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Appraisal of FDA’s Drug Safety Proces

A team of experts criticized Food and Drug Administration (FDA) for not being able to effectively track the safety of new drugs and take action promptly for problems.//

The Institute of Medicine’s report probably will strengthen the discussion on the safety of the country’s drug supply and the competence of the FDA.’s supervision. A serious discussion began in September 2004 when Merck removed its popular arthritis drug, Vioxx, after long-term use was associated with an increased risk of heart attack and stroke.

At the request of the FDA, the Institute of Medicine, a nonprofit organization formed by Congress to advise the federal government on health issues, conducted the study. According to the Institute of Medicine more funds, people and power are required in FDA to ensure it upholds focus on the safety of the drugs it regulates throughout the time they are on the market. Cultural modifications are also required to prevent the tensions that can upset the evaluation of drugs' risks and benefits.

Labeling and advertising restrictions on newly approved drugs are also needed to emphasize the doubts that remain about their safety, according to the institute in "The Future of Drug Safety," a report issued Friday.

According to the institute, a catastrophe in drug safety seemed to have appeared.

"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."

"Nor does FDA 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.

"I am committed to taking additional steps and will look to the initiatives recommen ded by the Institute of Medicine, to ensure we continue to fulfill our mission," said Dr. Andrew von Eschenbach, the FDA's acting commissioner. Others within FDA were quick to hype the steps the agency's already taken.

"We're simply saying we have been on a trajectory to address the issues," said Dr. Janet Woodcock, the FDA's deputy commissioner for operations.

Burke called much of the effort little more than "moving boxes" around on organizational charts. "They have not been an integrative solution. They have addressed pieces of it but not in a fulsome way," she said.

The institute recommended a series of steps to enhance safety review, like improving FDA's budget whether through an appropriation from Congress or taxes. It also advised to lift restrictions on how FDA can spend the charge collected from drug companies. Those fees now finance the cost of reviewing new drugs before approval.

The institute recommended the FDA to appraise the safety of all new drugs five years after their introduction, making their initial approval more or less speculative and subject to withdrawal.

A logo, probably a black triangle will be present on drugs for 2 years warning patients and doctors that doubts may remain about their risks and benefits. Advertising would be limited in that period, if officially acceptable.

A drug industry group responded unperturbedly to that proposal. "Drugs are approved as safe and effective by FDA under the conditions that are prescribed on the label. The label can highlight that there are issues with the drugs, with respect to how they are used. I don't think it's fair to characterize all new drugs as requiring heightened regulatory uncertainty," said Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America.

Some had expected the report to advise the introduction of a distinct center to supervise the safety of drugs, however, it did not. The report recommended t he Congress to give FDA the regulatory authority to make pharmaceutical companies to study the risk of their drugs once they are on the market.

"Vioxx was like a dead canary in a coal mine, a warning that worse may yet come. Today there's no question left that we need to strengthen post-market surveillance in order to improve drug safety and save lives," said Sen. Charles Grassley, R-Iowa, who with Sen. Christopher Dodd, D-Conn., has introduced legislation that would give the FDA such authority.

"This report confirms what many of us in Congress have been arguing all along - that the Food and Drug Administration's authority must be strengthened to empower the agency to take rapid and decisive actions on drug safety," said Rep. Rosa DeLauro, D-Conn. DeLauro is the ranking Democrat on the House subcommittee that oversees the FDA and its budget.

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