Generic Pharmaceutical Association President & CEO Kathleen Jaeger brings experience in legal and regulatory analysis that could help the trade association in its relations with FDA and in legislative drafting.

Jaeger, 37, joins GPhA, effective April 15, from Kirkpatrick & Lockhart, where she is a partner. The selection comes in advance of the association's annual meeting in Coral Gables, Fla., on April 8-10.

With a pharmacy degree from the University of Rhode Island, Jaeger is versed in technical pharmacological issues that affect generic and brand drug comparisons, which could add to the FDA dialogue.

Prior to joining Kirkpatrick & Lockhart in April 2001, Jaeger spent 10 years at McKenna & Cuneo representing firms before FDA and the Federal Trade Commission. Jaeger left McKenna with four other attorneys, including former Food & Drug Law Institute President Gary Yingling, to establish Kirkpatrick & Lockhart's food and drug practice.

The GPhA appointment represents a shift from the association's prior emphasis on political connections.

Former GPhA President Bill Nixon, who left the association in late February, had extensive Capitol Hill experience, having served as an aide to former Sen. William Roth (R-Del.) for 14 years. Jaeger was identified as a candidate immediately upon Nixon's departure (¹ Also see "GPhA In Transition: Milanese Steps In As Waxman/Hatch Hill Debate Looms" - Pink Sheet, 25 February, 2002., p. 6).

Nixon joined GPhA in November 2000 shortly after it was formed, and he undertook direct responsibility for lobbying efforts following the departure of VP-Government Affairs Buddy Menn (² Also see "GPhA Lobbying Will Be Led By CEO Nixon Following Departure Of VP Menn" - Pink Sheet, 19 March, 2001., p. 7). GPhA VP-Programs and Education Bob Milanese has served as acting executive director of the association since Nixon's departure. Nixon is pursuing a political consulting business.

The difference in background between the two heads of the association may signal a greater emphasis going forward on the more technical legal and regulatory issues surrounding generic drugs, rather than on proposals for broad legislative reform.

For example, Jaeger worked on GPhA's briefings for a "moot court" held by FDA Chief Counsel Daniel Troy in January at which the brand and generic industry presented arguments on how FDA should interpret existing statutes (³ Also see "“Orange Book” Patent Listing Declarations Need More Detail – GPhA" - Pink Sheet, 11 February, 2002., p. 12).

Jaeger will be challenged by a new legal team at FDA which is intent on sticking closely to existing statute for agency policy. FDA has put its discontinued labeling guidance on hold at the direction of the Office of the General Counsel. The decision could hold up approval of several pending ANDAs.

The strict interpretation of statutes affecting generic drugs could place even greater importance on legislative action to reform of Waxman/Hatch Act.

Jaeger has been active on behalf of the generic industry's efforts to reopen Waxman/Hatch and has developed congressional testimony for one GPhA predecessor, the National Pharmaceutical Alliance.

GPhA's major legislative efforts have been focused on McCain/Schumer, which would remove 30-month stays on generic approvals and also contains a provision stipulating that citizen petitions may not be submitted with the intent to unnecessarily delay generic approval (⁴ Also see "McCain/Schumer Generic Bill Would End 30-Month Stay Of Approval" - Pink Sheet, 7 May, 2001., p. 8). Jaeger has lobbied FDA to handle citizen petitions in an expedited manner.

The new GPhA president has also worked on defining the generic industry's position of generic biologics, and could aid in developing the legal framework for FDA regulation.

Jaeger also helped craft provisions in the Best Pharmaceuticals for Children Act specifying that pediatric and generic exclusivity would not overlap and permitting approval of generics that omit protected pediatric labeling. She represented NPA in an unsuccessful suit against FDA's pediatric exclusivity law (⁵ Also see "Pediatric Exclusivity Will Not Irreparably Harm Generic Firms, Court Says" - Pink Sheet, 26 April, 1999., p. 32).

Jaeger is especially well known to some of GPhA's larger members. Past clients include Barr, Ivax and Teva. Barr is one of the more politically active generic firms and has its own Washington office. In March, Jaeger represented Barr at a meeting on generic reform issues organized by Blue Cross/Blue Shield (⁶ Also see "Generic Drug Competition Hearing Planned For Senate Commerce Committee" - Pink Sheet, 18 March, 2002., p. 45).

GPhA CEO-Designate Jaeger Has Legal, Regulatory Background

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