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Opinion | Simon Waxman

Obama’s power grab threatens FDA

It has been nearly 10 years since the Food and Drug Administration recommended that the emergency contraception drug Plan B be approved for over-the-counter sale without age restrictions. Yet, until Wednesday, the drug was available without prescription only to women 17 and older.

The FDA has now decided to lower the restricted age to 15, a puzzling move given that, legally, there can be no age restriction at all. This according to Federal District Court Judge Edward R. Korman, who on April 5 ordered the FDA to follow its own policies and findings, which show that the pill is safe and effective and should be available over the counter regardless of age. On Thursday the Obama administration announced that it would appeal the ruling, a decision that makes little practical sense and one that threatens to undermine the separation of powers between Congress and the president, a core element of our system of government.


The morning-after pill prevents pregnancies and is not, as some claim, an “abortion pill.” But its use is nonetheless controversial, especially for the youngest women of childbearing age, who would seem to have the most to benefit.

This controversy, however, is purely political; the science on Plan B is unequivocal. FDA Commissioner Margaret Hamburg summarized the agency’s determinations in a December 2011 statement regarding Plan B One-Step, a single-dose version of the drug: “There is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of childbearing potential.”

A few days after Hamburg issued her statement — which came after years of dithering at the agency — Health and Human Services Secretary Kathleen Sebelius, an appointee of President Obama, who was seeking reelection at the time, ordered the FDA to deny unrestricted over-the-counter status to Plan B One-Step. “It was the first time a cabinet member had ever publicly countermanded a determination by the FDA,” The New York Times reported. The FDA complied with Sebelius’s diktat.

In his ruling, Korman points out that Sebelius lacks the authority to order the FDA to discard its own procedures, which would have led to the change in status that the drug’s maker, Teva Pharmaceutical Industries, sought. And whatever her authority, Seblius’s justification for overruling the FDA, which Obama endorsed, is nothing short of pitiful, relying on fear-mongering about 11-year-olds and false implications about unsafe use of the drug. “The secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent,” Korman concluded.


The decision to appeal Korman’s ruling is disappointing. There is no scientific or legal reason to restrict over-the-counter sale of Plan B. From the standpoint of social welfare, easy access to contraception is a no-brainer: There is nothing to be gained from unwanted, preventable teen pregnancies, though there is much to be lost. And denying young girls’ access to Plan B while condoms litter convenience store aisles is just sexist.

Of course, in this country, contraception is not even close to a no-brainer. But even birth-control opponents should be wary of the administration’s exploits, disdainful as they are of the separation of powers.

The FDA is chartered and empowered by Congress. And while the agency operates within the executive branch, Sebelius, as Korman points out, “overruled the FDA in an area which Congress entrusted primarily to the FDA.” Congress intended that the FDA, not the White House, would determine which drugs are safe and effective and which may be sold without a prescription. The executive branch does not have a say in those determinations. Pulling rank, as Sebelius did with the president’s blessing, is an affront to Congress’s authority. The power vested in the FDA is the power of Congress, and the president cannot simply usurp that power.


In the latest twist, the administration’s appeal is itself centered on a separation-of-powers claim. The Department of Justice now argues, dubiously, that by demanding that the FDA follow its own procedures, Korman has commandeered the agency’s role. The irony here could not be starker.

The tug of war between the executive and legislative branches is one of the means by which the founders of our government sought to prevent tyranny. Citizens — and courts — should be ever vigilant in ensuring that neither Congress nor the president gains the upper hand.

During the past two administrations, we have for the most part stood by as the executive branch exercised its lust for power, especially in the arenas of civil liberties and national security. Acquiescing to the White House’s political whims on Plan B would tip the scales further in the wrong direction.

Simon Waxman is managing editor of Boston Review.