Washington Report: Safety First - Pharmaceutical Executive

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Washington Report: Safety First
FDA seeks to regain public trust by making drug-safety information more transparent—and to head off more stringent legislation in the process. wave of collaborations between industry, non-profits, and government seeks affordable treatments for neglected diseases around the world.


Pharmaceutical Executive


Another hot issue is how to ensure the independence of FDA advisory committees. These panels were attacked as industry pawns during the Vioxx (rofecoxib) controversy. FDA's response is to establish clearer procedures for dealing with conflicts of interest, for presenting postmarket safety issues to advisory committees, and for bringing additional pharmacoepidemiology experts into advisory committee meetings that deal with safety issues. FDA also is establishing a new advisory committee on communication to gain more outside expertise on risk and crisis communication. These moves may not satisfy those who want to rid the committees of all experts with industry ties, but FDA hopes that more transparent procedures will address the most important concerns.

A central issued raised by IOM is that CDER's culture is pro-approval and has relegated safety reviewers to a secondary role in evaluating new drugs. Instead of establishing a separate drug-safety office, CDER director Steven Galson plans organizational changes to give CDER's Office of Surveillance and Epidemiology (OSE) greater authority for approving NDAs and requesting post-market studies and label changes. Each new-drug review office will have a high-level safety manager; meanwhile a new electronic tracking system will integrate multiple agency databases.

Stress on Science

An underlying theme of FDA's drug safety program is that new developments in biomedical science and information technology can provide more efficient ways to address drug safety early in drug development and to quickly detect safety problems after a drug goes to market. FDA deputy commissioner Janet Woodcock, now the agency's chief medical officer, heads up a range of efforts, many of them launched under the Critical Path Initiative, to accelerate risk assessment.

Collaborations involving FDA, industry, and academia, for example, are developing new tests for organ toxicity and cardiovascular risk. The Predictive Safety Consortium is sharing data to cross-validate preclinical safety markers. Another consortium of manufacturers, FDA, and the National Institutes of Health plans to assess biomarkers that can spur development of new treatments, beginning with lung cancer and lymphoma. And a new Serious Adverse Event Consortium plans to identify and validate genetic variants that may help predict the risk of drug-induced reactions, starting with liver disease and serious skin rashes.

These and many other initiatives are described more fully in a January report from FDA on progress made in implementing Critical Path opportunities during 2006. The goal is to "build safety into products" by better understanding the genetic basis of adverse events, explained Woodcock. This approach can screen out toxic compounds early on and identify patients most likely to have adverse reactions—or to respond well—to a test medicine. The aim, she said, is to "make products safer from the get-go."

At the same time, electronic health information systems provide new opportunities for FDA and manufacturers to tap into richer information sources on drug utilization and health outcomes. FDA now is collaborating with the Veterans Administration, Medicare, and other government agencies to access data on medical product use in public and private healthcare systems. A proposed FDA Sentinel Network would link multiple databases to establish a national medical product-safety network.

While media hype about drug safety may raise inappropriate fears in the public, that same hype also could boost adverse-event reporting and awareness of drug–drug interactions and the need to ensure proper use of medications. Woodcock envisions establishing "seamless links" to information on product use and medical consequences through electronic medical records. "As chief medical officer at FDA," she said, "I'm committed to lead in the development and use of these new tools."

Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at


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