File this under ‘lose-lose.’ In what had to be one of the more extraordinary developments involving the FDA in recent memory, U.S. Health & Human Services Secretary Kathleen Sebelius in December overruled the agency and thwarted a move to ease access to the Plan B pill, which is also known as the “morning after” pill. This contraceptive is available only to women age 17 and older without a prescription, but behind counters. The FDA was willing to make the pill available in store aisles, which would have made it possible for younger teenage girls to purchase without assistance or a prescription. FDA Commissioner Margaret Hamburg made a point of saying so in her own statement.
The unprecedented decision quickly generated harsh criticism that the White House was choosing political expediency over sound science. The controversial pill, you may recall, was the subject of controversy when President George W. Bush was in office, because some believe that Plan B prevents a fertilized egg from implanting in the womb, and that this is tantamount to abortion. Many doctors and pharmacists, in fact, still refuse to provide the pill. As a result, President Obama, who once championed scientific decision making and transparency, was tongue-lashed for pandering to conservatives during an election year.
The saga became more sordid a few days later. That was when the FDA was expected to comply with a court ruling as part of a citizen’s petition and lawsuit that was filed several years ago by a non-profit organization called the Center for Reproductive Rights. In 2009, U.S. District Court Judge Edward Korman ordered the FDA to reconsider its 2006 decision allowing only women ages 18 and older to buy the pill without a prescription, although this was later amended to age 17. He held the FDA in contempt for making decisions that were “arbitrary and capricious” and in “bad faith,” and for being influenced by “impermissible political and ideological considerations” imposed by the Bush White House.
So how did the FDA get out of this predicament? The FDA noted that the application to approve greater access to girls 16 and younger without a prescription was denied because the health group relied on older data for Plan B, not the newer Plan B One-Step for which Teva Pharmaceuticals was seeking approval. What’s the difference? Plan B One-Step has a different dosing regimen, but with the same active ingredient and indication as Plan B. However, Plan B uses a two-dose regimen with 0.75 mg of levonorgestrel in each tablet, to be taken 12 hours apart, while Plan B One-Step is a single-dose tablet that contains 1.5 mg of levonorgestrel. In other words, this was a different drug.
The real issue, though, is the extent to which the FDA may have been damaged by the overruling. The consensus is that Sec. Sebelius has the authority to override the FDA. And she explained her decision by arguing that Teva had failed to study whether girls as young as 11 years old could use the pill safely. And since about 10% of girls can bear children as early as 11, they need to be studied as well, according to the letter she sent to Dr. Hamburg. The commissioner replied that FDA scientists had, nonetheless, decided that adolescent girls could safely use the pill and understood the product was not for routine use nor to protect them from sexually transmitted diseases.
The move, unfortunately, raises the possibility that all manner of agency actions may now be second guessed by not only the White House, but also industry. By overruling the FDA, Sec. Sebelius may have also opened the door to ongoing speculation that the FDA is becoming politicized and the possibility that many others will question the motives behind even the most innocuous decisions. Just imagine a drugmaker or biopharma whose product was issued a complete response letter then turning around and saying the agency succumbed to some sort of outside pressure for whatever reason.
“I don’t understand why anyone at HHS or elsewhere thinks this was a good move for any reason — political or otherwise,” said Susan Wood, who was the top FDA official in charge of women’s health issues, and resigned in 2005 to protest against an agency decision to delay a final ruling on whether the Plan B pill should be more easily accessible. She is now an associated health professor at George Washington University.
“This is an administration that prides itself on scientific integrity,” she remarked. “The president issued a memo to make all decisions based on science and take politics out of decision making. This just doesn’t hold water. All it does is tell women that they and their health concerns are not valued. They overruled FDA scientific and medical decision making for reasons that have nothing to do with science.”
Of course, not every drug approval leads to a highly contentious and politically charged debate. Plan B, after all, is seen by some as an abortion pill. Others medicines may have their controversies — diet pills seem to be a perennial example — but generally the debates surround safety and effectiveness issues. Few medications, by themselves, are political hot potatoes. Still, it is not hard to imagine other instances in which FDA decisions are scrutinized for signs of interference, whether the perception points to alleged political arm-twisting or some other reason.
And so whether one supports or opposes greater access to the Plan B pill, an overriding principle is at stake. Now, though, yet another White House has slid down that slippery slope of political interference. In the case of Plan B, the immediate losers may be young teenage girls who do not have options for birth control. But the public at large loses when politics are allowed to trump decisions that are based on sifting through scientific evidence.
For this reason, Sec. Sebelius should not have overruled the agency. Or more specifically, Pres. Obama and his advisors should have kept away from the issue. Although he insisted he had nothing to do with the decision, it was hard to believe that the president — or others in his inner circle — did not foresee political trouble if the FDA granted wider access. Pres. Obama is battling to keep his job and any action that riles not only conservatives but more conservative-minded centrists is seen as a losing proposition. He may not have gained any votes when Sebelius overruled the FDA; after all, nothing on the ground actually changed. But the political calculus told him that he avoided losing some votes in the middle, which will be his most important battleground next November.
Meanwhile, in the immediate aftermath of the overruling, there was speculation that Dr. Hamburg might resign in protest. Certainly, the rebuff by the White House was a slap in the face, especially given that she has worked hard to restore credibility to an agency that was previously run by a series of caretakers during several burning crises — notably, the Vioxx and Heparin scandals, which refocused agency attention on product safety and securing the supply chain, respectively. Of course, Dr. Hamburg may not be widely admired by everyone — the FDA is still criticized for being too cautious on safety matters — but there have been more drug approvals lately, which she made a point of noting in a specially convened media briefing. In any event, her decision to immediately issue a statement in response to Sec. Sebelius that affirmed the FDA belief in its decision making sends a signal that she hopes to maintain as much independence as possible.
At the end of the day, though, the public was left with the sorry specter of an agency head trying to fend off the unwanted entreaties of her overseer. Politics is politics and sometimes everyone has to swallow a decision they believe is wrongheaded. This is nothing new and no government agency is going to be immune from such doings, even when evidence-based decisions are involved. Just the same, that does not make it right. And by interfering with the FDA, Pres. Obama signaled to the public that he does not really stand for better decision making and more transparency, after all. Yes, tough choices must be made in politics, but undermining the established mechanisms of an agency chartered with maintaining public health does not serve anyone in the long term.
Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, for more than 12 years. Prior to joining The Star-Ledger, Ed spent six years at New York Newsday and previously worked at Investor’s Business Daily. Ed blogs about the drug industry at Pharmalot, at www.pharmalot.com. He can be reached at ed.silverman@comcast.net.