2017: What’s in store for the US medtech sector?
Lu Rahman looks at recent events in the US medical device sector and what they mean for the year ahead.
It’s been interesting of late for US medtech. Recent legislation, the excitement of the election and even rumours that Trump may abolish the FDA, mean that there’s much to discuss about the future of the medical device industry.
One of the most talked about topics as 2016 drew to a close was the 21st Century Cures Act. Said to hold significant implications for the medical device industry – such as faster approval – the act received substantial media attention, both for and against. The Wall Street Journal (WSJ) described the bill as an attempt to ‘cut red tape’ at the agency” and that it was “expected to usher in a new, more industry-friendly era of drug and device regulation.”
The act was seen as significant. Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), commented:“AdvaMed commends the Senate for passing this important piece of legislation. The 21st Century Cures Act is a win for patients and for medical innovation. When fully implemented, this legislation will help accelerate the discovery, development and delivery of medical advancements to ensure more timely access to new treatments and cures for patients in need.
“AdvaMed has been a strong proponent of the 21st Century Cures initiative from its earliest stages. We are pleased that this legislation –which will have such a positive impact for patients and the American innovation ecosystem – has passed one more hurdle to becoming a reality.”
It wasn’t all hearts and flowers for this bill though. Some feared the legislation could herald less stringent criteria being applied to new devices.
Public Citizen, a lobbying group, voiced its concern: “This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices.”
The debate will continue and meanwhile we have Donald Trump’s relationship with the medtech sector to watch. In the run up to Trump’s victory the plus and minus points of him scooping a win were well documented. Discussions about the future of the medical device tax were rife with claims a Trump administration would repeal the tax.
AdvaMed has long argued that the tax – which was created as a funding measure for Obama’s Affordable Care Act – harms job creation, deters medical innovation and increases the cost of healthcare. It had put forward an argument that the tax should be scrapped.
At the time of writing it looks likely that Trump will do just that. Last month Nick Carey and Susan Cornwell, Reuters, described how Mark Throdahl, chief executive of OrthoPediatrics, Indiana, had been able to employ more workers since the medical device tax was suspended last January and that he hopes Trump will scrap the tax on a permanent basis.
According to Carey and Cornwell: “Trump and US lawmakers are likely to do that, according to lawmakers, lobbyists and industry executives, in a step that also would help larger medical device makers such as Medtronic Inc, Boston Scientific, St. Jude Medical Inc and Johnson & Johnson.”
Whitaker, AdvaMed is also watching the future for the medical device tax with interest.
“In the coming year, policymakers will be dealing with a number of important policy issues, including authorisation of the latest Medical Device User Fee agreement to continue improving the FDA regulatory process, repeal of the medical device tax, and ensuring that the coverage process allows patient access to the latest innovations. These have been and will always be bipartisan issues. The medical technology community stands ready to work with president Trump, his administration and the new congress on pro-innovation policy solutions to address the health care challenges facing the country and to ensure all Americans have timely access to the latest medical technologies, devices and diagnostics.”
And the rumours about the FDA? Nancy Bradish Myers, Catalyst Healthcare Consulting, writes in Clinical Leader: “In its most official position taken on FDA to date, the Trump team has prioritised FDA reform and putting a ‘greater focus on the need of patients for new and innovative medical products.
“This can be read several ways: For instance, it could simply reflect the many FDA reform initiatives included in the congressional 21st Century Cures reform efforts… On the other hand, it could be signalling a deeper desire to focus on significant FDA change. It could reflect a more conservative agenda that is in line with Trump’s anti-regulation, pro-innovation outlook, and could mean the new administration may have some initial areas of focus in mind for reform.”
Watch this space…