By Donald Zuhn --
Congressman Henry Waxman (D-CA), the Chairman of the House Committee on Energy and Commerce, addressed the Generic Pharmaceutical Association (GPhA) yesterday, telling attendees of the trade group's annual meeting in Naples, FL that "a workable scientific regulatory and legal pathway for biogenerics and biosimilar pharmaceuticals will ensure more affordable medications for Americans and we believe it will spur innovation in the bio tech markets" (see GPhA press release). It was fitting that Rep. Waxman appear before the group (even if via video), as the GPhA's annual meeting this year celebrates the 25th anniversary of the signing of the Hatch-Waxman Act.
Rep. Waxman (at left) called the issue of exclusivity "[o]ne of the biggest sticking points in the debate over biogeneric legislation," informing attendees that "[t]he brand industry is calling for 12, 14, 16, and even 20 years of exclusivity." As for the soundness of the brand industry's argument, Rep. Waxman told the GPhA that "[i]t makes my head spin trying to keep up with [the brands'] ever changing arguments for why these terms are justified." Acknowledging his own bias, Rep. Waxman argued that the Hatch-Waxman model, which "has worked well for 25 years," would achieve a strong balance between fostering innovation and making affordable biologics available to consumers.
Following Rep. Waxman's remarks, GPhA President and CEO Kathleen Jaeger (at right) and BIO President and CEO Jim Greenwood participated in a "lively" biogenerics panel discussion, in which both Ms. Jaeger and Mr. Greenwood agreed that biogenerics legislation has gained momentum. However, Mr. Greenwood reiterated BIO's position that there should be 14 years of market exclusivity. Ms. Jaeger responded that "the devil is in the details," pointing out that "the issue of exclusivity is likely the 'gordian knot' that must be cut loose for us to reach consensus and get legislation passed." However, she asserted that "[t]he generic industry has 25 years of experience that shows the balanced approach under Hatch-Waxman is a sound and successful model to use for biogenerics."
In a separate announcement, the Coalition for a Competitive Pharmaceutical Market (CCPM), an organization of large national employers, consumer groups, generic drug manufacturers, and insurers (a list of members can be viewed here), strongly praised Rep. Waxman's remarks at the GPhA's annual meeting.
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