JURIST Guest Columnist Alyson Schwartz, Indiana University Maurer School of Law Class of 2015, examines Tummino v. Hamburg and concludes that the district court correctly decided the case...
lthough it has been years since I was an teenager, I have been unable to forget the frantic desperation of racing against the clock to climb over unnecessary obstacles to simply have my doctor's office call in a prescription. It is validating to know now what I had already concluded as a teen: none of those barriers contributed to my health, safety or ability to administer emergency contraception.
I. District Court Determination of Agency Departures
The US Department of Justice and the Food and Drug Administration's (FDA) recent decision not to appeal a ruling that allows women of all ages to access emergency contraception (EC) without a prescription or point-of-sale restriction was a decision sound in health policy and law.
The FDA, an expert scientific agency within the Department of Health and Human Services, is responsible for scientific and medical decisions under the Federal Food and Drug Cosmetic Act (FDCA). While the FDA has undoubtedly made substantial strides in protecting America's health and well-being, their previous denial of requests for the removal of age and point-of-sale restrictions for emergency contraception represents a harmful and substantial departure from the FDA's own agency precedent.
The Administrative Procedure Act (APA) governs such departures and empowers a district court such as the Eastern District of New York to examine case law and set aside an agency's actions if they are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." In order for a district court to find an agency's decision "arbitrary and capricious," the agency must have "...relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could be ascribed to a difference in view or the product of agency expertise." In addition, the agency's decision can also be held "arbitrary and capricious" if there is an irrational departure from an adopted general policy or subjective bad faith.
II. The FDA clearly acted in such a matter by relying on factors that Congress had not intended it to consider and offering explanations for its decision that directly contradicted the evidence before the agency.
The FDA cited medically inaccurate and scientifically disproven defenses in explaining why EC should not be available over-the-counter and without point-of-sale restrictions, thus making a conscious decision to ignore clear scientific and clinical evidence that was provided.
Despite the FDA's claims, EC is a safe way to prevent unintended pregnancy. EC poses no risk of serious health consequences if taken in greater quantities than the directed amount. The only criteria the FDA utilizes in determining if a drug should be available over-the-counter is whether a consumer can understand how to use the particular drug "safely and effectively." Because FDA over-the-counter approval standards do not differ among types of drugs, whether it is as basic as aspirin whose overdose, unlike that of EC, could result in death or as complicated as contraceptives, the peculiar standard the FDA applied to EC would make it impossible for any drug to be approved for over-the-counter use. Therefore, it is obvious that the FDA did not single out EC for safety reasons.
Upon further analysis, the district court concluded that the FDA's opposition was based on a teen's ability to make decisions about whether or not to have sex, rather than their ability to understand how to use EC. The FDA ignored evidence that would have dismissed their opposition, showing that EC has no effect on risky sexual behavior. Studies have proven that access to EC without substantial barriers does not result in an increase of unprotected sex, less condom use, or less hormonal contraceptive use in either adolescents or adult women. As shown by the agency's departure from their usual review process, the FDA has never before considered behavioral implications due to differences in cognitive development in requests for over-the-counter applications.
Lastly, the FDA claimed there was insufficient data to determine whether it would be safe for young females to have access to EC over-the-counter. Once again the FDA completely abandoned precedent and declined to extrapolate clinical trail data from older patients to adolescents in both prescription and non-prescription approvals. It has been common practice for the FDA to extrapolate data to younger populations; the FDA has approved even prescription oral contraceptives through data extrapolation in the past. Extrapolating data [PDF] is a safe and scientific method, which has been recognized as a long-standing practice, as well as recently incorporated into the Pediatric Research and Equity Act. Therefore, the district court had no choice but to dismiss the FDA's claim of insufficient data as a pretext, further demonstrating the FDA's bad faith.
As found in Judge Korman's decision, this evidence shows that the FDA clearly chose to prioritize behavioral myths that would gain political points, rather than permissible health and safety concerns.
III. The decision-making surrounding EC represented an abandonment of long-standing traditions and policies of the FDA for ideological reasons, whose inconsistency could lead to a dangerous precedent.
The controversy surrounding the FDA's departure from precedent contradicted the FDA's mission to women's health and led to medical professional resignations. Even beyond reproductive justice advocates, many were alarmed that the new path of FDA's decision-making might set a dangerous precedent leading to negative consequences for other over-the-counter drugs.
The US Government Accountability Office found [PDF] the review process to be "unusual" and a significant departure from typical FDA review procedures. For instance, the Department of Health Secretary Sebillius's decision to override the FDA's determination that EC was safe and effective as an over-the-counter drug without age or point-of-sale restrictions marks the first time a cabinet member has publicly revoked an FDA determination. Furthermore, throughout the review process the FDA departed from long standing policy in countless ways, including adding committee members for ideological balance, rather than scientific expertise.
Even after the 2006 approval of non-prescription use for females over the age of 18, the FDA mandated point-of-sale restrictions. This action was in direct contradiction to case law that firmly states the FDA's authority over nonprescription drugs does not include point-of-sale restrictions of safe drugs. The FDA's attempt to institute point-of-sale restrictions, instead of the usual policy of relying on labeling for safe over-the-counter usage, demonstrated a continued and deliberate effort to restrict access.
IV. Placing politics above health produces harmful effects for all females of childbearing age and disproportionately impacts teenagers, low-income women, and racial minorities who face greater risks of unintended pregnancies.
As Judge Korman eloquently stated, "any system placing barriers to access would defeat the purpose of the drug and lessen its public health potential." With the FDA's defenses debunked by scientific studies and their departure from long standing agency practice exposed, there was no other conclusion for the district court to reach than the presence of impermissible political and ideological influences. At last, twelve years after the citizen petition was filed, EC is available to all regardless of age and without point-of-sale restrictions.
As a former Emergency Room Rape Crisis Counselor, a cousin to two teenage girls, and a woman of childbearing age, I express my sincere gratitude to Judge Korman for his bravery and rejection of the FDA's harmful ideology. Choosing politics over health has not only insulted our intelligence, but also put our health at risk for far too long.
Alyson Schwartz earned her BA and MBA from State University of New York at Stony Brook University. Her professional experience includes positions with the National Abortion Federation, Long Island Civic Engagement Table, Victims Information Bureau of Suffolk County, and Suffolk County District Attorney. For more information regarding emergency contraception and current efforts to increase access, please visit the Reproductive Health Technologies Project at http://www.rhtp.org/contraception/emergency/default.asp.
Suggested citation: Alyson Schwartz, Emergency Contraception: The FDA's Departure & Return to Health Over Politics, JURIST - Dateline, Aug. 21, 2013, http://jurist.org/dateline/2013/08/alyson-schwartz-emergency-contraception.php.
This article was prepared for publication by Elizabeth Imbarlina, the Section Head of JURIST's Student Commentary service. Please direct any questions or comments to her at firstname.lastname@example.org