Industry Lags Drug-Development Demand Naomi Aoki
January 28, 2001
c.2001 The Boston Globe
First, the good news: Scientific advances and regulatory changes
in recent years have created an environment of innovation in the
pharmaceutical and biotech industries that is ``nothing short of
remarkable,'' according to an annual report released by the Tufts
Center for the Study of Drug Development.
Drugs for devastating illnesses such as AIDS, cancer, and
respiratory disease are reaching patients much faster than was
possible a decade ago. In some cases, companies and regulators have
shaved years off the development and approval of breakthrough
treatments.
Now, the bad news: The pace of innovation - remarkable though it
may be - still can't keep up with the increasingly demanding
business of drug discovery and development, the report said.
While treatments for some illnesses reached the market faster,
drugs for heart disease, diabetes and chronic pain, among others,
did not. Research and development costs increased. Biotech
products, once considered quicker to develop than traditional
pharmaceuticals, are no longer winning the race to market.
And, Kenneth Kaitin, the Tufts center's director, said lawmakers
are likely to reverse some of the regulatory changes that helped
speed drug approvals in the face of growing public concern over the
safety of rapidly approved drugs and rushed clinical trials.
To make matters worse, all this is happening at a time when
pharmaceutical companies are coming under increasing pressure from
the public to produce lower priced drugs and from investors to turn
out an ever-steadier stream of blockbuster drugs.
``The pharmaceutical and biotech industries realize they are
heading into difficult territory,'' Kaitin said. ``They are trying
to achieve efficiency through better technologies, improved
recruiting of patients for clinical trials, and by streamlining
research. But the overall time it takes to get products to market
is somewhat out of the industry's control.''
Before 1992, when Congress passed an act allowing the US Food
and Drug Administration to charge companies an application fee to
help fund additional resources, it could take three or four years
for the agency to complete a review of a new drug.
Drugs developed by American companies were often approved for
use in Europe and Asia before passing regulatory muster in the
United States, Kaitin said. But faced with the AIDS epidemic and
other serious medical conditions, public perception of what
constituted an acceptable amount of risk shifted.
With the regulatory changes in 1992 and subsequent changes in
1997, the FDA pledged to decrease the review process from three or
four years to a single year for standard applications and to six
months for applications given priority status.
The changes encouraged more FDA involvement in the designing of
clinical studies to help companies shorten the time it takes to
develop a drug and help the agency learn about the drug before the
formal review process began.
Kaitin said the changes were enormously successful in speeding
review times. But he believes that the public is beginning to
question whether safety is being jeopardized in the rush to get
drugs to market.
Some complications are inevitable even under stringent review,
Kaitin said. But events such as the recall of the diabetes drug
Rezulin due to unforeseen side effects and the death of a young man
participating in a gene-therapy trial contributed to the changing
perception, he said.
``Certainly, the shift is going to put additional pressure on
industry,'' Kaitin said. ``If it goes back to the old days in early
1980s, when we were the last industrialized country to get new
medicines, that would be a mistake. But it's up to the public to
determine where the balance should be set.''
And the drug industry will have to adjust to meet those demands,
Kaitin said. Companies will have to continue decreasing the time it
takes to develop new drugs. They will have to weed out failures,
far more common than sucesses, earlier in the process. They will
have to cut costs while increasing the number of products they
bring to market.
``The industry is going to be changing - through mergers,
licensing deals, new technologies,'' Kaitin said. ``Biotechnology
will help open doors to potentially huge markets for new products.
What we're seeing now is an industry in flux.''
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