Vol. 28, No. 1 #6 (February 2005). Get Educated On Your Medications!.

• Author: By Roxanne Homar, R.Ph.

Wyoming Bar Journal

2005.

Vol. 28, No. 1 #6 (February 2005).

Get Educated On Your Medications!

WYOMING LAWYERFebruary 2005/Vol. XXVIII, No. 1Get Educated On Your Medications!By Roxanne Homar, R.Ph.

Recently there has been some controversy over the Food and Drug Administration's (FDA) approval process for new drugs and the tracking of safety information. This was prompted by the recent removal of Vioxx (rofecoxib), a medication used to treat pain and inflammation. Concerns about the increased risk of heart attack and stroke caused the drug manufacturer to remove Vioxx from the market. This has led to questions regarding similar products as well as several other medications, and increased scrutiny of the FDA's process for drug approvals and safety tracking in general. The Food and Drug Administration (FDA) has processes in place to review drug entities for both effectiveness and safety. A brief description of the new drug approval (NDA) process and post approval safety monitoring follows:

New Drug Approval (NDA) Process

All new drugs marketed in the United States are approved through the FDA. It is an extensive process and the FDA estimates it takes approximately 8.5 years to study and test a new drug before it is approved for general use and marketing.

The initial stage of the new drug approval (NDA) process is called "pre-clinical" research and involves animal testing. The purpose is to develop adequate data to support a decision to move forward with human trials.

If a drug entity makes it past the pre-clinical stage it will enter the next step, the "clinical studies" phase. During the clinical studies phase the NDA must provide sufficient information for the FDA reviewers to believe that the drug is safe and effective for proposed use. The FDA reviewers want to know that the benefits of the medication outweigh the risks and that it is reasonably safe to proceed with human trials.

According to the FDA website the results of this testing comprise the single most important factor in approval or disapproval of a new drug.

Post Approval Safety Monitoring

The FDA maintains post-marketing surveillance and risk assessment programs to identify adverse events that did not appear during the clinical trial period. The clinical trial period involves smaller numbers of individuals than those who would be exposed when the medication is...