Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.
Drug recalls reached a record high 1,742 in 2009 — more than four times the amount in 2008. Bowman Cox, managing editor of the Gold Sheet told CNN Money that in light of the 296 recalls issued in the first six months of 2010, there could be 600 or more recalls this year.
Why So Many Recalls?
Analysts and legislators are examining the recall statistics to find sources and solutions to the pharmaceutical safety issue.
1. Drug repackaging :
Advantage Dose, a now-defunct Shreveport, LA based drug re-packager, was responsible for more than 1,000 of the 2009 recalls. Companies like Advantage Dose repackage and re-label drugs into smaller units for resale or distribution to health care facilities. After excluding Advantage Dose from the count, there still remains a 50% jump in recalls from 2008 to 2009.
2. The generic rush :
Gold Sheet’s Cox suggests that generic manufacturers cut drug design costs in their rush to be first to market after a branded-drug’s patent protection expires, decreasing quality. “The first generic applicant typically gets the lion’s share of the business for the new drug…the 180 day exclusivity… So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug(product).” One example of a design failure is Caraco Pharmaceutical Laboratories’ “tablet thickness” recalls in March 2009…
Read more at http://www.pharm-education.com/2010/09/drug-recalls-in-usa-reached-record-high.html
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