By Meghan McCarthy, CQ Staff

No matter who wins November’s presidential election, biotech drug manufacturers are unlikely to get the 14-year period of data exclusivity they seek as part of follow-on biologics drug legislation, the candidates’ top health policy advisers said Thursday.

At an annual generics industry conference hosted by the Generic Pharmaceutical Association (GPhA), Douglas Holtz-Eakin, adviser to GOP nominee John McCain , and Dora Hughes, senior health adviser to Democratic nominee Barack Obama , said both candidates support the shortest time period possible.

“The basic instinct should be: push the period down to the shortest period that maintains the appropriate innovation incentives,” Holtz-Eakin said. Hughes agreed and said the 14-year period of data exclusivity supported by the biotech industry is “excessively” long.

Makers of generic drugs favor legislation (HR 1038) sponsored by Rep. Henry A. Waxman , D-Calif., that would provide an abbreviated pathway for the approval of follow-on biologic drugs and includes no period of data exclusivity for biotech companies. Rep. Anna G. Eshoo , D-Calif., introduced a measure (HR 5629) that would allow for a period of data exclusivity of 14 years, and is supported by the biotech industry. The Senate Health, Education, Labor and Pensions Committee has approved legislation (S 1695) that would authorize the Food and Drug Administration (FDA) to approve generic versions of biotech drugs after a 12-year exclusivity period for the original drug maker.

Also speaking at Thursday’s conference, Rep. Nathan Deal of Georgia, ranking Republican on the House Energy and Commerce Health Subcommittee, said follow-on biologics legislation would not move in the 110th Congress.

“I don’t see any way it can, time-wise — I don’t think there’s any way,” Deal said after he addressed the group.

During his speech, Deal said that determining an appropriate period of data exclusivity has been a major challenge to passing legislation.

“We’ve achieved a lot, even though we haven’t finalized anything. I think we’ve dispelled a lot of myths, and the biggest issue, of course, comes down to the period of data exclusivity. That time frame still remains one of those disputed issues and one of these things we have to deal with,” he said.

Both presidential campaign advisers agreed that determining an appropriate period of data exclusivity for biotech drugs is the key issue to address before establishing an approval pathway for follow-on biologics.

“About $20 billion in biologics go off patent in 2009, and we are going to need a pathway for biologics. Sen. McCain is willing to take on the tough issues of data exclusivity, and other issues that will affect how this pathway goes forward,” Holtz-Eakin said.

Hughes said that “14 years [of data exclusivity], as requested by the biotech industry, is excessively long  . . .  we’re tilted toward the shorter period.”

Obama is committed to establishing a follow-on biologics approval pathway in the FDA, Hughes said, and highlighted his efforts to pass this legislation in last year’s FDA reauthorization bill.

The Obama campaign has also pledged to prohibit the sale of authorized generics, the so-called generic drugs produced by brand name companies when a generic version of their drug is first introduced, and to investigate settlements between brand name and generic companies that keep lower-priced generics off the market. Increasing funding and transparency for the FDA, abolishing “carve-out” practices and eliminating provisions in free trade agreements that allow brand name companies to monopolize the sales of their drugs overseas are also among Obama’s priorities, Hughes said.