The Food and Drug Administration’s long-awaited approval of Plan B emergency contraceptives over the summer for non-prescription use came as welcome news to scientists and feminists alike. The “morning-after” pill will now be available to women over the age of 18 without a prescription. Though this is a significant step toward preventing unplanned pregnancies, it is unclear why exactly this decision needed to take so long. The Plan B approval process was caught up in political meddling, and although the outcome was positive, it may have come at the cost of the FDA’s reputation.
The proposal to make Plan B available without a prescription was first brought before the FDA in 2003. Despite a recommendation from members of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health, the FDA found excuse after excuse to delay Plan B’s approval, from concerns that taking it would be too confusing to young adolescents to worries about package labeling.
The approval is a victory for most women, but those under the age of 18 will still be unable to obtain Plan B over the counter. Girls still in high school are arguably those with the greatest interest in preventing an unwanted pregnancy, as the burden of raising a child is dramatically greater when the mother is 16 as opposed to 26. When access to emergency contraception requires a prescription, visiting a doctor or health clinic and then picking up a prescription may be impossible in the narrow 72-hour window in which the pill is most effective.
The FDA denies bowing to any political pressure, but it is difficult to find any other explanation for the delays. In an unprecedented move, the FDA chose to ignore the advice of two FDA panels of scientists that voted in favor of making Plan B available for non-prescription use. What should have been a relatively straightforward approval dragged on for years, and those under 18 are still denied unrestricted access.
The role of the FDA is to represent the interests of the American people by ensuring that food and medicine are safe for consumption. It is worrisome that a regulatory body with a history of independence from political influence would now risk damaging that reputation. The politically motivated delay in approving Plan B not only let down consumers whom the FDA serves, but also damaged the FDA’s credibility in the eyes of the American public.
The increased availability of Plan B is still an important victory for women’s health, but one that took far too long to achieve. The FDA has already seen effects within its ranks with the resignation of Susan Wood, the former director of women’s health for the FDA, who stepped down in protest of the delays.
From a medical perspective, the FDA’s hesitancy to approve emergency contraception in the face of political pressure could ultimately jeopardize future drug research and funding. The development of certain treatments and medicines are more politically sensitive than others, and if the FDA’s judgment can be influenced by the political debates of the day, medical research itself could eventually be stifled – an outcome no one should want to see.