In 2013 there were over 50 drug recalls. As you are probably aware, there are three different types of recalls; voluntary recalls initiated by the company to remove the product from the market, those recommended by the Food and Drug Administration (FDA) and those ordered by the FDA. A complete list of drug recalls can be found on the FDA website http://tinyurl.com/7z5l4xr
The defined classifications for market withdrawals are as follows, type I, II, or lll; assigned by the Food and Drug Administration “to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.
(1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violated product will cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a violated product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a violated product is not likely to cause adverse health consequences.”
You can review the regulation, 21 CFR Part 7 http://tinyurl.com/lcjv4k9
In my opinion drug recalls speak to quality assurance or the lack there of, and the appropriate implementation of quality assurance measures particularly the principal components of Good Manufacturing Practices (GMP). You can review the industry guidance regarding Pharmaceutical Quality Systems at http://tinyurl.com/mn5e7sh. I am of the opinion that quality has taken a back seat to immediate monetary gain. Perhaps, the number of recalls in 2013 in the grand scheme of things does not seems like a lot but when a product may cause serious adverse health consequences or death the recall in my opinion is a big deal. A quality assurance system increases customer confidence and a company’s credibility which is actually an important goal to a company’s financial success. What can we do to establish the correct focus on quality the beginning to end of the development process? Most companies have a separate department devoted to quality assurance; is this enough? What is the current philosophy/implementation of Quality Management in companies?
After the heparin recall in 2008, the Director of the Center for Drug Evaluation and Research (CDER), Dr. Janet Woodcock stated pharmaceutical quality includes “the absence of contaminants.” Quality pharmaceuticals is the reproducibility of the therapeutic benefit that their labels promise to the consumer. However, it is important to realize that the American drug supply continues to be among the safest in the world.