by MassDevice.com contributor Heather Thompson
After a decade of leadership and 16 years of service, Stephen J. Ubl is stepping out of his role as CEO of AdvaMed. He will soon be offering his talents as a lobbyist, a sounding board, and an ambassador to the pharmaceutical industry. Ubl has accepted the position of CEO of the powerful PhRMA association.
The move will mean a significant pay rise for Ubl. According to Politico, Current PhRMA CEO John Castellani earned $3.6 million in 2013, compared with Ubl’s $1.5 million.
Ubl’s challenges have increased as well. It is very likely that the pharmaceutical industry is about to undergo some scrutiny on drug pricing. The Shkreli–Daraprim drug fiasco highlighted a commonplace drug pricing formula that has worked well for the drug industry in the past. But it is very likely that under the magnifying glass of social and traditional media, some changes or, at the very least, some compelling arguments will need to assuage public and governmental pressures. Ubl is certainly up to the challenge.
After all, in the medical device world, Ubl has made some incredible strides. Under Ubl, AdvaMed became a powerful advocacy group. It also enjoyed a friendlier relationship with the FDA following the development of the AdvaMed Code of Ethics, among other accomplishments.
“During Steve’s time at AdvaMed, the association experienced significant growth in membership, policy development capabilities as well as advocacy impact,” said Vince Forlenza, AdvaMed’s board chairman, in a statement. “As CEO, he created dedicated divisions to address the unique needs of the diagnostics industry and emerging growth of companies — AdvaMedDx and AdvaMed Accel, respectively.”
Most importantly, Ubl oversaw increased engagement of medical device company CEOs in the political process. At no time in the history of the medical device industry have so many of it’s leaders seen the value of speaking to congressional leaders about the medtech industry.
The industry’s recognition as a political force is due to its strong advanced manufacturing and recession-proof technology. But Ubl has been a key voice in conveying that message. And the U.S. government got a taste of that power when, in October 2013, while arguing over budget, the device tax became a significant topic of conversation. Congress’s inability to agree over whether to repeal the tax contributed to the shutdown of government services. It was a telling moment in how far the industry has come as a sophisticated political voice.
Ubl and AdvaMed’s dedication to a device tax repeal, including gaining strong support for a repeal from both Democrat and Republican leaders, has been unflinching. It was brought to a Congressional vote more than 50 times since 2010. Nonetheless, Ubl’s central mission in repealing the device tax has not been successful.
Brad Thompson, a Medical Device, Digital Health and Combination Product Regulatory Attorney with Eptstein Becker & Green is glowing in his praise of the exiting CEO. “Steve will always be remembered as a consummate diplomat and strong advocate,” he says. “He served the industry well.”
As Ubl leaves the device world behind to face new trials, the medical device industry still has a number of challenges of its own to meet. AdvaMed is searching for a new leader that will continue to engage government and industry members in important causes. Forlenza noted in his press release that a nationwide search for a replacement is underway.
Which got me thinking about who would be the best person to replace Ubl. It won’t be an easy roll to fill. Should the replacement be a businessperson, a diplomat (like Ubl), a scientist, and engineer, or a regulatory expert?
Thompson says, “There are very big issues facing the industry.” He thinks that Ubl’s replacement will need to understand the FDA and the reimbursement process, for example. “The reimbursement situation becomes more bleak with each passing year as government payers try to figure out any possible way to pay less.” As Ubl has done, AdvaMed’s new leader will have to continue to argue that medical device technology is not a significant driver of healthcare inflation.
Other big issues are getting the 21st Century Cures Act passed, and helping industry navigate cutting-edge technology including standalone software and regulation of clinical laboratory payments.
“AdvaMed’s new CEO must have a good understanding of what it means to operate a medical device company in today’s environment,” says Thompson.
Ubl’s departure may be a signal to industry that AdvaMed will ease its campaign to repeal the device tax and look instead for ways to mitigate its effects. Thompson says he doesn’t see hope in seeking repeal of the device tax in the next year, and the issue will likely be tabled until after the 2016 election.
Those within AdvaMed seem confident that the association will do well, even without Ubl’s presence. Forlenza noted that Ubl “has built a very strong team. The experience of Advamed’s senior leadership team and AdvaMed’s actively engaged Board of Directors leaves it well positioned to continue our important work.”
Thompson had similar feelings. “I think the AdvaMed team is very strong all the way around including its lobbying staff and its technology and reimbursement teams.”