[caption id="attachment_4378" align="alignleft" width="200"]Not holding his breath[/caption]
FDA's device center is busily punching up draft guidances again, but today we're back into the faces-and-places discussion just like last time here at MDD Perspectives. This time, the churn is on Capitol Hill, which is also where two tax issues seem likely to end up on a more or less fast track to nowhere.
Paul Ryan's dirty job
Let's get one thing out of the way quickly. If you were Paul Ryan, would you want the job of Speaker of the House of Representatives? I'd pass, but it appears he has corralled a lot of the wayward tempers in the GOP. Still, there's time for him to think better of this idea.
Corporate American might think the problem with Ryan as speaker is that the tax reform push may lose steam over the near term. Nothing against Kevin Brady, but Ryan has a brand Brady lacks, so one has to wonder if tax reform is going to suffer if Ryan does indeed take the job, which by some accounts is a near certainty.
Of course, speaker Ryan would have the clout to make tax reform a priority, but how quickly will things move in the Ways and Means Committee if he's not there? There's little time left to act this year, and next year is an election year. All things considered, corporate tax reform may have to wait until 2017, and we'll see if the new occupant of the Oval Office is more interested in doing something both parties can accept than the incumbent.
The device tax repeal is back in vogue again, thanks to efforts on the part of House and Senate Republicans to repeal the Affordable Care Act. The House of Representatives passed a bill that would repeal much but not all of the ACA – including the device tax – and the authors of the bill apparently intended this legislation to show up in the Senate as a budget reconciliation bill, thus requiring only 51 votes for passage.
The problem? The Senate parliamentarian said the first edition of the House bill doesn't qualify as a budget reconciliation document. Ergo, any Senate vote on that bill would need 60 votes, which means the GOP would have had to bring over six votes from among 44 Democrats and two independents who caucus with them. As the saying goes, good luck with that.
Rep. Tom Price of Georgia has offered an amendment to the House bill that would pull the repeal of the Independent Payment Advisory Board to get the House bill in under the budget reconciliation requirement, but there are those who continue to insist on an all-or-nothing approach.
It's tough to predict how this Obamacare repeal push will work out on Capitol Hill, but it's really all for naught, isn't it? There is no way President Obama will sign anything like this, but getting a bill to the President's desk would at least look good on the campaign trail next year.
GOP leaders tried to tie the device tax repeal to the debt ceiling discussion in 2013, but the Senate leadership seems ill-disposed to try that again this year. Hence, it's safe to conclude that the device tax repeal is another 2017-or-bust item.
The policy realm of medical devices is rarely quiescent, but the current pace of activity is conspicuous. There are a couple of juicy legal issues churning these days, but we’re also watching a changing of the guard at some pretty important organizations. Some observers have misgivings about one case in which a clear line of succession has already been laid out, but one might ask whether those skeptics are missing something.
Califf, authorship and the election
The argument for and against Robert Califf as the next FDA commissioner took a turn for the more fascinating recently with the disclosure that his name was removed from the list of authors of a series of papers on clinical trials. Sheila Kaplan of the Boston Globe offers a good summation of the dilemma, but I have to admit to some misgivings as to whether this will derail Califf’s candidacy for the job.
Kaplan talked to Ross McKinney of a bioethics office at Duke, who apparently opined that he understood the excision of Califf’s name from the list of authors of the three articles on clinical trials. The subtext here is that these articles and/or the underlying effort to develop data for them were well underway by the time the Obama administration contacted Califf about the commissioner’s job, but Kaplan seems to suggest that it’s not at all clear whose idea it was to remove Califf’s name from the articles.
There will undoubtedly be a lot of noise about this issue from some quarters, but count me among those who do not believe this will fatally damage the cardiologist’s chances in the Senate. I’d also point out that the White House almost certainly knew about this going in, so…
You hear the most interesting things at some of these legal and industry gatherings, and one recent product of the rumor mill has it that Califf would be guaranteed nothing from the next administration should the Senate confirm him as the next FDA commissioner.
It’s tough to see why any Democrat who won in 2016 would jettison Califf if only because you then have to explain why you think he’s not right for the job despite your predecessor’s endorsement, not to mention the support of what is almost certain to be a hefty Senate majority.
Would a GOP winner in November 2016 show Califf the door? I don’t think so. Besides the reasons cited above, this guy is a cardiologist and there are a lot of people at the Center for Devices and Radiological Health who like that he “gets” medical devices. CDRH director Jeff Shuren said of Califf at AdvaMed 2015, “it’s great to have someone in the door who understands devices. It’s a breath of fresh air for us.”
Besides all that, Califf – thanks to his experience at the Duke Clinical Research Institute – also gets the clinical trial thing, which everyone in industry seems to agree needs a new set of engineers. But for me, the nail in the coffin of this one year-and-done notion is that the next president is going to be far more concerned about the CMS administrator’s job. The Obama administration is not even trying to get Andy Slavitt through the Senate, and this is a far more politically contentious job than that of the FDA commissioner. So if Califf gets in, he’ll almost surely stay after January 2017 unless he decides there are greener pastures elsewhere.
In fact, the only FDA job I have questions about is the director’s job at the Center for Devices and Radiological Health. Jeff Shuren has been at it for six years and that’s a burn-out job if ever I saw one. Will he decide over the next year or so that he’s had enough?
Leahey too easy a pick for AdvaMed CEO?
The vacancy at the Advanced Medical Technology Association is a big one, too, and it’s not clear yet who will succeed Steve Ubl as the association’s president/CEO. AdvaMed isn’t saying anything other than “we’re looking around,” but it strikes me that outfits like AdvaMed always have a succession plan at the ready.
Is Mark Leahey of the Medical Device Manufacturers Association on the short list for the AdvaMed job? Leahey certainly knows the FDA and the Medicare terrain, and he knows his way around Capitol Hill. Some will say a Leahey pick is all too pat, and I understand that line of thinking.
Still, there is a tendency for associations to stay within industry for these hires. After all, Marilyn Tavenner now sits in the corner office at America’s Health Insurance Plans, and Rick Pollack isn’t exactly a stranger to the American Hospital Association.
Expect AdvaMed to be cagey about this, but also remember that the next device user fee conversation is underway. If AdvaMed wants to go outside the device industry for this job, it’ll have to be someone with some serious brand on the Hill and more than a glancing familiarity with health care generally speaking. One thing to remember about this hire is that things at FDA have settled down quite a bit (compared to 2009 and 2010, anyway), while many device makers will tell you that the coverage and reimbursement problem is that one that most frequently keeps them up at night.
But I don’t think diagnostics have swamped therapeutic devices as investors’ principal point of med tech interest just yet, and AdvaMed does have a small business division, AdvaMed Accel, which fits neatly into Leahey’s portofolio.
ICYMI: FDA announced a couple of weeks back that it’s time for plain film mammography to join the eight-track tape deck in the technology dust bin of history. I wonder how poorly financed rural clinics feel about the federal government putting them on the spot like that.