FDA head supports quicker drug OKs

Stance part of push on fatal-disease treatments


WASHINGTON -- The nation's top drug regulator pledged his agency's support yesterday for research to develop the next wave of tools for preventing and treating fatal diseases like cancer.

Dr. Andrew C. von Eschenbach, acting commissioner of the Food and Drug Administration, said his agency is taking steps to encourage the development of safe and effective medical treatments tailored to a patient's particular condition.

"We can improve the processes by which that developmental process occurs, is regulated and is approved," von Eschenbach told the Personalized Medicine Coalition, an industry group.

Von Eschenbach also vowed to make faster drug approval "one of my highest priorities," however long he leads the agency.

The idea behind "personalized medicine" is that doctors will be able to prevent and treat serious diseases more effectively with genetic tests telling them which patients are at high risk of falling ill and which therapies will best treat those already sick, supporters say.

But some scientists caution that quick approvals of the treatments may come at the expense of a thorough understanding of possible side effects. They are especially concerned about the FDA allowing use of drugs without putting them through random testing.

Vera Hassner Sharav, president of the liberal Alliance for Human Research Protection in New York, said the acting commissioner and supporters of personalized medicine were moving too quickly and might harm patients.

"The science isn't really there yet," she said.

A cancer survivor and surgeon, von Eschenbach is a longtime advocate for speedier approval of diagnostic tests and treatments for cancer. As interim chief of the FDA, he is uniquely positioned to help implement the view.

Von Eschenbach, acting head of the agency since September and a formal candidate for the top job, also serves as director of the National Cancer Institute, which funds much of the cancer research across the country.

He said the FDA has already made one change, issuing new guidelines in January that make it easier for researchers to produce and then test experimental treatments.

Von Eschenbach also said the FDA is reexamining the standard measurements of a treatment's safety and effectiveness and the agency's requirements for clinical trials, the mechanism for assuring a drug works without causing undue harm.

"Today's clinical trial regimens are expensive, too lengthy and do not deliver all the answers that patients and physicians need," he said.

Some cancer groups support accelerated approval because terminal patients otherwise may not survive long enough to reap the benefits. Industry groups have lobbied for faster review of new drug applications generally.

"The current model of companies spending $1 billion over 12 to 15 years on a drug that only works in 15 percent of the population is not a sustainable model," said Dr. Raymond Woosley, president of the Critical Path Institute in Tucson, Ariz., which backs collaboration between drug companies and the FDA to speed development of medicines.


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