The Generic Pharmaceutical Association's incoming head of government affairs brings a wealth of experience on federal and state reimbursement issues.

John Coster was senior VP for government affairs at the National Community Pharmacists Association, before starting at GPhA with the same title on Feb. 14.

He replaces Bill Head, who left GPhA for the Consumer Healthcare Products Association last month (Also see "GPhA Enters 2011 Bigger And Stronger, But With A Broader Fight On Its Hands" - Pink Sheet, 10 January, 2011.).

Before NCPA, Coster worked in federal affairs positions at Rite Aid and the National Association of Chain Drug Stores and also held various academic and congressional posts. In the early 1990s, he was on the staff of the Senate Special Committee on Aging when it was chaired by David Pryor (D-Ark.) and was active on drug pricing issues.

Coster's presence will boost GPhA's ability to engage the Centers for Medicare and Medicaid Services on issues related to regs on average manufacturers price, Medicaid discounts and other reimbursement issues (Also see "In Absence Of AMP Rules From CMS, Manufacturers Make Their Own" - Pink Sheet, 24 January, 2011. and Also see "ASP Data Lag On New Generic Drugs Encourages Generic Utilization – CMS" - Pink Sheet, 17 January, 2011.).

Laying A Foundation For Stronger Lobbying

In addition to Coster, GPhA hopes to hire two new in-house federal lobbyists and one additional state affairs director in the coming months as part of a renewed push for outreach to Capitol Hill and state houses made possible by a restructuring of the association that increased dues revenue.

As the association staffs up, it will also need to engage Congress on three issues in particular:

Patent reform. The Senate Judiciary Committee just marked up its bill (Also see "Patent Bill Clears Senate Judiciary Cmte. Unanimously, But Floor Fight Looms" - Pink Sheet, 3 February, 2011.).
Restrictions on patent settlements. Republican control of the House makes any legislation highly unlikely, but Sens. Herb Kohl, D-Wisc., and Charles Grassley, R-Iowa, just reintroduced their bill that aims to essentially ban the practice.
Increased funding for FDA's Office of Generic Drugs. GPhA has been successful in years past in getting a generous earmark for OGD, but this is a particularly austere budget environment. A more reliable approach to better funding for ANDA reviews will probably be user fees that industry will negotiate with FDA. The agency just reopened the comment period on the user fee docket; it closes again on Feb. 23 (Also see "Generic User Fees: FDA Reaches Out To More Trade Groups; Plan Could Mix Inspection and Application Fees" - Pink Sheet, 3 January, 2011.).

One of Coster's first challenges may be working with states and pharmacy groups as HHS pushes for a change in how prices for Medicare drugs are calculated (Also see "Medicaid Rx Spend Could Be Cut By Shifting To Actual Acquisition Costs, HHS Suggests" - Pink Sheet, 14 February, 2011.).

Coster will be GPhA's fourth top lobbyist in the last four years. Head joined the association in September 2009; Lisa Layman (now at Brown Rudnick) had taken the post in February 2008, and Gary Heimberg had started in March 2007, joining from Akin Gump Strauss Hauer & Feld LLP.

GPhA is hoping that Coster, who himself has worked for four different employers in the last four years, will bring stability to the operation. But the appointment also could create an interesting dynamic once the association names a new CEO, since that person will not be able to shape the group's lobbying efforts in quite the way that would have been possible had the government affairs job remained vacant.

Coster's move might even be jokingly referred to as part of a GPhA/NCPA exchange program, but those shifts underscore how interdependent the relationship is between those that manufacture generic drugs and those that dispense them. GPhA's former CEO Kathleen Jaeger joined NCPA in October and she now gets the opportunity to more directly shape the association's lobbying strategy as NCPA searches for a replacement for Coster.

[Editor's note: A version of this article originally appeared in the Feb. 3 edition of "The Pink Sheet" DAILY. For a free trial, visit www.ThePinkSheetDaily.com and click “Subscribe,” or call 800-332-2181.]

By M. Nielsen Hobbs

GPhA Gains Medicaid/Medicare Expertise: Coster Joins As VP For Government Affairs

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