MedCity Influencers

The “PATIENTS’ FDA” Act — An Unexpected Legislative Initiative

Late on Tuesday evening this week, Senators Richard Burr (R, NC) and Tom Coburn (R, OK) quietly released the text of S.2292, the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act of 2012 (the PATIENTS’ FDA Act), which they described in a media release as “a bill to help make sure that the […]

Late on Tuesday evening this week, Senators Richard Burr (R, NC) and Tom Coburn (R, OK) quietly released the text of S.2292, the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act of 2012 (the PATIENTS’ FDA Act), which they described in a media release as “a bill to help make sure that the FDA fulfills its mission to ensure that patients have access to cutting-edge, life-saving drugs and devices as quickly as possible.”

The basic premise behind this piece of legislation — as expressed by Senators Burr and Coburn — is that the FDA needs to be subject to a great deal more Congressional oversight if it is to fulfill its public health mission in a predictable and timely manner and to keep medical innovation and job creation (related to the development of new drugs, diagnostics, and medical devices) from going oversees. The bill goes into extensive detail about how this should be done.

The full text of this piece of legislation is 55 pages in length, and even the summary explanation runs to 7 pages, so I am not going to try to  get into any of the details here. However, what I have been trying to understand since this piece of legislation was brought to my attention is the extent to which Senators Burr and Coburn really believe that this legislation could get passed by Congress this year, either in association with the renewal of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) or as an independent piece of legislation.

There has been a significant attempt on the part of the Senate HELP Committee to move PDUFA and MDUFA reauthorization through Congress in a timely manner. The relevant legislation is probably as close as we are going to get to “must pass” legislation during an election year. Multiple interest groups have worked closely with relevant members in the House and the Senate to find common ground on this legislation. By comparison, the bill introduced by Senators Burr and Coburn opens a whole new series of issues that have had little discussion, and it seems to have come as a surprise to almost everyone who might be affected by this bill — from the FDA itself to organizations like the Biotechnology Industry Organization, PhRMA, and the patient advocacy community.

With a few exceptions, as of today, there has been little media reaction to what would be major piece of legislation from many points of view. This in itself is a surprise. Not a word from the Wall Street Journal, as just one example, on a topic close to the hearts of editorial writers at that publication, although one of Forbes regular writers did publish commentary on this legislation yesterday.

Many of those most familiar with the workings of the FDA would argue that this agency is chronically underfunded — given its responsibilities for overseeing the safety of a vast range of products from food and drugs to cosmetics, diagnostics, and medical devices. The proposals put forward by Senators Coburn and Burr would likely increase the financial pressures on the FDA unless they were associated with a considerable increase in its annual appropriation (above and beyond the proposed increase in users fees). Such an increase in the FDA’s appropriation for 2013 would not appear to be an agenda item that correlates well with Republican desires to lower the federal budget by many billions of dollars.

How are we to interpret Senator Coburn and Senator Burr’s intent in introducing this legislation? Is this simply a signal of what they would hope to make law should the Republican party take control of the Senate in the upcoming elections? Sometimes it can be excruciatingly difficult to read the tealeaves that fall from Capitol Hill … and not least in an election year.

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.

Topics