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the Body Politic
Vol. 01, No. 08 - August 1991, Page 23
Copyright © 1991, 1998 by the Body Politic Inc.

The FDA & RU 486 -- Part II

Scientifically Regulated or Politically Entangled?

By Alissandra D'Aquanni

(This is the second part of an article started in the July Issue)

The Real Reason Behind the Import Alert

Dr. Frank Young was appointed as Commissioner of the FDA in 1984, at a time when the FDA was prospering and receiving strong support. He led the transition team when President Bush was elected and was reappointed as Commissioner. However, a scandal in the FDA's Generic Drugs Division was uncovered in 1989, following major investigations by the FDA, the Justice Department and Congressional Committees.

The scandal devastated congressional and administrative confidence in the FDA and resulted in Commissioner Young's forced resignation in November 1989. James Benson, the FDA's Deputy Commissioner was appointed as Acting Commissioner, and was not replaced until mid-1990.

In addition to the investigations regarding the generic drug scandal, Commissioner Young was receiving inquiries from key congressional members regarding the FDA's policy on importation of RU 486. Just prior to the issuance of the import alert, Commissioner Young was sent a letter signed by 11 members of Congress, all of whom are staunch anti-abortion advocates, stating "The U.S. Government should not be involved in abetting abortions." The letter suggested that the FDA draft regulations that would add abortifacient, and specifically RU 486, to the list of drugs prohibited from the pilot release program. Coincidentally, the import alert was against all abortifacient drugs, including RU 486.

It is not inconceivable that Commissioner Young, who is personally opposed to abortion, issued the import alert to bow to congressional pressure (and appease President Bush who is also well-noted for his strong opposition to abortion) in the face of an intensive investigation of the FDA's Generic Drug Division. Had he not done so, the pressure from anti-abortion advocates and Congressional members may have increased and brought additional unwanted attention to the FDA.

As an interesting side note, when Commissioner Young was forced to resign from the FDA, he was appointed to a newly created position in HHS as Assistant Surgeon General and Deputy Assistant Secretary for Health, Science and Environment.

During testimony presented to the Congressional House Subcommittee on Regulation, Business Opportunity, and Energy, on November 19, 1990, Mr. Chesemore, Associate Commissioner for Regulatory Affairs -- FDA, stated that the import alert was not motivated by politics, but strictly by health concerns. However, when questioned further by Congressmember Wyden, Chair of the Committee, he could not justify the import alert on any documentable occurrence.

Dr. Sobel, Director, Division of Metabolism and Endocrine Drug Products, FDA, stated that although Roussel had maintained tight controls on the drug and that there were no substantiated assertions of RU 486 being used unsupervised, "our policy has to cover the circumstances as they may develop, and that is the purpose of the policy...I really, frankly, don't believe that there is a strong scenario for importation from France of this drug for pregnancy." Not only was the import alert against RU 486 unwarranted, it was totally unnecessary.

The Impact of the FDA's Import Alert Against RU 486

Subsequent to the import alert, researchers testing RU 486 had their supply eliminated or sharply reduced. While importation of RU 486 for clinical trials was not banned by the import alert, Roussel reacted by reducing shipments of the drug and canceling meetings to discuss future testing.

The FDA was well within their authority to restrict the importation of RU 486 from the pilot release program, as well as any other unapproved drug. However, given the political climate which followed RU 486 from France to the United States, the actions of the FDA appear to be politically -- not scientifically -- motivated.

This sent a message to Roussel and any American pharmaceutical company which may have been considering seeking approval for RU 486. The message, quite simply, was that interest in any abortifacient -- despite its other uses -- would be closely watched and regulated.

The issuance of the RU 486 import alert was not illegal nor was it outside of the FDA's regulatory authority. However, the timing of the decision caused researchers, advocates and Congressmembers to ask questions, to the extent that it became the basis for a Congressional Hearing.

In closing the hearing, Congressmember Wyden asserted that "the American people want the FDA...to be the advocate, to be out front, rather than to be the identified obstacle that the researchers and patients have described today." Having established that the FDA's issuance of the import alert was within their jurisdiction -- albeit unjustified and unnecessary -- Wyden's assertion questioned whether the FDA has a responsibility to advocate for the research and marketing of new drugs with potentially life-saving effects.

Private Sector Hesitation and Public Sector Paralysis

Since Roussel's unveiling of RU 486, American pharmaceutical companies have shown little interest in testing or marketing it. The major issue facing most companies is one of liability insurance. Courts have been awarding large settlements to women who have been injured because of the IUD or the birth control pill.

As a result, U.S. pharmaceutical companies have had problems getting liability insurance for reproductive health devices and drugs. This has caused contraceptive research to be scaled down or eliminated completely.

An additional issue is increased political pressure from special interest groups who are anti-abortion. Companies who market contraceptives or abortifacient have been met with wide-scale boycotts or threats of violence.

Dr. Jack Wilke, President of the National Right to Life Committee (NRLC) has been very forthright in letting pharmaceutical companies know what the NRLC's response would be -- "It is a forgone conclusion that they would be hit with an instant, massive boycott of every product they made."

As a result, many private companies will not publicly promote research or marketing of drugs with abortion-inducing characteristics. Roussel's decision to cancel distribution, thereby strategically placing the French Health Ministry in a position of advocating for the distribution of RU 486, is a clear example of how this is not just an American problem.

In the United States, however, private industry has a responsibility only to its share holders -- which puts the onus on the American government to play advocate. If American pharmaceutical are unwilling to seek approval for a drug like RU 486 which could save thousands of lives each year by treating life-threatening diseases, does the federal government -- i.e. the FDA -- have a responsibility to ensure that these drugs are tested?

Because the FDA is not in the business of marketing drugs nor is it susceptible to boycotts of its products, it is in an ideal position to advocate for the research and testing of new drugs. However, there is a difference between being in a position to advocate and being mandated to advocate. The responsibilities of the FDA include:

While the FDA is not prohibited from advocating for research on a drug -- neither is it mandated to do so. This is where the public official's perspective and orientation plays a critical role. For example, in his correspondence to Congress, Commissioner Young condemned RU 486 as unsafe as an abortifacient and never mentioned its other uses.

Yet, Otis Bowen, the Secretary of Health and Human Services, in a reply to Congressmembers defended RU 486 research as a potential treatment for Cushing's syndrome and breast cancer. He stated "In view of the many potentially beneficial health uses of RU 486, I believe that it would be in the best interest of the American people to continue the HHS-funded studies on that compound."

The role of the two men was quite different in that Young was heading the FDA -- strictly a regulatory agency -- and Bowen was defending the actions of the entire Department of Health and Human Services which includes the FDA and many other public health and service agencies.

However, from Young's perspective, RU 486 was nothing more than an abortifacient, otherwise he would have defended its importation on the basis of its other uses. Bowen, on the other hand, assured Congressmembers that his agencies were not researching the abortifacient characteristics of RU 486 (which was prohibited) and took the opportunity to advocate for its treatment of life-threatening diseases.

Dr. Regelson, Professor of Medicine at Virginia Medical College, stated during the Congressional Hearing, that the FDA should have been advocating for further research rather than imposing restrictions. He stated "It should be the job of the FDA to expedite the entry of such drugs into this country, and they should encourage clinical trials, and clinical development, and the development of proper studies to get these drugs out."

Whether the role of the FDA is strictly regulatory or should include advocacy is debatable. What is not debatable is how the FDA, once a prestigious and professional agency, became entangled in a political web which may cost thousands of American lives.

What is also not debatable is that the perspective of the public official overseeing an agency has a tremendous impact in determining how and by what standards that agency performs.

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