Business and Politics First, Women Second: The FDA’s Drug Approval Process
In her new book, Reproductive Rights and the State: Getting the Birth Control, RU-486, and Morning-After Pills and the Gardasil Vaccine to the U.S. Market, Melissa Haussman analyzes the singular histories of these reproductive health medicines in the United States. For each of these medicines, Haussman details the often convoluted processes behind achieving FDA approval and bringing the product to market, highlighting the complex interplay of corporate and political interests that impeded or expedited the availability of each product in the US.
The book begins with a description of the history of the FDA and the evolution of the agency’s regulatory authority through its policy changes during the 20th century. The agency’s political strength derives from its reputation as the strictest and most deliberate regulator of drugs worldwide; however, the approval processes described in this book call the FDA’s objectivity into doubt. The FDA is empowered with policy tools to expedite the approval of drugs that have been proven safe and effective through years of use in other countries. In the case of mifepristone and levonorgestrel emergency contraception (Plan B), the agency’s mechanisms were used to impede and stall, rather than facilitate, availability. In the case of Gardasil, however, these same tools were used to expedite the approval of a new vaccine that had more to do with pressure exerted by pharmaceutical interest groups than it did with public health.
Next, Haussman details the history of the oral contraceptive pill, attributing its development to researchers from Mexico and the US as well as activists such as Margaret Sanger, who mobilized financial and popular support for development and research of the Pill and the reproductive rights movement more broadly. US pharmaceutical companies were reluctant to invest in contraceptives early on, citing concerns about risk and profitability; yet once the FDA approved the Enovid, G.D. Searle & Company’s contraceptive pill, in 1960, other companies were eager to enter this profitable market.
Since 1960, the year in which the birth control pill was approved, the so-called “prochoice” and “prolife” (hereafter, antichoice) movements have had their own the trajectories and strategic alliances. From 1960 to 1973, women’s reproductive policy interests were generally aligned with the interests of the government, as there was broad bipartisan support to address population issues both in the US and abroad. This support facilitated public funding of contraception through Title X. After 1973, the antichoice coalition attained a certain dominance in American political life as more social conservatives were elected at all levels of government. Significant policy gains were won by this newly prominent social conservative movement, including the passage of the Hyde Amendment (which prohibits most public funding for abortion) and reductions in public funding for contraception. Haussman describes the development of the leading organizations on both the pro- and anti- sides of the reproductive choice issue and explains how the balance of power shifted over time. Feminist and -prochoice organizations enjoyed -tremendous growth and success in the late 1960s and 1970s, but then found themselves in a reactive position as antichoice social conservatives simultaneously built capacity at the state level and influenced policy within the federal government.
Haussman develops her thesis that the profit motive of the US pharma-ceutical industry and the exclusion of women from drug policymaking work to create policies that utterly disregard women’s interests. She describes the drawn-out process through which mifepristone, a drug used for medical abortion, was finally approved in the US. Many years of use in Europe had proven its safety and efficacy, yet social conservatives in the political realm cited -spurious safety concerns about mifepristone in efforts to keep the drug out of the US market. In the business sphere, US pharmaceutical companies that had made -billions from the sale of contraceptives refused to manufacture mifepristone. This complex interplay of business and political influences served to shape FDA policy and impede access to this safe and effective medication for years. (It should be noted that the author describes only the FDA-approved regimen for medical abortion, which requires 600 mg of mifepristone and is indicated for use up to 7 weeks of pregnancy. In practice, this regimen has largely been replaced by a different evidence-based regimen that requires only 200 mg of mifepristone and is proven effective through 9 weeks gestation; this distinc-tion has important implications for access to medical abortion.)
The case of the emergency contraceptive pill known as Plan B is similar to the mifepristone story, in that political influence played heavily in its approval process. Despite clear and robust scientific evidence for the safety of Plan B, “OTC [over-the-counter] status for Plan B was treated as a political football.” The process of approval for Plan B has been fraught with political interference, and many decisions about the status of Plan B appear to have been made on the basis of political considerations rather than scientific evidence. The regulatory situation has evolved considerably in 2013, and continues to be complex and fraught with perplexing decisions. On July 22, the FDA approved Plan B One-Step for sale on drugstore shelves, and granted Teva (the manufacturer) market exclusivity for this product until 2016. Though this name-brand emergency contraception will be available without age restrictions, it comes with a steep price tag—about $50 for the single pill dose. The one-pill generic products, which cost about $10 less than the branded product, can be sold on the shelf as well, but will still be subject to age restrictions, as they are available only to consumers (both women and men) age 17 or older with a valid ID. The two-pill versions will still be held behind the counter, with the same age restriction.
Many years of use in Europe had proven its safety and efficacy, yet social conser-vatives in the political realm cited spu-rious safety concerns about mifepristone in efforts to keep the drug out of the US market.
The fact that this decision came after the issue was taken to court, and that there are different regulations for essentially the same product, mean that wider access to emergency contraception, and a true commitment on the part of the FDA, have yet to be realized. The approval of Plan B One-Step does, however, provide additional patent protection for the manufacturer, Teva Pharmaceuticals. Were this book to be written a year from now, Dr. Haussman would have excellent material to expand her discussion of the perplexing political context surrounding emergency contraception.
While mifepristone and Plan B, medications with proven safety records, have encountered significant barriers to market entry, the HPV vaccine Gardasil “has held a privileged position in the history of US state and market treatment of women’s reproductive drugs,” according to Haussman. While these other reproductive health medicines have had women’s groups lobbying for their approval for decades, Gardasil seemed to appear from nowhere. Gardasil was developed to prevent certain HPV strains, including some that are linked to cancer. Up to 80 percent of sexually active women in the US are infected with at least one strain of HPV in their lifetimes, but the incidence of cervical cancer has declined by 80 percent since the introduction of the Pap test. Still, Merck conducted an aggressive marketing campaign, targeting both the public and policymakers with its message that Gardasil was a cancer-prevention tool supported by nonprofits in the women’s rights and cancer-support arenas. Ultimately, the vaccine was granted expedited FDA review and approval. Merck needed a blockbuster drug in its portfolio, and company lobbyists targeted politicians such as conservative Texas governor Rick Perry, who had financial ties to Merck, to try to create markets for Gardasil through policies requiring the vaccination for girls. Haussman cites this as an example of how “Merck was able to transcend the social conservative ambivalence about drugs related to women’s sexuality that dominated Republican politics since 1980.” She implies that the money and political will expended on pushing through Gardasil could have been invested more wisely in other programs to support women’s health.
Throughout this book, Haussman excellently juxtaposes the slow, burdened approval processes for mifepristone and Plan B with the expedited approval of Gardasil, demonstrating how profit motives can drive corporate and political interests to switch sides when it comes to reproductive medicines. Reproductive Rights and the State is a fascinating read for anyone with an interest in women’s health, drug policy and the pharmaceutical industry, and the spaces where these intersect.
Reproductive Rights and the State: Getting the Birth Control, RU-486, and Morning-After Pills and the Gardasil Vaccine to the U.S. Market
(Praeger, 2013, 184 pp)