US Senator Edward Kennedy is reported to be circulating draft legislation which would provide an approval pathway at the Food and Drug Administration for generic versions of biotechnology drugs. His proposed bill would also provide a period of market exclusivity for brand-name biotechnology companies before generic versions of their products could come to market.

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

S 1082 would reauthorise the Prescription Drug User Fee Act, which expires on September 30, for a further 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 Sen 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.

Sen 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 Charles Schumer and Hillary Rodham Clinton.

Sen Kennedy described S 1082 as “commonsense bipartisan reforms to give FDA the authority it needs to protect public health and to expedite the delivery of safe and effective new drugs and medical devices to the patients who need them.” However, both he and Sen Enzi acknowledged that changes would likely be made to some of S 1082’s more controversial provisions before it goes to a full vote.

As it currently stands, S 1082 would increase FDA funding for tracking the safety of drugs after they have been approved by nearly $30 million, while drugs and biologics which represent serious risks would be approved with risk evaluation and mitigation strategies (REMS). The safety of new medicines would be reviewed after 18 months and again three years after launch, while the safety of medications approved for new uses would be monitored for at least three years. Moreover, agency officials would have new powers to fine manufacturers which fail to conduct post-approval studies.

The bill would also: – expand the data bank to include all Phase II and later drug trials, plus results information after the product has been approved or cleared for marketing; – require disclosure of conflicts of interest of FDA advisory committee members prior to committee meetings; – ban the advertising of new drugs to consumers for two years; and – amend current paediatric research incentives, with a reduction in the extra patent time for paediatric studies to three months in cases where drugs have annual sales of more than $1 billion.

Republican amendments fail

“The bill establishes a new way to oversee drug safety that is flexible enough to be tailored to each new drug, yet strong enough to allow decisive action when problems are discovered,” said Sen Kennedy, but Republicans, as well as Health and Human Services Secretary Mike Leavitt, described many of its provisions as too onerous. However, Republican-proposed amendments to rein them back were not accepted by the full panel.

After the vote, Sen Enzi acknowledged that the bill was “by no means a finished product.”

The debate had demonstrated “legitimate concerns about the potential unintended consequences of this bill and the amendments that were offered,” he said, and added: “I look forward to working with the Members of the HELP Committee in the coming weeks to address the concerns outlined in their amendments, and I am confident that we can work together in a bipartisan manner to strike the right chord for patient safety.” By Lynne Taylor