FDA Commissioner Aims for
Quicker Drug Reviews
Tue June 24, 2003 09:21
AM ET
By Toni Clarke
WASHINGTON (Reuters) - The nation's top drug
regulator said on Monday he aims to cut the time it
takes to bring new medicines to the public, while still
ensuring that any negative side effects are promptly
reported to the government.
Speaking at the annual meeting of the Biotechnology
Industry Organization in Washington, U.S. Food and Drug
Administration (FDA) commissioner Mark McClellan said
the agency will soon announce new initiatives to reduce
the cost of drug development by cutting the time the
agency spends reviewing applications.
The agency will also work closely with drug
developers to ensure that new drug applications are
properly organized from the first time they are
submitted, he said.
That would avoid time-consuming and costly setbacks
such as the 2001 rejection of ImClone System Inc.'s
application to market its experimental cancer drug
Erbitux because the agency was unhappy with how the
trials were conducted and the data were organized.
After the FDA's refusal, shares of ImClone sharply
declined, setting in motion an insider trading scandal
and delaying potential approval of Erbitux by at least
two years.
Since taking the job in 2002, McClellan has
repeatedly made clear he intends to speed the drug
review process. Over the past six months, some
half-dozen new drugs have been approved, some
unexpectedly, helping lift the American Stock Exchange
Biotechnology Index of biotech stocks more than 50
percent since March.
McClellan said he thinks the gain in the sector is
justified.
"I, too, think the upswing in the industry is real,"
he said.
He noted, however, that while the FDA is "working
hard" to reduce the cost of drug development,
biotechnology companies must do their part to cut
development time by devising new research techniques.
Reduced time for development, he said, makes it more
critical than ever that companies promptly report any
problems that arise from the use of new medicines.
"The FDA has always relied on a voluntary reporting
system for adverse events," he said. "The truth is there
are countless adverse events that go unreported."
He said he plans to institute systems to ensure that
adverse side effects are reported in a timely way.
For instance, McClellan said the FDA plans to
introduce a real-time electronic monitoring system that
will help alert the agency of potential risks with newly
approved drugs.
Many drugs are approved on the condition that
companies conduct further clinical trials to monitor the
drug's performance in a wider population. Few companies
actually conduct such trials.
"If we have this information, we can have more
confidence that potential problems will be identified,"
said McClellan, who spoke after President Bush at the
biotechnology conference. |