Magazine article Conscience

Business and Politics First, Women Second: The FDA's Drug Approval Process

Magazine article Conscience

Business and Politics First, Women Second: The FDA's Drug Approval Process

Article excerpt

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 (Praeger, 2013, 184 pp) 978-0313398223, $35.15

IN HER NEW BOOK, REPRODUCTIVE Rights and the State: Getting the Birth Control, RU-486, and Morning After Pills U.S. 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 pharmaceutical 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. …

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