Streamlining research
An important promise of an efficient and active postmarket surveillance system is that it will support FDA approval of more
new drug applications. If the regulators can expect that safety problems will be identified quickly and appropriately after
a drug goes to market, they may be more willing than before to approve a market application for a product that raises some
risk concerns. The hope is that the Sentinel System will give the public and FDA officials more confidence about approving
innovative and targeted medical products.
A related benefit of effective surveillance similarly could be to reduce the time and expense of pharmaceutical research and
development. Phase III studies are large and costly because they are needed to address safety issues about drugs, McClellan
points out. But a robust system for monitoring how drugs are used by patients, he says, "takes off some of the pressure on
Phase III studies to address all the safety issues before a drug comes to market."
Pharmaceutical marketers are nervous that earlier and broader assessment of postmarket data will yield false negatives that
set off alarms on every new drug. But FDA officials believe the Sentinel System may reduce the need for some postmarketing
studies as health-system information demonstrates its ability to identify safety concerns. Expanded postmarket assessment
may allay concerns about the safety of a new drug or vaccine that are raised in prelicensure studies, said CBER Director Jesse
Goodman: "The data can cut both ways." Instead of requiring a manufacturer to sponsor a long list of postmarket clinical studies,
FDA reviewers may call for six months or a year of database monitoring for certain anticipated safety concerns.
In the future, it may be possible to monitor medical-product safety through a Nationwide Health Information Network that connects
clinicians, consumers, and providers across the healthcare system. Government agencies such as FDA would have access to data
for public-health purposes, but would have to address privacy issues and ensure that health-information exchanges are secure.
FDAAA instructs FDA to examine methods for ensuring the privacy, confidentiality, and security of patient information in establishing
an active postmarketing risk-identification and analysis system, an issue that the Government Accountability Office will report
on next year.
A linked system would provide a broader picture of a health problem and improve tracking of patients that shift to different
healthcare providers, Woodcock noted at the Brookings forum, but it also would require a higher level of consent and transparency.
"This could be something for the future," Woodcock said. "We would not do this to start, but don't want to rule it out."
Effective communication about safety signals from interim results will be a challenge, as will efforts to provide adequate
and sustained financial support for what will be a costly undertaking. These are issues that FDA and its Sentinel partners
will address, as well as concerns related to scientific accuracy and data reliability, said von Eschenbach at the Brookings
forum. He emphasized that it is important not to regard every problem as a "fatal flaw" in an active surveillance system.
FDA is not implementing the Sentinel System "solely because Congress told us to, but because it's the right thing to do,"
he asserted. "FDA must, will, and needs to do this."
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com
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