Dietle, Samantha

English

Digital Commons @ American University Washington College of Law

Health Law and Policy BriefVolume 7 | Issue 1 Article 910-9-2013Science over Politics: Why the FDA Must AllowPlan B as a Nonprescription DrugSamantha DietleAmerican University Washington College of LawFollow this and additional works at: http://digitalcommons.wcl.american.edu/hlpPart of the Health Law CommonsThis In The News is brought to you for free and open access by Digital Commons @ American University Washington College of Law. It has beenaccepted for inclusion in Health Law and Policy Brief by an authorized administrator of Digital Commons @ American University Washington Collegeof Law. For more information, please contact fbrown@wcl.american.edu.Recommended CitationDietle, Samantha. "Science over Politics: Why the FDA Must Allow Plan B as a Nonprescription Drug." Health Law & Policy Brief 7,no. 1 (2013): 93-96.IN THE NEWSSCIENCE OVER POLITICS: WHY THE FDA MUSTALLOW PLAN B AS A NONPRESCRIPTION DRUGSamantha Dietle*On April 5, 2013, the United States District Courtfor the Eastern District of New York held that theFood and Drug Administration (FDA) had 30 days toallow the sale of Plan BI without a prescription andwithout age or point-of-sale restrictions.2 The courthad previously given the agency a chance to allowPlan B to have nonprescription status regardless ofage without a mandate from the court,3 but the FDAnot only refused to revise its decision on the drug'sstatus, but also failed to provide sufficient evidenceto support its decision. The fight over the approval ofPlan B for over-the-counter sale seems to be the resultof politics rather than scientific evidence, as evidencesuggests that Plan B is safe for use by all womenof childbearing age yet the FDA has continuouslyimposed age-based and point-of-sale restrictions.Plan B is an emergency contraceptive pill that can betaken by a woman up to 72 hours after unprotectedsex or birth control failure.' The side effects of PlanB are mild and similar to the side effects associatedwith regular birth control pills, including menstrualcycle changes and nausea. These mild side effectsmake Plan B safer than other drugs that are currentlyapproved for over-the-counter sale that rely labelingfor safe use of the drug, without any point of saleor age restrictions.6 Before a drug is approved forsale to consumers, the manufacturer submits a newdrug application (NDA) to the FDA.7 After a NDAis approved, if a drug manufacturer wants to makethe drug available for additional indications, thusmaking the drug available to more individuals, themanufacturer must submit a supplemental new drugapplication (SNDA). 8 When considering whetherto approve an NDA or SNDA, the FDA looks atevidence of the drug's safety and effectiveness inlight the indicated use(s) of the drug.9 When the* Samantha Dietle is a first year law student at AmericanUniversity Washington College of Law.FDA initially approved Plan B as an emergencycontraceptive, it was approved for women eighteenyears of age and older without a prescription but aprescription was required for women under eighteenyears of age. The practical effect of this decisionwas that point-of-sale restrictions were necessary, aswomen were required to show identification to provetheir age before purchasing Plan B and point of salerestrictions were enacted by selling Plan B behind thepharmacy counter.10After receiving the initial approval of Plan B, themanufacture was unable to obtain a change in thestatus of the drug until the court intervened. Themanufacturer of Plan B submitted three differentSNDAs in an attempt to change the status of Plan B.First, the manufacture attempted to expand access toall ages without requiring a prescription or imposingpoint of sale restrictions, but the FDA rejected theSNDA. Second, the manufacture attempted to expandaccess to all women sixteen years of age and olderwithout prescription but this SNDA was also rejectedby the FDA. Third, the manufacturer attempted toexpand access to all women seventeen years of ageand older without a prescription yet again the FDArejected the SNDA. 1' In 2009, however, the courtforced the FDA to expand access to Plan B withouta prescription to all women seventeen years of ageand older. The court also remanded the issue backto the FDA so that the agency could determinewhether available information on the safety ofPlan B warranted making additional changes tothe drug's status. 12 Specifically, the court indicatedthat the FDA should consider the status of Plan B,utilizing the agency's general policies for approvingdrugs for over-the-counter sale rather than politicalconsiderations. 1393Spring 9013The FDA denied the SNDA and citizen petition, apetition to change a drug's status made by the public,requesting to change the status of Plan B makingavailable to women of all ages without a prescription,based on Secretary of Health and Human ServicesKathleen Sebelius's Order. A December 2011memorandum to the Commissioner of the FDA, Dr.Margaret Hamburg, detailed Secretary Sebelius'sjustification for declining to switch Plan B to over-the-counter status. 14 Secretary Sebelius's involvementand disagreement with the FDA Commissionerwas unprecedented, Secretary Sibelius effectivelyoverruled a decision by the FDA despite strongscientific evidence supporting the FDA's position. TheFDA analyzed Secretary Sebelius's memorandumattempting to justify the denial of over-the-counterstatus to Plan B without age restrictions and foundlittle evidence in support of her position, which leadthe court to conclude that her position was focused onthe political consequences of allowing unrestrictedaccess to Plan B rather than scientific evidence.There are number of issues with Secretary Sebelius'sjustifications for declining to make Plan B available toall women over-the-counter. First, as she argued thatthe data related to label comprehension and actualuse did not account for women of all age ranges towhich Plan B would be available if the drug wereavailable over-the-counter without point of sale orage restrictions. 15 However, the FDA had previouslywaived the requirement that the studies includeparticipants between the ages of eleven and thirteenbecause the use of Plan B by girls in this age range israre and the number of participants in this age rangeincluded in the studies would have been so small asto be unrepresentative.16 Second, Secretary Sebeliuspointed to cognitive and behavioral differencesbetween older and younger adolescents as a relevantfactor in denying access to Plan B as an over-the-counter drug to women of all ages.17 The Directorof the Office of New Drugs at the FDA, however,determined that cognitive and behavioral differencesbetween older and younger adolescents did notaddress whether the younger girls of reproductiveage can safely understand and use Plan B but ratherwhether the younger girls of reproductive age shouldbe engaging in the types of sexual behavior thatnecessitate the use of Plan B;18 the latter issue is notan issue that the FDA is designed to regulate as the94role of the FDA is to determine whether a drug issafe and effective for its intended use. Furthermore,if the issue is that younger reproductive age girls maynot be able to comprehend the labeling and usage ofPlan B, in the past, data establishing such claims hasnever been required as part of a drug's approval forover-the-counter status.." Finally, Secretary Sebeliusfailed to identify the harm associated with makingPlan B available to all women of reproductive agegiven that the FDA typically approves drugs for over-the-counter sale without requiring the manufactureto show that the drug is safe for the youngestpopulations.2 0 The likelihood of unsafe use, abuse, ormisuse of Plan B is extremely low, especially whencompared to the risks associated with other moredangerous drugs21 that are currently sold over-the-counter without any restrictions.The same day that Secretary Sebelius sent thememorandum justifying the denial of the SNDA forPlan B, Commissioner Hamburg released her ownstatement2 2 explaining that the scientific data usedby the Center for Drug Evaluation and Research(CDER) supported the finding that Plan B couldbe safely used by all women of childbearing ageand that the role of the FDA was to approve drugsbased scientific evidence regarding the drug's safetyand efficacy for its intended use. 23 CommissionerHamburg went on to note that, "following SecretarySebelius's direction" 24 the FDA had to deny theSNDA for non-prescription access to Plan B forwomen under seventeen years of age, despite theFDA's typical approval process and evidence of PlanB's safety that she acknowledged in the rest of herstatement.In reviewing the FDA's actions in denying the citizenpetition 25 to remove point-of-sale and age restrictionson Plan B, the court looked to whether the agency'sactions were "arbitrary, capricious, an abuse ofdiscretion or otherwise not in accordance with thelaw."26 This standard is deferential to the agency,27 butthe court determined that the unprecedented natureof Secretary Sebelius's involvement, 28 particularly itsdisregard of the FDA's standards and typical practicesfor switching a drug's status and the secretary's lack oftechnical expertise, made the FDA's decision denyingthe SNDA arbitrary, capricious, and unreasonable. 29Health Law & Policy BriefIt seemed clear to the court that there was noscientific justification for the age or point-of-salerestrictions and, therefore, the denial of the citizenpetition was reversed; the FDA was given thirty daysto allow access to Plan B as a nonprescription drugand the issue was remanded to the FDA to makeany necessary labeling changes or changes basedon the different available doses of Plan B.30 Thecourt's decision looked past the potential politicalconsequences of allowing women of all ages toaccess a contraceptive designed for use after sex andupheld the FDA's role as a regulator of the safety andefficacy of drugs based on science. The court wasappropriately deferential to the FDA and provided theFDA with an opportunity to use scientific evidence tojustify its age and point-of-sales based restrictions onPlan B, but as seen through the analysis of SecretarySebelius's justification for the restrictions on thesale of Plan B, the science simply did not supportthe restrictions that the FDA placed on the sale ofPlan B. By maintaining the FDA's standards andtypical procedures for decisions to allow drugs to beavailable over-the-counter, the court has reinforcedthe idea that an agency's technical determinationsshould be based on scientific evidence, insulatedfrom political influence, to prevent inconsistent orunjustifiable results.I Plan B, also known as the "morning-after pill", is used torefer to Plan B One-Step, the specific one-pill dosage type atissue in this case; however, there is no meaningful differencebetween this type of Plan B and other forms aside from thenumber of pills that need to be taken for the drug to workeffectively.2 Tuimmino v. Hambwg, No. 12 CV 763 (ERK)(VVP), 2013U.S. Dist. WL 1348656, at *31 (E.D.N.Y 2013).3 Tummino v. Torti, 603 E Supp. 2d 519, 550 (E.D.N.Y.2009).4 Plan B One-Step (levonorgestrel): About. http://www.planbonestep.cosm/about-plan-b-one-step.aspx (last accessedApr. 12, 2013) (explaining that Plan B is not to be used asa regular form of birth control but rather it is to be usedas a back-up form of contraceptives when another formcontraception fails).5 Plan B One-Step (levonorgestrel): FAQs. http://www.planbonestep.com/faqs.aspx (last accessed Apr. 12, 2013).6 Tummino, WL 1348656 at * 15 (examining other drugsthat are approved for over-the-counter sale that pose a moresignificant risks to users under the age of 18 than Plan B,including cough syrup that contains dextromethorphan thatposes high risk of abuse by teens, and acetaminophen, whichis frequently ingested in high doses by individuals attemptingto commit suicide).21 U.S.C §355(b)(1) (2010).Spring 20131 21 U.S.C. §§ 355(b)(4)(A)-(B) (2010).9 U.S. Food and Drug Admin., Comm'r Statement, Statementfrom FDA Comm r Margaret Hamburg, M.D. on Plan B One-Step (Dec. 7, 2011) [hereinafter Hamburg Statement] http://www.fda.gov/NewsEvents/Newsroom/ucm282805.htm (lastaccessed Apr. 12, 2013).'o Alastair J.J. Wood, M.D et al., The Politics of EmergencyContraception, 366 New Eng. J. Med. 101, 101-02 (2012)www.nejm.org/doi/full/10.1056/NEJMpl 114439 (lastaccessed Apr. 12, 2013).1 Tummino v. Torti, 603 F. Supp. 2d 519, 523 (E.D.N.Y2009).12 Id. at 550.13 Id. at 548 (concluding that the FDA has not presented anyevidence to rebut the assertion that it was acting in bad faithand in response to political pressure in its review of the statusof Plan B).14 Memorandum from Kathleen Sebelius to MargaretHamburg, M.D. Comm'r of Food and Drugs (Dec. 7, 2011)[hereinafter Sebelius Memo] http://www.hhs.gov/news/press/20 I pres /12/201 11 207a.pdf (last accessed Apr. 12,2013).15 Id.'6 Tummino v. Hamburg, 2013 U.S. Dist. WL 1348656,at *7-*8 (E.D.N.Y 2013) (noting that Secretary Sebelius'disagreement over granting an age waiver for the study wasnot a valid reason to effectively overrule the FDA's decision).1 Sebelius Memo, supra note 14." Tummino. WL 1348656 at *8.11 Id. (noting that the FDA has never precluded the over-the-counter sale of drugs based on this reasoning).20 Id. at *9 (noting that the FDA approves drugs for over-the-counter status without such data, relying on labeling toeffectively indicate age-based restrictions).21 Id. (explaining that the reasoning offered would requireremoval of over-the-counter status for drugs containingdextromethorphan, laxatives, analgesics, and acetaminophen).22 U.S. Food and Drug Admin., Comm'r Statement,Statement fom FDA Comm'r Margaret Hamburg, M.D.on Plan B One-Step (Dec. 7, 2011). http://www.fda.gov/NewsEvents/Newsroom/ucm282805.htm (last accessed Apr.12, 2013).23 Id. (discussing the review of scientific evidence andrisk/benefit assessment conducted to reach the conclusionthat Plan B One-Step met the regulatory standard for anonprescription drug).24 Id.25 Tummino, WL 1348656 at * 19 (noting that the Courthad jurisdiction over the citizen petition and not the SNDA;however, the two are related because once Secretary Sebeliusdirected the FDA to deny the SNDA, there was no basis toapprove the citizen petition as the same data was relied on forboth applications).26 Id. (citing the Administrative Procedure Act 5 U.S.C. §706(2)(A)).27 Id. at *20.28 Alastair J.J Wood, M.D et al., The Politics of EmergencyContraception, 366 New Eng. J. Med. 101, 101-02 (2012)www.nejm.org/doi/full/10.1056/NEJMpi 114439 (lastaccessed Apr. 12, 2013) (discussing Secretary Sebelius'sdecision to overrule the FDA on Plan B and indicating95that it was the first time the Secretary of the United StatesDepartment of Health and Human Services had everoverruled a regulatory decision on drug approval that wasmade by the FDA).28 Alastair J.. Wood, M.D et al., The Politics of EmergencyContraception, 366 New Eng. J. Med. 101, 101-02 (2012)www.nejm.org/doi/full/1 0.1056/NEJMp 1114439 (lastaccessed Apr. 12, 2013) (discussing Secretary Sebelius'sdecision to overrule the FDA on Plan B and indicatingthat it was the first time the Secretary of the United StatesDepartment of Health and Human Services had everoverruled a regulatory decision on drug approval that wasmade by the FDA).29 Tunimino, WL 13648656 at *22.30 Id. at *31.96Health Law & Policy Brief

Science over Politics: Why the FDA Must Allow Plan B as a Nonprescription Drug

bepress Legal Repository

https://digitalcommons.wcl.american.edu/cgi/viewcontent.cgi?article=1009&context=hlp

Science over Politics: Why the FDA Must Allow Plan B as a Nonprescription Drug

Abstract

Similar works

Full text

Available Versions

Digital Commons @ American University Washington College of Law

bepress Legal Repository