We all know there’s no such thing as a free lunch, but what’s not always clear is the cost. The U.S. federal government in two of its incarnations recently put those in the life science industries on alert that the cost of doing business might go up to a degree that may surprise anyone who hasn’t been paying attention.
FDA proposed recently to make freely available “de-identified and masked data derived from medical product applications,” citing as a “national priority” the need to improve “the efficiency and effectiveness of medical product development.”
The agency’s argument is that “de-identified and masked clinical and pre-clinical data” mined from marketing applications “may be of value in the generation of new knowledge to facilitate innovation in the development and evaluation of critically needed medical products.” FDA argues further that the contributions of those who participate in clinical trials “should be maximized for the benefit of society.”
The first question this raises is when did the efficiency and effectiveness of medical product development become a national priority? I’ve never heard about it. I don’t recall any decrees to that effect coming from Capitol Hill or from the White House.
Here’s the rub. If you share those data from a first-of-a-kind marketing application, you are basically saying you’re going to go to invest millions on a project that might benefit everyone in your line of work except your company. I think it’s pertinent to ask: Who wants to be first on the dance floor if you’re likely to be penalized for being the first?
That's not a recipe for innovation. It's a recipe for stagnation.
Add to that H.R. 2301, the Clinical Trial Cancer Mission 2020 Act, which addresses disclosure of data from clinical trials funded at least in part by the federal government. This bill would beef up the requirements of the Food and Drug Administration Amendments Act of 2007 by requiring that data from failed trials be disclosed, not just data from successful trials.
I’m not entirely clear on how much federal funding in percentage or absolute terms would qualify a trial for such mandates – the mere licensing of a government invention would invoke this requirement for all I know – but those who do not report in a timely fashion not only might not get more funding, but could be on the hook for all taxpayer monies spent on the trial. H.R. 2301 might be sensible all things given, but it does reinforce the notion that doing business with Uncle Sam comes with strings.
But what of your application with the FDA’s medical device innovation initiative? Can you really afford to think that’s not fair game for disclosure, too?
The lesson here is that it may be a bit irrational to assume that doing business with Washington is no bigger a hazard than previously appreciated. All the signs point to the opposite conclusion, a very curious state of affairs given the government’s inability to balance its accounts, not to mention its penchant for politically motivated tax audits and snooping around in the phone records of the parents of a journalist the Obama administration doesn’t like.
But that’s the kind of government we have these days. My recommendation: Tread carefully and seriously consider keeping government at arms length as much as possible if you want to keep your data confidential.