OMB, HHS, or FDA: Who Really Makes FDA’s Decisions?

OMB, White House staff, and the Secretary of HHS review many FDA decisions and their oversight sometimes alters FDA’s positions. This was chronicled in a recent NY Times article and generated a number of editorial comments criticizing anyone tampering with FDA’s integrity. However, the individuals named in the article have the authority (on behalf of the President) to question FDA’s judgments.  

More importantly, FDA Matters observes that the vast majority of FDA-related decisions–and virtually all of the science-related decisions–are made by the FDA. The key is the strong public health and scientific expertise of FDA staff and the credibility this brings to any scientifically-based agency decision.

The President is in charge. The President’s responsibility is to “faithfully execute the laws” of the United States. The task is enormous, requiring a $3 trillion annual budget and 1.3 million civilian employees*. Delegation is necessary and is controlled by having a rigidly hierarchical structure of government that assures, to the extent possible, that decisions made by subordinate departments and agencies reflect the law and the President’s policies.

Department secretaries—those primarily responsible for carrying out the President’s policies—report directly as part of the President’s Cabinet. They also report indirectly through the Office of Management and Budget (OMB), which is the primary administrative structure for assuring that the Executive Branch makes decisions consistent with the President’s wishes.

FDA is part of the government, not separate from it. The very nature of government makes FDA’s independence an illusion**. The Commissioner is not elected; she is appointed by the President and the Secretary of Health and Human Services. Ultimately, all decisions are the President’s (and the Secretary of HHS’ acting on his behalf).

While oversight and review of FDA’s decisions by White House staff, OMB and the Secretary of HHS is quite real, it is also legitimate. Those named in the NY Times article all have the authority to question FDA’s judgments before they become final.  The positions they took may have been unwise, but they did not exceed their responsibilities.

Oversight and review of FDA is limited in its scope and impact. While FDA cannot escape oversight within the Executive Branch, the NY Times article cited only five examples among thousands of decisions FDA makes every year.

None of the five cases involved overriding the scientific and medical expertise of FDA. Two of the five were labeling issues (caloric content of movie popcorn, sunscreens with relatively low SPF factors). The other three were access issues (emergency hormonal contraceptives, the continued marketing of an asthma inhaler containing fluorocarbons, and whether FDA should waive enforcement against pharmacy compounding of a specific, newly-approved drug).

The most serious of the five was the decision on access to emergency hormonal contraceptives, where it is alleged that HHS overrode FDA’s scientific judgment. Without defending HHS’s actions, it is relevant that neither biological nor medical science was involved. Rather the FDA “science” involved label comprehension studies (can adolescents under-17 understand and properly follow the directions on the label). As an aside: decisions concerning emergency hormonal contraceptives have an almost-unique history of getting FDA leadership in hot water within the Executive Branch and with Congress and the public.

FDA’s medical and scientific expertise protects virtually all of its medical and scientific decisions. Since OMB and HHS oversight of FDA is continuous, there are undoubtedly other examples where FDA has compromised or yielded. Given FDA’s public accountability for its decisions (correspondence, hearings, reports, advisory committees), there can’t be many instances in which the agency’s scientific or medical judgments are overruled and it is not publicly known. So, I can’t say that FDA’s scientific judgments are never overruled, but it certainly appears to be rare.

The alleged problem of intrusions on FDA’s scientific integrity may appear larger because of a misunderstanding about the nature of FDA. Not all FDA decisions are based on scientific or medical expertise. For example, requiring caloric labeling of movie popcorn might create consistency of government policy across multiple food service settings, but it’s a policy judgment, not a decision based on science or medicine.

In fact, there is very good reason why White House staff, OMB and HHS will never significantly affect FDA scientific and medical decisions: they lack the credibility and scientifically-trained manpower to do it.