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FDA and the Republican Platform: Harsh Words, Unclear Intent


Between “the FDA today” and the “FDA in 2013” stands a U.S. presidential election—one that appears to offer Americans a choice of philosophy about the size of government and the role of regulatory agencies.  FDA Mattersprevious blog laid out some very early comparisons between the candidates on regulatory policy and the role of Commissioner.

Along with nominating Mitt Romney as its Presidential candidate, this past week’s Republican Party convention produced the party’s 2012 Platform –a series of policy positions to guide the campaign. FDA reform commands about 180 words—laying out the case for aggressive (although unspecified) changes.

Campaigning vs. Governing. Before looking at the specific words and thoughts in the Republican Platform, it is worth providing some context. One of the enduring lessons of my 50 years watching American politics is that there is often a profound difference between campaigning and governing. The Platform is put together by party delegates from every state, working with subject-matter experts and overseen by the Presidential nominee’s team.

Mitt Romney would not allow a party platform with which he disagreed. However, should he be elected, he will not feel bound by the positions taken in it. That said, the Platform’s words on FDA reform appear to generally reflect other things that Mr. Romney (and his surrogates) have said on other occasions.  What he will want to do about FDA if elected (or even what he will be able to do) is unknown.

The 2012 Republican Platform on FDA Reform. The  platform report states:

America’s leadership in life sciences R&D and medical innovation is being threatened. As a country, we must work together now or lose our leadership position in medical innovation, U.S. job creation, and access to life-saving treatments for U.S. patients. The United States has led the global medical device and pharmaceutical industries for decades. This leadership has made the U.S. the medical innovation capital of the world, bringing millions of high-paying jobs to our country and life-saving devices and drugs to our nation’s patients. But that leadership position is at risk; patients, innovators, and job creators point to the lack of predictability, consistency, transparency and efficiency at the Food and Drug Administration that is driving innovation overseas, benefiting foreign, not U.S., patients.

We pledge to reform the FDA so we can ensure that the U.S. remains the world leader in medical innovation, that device and drug jobs stay in the U.S., that U.S. patients benefit first from new devices and drugs, and that the FDA no longer wastes U.S. taxpayer and innovators’ resources because of bureaucratic red tape and legal uncertainty.

While the rhetoric expressed in the platform is not new to FDA Matters—it has a certain menacing quality when it is “the voice” of an American political party as opposed to a “government is bad” Tea Party leader or a frustrated medical device executive.

It begs the question: didn’t America’s global leadership in the life sciences come in part from the FDA’s competence and high standards and not despite them? I would emphatically say “yes,” but there certainly seem to be others that would answer “no.”

Harsh Words for FDA: Consistent with the Overall Tone of the Platform. FDA definitely needs some improving—as past FDA Matters’ columns have made clear. I try to stay constructive and be mindful that complex problems rarely have simple solutions.

Perhaps more to the point, FDA—by itself and working with Congress—seems to have made enormous strides over the last few years. One could even argue that FDA is already working hard on implementing a “pro-innovation” and “create more predictability” agenda that Republicans should like.

This, perhaps, brings us full circle around to our prior warning not to read too much into campaign rhetoric.

FDA reform is two paragraphs in a 50 page document—one that stridently and broadly promotes smaller government and fiscal prudence, almost regardless of consequences. For example, on budget issues, the Platform calls for “Reining in Out-of-Control Spending, Balancing the Budget, and Ensuring Sound Monetary Policy.”

When government is cast as incompetent and out-of-control, it leaves little space to say good things about federal agencies, such as FDA, that work hard, are underfunded, and are committed to improving their performance. When it comes to FDA, we can be hopeful that Republican candidates are more judicious while campaigning…..and, if elected, more restrained in their actions than their rhetoric suggests.


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