My first column of this year in the Daily dealt with Susan Wood’s resignation from the Food and Drug Administration in protest over its nondecision regarding over-the-counter sales of Plan B mediation. Eleven weeks later, and the FDA’s decision to refuse nonprescription sales of Plan B is back in the news, following a scathing report from the Government Accountability Office.
The report from the GAO called the FDA’s actions “unusual,” finding that the agency “did not follow its normal procedures in making the scientific assessment of the Plan B proposal and in having a top official sign off on the eventual decision after lower-ranking scientists refused,” as the Washington Post summarized. So is the GAO saying politics played a role in the FDA’s decision regarding Plan B? Well, my goodness, surprise, surprise.
Since that report was first requested by Congress more than 16 months ago, Lester Crawford, who had headed the FDA and who made the decision to trump the scientific advisory panel’s findings, has resigned from his position. The GAO report also suggested that, as Susan Dentzer, The NewsHour’s health correspondent phrased it, the “upper level officials made the decision before all the scientific evidence was really in.” Also highly unusual, the FDA had never before issued decisions based on separating older adolescents from younger adolescents as the FDA originally suggested doing with Plan B before Crawford rejected even that action.
Susan Wood, the former assistant commissioner of the Office of Women’s Health at the Food and Drug Administration had this to say regarding the GAO’s findings: “This report is a sad reminder of why I felt compelled to resign. Instead of improving and advancing women’s health, the FDA leadership is ignoring its process and not relying on science and medical evidence.” Instead, and it is all too easy to infer from the GAO’s report, the FDA has caved to the agenda of social conservatives.
The actual agenda of the FDA, which proved to be fully political and hardly scientific, was all too obvious in the characters that have headed the FDA since the Plan B debacle began. Since then, there have been two commissioners at the FDA. The first was Mark B. McClellan, who left the FDA two months before it rejected the over-the-counter sales of Plan B. Apparently months before that, McClellan raised “numerous objections” to nonprescription sales of Plan B in meetings and would not respond to questions from the GAO. The only comments he offered, as noted by the Washington Post, were that “he left before the decision was made and that his actions had been “consistent with his usual practices.’ ” After his resignation came Lester Crawford, a commissioner who proved to be no less steeped in partisan politics than Mark McClellan. Crawford denied playing any role in the first Plan B review, and as for the second ” where Barr Laboratories, the company that owns Plan B said they could make Plan B an over-the-counter pill for older women and by prescription for younger ones ” Crawford took it upon himself to reject even that decision. In effect, he issued a decision not to make a decision. That is where we are today.
Hopefully, though, that is not where we will be for long. There seems to be a silver lining in all of this. Democrats and even moderate Republicans are decrying the FDA for political handholding with social conservatives. While, as I mentioned in my first column Sept. 12, a decision regarding the nonprescription sales of Plan B is now infinitely on hold, Congress is actually doing something about it.
There is a bipartisan bill in Congress right now, called the Plan B for Plan B Act. This act gives the Food and Drug Administration thirty days to make a decision regarding over-the-counter sales of Plan B. If, at the end of those 30 days, the FDA has still not made a decision (or made a decision to wait to make a decision, as what took place most recently), the drug will be “considered to be approved for over-the-counter use,” as Dentzer reported. Additionally, some Democrats are now calling for hearings looking deeper into the matter. Rep. Louise M. Slaughter, D-N.Y., in explaining why hearings are necessary said, “This report is the “smoking gun’ which clearly demonstrates that the FDA based its decision on politics, and not science.”
The GAO report made it all too obvious. Even the science in Washington, D.C., is controlled by politics. And as long as science is at the mercy of social conservatives, so, too, are American women.
Abby Bar-Lev welcomes comments at [email protected].
