On July 29, 2011, a committee of the Institute of Medicine (IOM) released its report reviewing the FDA’s 510(k) process for approving medical devices. The FDA spent $1.3 million taxpayer dollars tasking the IOM committee to answer two basic questions. However, based on a review of the IOM committee’s membership, process, and funding, it is not at all clear if taxpayers were well served by the report.

Membership

• The membership of the IOM Committee was quite distinguished, but according to the FDA’s response to questions for the record before the House Energy and Commerce Committee, “no member of the committee [was] an entrepreneur or an investment capitalist,” and “no member of the committee [was] employed or otherwise works with a patient advocacy group related to medical devices.” Furthermore, it is not clear how many, if any, of the physician members of the panel currently practice medicine and use medical devices in a clinical practice. It would have been more prudent to include individuals with direct experience in the industry and process being evaluated. Omissions to the contrary are an unfortunate oversight.

Process

• It is not entirely clear that the IOM process was sufficiently through in a manner that engaged the necessary stakeholders. In response to questions for the record before the House Energy and Commerce Committee, the FDA noted that the IOM committee only held three public meetings – a public meeting and two public workshops – to discuss an issue of such great significance to patients and industry.

• The FDA tasked the IOM Committee to answer two basic questions:

1. Does the current 510(k) process protect patients optimally and promote innovation in support of public health?

2. If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally

• However, despite this important and simple charge, the IOM Committee largely punted on answering these questions in specificity. The committee recommended effectively scrapping the entire 510(k) process – a process that has been relatively widely praised by patients, consumers, innovators, and manufacturers.

• If committee’s report were merely the product of a private entity, it would be disappointing, but less concerning. However, the IOM committee’s methodology and results not only may have wasted $1.3 million taxpayer dollars, but points to a larger troubling trend.

Funding

• An examination of the data reveals that taxpayers may be disproportionately subsidizing the IOM.

• Based on a review of IOM’s federal funding from FY2001 through FY2011, taxpayers gave IOM $307.2 million over that timeframe.

• This is not only a lot of money, but it appears that, at least in some years, taxpayers funded more than half of IOM’s entire budget. For example, funding levels for 2009 are available in the "President’s Report Supplement Program Listing and View of IOM Finances, 2009 Edition." According to that report, “the program budget of the IOM in 2009 grew by more than 19 percent over the previous year. The trend toward an increasing fraction of support from non-government sources continued this year, with more than 40 percent of our total program budget in 2009 derived from private sources....” So was the remaining 60% was governmental? Yes, that’s roughly accurate. Page 53 of the report supplement has a figure showing that 55% of IOM program funding came from federal sources. The 55% is broken down as follows:

Conclusion

• While many well-intended professionals may make important contributions to their respective fields through work at IOM, in this case, based on a review of the IOM committee’s membership, process, and funding, it concerning that $1.3 million taxpayer dollars were spent on the IOM reviewing the FDA’s 510(k) process.

• There are further concerns that many of IOM’s taxpayer-funded projects and reports duplicate the capabilities of other organizations in and outside of government. For example, virtually all Departments within the federal government have employees who serve as policy analysts, budget crunchers, and issue experts that could be utilized in-house to produce reports or conduct research, at no extra cost to taxpayers.

• There are many intellectually interesting questions in life, and some are truly scientifically significant, but important questions deserve a rigorous, careful, transparent, and accountable process to produce constructive, concrete, and detailed answers for all Americans. Certainly in this case, Americans are right to ask if they got their money's worth.