AdvaMed member companies who are not represented on the group's executive search committee are circulating a list of potential replacements for President Pam Bailey.

The search committee is comprised of AdvaMed Chair and Medtronic President & CEO Art Collins, Chair-Elect Ed Ludwig, president & CEO of BD, and previous Chair Dennis Longstreet, J&J/Ethicon group chair.

While the process is expected be relatively short, with a new president likely to be hired in the next few months, AdvaMed firms want to ensure as comprehensive a search as possible. They will submit names to Collins' committee.

Bailey will become president & CEO of the Cosmetic, Toiletry & Fragrance Association April 4, CTFA said in a March 14 release. In a March 17 interview with "The Gray Sheet," she characterized the decision to leave AdvaMed "an extremely difficult one for me...because I believe so strongly in this industry and what innovation does for patients."

AdvaMed's executive committee, board and staff learned March 14 of the departure. Nevertheless, depicting the transition planning process as "very collaborative," Bailey said she has "been working directly with Art Collins, the search committee and the executive committee, and we...decided on the management committee process for the interim period."

The association's responsibilities for daily operations will be shared by four staffers: Senior Exec-VP David Nexon, Exec-VP Strategic Planning Blair Childs, Exec-VP Global Strategy & Analysis Ralph Ives and Exec-VP Finance & Operations Kristen Bogenrief.

Bailey also has recommended some candidates to the search committee. She says "a number of names have been mentioned," but she "would not presume to speculate on whom they might select." Bailey did predict that AdvaMed "will be able to attract - and have their choice of - very qualified candidates."

Keeping Up With PhRMA, BIO: Exec Profile Raised

Potential candidates floated by member firms include several of Washington's top health policy leaders - an indication that the industry seeks to follow the Pharmaceutical Research Manufacturers of America and the Biotechnology Industry Organization in tapping a prominent official.

In January, former House Energy & Commerce Committee Chairman Billy Tauzin (R-La.) became head of PhRMA, while Jim Greenwood (R-Penn.), took over the reins at BIO.

The device industry has few retired congressional members from which to choose. John Breaux (D-La), a prior senator with extensive health policy experience, joined Patton Boggs as a senior counsel in January.

Nevertheless, the list of potential candidates is stacked with health policy star power.

At least one member company wants Healthcare Leadership Council President Mary Grealy to be considered for the job. Grealy has extensive experience with healthcare issues, is well-known in Washington and has a management background - qualities the search committee is seeking.

J&J is a member company of HLC, which could help Grealy's chances. Abbott and Baxter also belong to the council; Guidant CEO Ron Dollens recently served a two-year term as HLC chair. Another factor in Grealy's favor is that Bailey spent 10 years leading HLC before joining AdvaMed.

America's Health Insurance Plans President & CEO Karen Ignagni - considered one of the top lobbyists in the nation - also is on the list. She began heading the American Association of Health Plans in 1993 and oversaw the group's merger with the Health Insurance Association of America in December 2003.

Having recently completed the merger, Ignagni is understood to have set several more goals for AHIP, and is unwilling to leave her post.

Darren Willcox, healthcare practice director at the lobbying and consulting firm Dutko Group, has been floated as another possibility. Willcox previously served as health policy advisor to House Speaker Dennis Hastert (R-Ill.).

Additional potential candidates include Barbour Griffith & Rogers President Bob Wood, previously HHS chief of staff, Pharmaceutical Care Management Association CEO Mark Merritt and White House Senior Health Policy Advisor Doug Badger. However, Badger told "The Gray Sheet" he was not interested in the position.

Should the search committee pursue someone with a solid grasp of device concerns, but who lacks seasoned management experience, Steve Ubl could prove an effective candidate. Ubl Health Solutions' clients include BD and Medtronic. Ubl, who was exec VP-federal government relations at AdvaMed for nearly six years, was instrumental in passage of MDUFMA and getting device provisions into the Medicare Modernization Act.

Bailey's Legacy: An Industry With More Clout

Although Bailey said she did not seek out the CTFA position, she anticipates the challenge of moving to a new industry, working to "expand global collabora-tions" and to "put together coalitions and lobby effectively on state issues and work collaboratively with the FDA." Bailey stressed those approaches during her six years at AdvaMed.

The AdvaMed chief cited similarities between the medical device and cosmetic industries as factors enabling her decision to move. For example, she contended, both industries exemplify "continuous innovation...centered on what the patient wants and needs" and "intense market competition that in turn feeds innovation." Further, both sectors "are impacted by regulation that, if it is inappropriate, will stifle innovation."

Part of what factored in her decision to leave is her belief that AdvaMed is "very strongly positioned in terms of our internal policy development, our board leadership and our staff leadership."

Reflecting on her tenure, Bailey takes pride in AdvaMed's accomplishment of doubling available resources from less than $10 mil. in 1999 to almost $20 mil. in 2005. When she assumed the top spot at the then-Health Industry Manufacturers Association, Bailey inherited a projected $1 mil. budget deficit and stagnant membership. Large Class III device companies were meeting separately and considering forming their own organization.

Bailey said AdvaMed strove to better understand the types of services it could provide to its members. For example, the group expanded its "sector" approach to member interests. When she arrived, the only sector in place was diagnostics. AdvaMed then formed five other sectors: health IT, wound care, orthopedics, ophthalmic and blood, allowing members and staff to focus more intently on policy reforms.

A greater attention to firms' goals "fueled membership growth, particularly in emerging growth membership and member retention, so that we now have a record number of members and a record amount of involvement throughout the member companies," she said.

Bailey also oversaw the association's name change in June 2000 to highlight advances in medical technologies. "The name AdvaMed better reflects the innovators we represent and our desire to educate patients, their families and government officials about the need to ensure access to the latest lifesaving and life-enhancing medical technology," she stated at a press briefing unveiling the name change.

Similarly, Bailey worked to revitalize the association by intensifying its Hill lobbying efforts and urging donations to the group's political action committee, formed in 1998. The organization realized lobbying successes under her tenure, with the passage of the Medical Device User Fee & Modernization Act of 2002 and the device provisions within the Medicare Modernization Act of 2003.

"This association has made it possible for industry to have a seat at the table on every healthcare issue affecting it," she said. "The industry has always been strong with FDA, but now we are equally strong with CMS."

MDUFMA, Drug Safety Challenges Await Successor

Despite those lobbying achievements, AdvaMed has been criticized for agreeing to a user-fee formula that resulted in higher fees for industry but failed to hold the government accountable for its appropriation requirements. Consequently, Congress must pass "trigger-fix" legislation to allow the program to continue beyond this fiscal year.

Among other issues, the new AdvaMed president must work to prevent public outrage over drug safety from spilling over to devices. In addition, he/she will have to grapple with CMS' new policy of granting coverage with additional clinical data requirements.

Bailey's successor also will need to address global challenges facing the industry, such as price re-negotiations in Japan, ensuring more adequate payment in Europe and infiltrating the Chinese market. A further challenge facing Bailey's successor will be to effectively manage a slew of new hires, as AdvaMed has seen significant turnover in the past year.

AdvaMed’s Bailey Gets Makeover As Cosmetic Head; Swift Search Anticipated

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