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Pill pushers

National | Did the FDA follow its own guidelines when it approved RU-486?

Issue: "Beginning of the end," March 29, 2003

TRUE OR FALSE: THE FOOD AND Drug Administration bent its own rules when it approved the use of RU-486 (the so-called abortion pill), ignoring evidence of risks to women and relaxing its distribution requirements because of political pressure.

Critics have leveled these charges, but it's hard to know whether they are fact or fiction because the FDA has failed to abide by its own guidelines and respond to a citizen's petition that raises the allegations.

Three groups representing more than a half-million members-the American Association of Pro-Life Obstetricians/Gynecologists, Concerned Women for America, and the Christian Medical Association-filed the petition on Aug. 20, 2002. The FDA missed the statutory six-month deadline-Feb. 20-to respond.

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The petition reads like a research paper. Using thousands of internal FDA documents, e-mails, minutes, and memos obtained under the Freedom of Information Act, the groups make the case for removing RU-486 from the U.S. market. The petition also creates a timeline that, according to David Stevens, executive director of the Christian Medical Association, "systematically details how the FDA buckled to political pressure in approving a drug regime that poses a significant threat to women's health."

The timeline starts in 1994, when then-FDA Commissioner David Kessler persuaded Roussel Uclaf, the French pharmaceutical company that developed RU-486, to donate the drug's patent to Population Council, a global family-planning organization. The council's scientists conducted RU-486's U.S. clinical trials. Two years later, the organization went to the FDA and announced that RU-486 was safe.

The FDA's Reproductive Health Drugs Advisory Committee agreed that the drug was safe-but only if prescribed correctly. It recommended more work on the drug's distribution plan.

That meeting took place in July 1996. Then came the back-and-forth between the FDA and the Population Council and Danco, the company set up to distribute RU-486. FDA officials sought stringent rules regarding the drug's distribution from the two groups, but everything they received fell short of the agency's expectations.

Fed up, the FDA wrote rules for them in June 2000: Physicians prescribing RU-486 had to be licensed to practice medicine, be able to perform a surgical abortion, perform an ultrasound on the woman first, be well-versed with the drug regimen, including how to respond to adverse effects, and have access to a hospital equipped for terminating pregnancies and giving blood transfusions.

The FDA wanted these guidelines because clinical trials found 2 percent to 10 percent of women who take RU-486 need surgery because of complications. Untreated complications can lead to severe infections or even death.

The distribution guidelines did not sit well with the Population Council and Danco; the groups presented the rules to the press as obstacles to a woman's right to choose, not as safety measures intended to protect women.

The tactic worked. California Sen. Barbara Boxer and others pressured the FDA, with Sen. Boxer complaining of "draconian restrictions."

FDA officials set up a meeting with the two organizations to "discuss the misrepresentations by the press" but later buckled. The FDA abandoned its proposal for verifiable physician qualifications and agreed to allow doctors to attest to their own qualifications; instead of requiring formal training, the FDA merely "requested that the physician also attest to having read and understood the training materials and labeling." The agency agreed not to require pre-procedure ultrasounds, and prescribing physicians did not need to know how to perform an abortion if things went wrong.

Also on the petitioners' grievance list:

The FDA's approval did not mandate the same type of requirements as those used in the clinical trials. For example, trials required ultrasounds.

The FDA exempted RU-486 from its own rule that new drugs be tested on minors.

The FDA approved RU-486 under its Subpart H-designed for drugs that are meant to treat life-threatening illnesses, such as AIDS and cancer.

The petition accuses the FDA of allowing "tainted data"-from French trials of the drug-to be used as proof that RU-486 is safe. FDA officials had found that there was a "failure to maintain complete and accurate records ... laboratory reports that were missing ... pages missing from the case record files ... unreported aspirations ... under-reported side effects [like] a patient bleeding with two subsequent [suction procedures]; convulsions reported as fainting; an expulsion which was actually a surgical evacuation."

FDA officials declined to discuss the petition because it's under review. But spokeswoman Susan Cruzan said the federal agency receives hundreds of petitions annually and cannot always process them within the required time frame.

But since the FDA approved RU-486 in 2000, there have been a handful of reports of serious complications, including two deaths, related to use of the drug. If not prescribed correctly, RU-486 can be deadly. Petitioners say the FDA's inaction is allowing a dangerous health concern to fester. c

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