Sen. Orrin Hatch, R-Utah, and Rep. Henry Waxman, D-Calif., continue to disagree on how to move toward what could be the next major milestone in the generics industry they essentially created in 1984: generic biologics.

The two legislators appeared at the Generic Pharmaceutical Association annual meeting both to praise the industry and appraise its future directions.

Appearing via satellite on March 2, the two senior statesman of bioequivalence gave separate addresses, their figures on the projection screens emphasizing their importance to the generics industry.

Although no one would question Hatch's significance to the industry, his lack of visibility on the issue of generic biologics may have been what prompted him to begin his speech by noting, "I still consider myself to be your great friend."

While Waxman has introduced legislation that would create a pathway for case-by-case approvals of generic biologics, Hatch has urged more discussion on the topic (see ¹ Also see "Generic Biologics: European-Style Regulation Is The Answer, Big Pharma Says" - Pink Sheet, 12 March, 2007.).

Hatch told GPhA that generic biologics has "been a high priority for me and I've worked with many of you over the past year to make this a reality."

"This year, I predict we will get it done," he said, noting, "I have begun initial discussions on the outlines of a bill with several HELP Committee senators."

Unlike 1984, Hatch and Waxman do not chair relevant committees as this new pathway is being debated, but their roles as significant arbiters in the current discussion is a testament to their expertise and equanimity.

To what extent the final legislation, if any is enacted, is an expression of their vision will be a testament to their legislative skill.

In introducing Waxman, Barr's CEO Bruce Downey, the newly re-elected chairman of GPhA board, said, "We want to encourage him to continue work for passage of this bill, and to ensure that the generic biologics bill bears his name, as did the generic pharmaceutical bill."

Technically, of course, the Drug Price Competition And Patent Term Restoration Act of 1984 bears neither of the legislators' names, but the fact that it was created because of the vibrant partnership between the two was recognized well before passage (² Also see "HATCH/WAXMAN MAY 3 LETTER TO PMA PRESIDENT ENGMAN ON ANDA LEGISLATION" - Pink Sheet, 7 May, 1984., p. 4).

In his GPhA address, Waxman described his role with pride and humor, referring to "what used to be the Waxman/Hatch Act and now the Hatch/Waxman Act, and I always said, I don't care what you call it as long as you don't call it the Hatchman/Wax Act."

This year, the omnibus nature of the user fee renewal legislation - which will almost certainly include new drug safety authorities and may well include a generic biologics pathway - suggests the bill could take on a broader name and be seen more as the creation of the chairmen who navigate the bill through the legislative waters.

Waxman's proposed legislation, the Access to Life-Saving Medicine Act (³ HR 1038), appears unlikely to be enacted as written, given the brand industry's concerns about the lack of intellectual property incentives.

Another naming issue could have broader ramifications for the adoption of generic biologics.

GPhA typically uses the term "biogenerics" to describe the products, capturing the favorable impression payers and the public have of generics for their cost-saving potential.

The brand industry uses "follow-on biologics," conveying an image of the products as having a different and derivative nature from their brand counterparts.

Some speakers, such as former FDA Commissioner Mark McClellan, are careful to use both terms at almost every mention.

Hatch, on the other hand, offered a laundry list at one point, referring to "generic biologics, follow-on bio-logics, biosimilars, or whatever you care to call them."

Another description that Hatch used in his remarks may be the most apt but least likely to be widely adopted. In introducing the topic, Hatch referred to the products as the "big kahuna."

- M. Nielsen Hobbs (n.hobbs@elsevier.com)

What’s In A Name? Hatch And Waxman Stake Claims To Generic Biologics Bill

More from Archive

More from Pink Sheet