PA) - In the May 3 issue of the Journal of the American Medical
Association, Brian L. Strom, MD, MPH, Professor
of Public Health and Preventive Medicine and Chair of the Department
of Biostatistics and Epidemiology at the University of Pennsylvania
School of Medicine, analyzes the limitations of the current
system of drug-safety monitoring and proposes a solution that addresses
overly aggressive early marketing practices; an absence of incentives
to complete post-marketing safety studies; direct-to-consumer (DTC)
advertising that can promote non-critical use of "blockbuster"
drugs; the current trend toward delaying drug approval; and public
misunderstanding about the safety of drugs. As Strom writes, “the
net effect of [the current system] is that the public misunderstands
drug safety, believing that a drug is safe at the time of marketing,
while [adverse] events occurring as frequently as 1 in 1000 are
Strom proposes an alternative approach with three elements: conditional
approval, an empowered US Food and Drug Administration (FDA), and
a complementary nongovernmental organization.
When a drug is initially approved, it should ideally enter a period
of conditional approval, he says. In this period, marketing, especially
DTC, would be restricted. Drug labels would need to be clearly marked
that the drug's approval is conditional and has only been studied
in a limited number of patients. Removal of label caveats would
depend on the outcome of subsequent studies and their findings,
depending on the numbers of individuals in the studies, and the
risk and novelty of the drug, as well as addressing all premarketing
“The current system is moving toward a delay in drug approval,
still followed by optional postmarketing studies,” notes Strom.
“Instead, the proposed approach would be conditional approval
followed by postmarketing studies required before the condition
Secondly, Strom maintains that the FDA needs an increased ability
to regulate drugs after marketing, so that it can require post-marketing
studies and labeling changes as a rule, rather than those changes
being subject to negotiation between the regulatory agency and industry.
It also needs substantially more resources for the postmarketing
study of drug safety.
Strom concludes by proposing that an independent, nongovernmental
organization is needed for nonregulatory tasks that are not within
the mission of the FDA. Since many of these tasks are academic in
nature - for example, performing postmortem examinations in the
event of drug disasters or developing new pharmacoepidemiological
methods - he suggests that the Agency for Healthcare Research and
Quality (AHRQ)-funded Centers for Education and Research in Therapeutics
(CERTS) or the Institute of Medicine (IOM) might play a role.
“A key benefit of this proposed approach for the public would
be that drug use immediately after marketing would be reduced to
those who truly need the drug, in whom the risk-benefit balance
in the face of uncertainty is more favorable,” Strom says.
Financial Disclosures: Strom receives funding from the
National Institutes of Health; the AHRQ (including CERT funding,
DEcIDE [Developing Evidence to Inform Decisions about Effectiveness]
funding, and patient safety funding); has received grants and served
as a consultant to most major pharmaceutical firms; and is an FDA
Special Government Employee for serving on FDA advisory committees.
There was no funding support for the work presented in this article.
Previous Presentation: These ideas were presented as an
invited talk at the IOM annual meeting, October 23-24, 2005, Washington,
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