The merger agreement between the National Association of Pharmaceutical Manufacturers and the Generic Pharmaceutical Association likely means that generic drug user fees will not be a focal point of the PDUFA reauthorization process.

NAPM favored user fees as a means to accelerate generic drug approval times. GPhA, however, is more skeptical of fees, telling FDA during a Sept. 15 meeting on the Prescription Drug User Fee Act reauthorization process that Waxman/Hatch reform and other steps to accelerate generic launches are more pressing (¹ Also see "GPhA Still Wary Of Generic User Fees; Issue Tied To Waxman/Hatch Reform" - Pink Sheet, 18 September, 2000.).

"NAPM has been pretty much out on their own supporting user fees for the industry," Chairman Tom Russillo (Ben Venue Labs) told the association's annual meeting Jan. 29 in Las Croabas, Puerto Rico. "We believe that appropriate user fees that are additive to FDA's budget could certainly improve review times and therefore accelerate a generic drug's speed to the marketplace."

"We, now with the GPhA, will work together to consider whether NAPM's previous position is really the way to solve some of these issues," Russillo said.

An aide to Rep. Waxman (D-Calif.) indicated that Congressional support for generic user fees remains. "If we can do it in an intelligent manner, one that really guarantees that you get results from [the Office of Generic Drugs], then that is something we definitely want to address, especially in the context of FDA reform," Paul Kim told NAPM.

GPhA will expand its board of directors on an interim basis under the merger agreement. The association will add four members chosen by NAPM to its 27-member board for the next year. GPhA's executive committee will also expand to six, adding one NAPM member. The GPhA board already includes two members, Warrick and Mova, who are in both associations.

The governance structure for GPhA will revert to its original design following board elections in 2002.

NAPM declined to join GPhA when it was formed in June through the merger of the Generic Pharmaceutical Industry Association and the National Pharmaceutical Alliance. NAPM was concerned that smaller companies would have limited influence in GPhA.

The departure of Faulding from NAPM at the end of 2000 is understood to have precipitated renewed merger discussions; the company had been a member of both associations. The NAPM board approved the merger Jan. 28.

GPhA has a board meeting scheduled for Feb. 6. Prospective board members from NAPM - Ben Venue, Dey, Duramed and Vinchem (which will serve on the executive committee) -have been invited to participate, although the merger process is not final. Shaw Pittman Partner Jeff Glassie has been advising GPhA on association legal issues.

In addition to new members, GPhA may soon have a new name. The association is contemplating referring to its products as "equivalent pharmaceuticals" to avoid the impression that generic drugs are of lower quality than their brand name counterparts.

NAPM President Robert Milanese is considering whether to remain with GPhA as VP-programs & education. If he does, the association will likely retain NAPM's Ronkonkoma, N.Y. offices.

GPhA's public affairs will be headed by Jim Courtney, who served as press secretary to former Sen. Roth (R-Del.). Courtney joined Roth's staff in March 1999; he was previously a TV reporter in Dover, Del. GPhA President Bill Nixon served as a senior advisor to Roth.

NAPM's counsel and lobbying firm Olsson, Frank & Weeda may be retained by GPhA. The firm received an endorsement from Sen. Johnson (D-S.D.) during a luncheon address at NAPM. Johnson referred to the firm three times, saying it "played a key role" in the development of his "Pharmaceutical Access & Choice For Consumers Act."

The legislation, reintroduced Jan. 25 as S 186, would mandate generic preference language for federal health plans and potential Medicare Rx benefits and would require states to recognize FDA ANDA approvals.

Johnson praised the merger between the associations. "Having one voice in Washington, D.C. no doubt will be helpful," he said. Johnson appeared in educational TV spots that NAPM ran in South Dakota.

Johnson now sits on the Appropriations/Ag Subcommittee, which oversees FDA funding.

NAPM/GhPA Merger Likely Ends Generic User Fees Push In 107th

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