Drugs, Medical Devices & Implants

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Law Topics >  Cause of Injuries > Drugs, Medical Devices & Implants

The Federal Food, Drug, & Cosmetic Act requires the Food & Drug Administration (FDA) to evaluate the safety and effectiveness of prescription and over-the-counter drugs sold in the United States. Developing a new drug is a risky process that takes an average of four years and typically costs substantial sums of money. The initial review process begins without the FDA's involvement. Typically, pharmaceutical companies initiate laboratory testing to estimate the effectiveness and safety of a proposed drug product. If the laboratory tests are successful, the pharmaceutical company will begin testing the drug on animals. The FDA does not become involved until the pharmaceutical company requests permission to test the drug on humans. The FDA, through its Center for Drug Evaluation and Research (CDER), evaluates the results of laboratory and animal testing prior to approving testing in humans. If approved, human trials are conducted in four phases:

Phase I

In Phase I clinical trials researchers test the drug on a small group of people (20-80) for effectiveness, safety, adverse reactions, and proper dosage.

Phase II

Phase II clinical trials are similar to Phase I trials except the drug is given to a larger group of participants (100-300).

Phase III

Phase III trials typically include between 1,000 and 3,000 participants who are monitored for their reaction to the drug and the drug's effectiveness when compared to existing treatments.

Phase IV

The Phase IV trial is really not a trial at all as the drug has already been approved for public use. Rather, the FDA tracks any reported adverse events (injuries, adverse reactions, side effects, deaths) and continues to monitor the drug's effectiveness.

In clinical trials an Institutional Review Board (IRB) is appointed to monitor the research. The IRB is made up of independent physicians, ethicists, statisticians, and community activists. The IRB is charged with ensuring that the clinical trial is ethical and that the participants are treated properly.

The Food & Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices as required by Congress in the Food, Drug, and Cosmetic Act (Act). The Act defines a medical device as "an instrument, apparatus, . . . machine, implant, . . . or other similar article that is intended for use in the . . . treatment or prevention of disease." Medical devices can be anything from a breast implant to a pacemaker to a hearing aid. The term is very broad and includes items that the public may not consider to be medical devices, such a condoms, the Lasik procedure, and tampons.

While the FDA undoubtedly provides a valuable service to the American people, questions remain regarding the impartiality of the review process. Many of the agency's scientific advisors, the very people who are in charge of evaluating proposed drugs and devices, are either employed by, or hold substantial financial stakes in pharmaceutical companies. Sometimes, the FDA advisor in charge of recommending approval of a particular drug or device is employed by the very pharmaceutical company that developed the drug. Experts have speculated that potentially dangerous drugs and devices have been approved as a result of these apparent conflicts of interest.

In addition, concern is mounting over the increasing role of private drug research companies. Known as Contract Research Organizations (CRO), these private firms are often hired by drug companies to perform research that was once conducted by impartial universities. The use of CRO's is growing as pharmaceutical companies search for scientists who are not tied to academic institutions. Consumer watchdog groups are concerned that the competing CRO's may compromise their standards, skewing their research in favor of approval in order to win additional contracts from pharmaceutical companies. With the pharmaceutical industry spending over nine billion dollars a year on research, the incentive for CRO's to "fudge" the science is considerable.

While many wonderful drugs have been developed over the past several decades, some deadly ones have emerged as well. If you have been seriously injured, or a loved one has been killed after taking either a prescription or over-the-counter medication, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.