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Health: New Steps Needed to Ensure Drug Safety, Panel Says

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New Steps Needed to Ensure Drug Safety, Panel Says

 

POSTED: 1810 GMT (0210 HKT), September 25, 2006

 

WASHINGTON (AP) -- Two years after the withdrawal of the painkiller

Vioxx, federal health regulators still lack the resources necessary to

track the safety of new drugs and respond quickly to any problems that

might crop up, a panel of experts who advise the government said Friday.

 

The Institute of Medicine experts said the U.S. Food and Drug

Administration needs more money, people and power to ensure the safety

of the drugs it regulates. Also needed are labeling and advertising

restrictions on newly approved drugs that would stress the uncertainties

that remain about their safety, the Institute of Medicine said in " The

Future of Drug Safety, " a report issued Friday.

 

Problems in FDA oversight were highlighted when the popular painkiller

Vioxx was pulled from the market in 2004, five years after its approval,

after long-term use was linked to an increased risk of heart attack and

stroke.

 

" FDA's performance in approving drugs or monitoring their safety after

approval has been questioned and criticized, " the report noted.

 

In a statement, the FDA cited its current work toward change.

 

The institute said there was an appearance of a crisis in drug safety

but did not determine whether one actually exists. It did paint the

picture of a lopsided agency, with less-than-adequate amounts of time

and money being spent on drugs' safety once people begin using them in

great numbers.

 

" More drugs are being approved faster with less time to intensively

investigate premarketing safety data, " the report said. And FDA does not

have the resources to keep up once the drugs reach the market in

assessing safety or informing the public about any risks that might develop.

 

" We found an imbalance in the regulatory attention and resources

available before and after approval, " said Sheila Burke, chairwoman of

the committee that wrote the report. " Staff and resources devoted to

pre-approval functions are substantially greater. Regulatory authority

that is well-defined and robust before approval diminishes after a drug

is introduced to the market. "

 

The experts acknowledged that the agency and others in the drug industry

had taken some steps to try to improve drug safety but that they were

not " equal to the task. Major obstacles remain. "

 

" While we have done a lot of work over the past two years to improve the

drug safety enterprise at FDA, we recognize more remains to be done, "

said FDA spokeswoman Susan Bro, adding that new efforts were

forthcoming. " All drugs have risks. Our challenge is to uncover them as

soon as possible and effectively communicate them to providers and

patients so they can make informed decisions about their health care. "

 

The institute proposed a series of steps to improve safety review,

including boosting FDA's budget whether through an appropriation from

Congress or taxes.

 

It also recommended the FDA review the safety of all new drugs five

years after their introduction -- making their initial approval almost

tentative and subject to withdrawal.

 

New drugs also would carry a symbol -- perhaps a black triangle _ for

two years alerting patients and doctors that uncertainties may remain

about their risks and benefits. Advertising would be restricted during

that two-year period, if legally permissible, according to the report.

 

The report does not recommend the setting up of a separate center to

oversee drug safety, as some anticipated. It does suggest that Congress

grant the FDA the regulatory authority to compel pharmaceutical

companies to study the risk of their drugs once they're on the market.

Such authority should include the ability to assess fines and impose

injunctions, the report said. The FDA also should step up its own

monitoring of the safety of drugs, it said.

 

The Institute of Medicine advises the government on health policy. The

FDA partially sponsored the report.

 

Copyright 2006 The Associated Press. All rights reserved.

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