With Democrats taking power on the Hill, it seems likely that they'll push through rules making it easier to bring generics to market. In fact, observers say next year could be as important as 1984, the year new laws kicked off the current generics system. While it's not clear whether the Dems will let the FDA move from approving generic versions of chemically-derived drugs to generic biotech drugs, they may very well limit brand drug manufacturers' ability to thwart competition from generics manufacturers. FDA's generics office should get more funding, and may have less ability to delay generic-drug approvals or grant six-month exclusives for brand drugs given in exchange for pediatric research. While other reforms are in the pipeline, biotech generics could remain controversial. Biotech industry reps argue that generics makers aren't prepared to make identical versions of their products, and will need to duplicate their research before they can go to market.
Learn more about the upcoming generics fight:
- read this Wall Street Journal article (sub. req.)
- check out this piece from FierceBiotech. Report
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