Drug Review Process Doesn�t Protect Consumers

The federal government�s drug review process does not ensure that consumers will be protected from harmful prescription medications, according to a report from the U.S. Department of Health and Human Services (HHS).

Since 1996, seven drugs have been removed from the market for safety reasons.

Further, 40 percent of U.S. Food and Drug Administration (FDA) long-term reviewers believe the drug review process has worsened. Currently, the review period for new drugs ranges from six to 12 months, however the report recommends that the period be extended by one to two months.

New drugs are required to be reviewed for safety and efficacy before they reach the market, and drug companies pay �user fees� that essentially pay the salaries of drug reviewers.

The report includes a survey of 401 new drug reviewers. In regard to the six-month time period allotted for review of priority New Drug Applications (a breakthrough drug or one that treats an unusual condition), 58 percent of reviewers said the time period was inadequate.

Additionally, 25 percent felt that the10 months provided for review of most standard drug applications was also inadequate.

Some 18 percent of the reviewers said that they felt pressured to approve drugs for sale despite their uncertainties about the drugs� safety or efficacy.

What�s more is that 21 percent of participants indicated that scientific disagreement was only allowed to a small, or no, extend in the FDA work environment.

Previous research has shown similar results. For instance, a 1998 study showed that FDA medical officers found 27 new drugs that they had reviewed and did not think should be approved but were approved by the agency anyway.

Report authors note that the FDA�s reliance on user fees from drug companies skews the drug approval process toward the industry. They conclude that their findings present a significant warning signal that unsafe and ineffective drugs may not be kept off the market.

The Citizen March 31, 2003

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DR. MERCOLA’S COMMENT:

The drug review process cannot work when drug companies are paying the salaries of the drug reviewers. As a consumer, it is your responsibility to determine the safety of what you put in your body–drug, food or otherwise.

Don�t be persuaded into thinking a drug is safe simply because it has been FDA approved and is featured in numerous advertisements. As this article shows, even the people reviewing the drugs are doubting the effectiveness of the review process.

The drug industry�s grasp is far reaching and this area is no exception. As stated above, 18 percent of drug reviewers felt pressured to approve a drug even if they questioned its safety. This is not surprising considering who is paying their salaries.

If you are considering taking a drug, please look out for your own safety and do some research of your own. You�ll likely be able to find information about the drug�s trials, side effects and warnings.

Or, better yet, give yourself the best chance of avoiding drugs altogether by boosting your body�s natural defense–its immune system. You can start the process by looking into the nutrition plan and implementing an exercise program.