The U.S. Food and Drug Administration’s regulatory process is too slow, too inconsistent and too fraught with uncertainty, which in turn stifles innovation and job growth, the industry says. And add to that another industry complaint about the FDA: The agency suffers from excessively high turnover.
A recent industry survey found that, in the last three years, responding device firms saw turnover in the lead FDA reviewer for about 14 percent of their regulatory submissions to the agency. Of those who experienced a lead reviewer change, 60 percent said it negatively affected the product review process.
Even Dr. Jeffrey Shuren, director of the FDA’s device-regulating group, the Center for Devices & Radiological Health (CDRH), agrees that turnover within his group is too high.
“It’s critical that we reduce the unacceptably high staff turnover at CDRH,” he said in response to the survey.
It would logically follow that the best policies to reduce turnover — paying employees better and hiring new co-workers to shoulder some of their workload and ease their stress — would most easily flow from increased government spending.
That’s why the industry may want to rethink its recent pattern of federal political donations. The Republican party — which doesn’t much care for nondefense government spending, at least in its public rhetoric, and is frequently hostile to the very concept of regulating industry — has received 61 percent of the industry’s federal donations since 1996, according to data from the Center for Responsive Politics (CRP).
While the device industry — again, just like nearly all industries — may find that its general interests are better served by the conservative dogma that embraces laissez-faire capitalism and deregulation, the FDA turnover issue seems to be one in which the industry would benefit from the pro-regulation, pro-government-spending approach that’s stereotypically the province of Democrats. (Another option to fund improvement in the FDA’s workforce would be to jack up the user fees the agency charges device companies to apply for product clearance and approval.)
But in the nine election cycles between 1996 and 2012, only once (2010) have Democrats received more money from the industry. Over that time frame, federal Republican candidates have received $18.6 million from the device industry, while Democrats have received just $12 million.
Now, with the apparent recognition by the device industry that a stronger, better-staffed FDA won’t necessarily lead to a more-threatening FDA, it would seem a wise move to narrow that 61-39 pro-GOP split. It’s highly likely that 2010 was an aberration, and the industry will almost always favor Republicans since the GOP is generally, and correctly, perceived to be more business-friendly. But it would seem to be in the industry’s best interests to move that split into something closer to 55-45.
In the year of the last presidential election, 2008, the industry contributed $6.5 million to federal candidates, its most ever — but that number could easily be eclipsed in the 2012 cycle as device manufacturers and consumer health groups wage battles over the future of industry regulation.
And if voters in 2012 re-elect President Obama despite what will inevitably be a 7 percent or 8 percent unemployment rate — or if they’re not impressed by a weak-looking field of Republican candidates, or if they decide to hold House Republicans accountable for an agenda that promised to focus on jobs, but has been more preoccupied with abortion — the device industry may have little choice but to start sending more cash Democrats’ way. But still probably less than Republicans.
Note that the CRP’s numbers cited in this article apply to the “medical supplies” industry, which includes “medical supplies manufacturers and dealers.” The biggest contributors in the sector are all big device manufacturers — Boston Scientific, Medtronic and Invacare were the top three in 2009 and 2010. No. 5 on the list was AdvaMed, the device industry’s top lobbying and trade group. AdvaMed declined to comment on questions about the industry’s political donation strategy and commented only on an emailed question about FDA turnover.
“The industry is concerned when reviewer turnover at FDA’s device center is excessive, as it can add to delays and inconsistencies in the review process,” said Janet Trunzo, AdvaMed’s executive vice president of technology and regulatory affairs.