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 Currently a company with a drug approved for lung cancer must
conduct additional studies if it wants to market it for breast
cancer.
A bill drafted by the House Energy & Commerce Committee's health
panel would eliminate the need for randomized, controlled clinical
trials, the gold standard for assessing whether a product is safe
and effective.
Instead companies could submit data from observational studies, in
which researchers have no control over the experiment, ongoing
surveillance studies and other clinical experience.
"Calling for the FDA to use this data is pretty revolutionary," said
Peter Pitts, a former FDA associate commissioner for external
relations and co-founder of the industry-funded Center for Medicine
in the Public Interest. "In the past this kind of data was not
considered gold standard."
If included in the final version of the bill, known as 21st Century
Cures, "it really would allow the FDA to have a broader view of how
the drugs work in the real world," he added.
In addition, the FDA would be allowed to approve new indications
based on a review of clinical data summaries, rather than full
packages, potentially speeding up the approval time.
The bill would also require the agency to consider using real world
experience as opposed to randomized trials to support or satisfy
requirements for post-market studies.
The FDA frequently approves drugs based on "surrogate" endpoints
that are expected to reflect clinical benefits. If a drug causes a
tumor to shrink there is an expectation it could also delay
progression of the disease or prolong life.
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But companies are required to conduct additional trials to confirm
that the expected benefit actually materializes. The bill would
reduce the need for such trials.
It would also make it easier for companies to provide economic
analyses to insurance companies and others involved in
reimbursement. A company with a high-priced drug might want to show
why it is more economical than others in the long run.
An prior version of the bill was circulated for discussion earlier
this year. A parallel bill is being developed in the Senate.
(Reporting by Toni Clarke in Washington; Editing by Ted Botha)
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