS Secretary Mike Leavitt said.

The agency wants to change the face of medicine, moving toward drugs and biologics that are developed to treat specific subsets of the population, and it has the full support of the pharmaceutical and biotechnology sectors. But in order for this approach to become a reality, the agency needs to change the way it operates and companies need to change the way they finance these projects, he told attendees at the Biotechnology Industry Organization (BIO) annual conference in Chicago.

The next decade will be "a signal point that transforms medicine," ushering in "the era of patient-centered care," said Leavitt, but agency and industry approaches to drug development must change. "Our current system is remarkably inexact and frustratingly slow. We need better tools."

Leavitt pledged to focus on this issue over the next 1,000 days. Personalized medicine "will be my focus" during this period, he said. As part of this effort, Leavitt has convened a team of officials within the Office of the Commissioner to study the issue. Leavitt also pledged to use HHS resources to serve as a rallying point behind this effort to change the regulatory structure.

But the main obstacle to reaching personalized medicine may be privacy concerns on the part of the public. Privacy is "one of the most pressing questions" personalized medicine will face, Leavitt said. "It will not be the technology or the science that limits us; it will be the sociology that limits us."

The agency must explain the benefits of people providing their specific genetic information to the FDA to overcome fears about the data being misused, he added. "If we're not fully confident in the security of our data, people are not going to participate. It's as simple as that."

The Office of Human Research Protections within HHS has also raised this privacy concern, Doug Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research (CDER) told FDAnews. One solution is to make sure the parties collecting this genetic data know how the agency will use it.

New financing mechanisms will also be necessary to make personalized medicine a reality, Leavitt said. For example, companies could sell shares of precompetitive compounds to fund research, Leavitt added.

There also need to be major changes in the way clinical trials are conducted. Currently, these trials are too long, expensive and inexact, Leavitt said. The cost and time involved precludes many new drugs from being developed. In the future, the "painstaking plodding of trial-and-error that characterized clinical trials in the past will be transformed into a six-month sprint," he said. (http://www.fdanews.com/did/5_72/)