Thinking (Re)Productively – October 2013

Plan B: access to emergency contraception in the legal and political cross hairs

I. Glenn Cohen	Lisa Sullivan	Eli Y. Adashi

The 8-year legal feud over access to emergency contraception between reproductive health advocates and the Food and Drug Administration (FDA) took multiple unexpected turns before coming to an abrupt end on June 10, 2013.^1,2,3 On that day, after mounting legal setbacks and obstacles, the US Attorney for the Eastern District of New York served notice to the effect that the “government intends to…voluntarily withdraw its appeal in this matter”.¹ In so doing, the FDA committed to making Plan B One-Step^® (a one-dose levonorgestrel-based emergency contraceptive) available over-the-counter without age or point-of-sale restrictions.¹ In this Commentary, we trace the origins of this long-running conflict, analyze the implications of the latest developments and reflect on what this case reveals about the precarious positioning of the FDA across the scientific–political divide.

The legal dispute over access to emergency contraception dates back to January 21, 2005, at which point a coalition of reproductive health advocates brought legal action against the FDA.⁴ It was the assertion of the plaintiffs that the denial of prescription-free over-the-counter access to emergency contraception to all women regardless of age was “arbitrary and capricious”.^4,5 On March 23, 2009, Judge Edward R. Korman of the US District Court for the Eastern District of New York — siding with the plaintiffs — directed the FDA “to make Plan B available to 17-year-old women without a prescription”.⁴ In so doing, the court set aside arguments of the FDA in favor of a more restrictive age cutoff on the grounds that they “lack all credibility”.⁴ In addition, the court instructed the FDA to reconsider its decision to deny prescription-free over-the-counter access to emergency contraception to all women regardless of age without “impermissible political intrusion”.⁴

The above notwithstanding, almost 3 years passed during which the FDA failed to reconsider its position on access to emergency contraception.⁶ Instead, the FDA set out to evaluate a Supplemental New Drug Application (SNDA) seeking over-the-counter access to Plan B One-Step^® without age restrictions.⁶ On December 7, 2011, FDA Commissioner Margaret A. Hamburg announced that the FDA was prepared to approve the SNDA in question for “nonprescription use for all females of child-bearing potential”.⁷ However, on the very same day, “invoking authority under the Federal Food, Drug, and Cosmetic Act,” Secretary of Health and Human Services Kathleen Sebelius overruled Commissioner Hamburg.⁸ Rationalizing the decision to deny the SNDA in question, Secretary Sebelius maintained that the data submitted in support of the application did not establish that the “prescription dispensing requirement should be eliminated for all ages”.⁸

In responding to this latest setback, the plaintiffs filed a motion to reopen the case against the FDA and to add Secretary Sebelius as a defendant.⁶ In addition, the plaintiffs sought an order requiring the FDA to grant access to all levonorgestrel-based emergency contraceptives absent age or point-of-sale restrictions.⁶ On April 4, 2013, ruling for the plaintiffs, Judge Korman granted the motion for summary judgment and instructed the FDA to lift all restrictions on access to emergency contraceptives for women of all ages.⁶ Specifically, the court ordered the FDA to make “emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days”.⁶

In considering the political dimensions of the case, Judge Korman, in a sharply worded opinion, characterized the unprecedented action of Secretary Sebelius as the “most significant departure from agency practice”.⁶ Moreover, Judge Korman concluded that, in overruling the FDA, Secretary Sebelius was acting in a manner that was “politically motivated, scientifically unjustified, and contrary to agency precedent”.⁶ The court further observed that Secretary Sebelius waded into “an area which Congress entrusted primarily to the FDA” and which fell “within the scope of the authority expressly delegated to the Commissioner.⁶ All told, the breach of agency practice and the failure to offer “coherent justification” for the denial of the SNDA led the court to conclude that the “motivation for the Secretary’s action was obviously political”.⁶ The court went on to assert that an agency that has previously announced and followed “a general policy by which its exercise of discretion will be governed” must not irrationally depart from that policy.⁶ However, should such departure prove “‘arbitrary, capricious, [or] an abuse of discretion’ within the meaning of the Administrative Procedure Act,” the court has an obligation to intervene, as it did”.⁶

Reflecting on the scientific rigor of the positions held by the defendants, the court took special issue with the assertion of Secretary Sebelius that “label comprehension and actual use studies submitted to the FDA do not include data on all ages for which the drug would be approved and available over the counter”.⁶ Indeed, the court observed that Secretary Sebelius ignored a previous agency waiver of the “all age” requirement as well as the common reliance of the FDA on extrapolation from adult to pediatric populations when required.⁶ In this regard, the court noted that the “case was not about the potential misuse of Plan B by 11-year-olds” and that the “invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions”.⁶ The court further observed that Plan B One-Step® is likely far safer than abuse-prone diet pills and cough syrups which are presently available over-the-counter without age restrictions.⁶

On April 30, 2013, in a move it characterized as independent of the recent court mandate, the FDA approved Plan B One-Step^® for “use without a prescription by women 15 years of age and older”.⁹ In so doing, the FDA lowered the prescription-free age limit (from 17 to 15) as well as transitioned the point-of-sale from behind-the-(pharmacy) counter to over-the-counter (i.e., off the pharmacy shelves).⁹ However, scarcely a day later, on May 1, 2013, the Department of Justice filed for a stay pending appeal with the US Court of Appeals for the Second Circuit.^10,11,12 In that filing, the FDA renewed two arguments relative to the remedy chosen by the lower court. First, the FDA argued that the court lacked authority to issue an order relating to Plan B One-Step® because that was not part of the initial matter before the court.¹⁰ Second, the FDA argued that, under principles of administrative law, the court jumped the gun in ordering the agency to make emergency contraceptives available without age or point-of-sale restriction instead of remanding the case to the FDA to vacate the initial order, reconsider the question and provide a more complete explanation, ⁹ essentially another bite at the apple.¹³

On June 5, 2013, in a brief ruling, the US Court of Appeals for the Second Circuit ordered that the “appellants’ motion for a stay pending appeal is granted in part and denied in part”.¹⁴ In relevant parts, the order read: “Insofar as the district court order requires Appellants to immediately provide over-the-counter access to the one-pill variants of emergency contraceptives, a stay, pending appeal, is granted. Insofar as the order mandates immediate over-the-counter access to the two-pill variants of emergency contraceptives, a stay is denied because the Appellants have failed to meet the requisite standard”.¹⁴ The Court further ordered that the full appeal “shall be heard on an expedited basis”.¹⁴

On June 10, 2013, the US Attorney for the Eastern District of New York informed Judge Edward R. Korman that the “Food and Drug Administration and the Department of Health and Human Services have complied with the Court’s April 5, 2013 judgment…by making Plan B One-Step available over-the-counter without age or point-of-sale restrictions”.¹ The US Attorney also advised Judge Korman that the “FDA has invited the sponsor of Plan B One-Step…to promptly submit an SNDA…that would permit Plan B One-Step to be sold without a prescription and without age or point-of-sale restrictions”.¹ Additionally, note was made of the fact that “upon receipt of the SNDA in question the FDA will approve it without delay”.¹ On June 12, 2013, Judge Korman issued a memorandum stating that the plans proposed by the US Attorney were deemed “sufficient to comply”.¹⁵ However, Judge Korman expressed lingering concerns with respect to any potential undue delays in approving the forthcoming Plan B One-Step^® SNDA, in which case the “plaintiffs will have remedy available”.¹⁵ Judge Korman raised additional concerns over the possibility that the FDA might grant marketing exclusivity to the sponsor of Plan B One-Step®, thereby creating a “near monopoly” and limiting the access of “many poor women”.¹⁶

On June 20, 2013, in a press release, the FDA announced the approval of “Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential”.¹⁶ In light of this development, it is all but certain that sponsors of the generic versions of Plan B One-Step^® will submit amendments to their abbreviated new drug applications with an eye towards securing approval for comparable labeling. Concurrently, the FDA announced that it will not at this time “take steps to change the approval status of the two-pill Plan B or its generic equivalents”.¹⁶

The final resolution of this controversy offers an ideal vantage point to examine the vulnerability of the FDA to political influence.^17,18 While the FDA has “consistently been named or identified as one of the most popular and well-respected agencies in government”,¹⁹ the ability of the FDA to resist political influence is more precarious than its apparent reputation might suggest. After all, the FDA is not an independent agency. Indeed, the FDA Commissioner serves at the pleasure of the President.¹⁹ What is more, the idealized notion that the science-driven decision-making process of the FDA is insulated from and resistant to the political discourse is incommensurate with precedent.

A striking example of politics in action was already in full display at the height of the AIDS crisis during which intense advocacy by the gay community led the FDA to establish the “Parallel Track” mechanism with an eye towards expanding the availability of promising investigational drugs to those lacking satisfactory therapeutic alternatives and who could not participate in clinical trials.²¹

More recently, some of the same principles were in play relative to the pricing of Makena^®, a synthetic progestin approved for the prevention of preterm birth. First approved in 1956 under the brand name Delalutin^® and the recipient of an orphan drug designation, Makena^® was initially priced at $1440 per injection ($30,000 per pregnancy) at a time when a compounded version sold at $15 per injection ($300 per pregnancy). Faced with significant public and congressional backlash and unable to revoke the relevant orphan drug status, the FDA elected to signal via a press release that it did not intend to “take enforcement action against pharmacies that compound” the “recycled molecule” in question, thereby effectively undermining the regulatory exclusivity previously granted to Makena®.²² Whatever the outcome of the legal process that has since ensued,²³ the discord over the pricing of Makena® affirms yet again the vulnerability of the FDA to political as distinct from purely scientific perspectives. 24

In certain ways, the nature of the action taken by Secretary Sebelius in the Plan B saga — a direct and public overruling of the FDA commissioner — might be viewed by some as less threatening to good government than the far less transparent forms of political control that have plagued the agency in the recent past. As one legal scholar put it: “[a]gencies today generally try to meet their reason-giving duties…by couching their decisions in technocratic, statutory, or scientific language, either failing to disclose or affirmatively hiding political factors that enter into the mix”.²⁵ Examples abound. One striking example of this more surreptitious form of influence by the Clinton administration on FDA rulemaking concerns the matter of teen smoking. “Even though President Clinton played a very active role in directing the rulemaking (going so far as to personally announce the final rule in a Rose Garden ceremony), the FDA’s statement of basis and purpose accompanying the final rule relied upon statutory, scientific, and expert justifications—barely even hinting at President Clinton’s role in the rulemaking”.²⁵

The deepest question raised by the Plan B case is whether a politically insulated FDA is possible or even desirable? In deciding how to trade off demands to demonstrate safety and efficacy against speed and access, the FDA cannot avoid making decisions that are in some sense political and has always done so. The desirability of this state of affairs (or the lack thereof) notwithstanding, there can be little questioning the foot dragging and active role played by two successive presidential administrations in shaping the emergency contraception debate. When it comes to tough judgment calls — how much access should be granted to experimental drugs for HIV, how much market exclusivity should be accorded a “recycled molecule,” how much authority should be exercised to limit teen smoking or at what age should emergency contraception be made available — is it possible that there are no technocratic or scientific answers, only political ones? The Plan B affair confronts us with a tension between the desire to maintain the public trust in the FDA as a scientific and completely apolitical institution and the bare-knuckle reality of the “sausage-making factory” which enables rank-and-file voters and their elected representatives to have their say.

References

1. US Department of Justice . United States Attorney. Eastern District of New York. June 10, 2013.
2. McCarthy M. US court lifts restrictions on some emergency contraceptives. Br Med J. 2013;346:f3760
3. Editorial. Science prevails. The US government gives up its fight to keep age restrictions on the morning-after pill.Nature. 2013;498:272
4. Tummino v. Torti. 603 F. Supp. 2d 519 (E.D.N.Y 2009). March 23, 2009. http://www.nylj.com/nylawyer/adgifs/decisions/032409korman.pdf. Accessed July 5, 2013.
5. GAO , US Government Accountability Office . Food and Drug Administration: decision process to deny initial application for over-the-counter marketing of the emergency contraceptive drug Plan B was unusual. November 14, 2005.
6. Tummino v. Hamburg. April 4, 2013.
7. US Food and Drug Administration . Commissioner statement. Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step. December 7, 2011.
8. HHS.gov , US Department of Health & Human Services . A statement by US Department of Health and Human Services Secretary Kathleen Sebelius. December 7, 2011.
9. US Food and Drug Administration . FDA news release. FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older. April 30, 2013.
10. Tummino v. Hamburg. Memorandum in support of defendant’s motion for stay pending appeal. May 1, 2013.
11. Tummino v. Hamburg. F.Supp.2d _, 2013 WL 1921414 (EDNY May 10, 2013).Tummino v. Hamburg. Amended order (2d. Cir. May 13, 2013).
12. Tummino v. Hamburg. Government motion for a stay pending appeal (2d Cir. May 13, 2013).
13. Tummino v. Hamburg. 2013 WL 2435370, order (2d Cir. June 5, 2013).
14. Tummino v. Hamburg. Memorandum. June 12, 2013.
15. FDA . FDA news release. FDA approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential. 
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17. Steinbrook RS. Science, politics, and over-the-counter emergency contraception. JAMA. 2012;307(4):365–366
18. Carpenter D. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton, NJ: Princeton University Press; 2010;
19. Hutt PB, Merrill RA, Grossman LA. Food and drug law: cases and materials. New York, NY: Foundation Press; 2007;
20. Rossen BR. FDA’s proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform. Food Drug LJ. 2009;64(1):183–223
21. FDA . FDA statement on Makena. November 8, 2011.
22. K-V Pharmaceutical Company v. FDA . Memorandum opinion. 
23. Greenwood K. Turning “recycled molecules” into orphan drugs: time to experiment with calibrated incentives?
24. The Food and Drug Administration in the 21st Century, 7–9 April, 2013 (Lynch HF and Cohen IG eds). Book Proposal Currently Under Review at Oxford University Press.
25. Watts KA, Proposing A. Place for politics in arbitrary and capricious review. Yale LJ. 2009;119(2):1–84