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FDA Approval Process & the Pharmaceutical Manufacturers

The Food and Drug Administration (FDA) is the government agency responsible for overseeing public health and welfare by monitoring drugs and medical devices sold in the United States.  The FDA is given legal authority by the Federal Food and Drug Act of 1938 (“the Act”) to review and approve new drugs for sale in the United States based on scientific support provided by the drug manufacturer as to the safety and efficacy of the drug or medical device.  The FDA is not responsible for conducting its own pre-approval or pre-clinical trials of a drug or medical device before approving the product for sale.  Further, the FDA’s role is not to provide a guarantee of safety for the drugs and medical devices sold on the market.

The Act provides only a “minimal standard of conduct” that is required in order to allow a manufacturer to sell drugs and devices.  This means that pharmaceutical manufacturers, who sponsor drugs and medical devices for sale, are responsible for assuring that complete, thorough, and adequate testing of its products have been completed prior to selling their products on the market. Pharmaceutical manufacturers, not the FDA, are responsible for writing the warning labels for their products and taking the necessary steps to ensure that any changes, including strengthening their warning labels are made timely.  Nonetheless, pharmaceutical manufacturers often times take the position that the FDA controls the process for changing drug labels, including dictating whether warnings of adverse side effects to a medication must be added.  However, this is simply not the case.  In fact, in a recent United States Supreme Court opinion, Wyeth v. Levine (No. 06-1249) – -S.Ct. – –, decided March 4, 2009,the Supreme Court reaffirmed this responsibility on the part of pharmaceutical manufactures, stating that “the manufacturer bears responsibility for the content of its label at all times.” Unfortunately, sometimes pharmaceutical manufacturers do not comply with their necessary obligations to ensure that safe and effective products are placed on the market, which in turn results in filing lawsuits to recover for the injuries and damages caused by their conduct.

Further, sometimes the resources of the FDA are stretched thin, which can contribute to the sale of defective medical devices and dangerous pharmaceuticals particularly when manufacturers fail to conduct adequate testing of their products or otherwise fail in some way to be a responsible drug manufacturer.  This process can sometimes be complicated by the short time frame for approval of new drugs, which was exacerbated by the 1992 Prescription Drug User Fee Act (PDUFA) that sets a goal that 90% of drug approval applications would be acted on within 10 months of receipt.  In fact, the agency has increased this timetable to get 90% of drugs approved within 6 months of receipt. Many officials at the FDA feel this process is too fast and have reported feeling pressure to approve a drug despite serious concerns over its safety, its safety, efficacy, or quality, according to a March 2003 report by the Inspector General of the Department of Health and Human Services.

Other problems with the FDA approval process may also contribute to the sale ofdefective drugs and medical devices.  For instance, according to a New England Journal of Medicine editorial, one of the main problems with the FDA approval process is that it often asks irrelevant questions. In many cases, drugs are compared only to placebos, not to existing drug alternatives, before being approved. And the amount of improvement necessary for approval is nominal–basically any statistically significant improvement over placebo is sufficient for approval.

Another problem with the FDA approval process is that drugs are studied for only very short periods of time. Trials for drugs are typically only for a few months, but many drugs will be taken for years or even decades. Long-term consequences of a drug cannot be evaluated with short trials. To attempt to detect and assess long-term consequences, drug companies are supposed to perform post-marketing studies as a condition of approval, but over 2/3 of these studies are started well after a drug is approved.  In addition, many drug companies do not take post-marketing studies seriously because the FDA has little enforcement power after a drug is approved.

If you have been injured by an FDA-approved device or drug, you may be facing medical bills, lost work, or even an inability to work.  Those responsible for your injury should be made to pay, and the attorneys at Schlichter, Bogard & Denton are prepared to seek compensation for your injury. Schedule a drug or medical device injury consultation today.

You Can Help the FDA Regulate Dangerous Drugs

With hundreds of new drugs and devices being approved every year, the possibility of serious injury from these products increases daily.  After a drug or device is approved by the FDA, the FDA’s role and responsibility related to that product is limited.  The FDA cannot require the company to conduct post approval safety studies or mandate labeling changes.  Sometimes, pharmaceutical companies do not act responsibility and fail to use best practices with the drugs and devices placed on the market, fail to conduct necessary studies to test the safety of the product, and fail to appropriately update their warning labels.  As a result, we have a responsibility to watch drug and medical manufacturers closely to detect dangers and get defective drugs and devices withdrawn from the market before they destroy too many people’s lives.

If you have been hurt by an FDA-approved drug, it is possible that drug companies knew their drug was defective, but manipulated the approval process. Schlichter, Bogard & Denton has the legal and medical knowledge necessary to expose dangerous drugs and get compensation for victims.  We have identified many drugs with known serious risks, including RaptivaDilantin, and NuvaRing, but there are many dangerous drugs whose effects are not commonly known. If you have been injured by an FDA-approved drug, chances are you are not the first or the last. Working with the pharmaceutical litigation lawyers at Schlichter, Bogard & Denton can help bring new risks to light and prevent others from suffering as you have suffered while punishing those responsible for your injury. Schedule an FDA-approved drug injury consultation today to learn what you can do for others and what we can do for you.

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