GPhA's 2005 Priorities Include Generic Biologics, Biodefense Incentives

The Generic Pharmaceutical Association will continue to push for an approval pathway for generic biologics and work against "authorized" generics and patent term exclusivity extensions contained in biodefense legislation, President Jaeger tells group's annual meeting.

The Generic Pharmaceutical Association will focus on generic biologics, biodefense incentives and "authorized" generics as three key policy issues in 2005.

A "major priority, something I like to think of as the 'new frontier' for everyone in this room and for all Americans, is generic biopharmaceuticals," GPhA President Kathleen Jaeger said Feb. 25 at the association's annual meeting in Boca Raton, Fla.

Jaeger renewed the group's call for FDA and Congress to immediately establish "a definitive, abbreviated approval process for affordable biopharmaceuticals."

GPhA previously requested that FDA establish a "task force" to identify unresolved scientific issues for generic biologics (¹ (Also see "GPhA Asks FDA To Create Task Force On Generic Biopharmaceuticals" - Pink Sheet, 15 Nov, 2004.)).

The agency is approaching the issue through a series of public meetings, including a recent meeting co-sponsored with the Drug Information Association (² (Also see "FDA Follow-on Proteins Draft Guidance Will Be Followed By Third Public Meeting" - Pink Sheet, 14 Feb, 2005.)).

Center for Drug Evaluation & Research Acting Director Steven Galson told GPhA that a series of guidances on the topic should be issued in the next six months.

GPhA will continue to lobby against patent and exclusivity extensions for brand products included in biodefense legislation, Jaeger said.

The "Bioshield II" bill (S 3) introduced in the Senate Jan. 24 contains a "wild card" patent extension that would allow manufacturers of counter-terrorism agents to extend a patent for an unrelated product. The proposal is similar to one opposed by GPhA last year (³ (Also see "BioShield II Patent Extensions Will Increase Drug Costs, GPhA Says" - Pink Sheet, 4 Oct, 2004.)).

Although "GPhA supports the concept of incentives that enhance our nation's security during the war on terror," biodefense proposals in Congress would inappropriately delay entry of generics, Jaeger said.

"Perhaps the most outrageous provision is wild card exclusivity - a supposed incentive for research into counter-bioterrorism drugs. But wild card exclusivity would allow the brand industry to reach into the medicine cabinet of every American and unfairly extend exclusivity on the drug of their choice," Jaeger said.

"Likewise, another harmful concept is to extend patents for already approved drugs. This does little in the way of enhancing our security."

The trade association also will push to eliminate authorized generics. "GPhA will vigorously oppose this blatant effort to undermine the incentive to bring patent challenges under Hatch/Waxman," Jaeger said.

Rep. Henry Waxman (D-Calif.) echoed GPhA's policy positions in his remarks to the meeting.

Authorized generics were not part of the intent of the Waxman/Hatch law, Waxman said.

"When a brand company develops its own generic, it's taking advantage of a loophole that we never intended to be a loophole. What we intended was to give an incentive for generic companies to go out and challenge these patents so that we could get generic competition in the market, not a phony competition to block other generics."

"I would like to see that changed. I think there's reason for us to be concerned about it," Waxman said.

Waxman also opposes Bioshield II. The bill's provisions on exclusivity and patent restoration "would dramatically limit access to generic drugs and raise the price of prescription drugs," he declared.

In the area of generic biologics, FDA should move forward on a case-by-case basis, Waxman said.

"If the FDA issues guidance on approval" of simpler biologics such as generic insulin and human growth hormone products, "it will demonstrate for the first time that there is sufficient scientific knowledge to establish the safety, effectiveness and equivalence of at least some biogenerics. It will also provide the first test of the FDA's ability to create a defensible case-by-case approval process for biogenerics, because ultimately, that seems to be where we are headed."

The case-by-case approach is the most appropriate because "these products range in complexity and the types of studies that will be necessary to demonstrate the safety, effectiveness and equivalence of the generic counterpart," Waxman said.

FDA's past development of standards for topical and inhaled generic drugs "suggests to me that we will be able to create a legislative scheme in which the methods of establishing equivalence for each class of biologics are left to be developed by the FDA as the science evolves."

- Elizabeth Walker