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
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 email@example.com