Recent past safety and recall alerts have identified a number of commonly prescribed medications as being problematic to consumers. Examples of these commonly prescribed medications noted in the recent safety, labeling and recall alerts include asthma and COPD inhalers, Plavix, Zocor, Avandia and Zuprexa [adolescents]. The product recall process is a lengthy one, in which the U.S. Food and Drug Administration (FDA) progresses. As the process continues it can lead up several actions, including a recall or safety alert.
A First Alert occurs when a product problem surfaces and is presented to or identified by the FDA. This information can come from the company itself, an FDA inspection, or health-related reports, such as those received from The Centers for Disease Control and Prevention (CDC), among other sources.
Public alerts are the next step in the product recall process. This step is taken when there is the belief that a serious hazard exists to which the public should be alerted. The news media is the usual, and is considered to be, the most effective approach to distributing this information. In addition to the media alert, the FDA posts the information on its website and distributes the information through its email alerts. These postings and alerts are then listed in the weekly FDA’s Enforcement Report. This report also lists the recalls via each recall’s classification.
Follow-up to these alerts is completed through the effectiveness checks that the FDA conducts. These are completed in order to determine if all reasonable efforts have been taken and that the recall has been completed efficiently with appropriate investigations undertaken.
There are three classes of recalls:
- Class I: Products that predictably could cause serious health problems or death.
- Class II: Products that might cause a temporary health problem, or pose only a slight serious threat.
- Class III: Products, while unlikely to cause any adverse health reaction, but violate FDA labeling or manufacturing laws.
The FDA also recently released a new transparency product, i.e., FDA-Transparency, Results, Accountability, Credibility, Knowledge-Sharing [TRACK]. The complete information on the FDA-TRACK process is available on line at http://www.fda.gov/AboutFDA/WhatWeDo/track/default.htm.
In another recent action the FDA’s Center for Drug Evaluation and Research approved a new Oxycontin controlled-release product formulation. This has been approved as a result of abuse and misuse issues, which resulted in an abuse deterrent addition to the formulation. In addition to the formula revision, a follow-up study is required relative to the measured effectiveness of this reformulation action. Several additional requirements were included in this initiative. For the complete information, please access the complete Purdue Pharma L.P. release at http://www.purduepharma.com/pressroom/news/20100405.htm.
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