01 Sep 1998 To Save Lives, End Business As Usual at the FDA

While most Americans are caught up in the Clinton-Lewinsky soap opera, another Washington drama may have far more immediate impact on the lives of most Americans.

At issue is the future direction of the Food and Drug Administration (FDA), the federal agency that regulates $1 trillion of our economy, or 25% of every dollar spent by American consumers,i including all food, cosmetics, pharmaceuticals, biotechnology, blood, medical devices and veterinary medicine expenditures.

President Clinton is seeking to replace former FDA Commissioner David Kessler with Kessler’s former Deputy Commissioner for Operations, Dr. Jane Henney. Henney, who directed FDA operations from 1992-94, would be a director in the mold of Kessler.ii

Senators on the Labor and Human Resources Committee approved Henney’s nomination, making way for a vote in the full Senate, but several Senators on the panel, including Senator Mike Enzi (R-WY) and Senator Tim Hutchinson (R-AR) weren’t convinced that approving Henney was wise. There have been sharp criticisms of the Kessler/Henney FDA:

* The FDA ended clinical trials in 1993 for a cardio-resuscitation device because patients couldn’t give consent to the trials because they were unconscious due to cardiac arrest. The device, designed for use on such patients, is now available for use in most of the world — except the U.S.

* During Henney’s term as the FDA’s director of operations, the FDA banned drug companies from sharing information on off-label uses of cancer drugs with doctors. The result was a rapid drop in information available to doctors about available, legal drugs useful in fighting cancer.

* The public has suffered from slow approval times for FDA approval of drugs and devices that aren’t supported by a political constituency. Under Dr. Henney’s tenure as the FDA’s operations director, for instance, formal approval for an implantable defibrillator for cardiac patients was delayed 17 months after a FDA research panel had recommended approval of the device (similar delays occurred with approvals for an intracoronary stent, a rotablator and an atherectomy device). Drugs for the treatment of AIDS, however (ddI and AZT), were “fast-tracked” for approval within the agency, although other potentially life-saving drugs and devices were not.

In 1988-90, before the Kessler/Henney tenure, applications for FDA pre-marketing approvals were processed in 337-415 days. From 1991 until the end of Kessler’s tenure, however, approvals took much longer, peaking at 823 days in 1994, Dr. Henney’s last year as director of FDA operations. According to the Small Business Survival Committee, the overall time it takes for a drug company to create, develop and gain approval for a drug went from 8.1 years to 15 from the 1960s to the 1990s.iii

By contrast, when the FDA decided to promulgate regulations on the politically-advantageous issues of teenage smoking (an area the federal courts have ruled lies outside the FDA’s purview), it took just one year to process over 700,000 public comments and publish a final regulation.iv

* The FDA has refused to examine, before approval, the effect of the abortion drug RU-486 on unborn babies. Although the impact of the drug on a fetus when the drug is taken specifically to induce abortion is clear — 95% fatal when taken in prescribed doses up to 49 days since the last menstrual periodv — the FDA has refused to examine the impact of the drug on an unborn baby if the drug is taken by a pregnant woman for other reasons.

The possibility that a doctor might prescribe an abortion drug for a pregnant patient is not as unlikely as it might at first seem. RU-486 works in early pregnancy by blocking the hormone progesterone, as supplied by the mother, which builds the lining of the uterus for the fertilized egg and maintains the early pregnancy. Approximately nine weeks into the pregnancy, however, the placenta produces its own progesterone. A doctor might well conclude that RU-486 is safe for the baby at that time, although the FDA refuses to conduct tests to determine if this is so.

The issue is important because the U.S. patent holder of RU-486, the Population Council, believes and publicizes the information that the drug can be useful for “treating a wide range of conditions relating to pregnancy (induction of labor and cervical ripening); gynecological disorders (infertility, endometriosis and uterine fibroids); and other medical problems (Cushing’s disease, meningioma and breast cancer).”vi The Feminist Majority Foundation publicly promotes RU-486 as a possible treatment for brain, breast and spinal cord tumors and speculates that it may even be useful in treating AIDS, depression, alcoholism, substance abuse, anorexia nervosa, ulcers, diabetes, Parkinson’s, Multiple Sclerosis and Alzheimer’s.vii Others have said that RU-486 may have uses in treating brain tumors and some hormone-dependent tumors, including those in the breast.viii

Explaining the FDA’s unwillingness to examine a seemingly important issue, both for mothers and their children, Dr. Henney told the Senate Labor and Human Resources Committee on September 2 that it will be up to doctors to decide for themselves if it is safe to give RU-486 to women. This despite the fact that other drugs routinely carry warnings if they are potentially harmful to the unborn, and despite the fact that Section 505(d) of the Federal Food Drug Cosmetic Act requires this labeling.

The FDA’s RU-486 decision seems especially inconsistent because the FDA has long argued that doctors do not have the skill to evaluate drugs for “off label” (legal but not specifically endorsed by the FDA) uses. In a court filing in a case brought against the FDA by the Washington Legal Foundation, for instance, the FDA argued: “Most physicians, well-educated and experienced as they may be, do not have the resources, experience or education to critically evaluate evidence concerning off-label uses.”

The FDA’s inconsistent attitude toward the safety of RU-486 may be the result of political pressure. In January 1993, his first month in office, President Clinton issued a formal Memorandum to the Secretary of Health and Human Services (of which the FDA is a part), directing the Secretary to swiftly “assess initiatives by which the Department of Health and Human Services can promote the testing, licensing and manufacturing in the United States of RU-486.” The FDA then met with the French manufacturer and U.S. patent-rights holder of RU-486, Roussel Uclaf, which did not want to test or receive approval for RU-486 in the U.S. At the FDA’s request, Roussel donated the U.S. patent rights to RU-486 to a U.S. nonprofit of which the FDA approved, the Population Council. The FDA then took only six months to give preliminary approval to RU-486, although the Center for Drug Evaluation and Research reports that the median total FDA time for new drug approvals that year, 1996, was 14.8 months.

* The FDA’s controversial 1992 decision to place an indefinite voluntary moratorium on silicon breast implants despite a decision two months prior by the FDA’s General and Plastic Surgery Devices Advisory Panel that continued availability of the devices was warranted on public health grounds, and despite 40 years of safe use of silicone as a biomedical material.

The FDA’s decision, taken after the FDA solicited the advice of persons with a financial stake in lawsuits against silicon implant manufacturers, contributed to billions in unnecessary class action lawsuits, frightened millions of women and their families, and drove a major manufacturer into bankruptcy. Three years later, Commissioner Kessler announced that the fears of implants the FDA itself had helped to engender were unwarranted. Rep. Marilyn Lloyd (D-TN), commented, “Instead of protecting the health of women, this moratorium has caused undue stress and anxiety for women.” To this day, many women who have lost a breast to cancer remain fearful of silicon implants.

* Rejecting applications for approval on day 89 of a 90-day approval period and inviting resubmission to disguise the extent of the FDA’s approval backlogs.

* In 1992 the FDA recalled balloon catheters, used to treat bleeding blood vessels in the brain, depriving patients of a lifesaving therapy. At the time, Dr. Henney explained that patients must do without this lifesaving device because the manufacturer of the catheter distributed three times as many of the devices during clinical trials as FDA regulations call for. The manufacturer’s appeal that it had done so only under the FDA’s regulations allowing exceptions for “emergency” or “compassionate use” was rebuffed by the FDA leadership. RU-486, however, is being distributed under “compassionate use” regulations.ix

* The FDA has involved itself in issues outside its purview, seeking, for instance, to supercede some state and local tobacco regulations with expensive new regulations of its own. Although a federal court on August 14, 1998 ruled that the FDA has no constitutional authority to impose these restrictions,x the Clinton Administration’s proposed FY 1999 $1.26 billion FDA budget includes $134 million for “youth tobacco prevention.”xi That’s $134 million that could be used to get lifesaving drugs and medical devices more swiftly to market.

Speaking before the U.S. Senate Committee on Labor and Human Resources at Dr. Henney’s confirmation hearing September 2, 1998, the Chairman of the Committee, liberal Republican James Jeffords, commented: “I continue to be concerned about FDA’s priorities and the appropriate use of its finite resources. Like most government agencies, the FDA has demonstrated a desire to take on more and more responsibilities regardless of legislative authority or funding.”xii

* The FDA under Kessler/Henney has adopted a tough anti-business posture, tripling warning letters to businesses (once the FDA issues warning letters, it can seize a company’s products or get court injunctions to halt a company’s operations). In a widely publicized incident, the FDA raided Proctor and Gamble, seizing and destroying 12,000 gallons of orange juice, all because Procter and Gamble had used the word “fresh” when naming the juice “Citrus Hill Fresh Choice.” Procter and Gamble pointed out that survey data showed that “fresh” did not mean “freshly-squeezed” to consumers, and that the juice was labeled “made from concentrate,” but the FDA was unmoved.xiii

In another prominent incident, 16 FDA inspectors and local police in Kent, Washington held the staff of a clinic at gunpoint while seizing more than $100,000 in products, office supplies and personal items and tearing the phones from the wall. The FDA said it was concerned that the clinic had injected B vitamins into patients.xiv

In 1997, concerned about the direction of the FDA during the Kessler/Henney tenure, the Senate unanimously approved, and President Clinton later signed, a comprehensive overhaul of the FDA. It would be ironic now if the Senate ignored the factors that led them to pass this landmark legislation and approved one of the FDA officials that made the overhaul necessary, Dr. Jane Henney, to be the new FDA commissioner.

Amy Ridenour is president of The National Center for Public Policy Research. Comments may be sent to [email protected].

Footnotes

i Food and Drug Administration Web Page, Downloaded September 20, 1998; Statements of Senators Barbara Mikulski and Edward M. Kennedy, U.S. Senate Committee on Labor and Human Resources, September 2, 1998
ii Statement of Senator Chris Dodd, U.S. Senate Committee on Labor and Human Resources, September 2, 1998
iii “FDA Hazards: How FDA Red Tape Impacts Entrepreneurs and the U.S. Economy,” by Raymond J. Keating, Small Business Survival Committee, August 1995
iv “Comments Couldn’t Kill Tobacco Rule Process,” by John Schwartz, Washington Post, February 19, 1997, A19
v “Medical Abortion with Mifepristone and Misoprostol,” Population Council, May 1998
vi “Medical Abortion with Mifepristone and Misoprostol,” Population Council, May 1998
vii “Feminist Majority Foundation Reports on Mifepristone,” Feminist Majority Foundation, 1998
viii “RU-486: The Rest of the Story,” by Dr. Eugene Diamond, Professor of Pediatrics Loyola University Stritch School of Medicine, Family Resources Center News, Peoria, Illinois, January 1993
ix “Feminist Majority Foundation Reports on Mifepristone,” Feminist Majority Foundation, 1998
x “Court Rules F.D.A. Lacks Authority to Limit Tobacco,” by Berry Meier, New York Times, August 15, 1998, page one
xi FDA Talk Paper T98-4, February 2, 1998
xii Statement of Committee Chairman James Jeffords, U.S. Senate Committee on Labor and Human Resources, September 2, 1998
xiii “FDA Facts: Strong-Arming American Business,” by Raymond J. Keating, Small Business Survival Committee, July 1995, citing James Bovard in the January 1995 American Spectator
xiv “FDA Facts: Strong-Arming American Business,” by Raymond J. Keating, Small Business Survival Committee, July 1995, citing James Bovard in the January 1995 American Spectator