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Dtakes 30

A Publication of the Population and Development Program at Hampshire College • No. 30 • Spring 2005
Reproductive Health and the FDA:
Buffeted by Political Battles

By Amy Allina
Since its inception, the Food and Drug
interference between sexuality and fertility is Administration (FDA), the U.S. government’s detrimental to marriage4) and Susan Crockett (a main watchdog agency over the pharmaceutical board member of the American Association of Pro- industry, has been subject to political pressures that Life Obstetricians and Gynecologists) to the undermine its mission to ensure drug safety and protect consumer health. In the last several years,these pressures have intensified as the FDA is Reproductive rights advocates and FDA watchers buffeted by the Bush administration’s right-wing saw these appointments as a sign of the Bush agenda and an ever more powerful pharmaceutical administration’s allegiance to the religious right and industry. More often than not, women’s reproductive pointed out that they set the stage for a fight over health and safety are caught in the crossfire of these the pending FDA decision on whether to make emergency contraception (EC) available over-the-counter. Following that discouraging development, The Religious Right and the Battle over
feminist activists and reproductive health advocates Emergency Contraception
cheered the triumph of science a year later when thecommittee voted unanimously that emergencycontraception was safe for use in an over-the- In 2002, the Bush administration set off a powerful counter setting. In the face of overwhelming reaction when it tried to install W. David Hager as scientific evidence, even the three staunch opponents chair of the reproductive health drugs advisory of reproductive rights on the committee had to committee responsible for advising the FDA on acknowledge that this after-the-fact contraceptive questions relating to contraception and abortion.
method could be used safely without a prescription The outrage of women around the country — requirement. Among the doctors, scientists and expressed by more than 10,000 protest email activists who had been working for years to expand messages to the FDA — led to a close public women’s access to EC, most had expected far worse scrutiny of Hager’s record. Hager had been the lead spokesperson for the Christian Medical Association’spetition for a ban on mifepristone,1 the drug The victory was short-lived, however. Despite the approved by the FDA for abortion. He had spoken overwhelming recommendation from FDA’s science publicly of his reluctance to prescribe contraception advisors, opponents of contraception prevailed and to patients who are not married.2 And as headlines across the country proclaimed, he was co-author of a book recommending prayer as treatment for PMS.3 Scientists and medical experts joined reproductive In the face of this storm of public opposition, the rights advocates in criticizing that decision, pointing Bush administration backed off from the original out that by bowing to anti-choice political pressure, plan of putting Hager in charge of the committee, the FDA has denied women access to a safe and effective contraceptive and has undermined its own provided him with like-minded colleagues, credibility as a scientific agency around the world.
appointing Joseph Stanford (who has written that he An editorial in the New England Journal of is unwilling to prescribe contraception even to Medicine lamented the loss of FDA’s “enviable married patients because of his belief that any international reputation” and pointed out that the scope of FDA regulation. Sadly, many of the events decision was “likely to mean that both physicians that have persuaded Congress of the need for better and patients will wonder whether future drug- regulation of drugs and medical devices have approval decisions are based on the evidence with specifically involved damage to the life and health of regard to efficacy and safety or, rather, on political women. Only after thalidomide, given to pregnant women to reduce morning sickness, was found tohave caused nerve damage in the women who took Mission in Flux
it and sometimes fatal birth defects in their children,did Congress mandate that FDA must review The EC controversy was not a typical, everyday evidence of a drug’s safety and efficacy before a occurrence at FDA. The FDA usually operates company could begin to sell it. And pre-market behind-the-scenes, unnoticed by most people — even review of medical devices came even later. In the those concerned about health. Yet, despite being out United States alone, 17 women died and thousands of the public eye, the FDA is still under constant more had emergency hysterectomies to save their pressure from political forces of a different kind lives as a result of using the unsafe Dalkon Shield than the very public battles that take place over IUD before the FDA was given the authority to reproductive rights. The standard battle at the agency is between the interests of the companies thatmake the drugs and devices it regulates and In the last decade, however, the trend has gone in consumer advocates concerned about the safety of the opposite direction. When conservative lawmakers won control of Congress in 1994, theywent to work on a broad reform agenda that Since the FDA was first created early in the reflected the wish lists of industries from financial twentieth century, there have been struggles between businesses, determined to fight off government Modernization Act of 1997 reshaped the agency in interference, and consumers and their advocates, response to the drug industry’s long-held desires.
working to establish a role for the federal The new law speeded up drug approvals, scaling government in protecting the public health.6 At its back safety requirements, and even redefined the start the FDA was made up of a handful of scientists agency’s mission statement to commit it to working in consultation with “manufacturers, importers, Department of Agriculture; as the scope of drugs packers, distributors, and retailers of regulated and medical devices in the world has expanded, the FDA has grown as well, now responsible forregulating over a trillion dollars worth of food, Recent news about drug safety problems with widely drugs and medical devices, more than a fifth of the prescribed pain relievers, however, has led to a growing public understanding that FDA’s ability toprotect the public has been eroded. Public outrage This growth has taken place in spite of industry has already translated into Congressional interest, resistance. It has taken fierce fights between and these developments may lead to drug safety consumer advocates and industry, and all too often, reform legislation to restore some of FDA’s capacity national and international tragedies to expand the The False Choice Between Speed
and Safety

Over the years as these trends have evolved, drugcompanies have not always been alone in criticizing FDA for its slow approval process. Patient activists CLPP • Hampshire College • Amherst • MA 01002 have sometimes made common cause with industry, 413.559.5506 • http://popdev.hampshire.edu pushing for faster drug approvals even at theexpense of rigorous safety testing. Early AIDS Opinions expressed in this publication are those of activists, in particular, urged FDA to dispense with the individual authors unless otherwise specified.
stringent safety requirements to give dying patientsaccess to new treatment drugs. Later, as more AIDS drugs became available, many of these same activists industry agenda that promotes fast approval without responded to the changed circumstances and urged adequate safeguards for women’s health.
the FDA to reprioritize the need for evidence oflong-term effectiveness and safety in its These controversies (as well as the fact that the Baby Boomers, who drive so many marketing choices inthe United States, need less and less contraception as Women’s health advocates similarly urged faster they age) have sometimes led major companies to approval for the female condom and other barrier shy away from contraceptive products, except in methods of contraception that hold the potential to cases where they expect very high levels of protect women from HIV infection and other profitability to counterbalance their concerns about sexually transmitted diseases. The question of how political controversy. Both mifepristone and EC fell to balance safety concerns with the urgent need for a into this category, failing to attract the interest of the product will again be at center stage when FDA big pharmaceutical companies and only advancing eventually considers approval of microbicides now in to FDA approval with the support of smaller development — topically applied products that help companies committed to providing women access to prevent the transmission of HIV and other infections.
Drug companies and device manufacturers have watched these developments carefully and learned from them. Industry-funded patient groups now often play a very public role in companies’ plans for obtaining FDA approval; in some cases these patient groups have been found to be wholly created by the companies whose products they are demanding access to. But activists who are accountable to real- life patients suffering from illness are learning as well. They have learned to reject the false choice safety concerns were seriously addressed. This between faster approval and safer products. The cooperative approach headed off the potential for demand for efficient consideration of urgently internal controversy and created a united front of needed products does not have to result in the women’s advocates to face the anti-choice elimination of safeguards for the public health.
opposition which was thus effectively marginalized.
Addressing Safety Concerns and
Lack of Credibility Undermines FDA’s
Overcoming Division
Ability to Protect Women’s Health
When it comes to contraception, the political battles Last fall, a new development in the regulation of sometimes converge, subjecting these critical Depo Provera proved the truth of the New England women’s health products to the complicated tensions Journal of Medicine editorial warning that FDA’s of the safety/access balance as well as the bruising motivation for future decisions would be called into assaults of the anti-choice, anti-family planning right-wing. In the past, this convergence has createddivision within the reproductive health community, Women’s health advocates have raised concerns as was seen with Depo Provera, the contraceptive about the safety of Depo Provera for decades. Over injection, and Norplant, the contraceptive implant.
time, research has laid to rest some but not all of the Women’s health advocates who asked the FDA not questions about the effects of this drug. One to approve a contraceptive because of safety uncertainty that had remained was about Depo’s concerns have been seen by family planning effect on the strength of the bones of women using advocates as unwitting accomplices to anti-choice it; some preliminary research indicated that women efforts to block access to products that improve using Depo experienced a loss of bone.8 Health women’s ability to control fertility. Family planning advocates have continually called for better information on this and other possible risks of long- contraceptive products in spite of unanswered term use of the method. The kind of cooperative questions about safety have been seen by consumer approach that created unity among women’s health advocates as unwitting accomplices to an advocates on EC and mifepristone has not yet evolved with respect to Depo Provera. Meanwhile, advocates have been pleased to see the FDA the FDA — its credibility weakened by the Bush requiring that the bone loss information be provided administration’s appointment of unqualified to women. 9 But at the same time, the agency’s candidates like David Hager and by denying women recent history of manipulating and suppressing improved access to safe and effective EC — scientific data for political ends and the Bush announced labeling changes for Depo Provera that administration’s track record of attacks on family revealed the fault lines in the women’s community.
planning cannot help but raise questions about whatis really behind this label change. Is it a genuine Based on new data, submitted by the company that effort to protect women’s health by sharing new makes Depo, the FDA has instructed the company scientific evidence? Or is it a politically motivated to add information to the drug label about bone loss attack on contraception, using science as a and to recommend that clinicians limit use of Depo smokescreen for an anti-choice agenda? Just as the to two consecutive years. This new information is editorial warned, FDA’s distorted decision on EC has being conveyed in the form of a black box warning undermined the agency’s credibility and led even on the label — FDA’s most severe label warning, those who support its role as a protector of the commonly although not exclusively, used for life- public health to question the motivations behind threatening conditions. Many women’s health Amy Allina is Program Director of the National Women’s Health Network, a national organization thatis committed to ensuring that women have self-determination in all aspects of their reproductive andsexual health. Prior to joining the NWHN in 1999, she worked on women’s health policy issues at theconsulting firm of Bass and Howes and as the Political Organizer for the Maryland affiliate of NARAL.
She serves on the board of directors of the Reproductive Health Technologies Project and the AlanGuttmacher Institute.
References
* While this is being written, a revised application to make EC available over-the-counter is still pending and may eventuallybe approved, but it’s been seriously weakened by a plan to restrict over-the-counter access to women 16 and older, setting up atwo-tiered system of access based on age and denying improved access to younger women.
1. “Christian Medical Association Petitions FDA to Shelve RU-486,” http://www.cmdahome.org/index.cgi?cat=100041&art=1893&BISKIT=246794947&CONTEXT=art, last visited October12, 2004.
2. “Roundtable on Abstinence,” http://www.family.org/physmag/issues/a0023927.cfm, last visited October 12, 2004.
3. Stress and the Woman’s Body, by David W. Hager and Linda Carruth. Revell, 1998.
4. “Sex, Naturally,” First Things: the Journal of Religion, Culture and Public Life, 97 (November 1999): 28-33.
http://www.firstthings.com/ftissues/ft9911/articles/stanford.html, last visited October 12, 2004.
5. “The FDA, Politics, and Plan B,” New England Journal of Medicine 350;15: 1561-1562.
6. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation, by Philip J. Hilts. Alfred A.
7. Food and Drug Administration Modernization Act of 1997, Public Law 105-115, 105th Congress.
8. “Injectable hormone contraception and bone density: results from a prospective study,” Scholes D., LaCroix A.Z., Ichikawa L.E., et al. Epidemiology. 2002 Sep;13(5):581-7.
9. “Depo Provera and Bone Mineral Density,” http://www.nwhn.org/publications/fact_details.php?fid=21, last visited

Source: http://www.global-sisterhood-network.org/gsn/downloads/2005-32.pdf

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