Woodcock cites generic skepticism as priority

Share this article:
There is a “rising tide of skepticism” about generic drugs' therapeutic equivalence and CDER efforts to address this has become a top priority, the FDA's director of drug evaluation and research, Janet Woodcock, told a Generic Pharmaceutical Association conference recently. 

While generics make up about 65% of prescriptions written and equivalence issues between generics and innovator drugs have been raised in the past, “now we are seeing a lot of pressure about this issue again,” she said. “The generic system works well with bioequivalence determinations and chemistry reviews and so on, but questions do arise, for example ‘are bioequivalence limits tight enough for some specific drug' and I think usually the answer there is ‘yes.'”

During the summer Woodcock's center met with People's Pharmacy columnist and advocate Joe Graedon to discuss reports about therapeutic failures and adverse events when patients were switched from brand name Wellbutrin  to Impax's (marketed by Teva) generic equivalent. The FDA agreed to consider doing a bioequivalence study. 

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.