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the Body Politic
Vol. 01, No. 07 - July 1991, Page 23
Copyright © 1991, 1998 by the Body Politic Inc.

The FDA & RU 486

Scientifically Regulated or Politically Entangled?

By Alissandra D'Aquanni

RU 486 -- New Miracle Drug

On September 23, 1988, the French Government approved the marketing of a new drug called RU 486, created by Dr. Etienne-Emile Baulieu and manufactured by Roussel-UCLAF, a French pharmaceutical company.

RU 486 had been tested and approved as an abortifacient. The drug had also shown great promise as a contraceptive and in the treatment of breast cancer and Cushing's syndrome.

Despite the indications of RU 486 as a wonder drug, on October 26th, Roussel announced the cancellation of their plans to distribute the drug in France. They cited intense pressure from anti-abortion groups both in France and the U.S., including threats of violence and boycott. The French Health Minister, Claude Evin, ordered Roussel to resume distribution on October 28th, declaring from "the moment Government approval for the drug was granted, RU 486 became the moral property of women, not just the property of the drug company."

The Health Minister had the authority to order that Roussel continue manufacturing RU 486 because the French Ministry owns 36% of Roussel's stock and, most importantly, had passed a law in 1968 stating that if a company refused to make a drug available, the French Health Minister could withdraw the company's license to market the product and award that license to another company. Roussel complied with the order.

Other countries immediately approved RU 486 for use as an abortifacient and researchers within the United States began requesting samples for testing. However, because of political pressure from anti-abortion groups, Roussel maintained tight controls on the drug and refused to allow its use in other countries. In addition, they hesitatingly sent samples in small doses to researchers. United States' researchers who wanted permission to perform clinical tests of the dug on humans had to apply to the federal Food and Drug Administration (FDA) for an IND -- Investigational New Drug -- permit.

FDA officials confirm that several pharmaceutical companies and others have filed applications to conduct preliminary tests on the drug -- but by law, the names are confidential. One non-profit which went public with its findings is the Population Council of New York. They tested the drug in 1986 at the University of Southern California to determine its effectiveness as an abortion-inducer. They reportedly found the drug to be highly effective and safe in the termination of pregnancies less than 7 weeks with a 90% success rate when used by itself. Another study reported a 96% success rate when used with a prostaglandin.

Many private researchers reported that RU 486 was safer and less expensive than other methods of abortion and was preferred by their patients. Publicly-funded researchers were barred from testing RU 486 as an abortifacient because Congress banned the federal government from conducting or funding research on abortion-inducing drugs through Title X, the family planning law.

However, agencies within the National Institutes of Health (NIH) have conducted studies to determine the effectiveness of using RU 486 in treating breast cancer, Cushing's syndrome and other diseases. Early tests concluded that RU 486 inhibits the growth of breast cancer tumors and relieves the symptoms of Cushing's syndrome. Both diseases can be fatal if not detected and treated in the early stages. Unfortunately, even with increased screening, breast cancer claims the lives of 44,000 women per year.

Despite such optimistic finding, research on RU 486 has been slowed to a halt. Why, in such a technologically and medically advanced country, is the United States not testing this drug at great speed? Pro-choice groups and members of Congress point to the FDA; the FDA points to Roussel; Roussel points to anti-abortion groups. In the meantime, individuals suffering from breast cancer and Cushing's syndrome watch the clock and wait.

The Food and Drug Administration

The FDA is an agency within the Health and Human Services Department (HHS). The Commissioner of the FDA is appointed by the Secretary of HHS, who is appointed by the President of the United States.

In 1906, potential health hazards presented by adulterated and mislabeled foods, drugs, cosmetics and medical devices prompted passage of the Food and Drug Act. Harvey W. Wiley, chief chemist of the Agriculture Department's Bureau of Chemistry began administering the act in 1907.

Eventually, responsibility for administering the act was transferred to the Food, Drug and Insecticide Administration and in 1931, the name was changed to the Food and Drug Administration. In 1940, the FDA was transferred to the Federal Security Agency, a new agency created to protect the public's health, which was incorporated into the Department of Health, Education and Welfare (HEW) when that department was created in 1953.

Finally in 1979, Congress removed education functions from HEW and created the Department of Education. The remaining agencies, including the FDA, were renamed the Department of Health and Human Services. One would expect that the FDA was in a constant state of flux and change during this time because of all the transfers -- however, quite the opposite occurred.

During these transfers, Congress passed the Food, Drug and Cosmetic Act of 1938 which authorized the FDA to require that a manufacturer prove the safety of a new drug before it would be allowed on the market. Additionally, the Food and Drug Act Amendments of 1962 required drug manufacturers prove the effectiveness as well as the safety of their products before they could be marketed, and authorized the FDA to order immediate withdrawal of dangerous drugs from the market.

This is just a sampling of the legislation that was passed to expand and increase the powers of the FDA. The result was an agency which, during the Reagan years, was considered one of the most prestigious and professional of the federal regulatory agencies.

The FDA and RU 486

In addition to being regarded as prestigious and professional, the FDA was also regarded as compassionate. On July 20, 1988, it issued a pilot program which allowed the importation of certain unapproved drugs with several restrictions. This program was specifically designed for individuals who had been purchasing unapproved products from foreign countries to treat life-threatening conditions such as AIDS and certain cancers. The guidelines the FDA set up were:

RU 486 was not one of the drugs excluded from the personal importation program.

However, less than a year later, on June 6, 1989, the FDA issued an import alert banning the importation for personal use of all unapproved abortifacient drugs -- including RU 486 -- stating the "FDA has concluded that unapproved products of this kind would be inappropriate for release under the personal importation policy. The intended use of such drugs could pose a risk to the safety of the user."

Yet, in a letter dated November 28, 1988, seven months prior to the import alert, Diane Walker, the FDA's Consumer Safety Officer, stated "Before we will permit testing a drug in humans, the sponsor of the drug must provide us with information demonstrating that the drug is reasonably safe to administer to humans... These requirements were met by the Population Council..."

Ms. Walker's letter was referring to the IND which was granted to the Population Council for their 1986 USC study. Additionally, all published studies of RU 486, whether relating to its use as an abortifacient or in treating life-threatening diseases, concluded that the early tests indicated RU 486 was safe and effective. This obvious contradiction is one flaw in the FDA's basis for an import alert against RU 486.

In a response to a February 23, 1989 inquiry by Senator Jesse Helms as to the FDA's policy on RU 486, Dr. Frank Young, Commissioner of the FDA, wrote "the intended use of this drug makes it likely it would be used without benefit of supervision of a physician and indiscriminate or unsupervised use could be hazardous to the patients' health."

This, as Young explained, was another reason to ban RU 486 from the personal importation program. However, the FDA guidelines for this program required the patient seeking the import to provide the name and address of the doctor responsible for his or her treatment with the product. This apparent contradiction was yet another flaw in the FDA's basis for the RU 486 import alert.

The third flaw appeared under closer inspection of the Regulatory Procedures Manual, section 9-71-40 entitled Import Alerts. It reads, "FDA personnel should recommend to HFC-131 the issuance of an import alert if they encounter:

Not one of these criteria were met. Because of the heightened political tensions, Roussel had not allowed RU 486 to be imported for personal use nor were they actively promoting the product.

Additionally, there were no reports of problems regarding the importation or testing of RU 486. In a letter dated March 10, 1990 to the Assistant Secretary for Health, Acting FDA Commissioner James Benson states that as of January 12th of that year, "no actual detention of RU 486 could be identified in the Import Detention System's national detention file." Considering that there was no justification for the import alert, why did the FDA issue it?

(continued in August)

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