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FDA Allowed Drugs on Market without Key Data

June 30, 2011

Think it's complicated to get a new pharmaceutical drug put on the market? Think again. A new report indicates only about half of the new prescription medications that were introduced in the U.S. in the last decade had the appropriate information submitted to the U.S. Food and Drug Administration (FDA), but the FDA approved the drugs to go to market anyway.

The information that is supposed to be provided to the FDA is called comparative effectiveness data, and it should be a critical factor in whether or not a drug should be approved and sold to the public. In layman's terms, the data lets the FDA know how the new drug compares to other treatments already on the market. It outlines whether the new drug is more beneficial, and whether or not it is safer. This new information on the FDA's lax method of approving new drugs was part of a study just published in the May 4th issue of the Journal of the American Medical Association (JAMA).

New Kid on the Block

After a new drug is put on the market, it takes awhile for reports about reactions, side effects, and deaths to come in from people who are actually using the drug. Doctors rely a great deal on the information provided to them from the pharmaceutical companies and from the FDA.

When the researchers examined evidence of comparative effectiveness data on recently approved drugs, they found that only about half of 197 eligible approved drugs between 2000 and 2010 had comparative efficacy data available at the time they were approved to be marketed.

In one recent study by Harvard University and the University of California, researchers found evidence that a drug used to treat bipolar disorder found its way to the market with just one clinical trial behind it. The findings of the clinical study were skewed in favor of the drug, and the drug manufacturer sponsored the trial.

Defective Products

There are a number of ways that drug companies can injure the public with their products, but the most common method may involve deceptive and even fraudulent marketing methods. Pharmaceutical companies often promote drugs for unapproved uses or understate side effects in television advertising. Drug companies' marketing methods also often include use of marginal medical journals that are little more than advertising forums for drug manufacturers. The FDA is the key public watchdog to protect the public so one would hope these new revelations motivate the FDA to take corrective action.

If you or your loved one has suffered a serious side effect resulting from your use of a dangerous or defective drug, Montlick and Associates offers a free initial case evaluation. Our Georgia Dangerous & Defective Drug Attorneys are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

Please Note:
All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.