Forget about championing one side or another. The politically charged "generics vs. namebrand drug" debate offers an opportunity to study the impacts of process and ingredient variability on drug manufacturing and on clinical effects in patients. (For material to analyze, click here). At IFPAC 2008 in January, FDA's Dr. Janet Woodcock noted the fact that the industry still cannot definitively trace clinical issues in patients to specific manufacturing challenges or problems.
Quality of excipients and other ingredients may meet basic specifications and yet vary from batch to batch. Cost-pressured generics manufacturers may have to use alternative ingredients and tests (e.g. for bioequivalence).
But couldn't a "Quality by Design" framework, even for developing generic drugs, eliminate these problems?
Yesterday, ConsumerLab.com reported results of its investigation of generic versions of the blood pressure medication, Toprol XL, which, according to consumers, may raise blood pressure rather than lower it and cause side-effects. ConsumerLab found that certain generic brands, such Sandoz's, contain ingredients not found in the original and do not necessarily dissolve like Toprol XL. These differences can potentially to trigger chemical sensitivities and result in differences in absorption.
ConsumerLab, citing previous studies of generic Wellbutrin XL last year, suggests that generic "inequivalence" affects a wide range of generic drugs. ConsumerLab.com and The People’s Pharmacy are jointly calling on the FDA to disclose inherent differences between generics and originator drugs. The FDA has yet to release findings from its investigation of generic Wellbutrin XL, but new information from both the USP and an FDA official corroborate ConsumerLab.com’s findings
What do you think?
