Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States. The Food and Drug Administration reported more than 1,742 recalls last year, up sharply from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data. One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has been shut down, recalls jumped 50% last year. Bowman Cox, managing editor of the Gold Sheet, observed:
We’ve seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988. That’s a meaningful development.
The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year. If this trend continues there could be 600 or more recalls by the end of the year, which is a very high rate of recalls. High-profile recalls of Tylenol and other products by McNeil Consumer Healthcare, a unit of Johnson & Johnson, have drawn attention to quality concerns in manufacturing.
The mounting problems over recalls have also drawn attention from lawmakers. Two bills introduced this year would impose stricter regulations on the industry and give the FDA authority to mandate recalls. The increase in recalls, especially of generic and over-the-counter drugs, is being driven by manufacturing lapses. Some of the biggest culprits: the quality of raw materials, faulty labeling and packaging and contamination.
A number of factors appear to be fueling the recall surge. The stampede by drugmakers to be first to bring generic versions to market, after drugs lose patent protection, is one of these factors. Generic drugs account for about three quarters of all prescription drug sales, according to industry group PhRMA.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.