FDA says focused on tracking drugs after approval

ATLANTA Sat Apr 21, 2012 8:09pm EDT

Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, speaks during the Reuters Health Summit in New York, May 9, 2011. REUTERS/Brendan McDermid

Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, speaks during the Reuters Health Summit in New York, May 9, 2011.

Credit: Reuters/Brendan McDermid

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ATLANTA (Reuters) - The U.S. Food and Drug Administration said on Saturday it now spends as much effort and resources on surveilling a drug after it is approved as it does in the pre-approval process.

The FDA was responding to critics who say the agency is toothless when it comes to tracking the safety of drugs already on the market, when industry funds that supported pre-approval reviews tend to dry up.

"We think we've really balanced this," Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, told reporters attending the Association of Healthcare Journalist meeting in Atlanta.

In a report released on Saturday, the FDA says it has required companies to do 385 post-market studies since 2008, and to change the label based on new safety information 65 times.

Before 2008 the FDA could not compel label changes or require additional safety trials and had to rely on voluntary action from drugmakers, she said.

The FDA's focus on post-market drug safety comes after the agency was sharply criticized as being slow to respond to drug side effects, notably Vioxx, a painkiller that Merck & Co Inc pulled five years after approval because of a link to heart attacks and strokes.

A 2006 report from the Institute of Medicine, an independent research body that advises the government on scientific matters, found the FDA needed to do more to police the safety of medicines after they reach the market.

Congress later gave the FDA more power to oversee drugs after approval, such as ordering companies to change their labels or conduct additional safety trials, and fining them if they fail to do so.

SENTINEL

But critics question how often the agency actually follows through on penalties.

In 2008 the FDA also launched Sentinel, a computer tracking system designed to help identify problems with drugs and medical devices already on the market by searching various databases for possible side effects - rather than just relying on voluntary reports from companies and patients.

The FDA said it used the system to see if there were negative drug interactions for Chantix, the smoking cessation drug manufactured by Pfizer Inc, but did not find any.

Last November U.S. researchers said Chantix carried too many risks and should only be tried when other treatments fail.

The findings, which Pfizer said were flawed, contradicted two studies released in October by the FDA that showed Chantix (sold as Champix outside the United States) did not increase the risk of being hospitalized for psychiatric problems such as depression.

The agency at the time acknowledged those studies were flawed because they were too small to identify rare events and captured only cases severe enough to land people in the hospital.

Woodcock could not immediately provide examples of where Sentinel alerted the agency to safety information they had not been aware of before.

(Additional reporting by Anna Yukhananov in Washington; Editing by Xavier Briand)

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Comments (1)
Much time and energy could be saved if the FDA would stop depending on the companies own in-house testing data when approval status is sought. We all know that material is going to be biased towards its safety and effectiveness anyway. If you truly want to cut time and expenses, there is only two ways to do this that I can think of.

1. When a new drug/device starts the approval process, in house testing is now done on it by the FDA or an independent testing facility of the FDA’s choice. Sure, this may take time but at least we (the general public and Everyone concerned) would have more faith in the final test results.

2. Or the second method of testing, an arbitrary listing of independent facilities will be assigned to every company somewhere in the testing process. During each step of the process, if a company wishes more testing done, for an approval stamp, then the information must be sent to the FDA and a testing facility is randomly assigned that task. When the FDA, the testing facility itself and the company never knows who is going to be assigned the work, final test results are generally much more reliable.

Sure we are talking time here. But if the company wishes for approval, they are still responsible for the costs of testing with whichever lab gets the contract from the random pick.

If they squabble, as far as I am concerned, they did it to themselves. If their testing was reliable and truthful, deceit was not a standard protocol, then none of this would be necessary.

Employee moral would automatically become higher because now people can go to work and realize they had better not doctor their results because an independent lab is going to be running the same tests eventually as a cross-check. Honesty can once again be instilled in a job.

Apr 23, 2012 12:21pm EDT  --  Report as abuse
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