Reasons for this sudden rise in recalls were cited as carelessness during manufacturing, drug repackaging, a more attentive FDA and the generics rush. But how much are generics manufacturers really to blame for all these recalls?

Former drug re-packager Advantage Dose, was responsible for more than 1,000 of the 2009 recalls. However even after excluding these from the total number of recalls, there still remains a 50% jump from 2008 to 2009.

Some experts say the biggest culprits include the quality of raw materials and contamination. India’s largest pharmaceutical manufacturer (Ranbaxy) has been cited several times in recent years for manufacturing violations.

Stricter scrutiny of manufacturing facilities by the FDA is also purported to contribute to the spike. A new bill – the Drug Safety and Accountability Act of 2010 – aims to strengthen manufacturer quality standards by giving the FDA authority to recall potentially dangerous drugs. The FDA currently only has the power to issue warnings and recommend recalls. Two other bills (The Protect Consumers Act of 2009 and HR 6740) currently in congress will also increase the FDA’s powers to demand recalls.

Statistics generated by The Gold Sheet, however, indicate that generics manufacturers may have a role to play in the rocketing number of recalls. It is suggested that they may sometimes cut development costs in their rush to be first to market. Implying that they may not take the time to optimise drug manufacture, subsequently leading to recalls due to quality issues.

One thing is for sure the outcome of increased FDA regulatory power is likely more recalls and not less.

Reference:

Health Reform Watch. Trouble Brewing for Pharmaceutical Companies. 18 August 2010