A single incident of an extended-release formulation that released its drug too quickly has caused FDA to change its policy. An FDA official said in October 2012 that the agency would be looking more closely at the techniques generics drugmakers use to make extended-release drugs.
Generic 300 mg extended-release bupropion has been withdrawn
Complaints about generic bupropion surfaced soon after the drug was approved in December 2006. Patients who took the 300 mg dose claimed their depression returned after switching from Wellbutrin XL (bupropion), the original brand-name medicine sold by GlaxoSmithKline.
FDA had approved the 300 mg dose without requiring a direct study in patients. Instead, it extrapolated from the results from an earlier study of a 150 mg dose. Impax and Teva’s 150 mg dose remains on the market.
In 2010, FDA took the rare step of conducting its own study of the 300 mg strength. In early October 2012, it announced that the drug did not, in fact, perform as well as the original brand.
GPhA reacts
Mr Ralph G Neas, President and Chief Executive of the Generic Pharmaceutical Association (GPhA), the industry trade group, said in an email that ‘FDA’s science surrounding the approval criteria for all drug products, including extended-release products, is well-grounded and rigorous.’
His group, he said, supports the agency’s ‘ongoing examination of current science, as well as embracing evolving scientific methods for all drug products.’
The popularity of extended-release drugs has increased in the last decade or so. Patients like the drugs because they can take them less frequently. But developing a longer-acting version of a best-selling medicine is also a classic strategy to extend the time that a company can sell a drug exclusively. The popularity of generics has also increased, despite negative publicity from the originator pharmaceutical industry, and generics today account for nearly 80% of medicines dispensed in the US.
FDA reacts
FDA has not identified any new safety information associated with Budeprion XL 300 mg; however it issued a statement that, in some patients, the drug may not provide the desired beneficial effect.
FDA did not conduct bioequivalence studies of the other four generic versions of Wellbutrin XL 300 mg. FDA did, however, recently ask each of the other manufacturers – Anchen, Actavis, Watson and Mylan – to conduct their own studies to assess the bioequivalence of their 300 mg extended-release bupropion tablets to Wellbutrin XL 300 mg. FDA has asked these companies to submit the data from those studies no later than March 2013. FDA believes the study results may be unique to the Impax/Teva version of 300 mg bupropion hydrochloride. FDA does not currently have data indicating that the other four generic drugs are not bioequivalent to Wellbutrin XL 300 mg. The agency will review the data from the additional bioequivalence studies when the data are received and will provide additional updates at that time.
FDA change of heart will require more resources
FDA accepts that its testing process may have been flawed and says it’s looking into this and other issues. In a recently revised generic drugs fact sheet on its website, the agency notes:
‘FDA is encouraging the generic[s] industry to investigate whether, and under what circumstances, such problems occur. The agency does not have the resources to perform independent clinical studies and lacks the regulatory authority to require industry to conduct such studies. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises.’
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Source: FDA, New York Times
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