As part of the Critical Path Initiative [1], the FDA issued a new report identifying many of the roadblocks [2] that prevent the development of generic versions of commonly used drugs. Companies must prove their generic drug's bioequivalence to brand-name therapies. For most drugs this can be established with blood plasma tests. However, it's more difficult to prove the bioequivalence of inhalers, nasal sprays, and topical skin applications, and fewer of these drugs are available in generic forms. The report calls for research on new bioequivalence methods for each challenging drug class By pinpointing the barriers preventing generics to enter the market, the FDA hopes to improve patients' accessibility to commonly-used treatments.
- see the report [3] for more
Related Articles:
FDA pushes ahead with Critical Path Initiative. Editorial [4]
FDA backlog slows generic drug approval. Report [2]
Sanofi chairman lambastes generic drug makers. Report [5]
FDA offers accelerated review for select generics. Report [6]
Links:
[1] http://www.fiercehealthcare.com/story/fda-streamlining-drug-approval-process/2006-12-05
[2] http://www.fiercebiotech.com/story/fda-backlog-slows-generic-drug-approval/2006-04-10
[3] http://www.fiercebiotech.com/node/6754
[4] http://www.fiercebiotech.com/story/editor-s-corner/2006-03-20
[5] http://www.fiercebiotech.com/story/sanofi-chairman-lambastes-generic-drug-makers/2007-01-02
[6] http://www.fiercebiotech.com/story/fda-offers-accelerated-review-for-select-generics/2006-10-20