More disclosure
The FDA plan addresses many of the IOM recommendations for improving how it assesses and communicates risk information, although
not always in the way the expert panel suggested. Experts have clamored for FDA to make public more drug-safety information
from postapproval studies and adverse-event reports, but industry has opposed the idea of posting emerging safety information
before it is fully evaluated by sponsors and regulators. Instead of launching a "Drug Watch" Web site that would have posted
emerging safety information, FDA now proposes to publish an on-line newsletter with summaries of FDA postmarketing drug reviews,
new safety concerns, and information about newly approved products. The postings will be cleansed of confidential commercial
information, however, and FDA does not plan to disclose supplement reviews.
Fees for safety
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Instead of establishing some kind of conditional approval for new drugs, which probably requires legislative change, FDA is
launching a pilot plan to re-evaluate newly approved drugs after a year on the market. The agency will review adverse-event
reports and additional information for two or three NMEs in a pilot program that will issue its first assessments in about
18 months. The reports will be made public, and the pilot could be extended to all new drugs if it succeeds in providing a
more complete picture of safety issues throughout the product life cycle.
A central issued raised by the IOM is that CDER's pro-approval culture relegated safety reviewers to a secondary role in evaluating
the risks and benefits of new drugs. Galson plans organizational changes that will give CDER's Office of Surveillance and
Epidemiology staff a clear role in approving new drug applications (NDAs) and requesting postmarket studies and future label
changes. Each new drug-review office will have a high-level safety manager, and a new electronic tracking system will integrate
multiple agency databases.
A leading legislative proposal requires all NDAs to include risk-management plans, and the IOM report urges further evaluation
of such approaches. FDA says it will assess the effectiveness of RiskMAPS and publicly review one or two risk programs every
year to better determine whether RiskMAPS or other approaches can improve public awareness of serious safety issues.
FDA also is expanding programs to use emerging electronic health-information systems to gain more information about drug use
and health outcomes. The agency is collaborating with the Veterans Administration, Medicare, and other government agencies
to access data on medical-product use in federal healthcare systems. A proposed FDA Sentinel Network would link private and
public databases to establish a national medical-product safety network.
Stress on science
An underlying theme of FDA's drug-safety program is that new developments in biomedical science can detect risk issues early
in development. FDA Deputy Commissioner Janet Woodcock, now the agency's chief medical officer, heads a range of efforts to
accelerate risk assessment by sponsors and FDA, many launched under the Critical Path Initiative.
For example, FDA is collaborating with industry and academia about developing new tests for organ toxicity and for identifying
the cardiovascular risk of drugs. The Predictive Safety Consortium is sharing data to crossvalidate preclinical safety biomarkers.
Another consortium of manufacturers, FDA, and the National Institutes of Health (NIH) plans to assess biomarkers that can
spur development of new treatments, beginning with lung cancer and lymphoma. And, a new Serious Adverse Event Consortium seeks
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 efforts to improve clinical-program success rates and reduce development time and cost were described in FDA's Critical
Path Opportunities List, which was issued in March 2006 and updated in a January 2007 report on collaborations and research
activities undertaken in 2006. The aim is to "build safety into products" by better understanding the genetic basis of adverse
events, explained Woodcock. These approaches can screen out toxic compounds early on and identify patients most likely to
have adverse events—or to respond well—to a test medicine. FDA, she said, wants to "make products safer from the get-go."
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