When Ralph Neas joins the Generic Pharmaceutical Association as CEO on Sept. 12 he will face many of the same challenges he's had as the CEO of the National Coalition on Health Care: energizing reform-minded partners to advocate for legislative and policy changes.

Neas will also face an environment as challenging as the one his predecessor at GPhA, Kathleen Jaeger, confronted: legislative setbacks, new regulatory hurdles, and the need to position the generics industry as a provider of cheaper health care while still ensure member companies can remain profitable.

Jaeger departed the trade association at the end of June 2010, after the generics industry had suffered a crushing loss on what they had hoped would be a signature achievement: the biosimilars pathway enacted as part of the healthcare reform legislation had a longer brand exclusivity and a more serpentine approval process than the generic industry thought was reasonable (Also see "GPhA After Jaeger: Will Industry Pressures Push Firms Together Or Pull Association Apart? New CEO Must Face Down FOBs" - Pink Sheet, 10 May, 2010.).

Neas takes over as the association seems on the brink of another defeat: the patent reform legislation about to be passed by the Senate will likely permit patent-term extensions for The Medicines Company and other sponsors that had missed their initial filing deadlines, and create a mechanism for "supplemental examination" of patents that generics feel will limit their ability to mount inequitable conduct defense during litigation (Also see "Patent Reform: Senate May Amend Two Provisions In House Bill" - Pink Sheet, 5 September, 2011.).

And while Jaeger had to work with an FDA that firms thought was too slow to approve their products because of a growing application backlog, Neas will have to deal with an agency that will be inspecting manufacturing facilities at an unprecedented rate as part of a new user fee program (Also see "FDA, Industry Reach Agreement On Major Portions Of Generic User Fee Program" - Pink Sheet, 10 August, 2011.).

Manufacturers and agency officials alike hope that the user fee agreement - details of which are expected to be released shortly - will increase the predictability and credibility of generic reviews.

But implementation will require industry to work with the agency on a whole new level because of the intertwining commitments, a task complicated by the fact the association's top regulatory science post remains vacant (Also see "GPhA Seeks New Driver As Outgoing VP Johnston Continues To Ford Across User Fee Stream" - Pink Sheet, 4 April, 2011.).

And perhaps most pressingly, Neas must convince lawmakers that generics should be an object of affection, not a target for savings, as they consider deficit-minded reforms (Also see "Deficit Super Committee Inaction May Be Best Scenario For Biopharma" - Pink Sheet, 5 September, 2011.).

Making Generics A "National Security Issue"

To accomplish all these tasks, Neas will need to use the collation-building skills that he's honed over several decades of political work, first on civil rights and judicial issues, and more recently on health care.

Neas takes pains to emphasize the bipartisan nature of his work - his resume notes that he "began his public service career as Chief Counsel to Republican U.S. Senators Edward W. Brooke (1973-1978) and Dave Durenberger (1979-1980)" - but many of his accomplishments have been associated with liberal, Democratic principles.

Neas has been with the National Coalition on Health Care - a group of patient advocates, labor unions and large employers advocating for "fair and effective cost containment" - since 2007, first as a senior advisor, and then as CEO.

Despite that background, Neas does not see a problem in reaching out to lawmakers in both parties.

"GPhA's issues are neither conservative nor liberal; they are neither Republican nor Democratic; they are national security issues," Neas said in a Sept. 7 phone interview as he packed up his NCHC office.

"Slowing the annual growth of health care costs are essential to sustainability of the health care system and national economy, and generics are an important part of that. ... I want to be part of the effort to do a much better job of getting our story out there," Neas said.

Three Models For A CEO

Neas will become the third CEO of the unified trade association generic industry, which for many years after Hatch-Waxman created the business model had organized itself into smaller groups along company size and focus.

The big GPhA tent they all sit in now is not without its squabbles over table arrangements, but it has allowed the industry to accomplish more on the policy legislative front than it had in the past (Also see "GPhA Enters 2011 Bigger And Stronger, But With A Broader Fight On Its Hands" - Pink Sheet, 10 January, 2011.).

Neas has a distinct background from the other two CEOs of GPhA. Bill Nixon, the first CEO who helped complete the unification process, had a long resume on the Republican side of the aisle and was able to open doors for an industry that had been mostly associated with the Waxman side of the legislation. Kathleen Jaeger, the second CEO who served during a time of considerable industry growth, used her pharmacy and law background to clear many of the procedural landmines that had found their way into the ANDA approval path.

Neas, in contrast, as long worked on issues related to the themes that GPhA wants to emphasize in its public presentations: access, opportunity, fairness.

In that sense, Neas is a approaching the job of communicating GPhA's agenda with a philosophical alignment that's arguably the strongest the association has ever had; he's been advocating on these kinds of issues nearly his entire career.

Even with that background, of course, Neas' job of making life easier for generic companies will be no easy task given the political and regulatory environment.

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

GPhA's New CEO Ralph Neas Brings Health Reform Advocacy Experience

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