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Plan B – Victim to a Politicized FDA - We Hope Not!

In the battle between science and politics concerning Barr pharmaceutical’s controversial “morning after” pill, politics seems to have won the latest round. And this is when many people think there were no grounds for the contest to start in the first place.  Last month, FDA’s newly appointed Commissioner Lester M. Crawford indefinitely deferred a decision to allow over-the-counter sales of the emergency contraception drug Plan B, by opening the issue for public discussion and comment, with no timeline for making a definitive decision either way.

Plan B is a pill (containing the synthetic hormone levonorgestrel) for emergency contraception. It is used to reduce the chances of pregnancy after unprotected sex. It works by stopping the release of an egg from the ovary and may also prevent the fertilization of an egg and prevent the egg from attaching to the uterus in case of fertilization. It can be used to prevent pregnancies only, and hence is not useful against existing pregnancies.

FDA approved Plan B in July 1999 as a prescription medication. However, many people felt that the medication served its purpose best as an over-the-counter product. Studies have shown that the pill is effective 95% of the time if taken within 24 hours of unprotected sexual intercourse and 75% to 89% if taken within 24 to 72 hours of the incident. Thus, the earlier the pill is taken the better the chances of avoiding a pregnancy. Since, most such incidents take place on weekends or in the evening when the health care practitioner’s office is closed, selling it by prescription isn’t the ideal situation and might lead to pregnancies that could have been avoided had it been sold over the counter. The American College of Obstetricians and Gynecologists (ACOG) estimates that making emergency contraception widely available (as OTC) could prevent about 2 million pregnancies annually and about 500,000 abortions per year.

An FDA advisory committee meeting in December 2003 had sent out an unequivocal message. It had voted 28-0 in favor of the drug being safe and had 24 members voting in favor of (with four against) switching the pill from prescription to over-the-counter status. Even the FDA has, in the past, publicly acknowledged that Plan B is safe. Mr. Crawford, in his confirmation hearing, acknowledged “The Science part is generally done,” “We’re just now down to what the label will look like.”

In a rare move however, the FDA went against the council of the advisory committee and the findings of its own scientists, and in May 2004, rejected Barr’s application to sell the drug over the counter. According to the FDA, the company failed to provide enough information about how well girls younger than 16 understood the drug’s label and whether they might engage in riskier sex if the drug was easily available.

Barr then submitted an amended application in July 2004 requesting FDA to allow over-the-counter sale of the pill for women 16 years and older only and remain as prescription for those below that age. Even this apparently is not good enough for the FDA, which in its latest statement expressed its present inability to regulate a medication that would have dual status, i.e., over the counter or prescription, based on age, citing fuzzy legal and regulatory precedents in this case.

Expressing anguish at this latest development, many people have complained that the agency had enough time on hand to workout a solution for this so called regulatory dilemma it faces. “I am disappointed that FDA waited until this late hour to address a legal question that could and should have been resolved months ago,” Sen. Edward Kennedy, D-Mass., said in a statement. In addition, these are not entirely unchartered waters for the FDA, it having had past experience with restricted over-the-counter sales of nicotine and tobacco.

Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January. As the months passed and there was no activity from the FDA, two Democratic senators who support abortion rights, Hillary Rodham Clinton of New York and Patty Murray of Washington, pledged to block any vote on President Bush's nomination of Crawford to become agency commissioner unless the FDA made a decision on the pill, for or against. The senators relented in July after the secretary of health and human services, Michael Leavitt, promised that a decision would be made by Sept. 1. My Crawford, in his confirmation hearing promised the two senators that a decision would be made.

By indefinitely delaying a decision on the application, Mr. Crawford, seems to have gone back on his words. Many critics’ feel that by rejecting an application that has met all FDA requirements, the agency has succumbed to the influence of ‘moral’ and anti-abortion lobbies when it is has been charged to make decisions solely based on scientific and legal grounds.

This latest decision, or rather indecision from the FDA led to the resignation of Susan Wood, the director of the FDA’s Office of Women’s health. “I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled.”  She further said that “There’s fairly widespread concern about FDA’s creditability” among agency veterans as a result. According to Wood, the final decision was not made in FDA’s usual manner, but “at the commissioner level……where most if not all of the professional staff were excluded.”

Opponents of Plan B over-the-counter status hailed Crawford’s decision, saying easier access to emergency contraception may encourage teenage sex. Groups opposing OTC status include the American Association of Pro-Life Obstetricians and Gynecologists and Concerned Women for America, a public policy organization. According to them, since birth control pills, which contain lower doses of progestin, are available only by prescription, how can Plan B, which has a much higher dose of the same synthetic hormone be available over-the-counter. Contrary to well established scientific evidence, many opponents even regard the morning after pill as an abortion medicine.

Other opponents contend that broader access to the pill leads to a higher incidence of sexually transmitted infections (STIs). A Swedish study published in 2002 reported that STIs were on the rise among adolescents who had OTC access to emergency contraception and other forms of contraception.

Most of the above concerns have no or minimum scientific backing. Further supporting the reams of data that already establish Plan B as safe, a new study published in the journal of Obstetrics and Gynecology suggests that the pill is safe for adolescents and younger women. The analysis, which draws on information derived from an earlier randomized controlled trial, reports the experiences of 2,117 young women given access to Plan B, either directly (they were given three packets of Plan B in advance), through a pharmacy (where they could get Plan B for free and without a prescription) or at a clinic (where they had to see a doctor to get the drug).

"We didn't find, with regard to health issues, that younger women were any different than older women," said study co-author Philip Darney, chief of obstetrics and gynecology at San Francisco General Hospital and a professor at the University of California, San Francisco. The study also found that sexual behavior was not riskier among those who had pharmacy or direct access to the drug than among those who saw a doctor to obtain it.

Circumventing this delay on Plan B’s approval, seven states have already allowed the Plan B pill to be purchased without a prescription by asking the pharmacist. The states include California, Alaska, Hawaii, Maine, New Hampshire, New Mexico and Washington. Even Barr Pharmaceutical’s CEO acknowledged that in view of this perpetual limbo, the company might lobby individual states to make the product more accessible.

In a joint statement, 12 democratic senators and one independent said,” The FDA’s decision leaves the strong impression that concerns about politics have overridden concerns about public health.” Such kind of publicity is not doing FDA’s image any good, especially coming right after the Vioxx debacle where the agency was accused of ignoring scientific warnings about cardiovascular side-effects.

FDA’s action on Plan B reek of considerations outside the scientific and legal domain the agency is mandated to restrict itself to. Its silence, especially in the after-math of strong opposition and outcry to its latest actions suggests that strong political influences are at play. If this is the case, and we certainly hope that it isn’t, our faith in an agency long regarded as a protector of public health, based solely on strong scientific foundations, would be severely damaged. We hope that even if this Plan B case has succumbed to political considerations, it is a one-of-a-king case and that future FDA actions would be based entirely on scientific and legal merits.

The real direction of the FDA can be seen in future decisions and we hope that the FDA takes the high road and sticks to science and not politics. If they decide to continue to go down this road of politics over science then the country’s innovative prominence will surely be a thing of the past.

If any questions on the report or comments please email us at info@mdiconsultants.com.

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