Drug Recalls Increase 309% in 2009
August 19, 2010
The U.S. Food and Drug Administration (FDA) reported more than 1,742 prescription and over-the-counter (OTC) drug recalls in 2009. That number is a huge increase from the 426 recalls reported in 2008 and the 391 recalls reported in 2007. With the spike in the number of drug product recalls, product and manufacturing quality is being called into question in the media and in the public.
Recalls are actions taken by a drug manufacturer, repackager, or distributor to remove a drug from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority. The FDA publishes information regarding recalls, market withdrawals, and safety alerts here.
The increase in drug recalls has continued into 2010 with 296 recalls reported in the months of January through June. This rapid increase in drug recalls likely prompted two bills that have been introduced this year in Congress that would impose stricter regulations on the drug industry (see here and here). The bills would also give the FDA authority to mandate drug recalls.
Recent recalls of drug products by Tylenol and McNeil Consumer Healthcare, a Johnson & Johnson unit, (see here and here) have brought concerns regarding manufacturing and product quality to the publics attention. The quality of raw materials used in manufacture as well as contamination and faulty labeling and packaging could be to blame for the lack of manufacturing quality. This lapse in quality could be credited to the fierce competition in the drug manufacturing industry. Drugmakers are cutting costs and cutting back on manufacturing investments to stay competitive.
The generic drug market also fuels the competition in the industry. Generic drugs muake up approximately 75% of all prescription drug sales. The rush by generic drug manufacturers to be the first to market a generic version of a drug after the drug loses patent protection can create a deficit in manufacturing quality.
Advantage Dose, a drug repackager, accounted for more than 1,000 of the reported recalls in 2009. Repackagers that relabel drugs into smaller resale units have also drawn attention for increased recalls due to flawed labeling and packaging.
In an industry that is already rife with competition, drugmakers must be conscientious of quality control. In light of the new attention given to manufacturing quality by the public, policy makers and the media, drugmakers, more than ever, must ensure they are producing compliant, quality products.
For information on how Fuerst Ittleman, PL can help your company with issues surrounding drug manufacturing, repackaging, importing, and distribution, contact us at contact@fidjlaw.com.