To those who feel the increased presence of FDA investigators responding to commissioner Margaret Hamburg’s purported new emphasis on enforcement, and to those frustrated by slower 510(k) processing and more reviewer questions, that headline may seem hard to take seriously.

But hidden beneath the increasingly dense opacity of the internal relationship between FDA and its parent Department of Health and Human Services (HHS), there has been a rarely seen reduction of the subordinate agency’s traditional autonomy and freedom to decide. 

No doubt a significant catalyst for this has been the ongoing controversy over the 510(k) program at CDRH, including most recently high-profile allegations of managerial incompetence and the Institute of Medicine recommendation that it be scrapped. The trend, however, long predates that report and has been so slow and incremental as to be unnoticeable outside of FDA. 

Examples of FDA's Internal Emasculation

The public got a startling glimpse of the agency’s internal emasculation in December when HHS secretary Kathleen Sebelius overrode FDA’s science-based decision to approve the “morning after” emergency contraceptive pill, Plan B One Step. Contrary to unbelievable public disavowals by President Obama, this was not Sebelius’ unguided independent decision. With a court-ordered deadline less than 24 hours away, she announced it immediately after traveling with Obama to and from Kansas aboard Air Force One. 

As George Neumayer in the American Spectator, among others, quickly observed, Sebelius has a long record of supporting FDA science. Her liberal attitude to abortion and contraception, not her unqualified, professed dissatisfaction with FDA science, ruled this decision. As Neumayer wrote, the politics was an Obama re-election strategy to remove an issue from the Republicans’ agenda. 

There is a lot more to this rare public glimpse of HHS dominance over FDA than has been revealed in this one episode.

FDA careerists have been chafing for many years under HHS’ steadily increasing and politically directed intrusions into their policy and decision-making. All of this is concealed from public view by internal institutional secrecy. The agency’s much-vaunted “transparency initiative” was never allowed to extend to such hidden management practices and political initiatives.

As one FDA commenter on my Web site complained, HHS has directed the reorganization of the FDA Office of Regulatory Affairs, taken senior executive service positions from FDA and assigned them elsewhere in its sprawling empire, restricted “necessary” FDA travel and restricted FDA actions against individual companies.

If true, this suggests a depth of HHS interference in internal FDA affairs that is unprecedented and shielded from public view. In bygone years, when such opacity could be readily broken by anonymous “deep throats” (think Watergate) and available news reporters, HHS never meddled in FDA’s arcane business. It also never publicly overruled a scientific FDA decision.

In any of the above alleged situations — HHS reorganizing the FDA Commissioner’s Office, or taking SES positions from the agency, or restricting FDA actions against companies, etc. — some enterprising news reporter on the scene would have heard about it from a credible, angry but nervous FDA source. The proverbial s— would have hit the fan. The fact that such never happened is highly suggestive of an HHS practice, long ago, of not meddling. 

A Formerly Hands Off Policy

As former secretary Joseph A. Califano was reputed to have told two FDA commissioners: “I don’t want to know what you are doing — just don’t let me get any nasty surprises in the Washington Post over breakfast!” This hands-off policy, intuitively and intelligently observed, served both sides well, and lasted through successive administrations until Bill Clinton ordered the approval of the abortion pill, RU-486, as he was leaving office, thereby setting a precedent for what happened on Plan B in both the Bush and Obama administrations. Institutional power grabbed is seldom later relinquished. 

As others have publicly observed since Sebelius’s precedent-setting power grab, FDA science ought not to be the stuff of politics. True, the FD&C Act speaks almost exclusively of “the secretary” as the repository of FDA’s authority to deliver scientific judgments. That is no excuse for upturning decades of commonsense delegation of real-world authority from the politicians to the scientist-regulators.

A Dangerous Precedent

And, as Reproductive Health Technologies president and CEO Kirsten Moore observed: “When we end up looking back on this ill-conceived decision, the worst consequence of all might well be that Secretary Sebelius established a dangerous precedent extending well beyond the future of Plan B One-Step or the next presidential election. When Sebelius overruled the reasoned and researched medical and scientific analysis, she cleared the path for future Department of Health and Human Services secretaries to do the same.” 

The implicit message to regulated industry in this situation—not invisible to FDA managers as well—is that when you don’t get what you want from FDA in any given regulatory disagreement, you’ll probably find receptive ears in the HHS secretary’s office where FDA’s actual authority resides.

In the short term, this may be a comforting and reinforcing backdrop for industry in its negotiations over product reviews and enforcement disputes. However, there is the obvious longer-term risk that the market value of FDA clearance and approval could be degraded in the broader scientific, medical and regulatory environment if HHS political domination of FDA decisions becomes, rightly or wrongly, the perceived norm.  

Roaming bands of free-range reporters have been expelled from FDA’s hallways, presumptively for anti-terrorism security reasons. As a result, rumors of hidden power grabs by HHS meddlers no longer may be confidentially heard and publicly pursued, and equally, the fear that they might be heard and publicly pursued is no longer a deterrent to their initiation. 

Although some would abhor greater FDA independence from political direction and redirection, relocating it outside of HHS and giving it a Federal Reserve-like independence from politics, as proposed by Harvard professor Daniel Carpenter in a New York Times op-ed, would seem a prudent solution to the creeping politicization that has tarnished its “gold standard” in recent times. And this might provide an opportunity to develop necessary, full transparency and accountability that could be a model for the rest of government.

Meanwhile, the growth of politicization across all federal agencies is recognized by some observers as a symptom of authoritarianism. It is defined in Wikipedia as “characterized by highly concentrated, and centralized power maintained by political repression and the exclusion of potential challengers. It uses political parties and mass organizations to mobilize people around the goals of the regime.” More details applicable to modern-day American governance abound on the Web.