SAFETY CONCERNS MAY CURB DRUG INDICATION EXPANSIONS, SAYS REPORT
Safety concerns are setting up new barriers for drug indication expansions,
according to a recent report by industry analyst Datamonitor.
"Recent high-profile drug safety concerns are also threatening to reduce
the potential for companies to profit from off-label use of their products in
an expanded patient population," Datamonitor analyst Adele Schulz said
in the report.
This poses a problem because "some of the most successful forays of products
into new indications in recent years have been driven by off-label usage,"
Schulz said. For example, the success of blockbuster cancer drug Rituxan (rituximab),
which is jointly marketed by Genentech, Biogen Idec and Roche, largely stems
from off-label prescribing to leukemia patients, Schulz said.
In the wake of recent drug safety scares such as the late-2004 withdrawal of
painkiller Vioxx, the FDA plans to ramp up drug safety regulation with a number
of reforms, including the Drug Watch website, which Schulz said "may have
particular implications" for off-label prescribing because it will draw
attention to "adverse events experienced during off-label use of products."
The FDA may also "become more active in enforcing penalties for breaching
of its guidelines to industry," Schulz added.
Meanwhile, the UK Parliament's Select Health Committee this year issued a report
recommending that clinical trial results one of the main ways drug companies
encourage off-label drug use be published in an "independent register"
so as to "avoid publication bias," the Datamonitor report said.
Moreover, new U.S. and EU regulations have curbed brand drugmakers' ability
to extend drug lifecycles through on-label indication expansion. The Medicare
Modernization Act of 2003, for example, now limits brand drug companies to one
30-month stay of generic approval per product rather than multiple stays. In
Europe, new regulations prevent drug companies from filing for new indications
in different European markets to fend off generic competition, Schulz said.
In this new environment, drug firms should plan and implement indication expansions
earlier than they do now, and look at indication expansion as a "mid-lifecycle
ROI [return on investment] boosting strategy," rather than a "late-lifecycle
generic defense strategy," the report said. Drugmakers will also switch
from indication expansion to indication "targeting," Schulz said.