Ted Kennedy is reported to be circulating draft legislation which would provide an approval pathway at the FDA for generic versions of biotech drugs. His proposed bill would also provide a period of market exclusivity for brand-name biotechs before generic versions of their products could come to market.

The Democrat, who chairs the Senate Help, Education, Labor and Pensions committee, began circulating his proposals this month after the committee voted 15-5 in favor of the Food and Drug Administration Revitalization Act (S 1082), which he co-sponsored with the panel’s ranking member, Republican Senator Mike Enzi.

That bill would reauthorise the Prescription Drug User Fee Act, which expires on September 30, for another five years, and increase by $50 million the amount which has been agreed between the FDA and industry to fund drug safety activities. It would not, however, create a biogenerics approval pathway at the FDA, although Kennedy forecast after the vote that this would be added before the bill goes to the Senate floor for a full vote, which he expected would be some time in June.

Kennedy’s draft proposals would establish tighter circumstances under which a pharmacist could substitute a biogeneric for a branded generic drug than those included in the Access to Life-Saving Medicine Act (S 623), introduced in the Senate in February by Democrats Chuck Schumer and Hillary Clinton.

Further reading…
PharmaTimes[tags]Biogenerics, Biotech, Generics[/tags]