{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T15:20:04Z","timestamp":1781623204668,"version":"3.54.5"},"reference-count":68,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,12,14]],"date-time":"2020-12-14T00:00:00Z","timestamp":1607904000000},"content-version":"vor","delay-in-days":43,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100001146","name":"Greenwall Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001146","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hastings Center Report"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:italic>When new drugs are approved by the Food and Drug Administration, the default assumption is that they will be available by prescription only, safe for use exclusively under clinical supervision. The paternalism underlying this default must be interrogated in order to ensure appropriate respect for patient autonomy. Upon closer inspection, prescription requirements are justified when nonprescription status would risk harm to third parties and when a large segment of the population would struggle to exercise their autonomy in using a drug safely and effectively on their own. Although these justifications can support prescription status for many drugs, we propose that reversing the FDA's current default to instead begin with a presumption in favor of over\u2010the\u2010counter status is the best way to avoid interference with valid claims of patient autonomy. Under this approach, a range of drug products could be considered for an OTC switch, including oral contraceptives, statins, and HIV\u2010prevention drugs<\/jats:italic>.<\/jats:p>","DOI":"10.1002\/hast.1195","type":"journal-article","created":{"date-parts":[[2021,1,19]],"date-time":"2021-01-19T13:38:09Z","timestamp":1611063489000},"page":"15-26","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Prescription Requirements and Patient Autonomy: Considering an Over\u2010the\u2010Counter Default"],"prefix":"10.1002","volume":"50","author":[{"given":"Madison","family":"Kilbride","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Joffe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holly Fernandez","family":"Lynch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.14382"},{"key":"e_1_2_9_3_1","unstructured":"Roman https:\/\/www.getroman.com\/; Hers https:\/\/www.forhers.com\/; Hims https:\/\/www.forhims.com\/."},{"key":"#cr-split#-e_1_2_9_4_1.1","unstructured":"Y.GagneandB.Helm \"Buying Prescription Drugs Online Is Easier Than Ever. But There Are Side Effects \"Fast Company September 11 2019 https:\/\/www.fastcompany.com\/90396205\/buying-prescription-drugs-online-is-easier-than-ever-but-there-are-side-effects"},{"key":"#cr-split#-e_1_2_9_4_1.2","doi-asserted-by":"crossref","unstructured":"H. Curtis and J. Milner \"Ethical Concerns with Online Direct-to-Consumer Pharmaceutical Companies \"Journal of Medical Ethics46 no. 3 (2020): 168-71.","DOI":"10.1136\/medethics-2019-105776"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1912293"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.12291"},{"key":"e_1_2_9_7_1","unstructured":"\u201cWhat's the Plan B Morning-After Pill? \u201d Planned Parenthood 2019 https:\/\/www.plannedparenthood.org\/learn\/morning-after-pill-emergency-contraception\/whats-plan-b-morning-after-pill."},{"key":"e_1_2_9_8_1","unstructured":"KathleenMiller senior economist Office of Orphan Products Development U.S. Food and Drug Administration personal correspondence with Holly Fernandez Lynch December 4 2019(on file with the authors)."},{"key":"e_1_2_9_9_1","unstructured":"\u201cInnovative Approaches for Nonprescription Drug Products: Guidance for Industry (DRAFT GUIDANCE) \u201d U.S. Food and Drug Administration 2018 https:\/\/www.fda.gov\/media\/114328\/download."},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/oso\/9780190684549.001.0001"},{"issue":"2","key":"e_1_2_9_11_1","first-page":"345","article-title":"The Role of the FDA in Innovation Policy","volume":"13","author":"Eisenberg R. S.","year":"2007","journal-title":"Michigan Telecommunications and Technology Law Review"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/1073110520935352"},{"key":"e_1_2_9_13_1","unstructured":"Eisenberg \u201cThe Role of the FDA.\u201d"},{"key":"e_1_2_9_14_1","first-page":"427","article-title":"A Legal Framework for Future Decisions on Transferring Drugs from Prescription to Nonprescription Status","volume":"37","author":"Hutt P. B.","year":"1982","journal-title":"Food, Drug and Cosmetic Law Journal"},{"key":"e_1_2_9_15_1","unstructured":"Pure Food and Drug Act Pub. L. 59-384(1906)."},{"key":"e_1_2_9_16_1","unstructured":"Federal Food Drug and Cosmetic Act Pub. L. 75-717(1938)."},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1086\/466934"},{"key":"e_1_2_9_18_1","unstructured":"Hutt \u201cA Legal Framework\u201d; Temin \u201cThe Origin.\u201d"},{"key":"e_1_2_9_19_1","unstructured":"Temin \u201cThe Origin \u201d97."},{"key":"e_1_2_9_20_1","unstructured":"Durham-Humphrey Amendment Federal Food Drug and Cosmetic Act Pub. L. 82-515(1951)."},{"key":"e_1_2_9_21_1","unstructured":"Kefauver-Harris Amendments Federal Food Drug and Cosmetic Act Pub. L. 87-781(1962)."},{"key":"e_1_2_9_22_1","doi-asserted-by":"crossref","unstructured":"21 U.S.C. \u00a7?353 (b)(1)(2016).","DOI":"10.2307\/jj.10984400.25"},{"key":"e_1_2_9_23_1","unstructured":"\u201cDrug Applications for Over-the-Counter (OTC) Drugs \u201d U.S. Food and Drug Administration 2015 https:\/\/www.fda.gov\/drugs\/types-applications\/drug-applications-over-counter-otc-drugs."},{"key":"e_1_2_9_24_1","unstructured":"\u201cHow FDA Strives to Ensure the Safety of OTC Products \u201d U.S. Food and Drug Administration 2016 https:\/\/www.fda.gov\/drugs\/special-features\/how-fda-strives-ensure-safety-otc-products."},{"key":"e_1_2_9_25_1","doi-asserted-by":"crossref","unstructured":"21 U.S.C. \u00a7353 (b)(3)(2016).","DOI":"10.2307\/jj.10984400.25"},{"key":"e_1_2_9_26_1","unstructured":"\u201cDrugs: Adequate Directions for Use \u201d U.S. Food and Drug Administration 21 C.F.R. \u00a7201.5 (1976)."},{"key":"e_1_2_9_27_1","unstructured":"\u201cStandards for Safety Effectiveness and Labeling \u201d U.S. Food and Drug Administration 21 C.F.R. \u00a7330.10(a)(4)(v) (2002)."},{"key":"e_1_2_9_28_1","unstructured":"\u201cFrequently Asked Questions about CDER \u201d U.S. Food and Drug Administration 2019 https:\/\/www.fda.gov\/about-fda\/center-drug-evaluation-and-research-cder\/frequently-asked-questions-about-cder#4."},{"key":"e_1_2_9_29_1","unstructured":"U.S.FoodandDrugAdministration \u201cGuidance for Industry: Self-Selection Studies for Nonprescription Drug Products \u201d 2013 https:\/\/www.fda.gov\/files\/drugs\/published\/Self-Selection-Studies-for-Nonprescription-Drug-Products.pdf; U.S. Food and Drug Administration \u201cGuidance for Industry: Label Comprehension Studies for Nonprescription Drug Products \u201d 2010 https:\/\/www.fda.gov\/media\/75626\/download."},{"key":"e_1_2_9_30_1","unstructured":"\u201cDivision of Nonprescription Drugs \u201d U.S. Food and Drug Administration 2018 https:\/\/www.fda.gov\/about-fda\/center-drug-evaluation-and-research-cder\/division-nonprescription-drugs."},{"key":"e_1_2_9_31_1","unstructured":"Hutt \u201cA Legal Framework.\u201d"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e318277c93b"},{"key":"e_1_2_9_33_1","unstructured":"\u201cAcetaminophen Overdose \u201d MedLinePLus National Institutes of Health November 8 2020 https:\/\/medlineplus.gov\/ency\/article\/002598.htm."},{"key":"#cr-split#-e_1_2_9_34_1.1","unstructured":"D. C.Throckmorton \"FDA Update: 2018 \" presented at the Consumer Healthcare Products Association Regulatory Scientific & Quality Conference May 17 2018 (for an outline and other slides seehttps:\/\/www.fda.gov\/media\/113964\/download)"},{"key":"#cr-split#-e_1_2_9_34_1.2","unstructured":"R. S. Mehta \"Nonprescription Drug Safe Use Regulatory Expansion (NSURE) \" presented at the U.S. Food and Drug Administration's 2nd Annual Health Professional Organizations Conference October 4 2012 (for slides seehttps:\/\/www.fda.gov\/media\/85156\/download)."},{"issue":"39","key":"e_1_2_9_35_1","first-page":"12059","article-title":"Notice of Public Hearing: Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription","volume":"77","author":"Food U.S.","year":"2012","journal-title":"Federal Register"},{"key":"e_1_2_9_36_1","unstructured":"\u201cInnovative Approaches for Nonprescription Drug Products \u201d U.S. Food and Drug Administration."},{"key":"e_1_2_9_37_1","unstructured":"B.van derVossen \u201cLibertarianism \u201dStanford Encyclopedia of Philosophy 2019 https:\/\/plato.stanford.edu\/entries\/libertarianism\/; S. Mill On Liberty(London: J. W. Parker and Son 1859)."},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.4151"},{"key":"e_1_2_9_39_1","unstructured":"\u201cAbout FDA Product Approval \u201d U.S. Food and Drug Administration 2017 https:\/\/www.fda.gov\/news-events\/approvals-fda-regulated-products\/about-fda-product-approval."},{"key":"e_1_2_9_40_1","unstructured":"Flanigan Pharmaceutical Freedom."},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1136\/jme.21.6.327"},{"key":"e_1_2_9_42_1","volume-title":"Harm to Self","author":"Feinberg J.","year":"1986"},{"key":"e_1_2_9_43_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-8519.1989.tb00327.x"},{"key":"e_1_2_9_44_1","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9781139176101"},{"key":"e_1_2_9_45_1","unstructured":"Bateman-House \u201cDon't Let Medical Autonomy\u201d; C. Sandefur \u201cTear Up the Permission Slip: Medical Autonomy Is a Fundamental Right \u201dCato Unbound July 19 2017 https:\/\/www.cato-unbound.org\/2017\/07\/19\/christina-sandefur\/tear-permission-slip-medical-autonomy-fundamental-human-right."},{"key":"e_1_2_9_46_1","first-page":"1159","article-title":"Rational Non-interventional Paternalism\u201d; C. R. Sunstein and R. H. Thaler, \u201cLibertarian Paternalism Is Not an Oxymoron","volume":"70","author":"Savulescu","year":"2003","journal-title":"University of Chicago Law Review"},{"key":"e_1_2_9_47_1","unstructured":"Flanigan \u201cThree Arguments.\u201d"},{"key":"e_1_2_9_48_1","unstructured":"Brass \u201cChanging the Status.\u201d"},{"key":"e_1_2_9_49_1","doi-asserted-by":"publisher","DOI":"10.1353\/hcr.2007.0044"},{"key":"e_1_2_9_50_1","unstructured":"U.S.FoodandDrugAdministration \u201cGuidance for Industry: Self-Selection Studies\u201d; U.S. Food and Drug Administration \u201cGuidance for Industry: Label Comprehension Studies.\u201d"},{"key":"e_1_2_9_51_1","unstructured":"U.S.FoodandDrugAdministration \u201cInnovative Approaches for Nonprescription Drug Products.\u201d"},{"key":"e_1_2_9_52_1","unstructured":"U.S.FoodandDrugAdministration \u201cNotice of Public Hearing: Using Innovative Technologies.\u201d"},{"key":"e_1_2_9_53_1","unstructured":"Ibid."},{"key":"e_1_2_9_54_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2016-4262"},{"key":"e_1_2_9_55_1","unstructured":"U.S.FoodandDrugAdministration \u201cNotice of Public Hearing: Using Innovative Technologies.\u201d"},{"key":"e_1_2_9_56_1","doi-asserted-by":"publisher","DOI":"10.5840\/monist197256119"},{"key":"e_1_2_9_57_1","unstructured":"K.Eder \u201c7 OTC Product Categories Completely Covered by Insurance \u201dPharmacy Times December 8 2015 https:\/\/www.pharmacytimes.com\/news\/8-otc-product-categories-completely-covered-by-insurance."},{"key":"e_1_2_9_58_1","unstructured":"M.Petersen \u201cA Push to Sell Top Allergy Drugs over the Counter \u201dNew York Times May 11 2001."},{"key":"e_1_2_9_59_1","unstructured":"Fleming-Dutraet al. \u201cPrevalence of Inappropriate Antibiotic Prescriptions\u201d; Kaiser Family Foundation \u201cMedicaid Benefits: Over-the-Counter Products \u201d2018 https:\/\/www.kff.org\/other\/state-indicator\/medicaid-benefits-over-the-counter-products\/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22 %22sort%22:%22asc%22%7D; E. Tahmincioglu \u201cOver the Counter Yes but Out of the Insurance Plan \u201dNew York Times July 4 2004."},{"key":"e_1_2_9_60_1","unstructured":"\u201cInnovative Approaches for Nonprescription Drug Products \u201d U.S. Food and Drug Administration."},{"key":"e_1_2_9_61_1","unstructured":"L.Larner \u201cNew Health Policy Brief: Off-Label Drug Promotion \u201dHealth Affairs Blog July 6 2016 https:\/\/www.healthaffairs.org\/do\/10.1377\/hblog20160706.055728\/full\/."},{"key":"e_1_2_9_62_1","unstructured":"\u201cFDA Adverse Events Reporting System (FAERS) Public Dashboard \u201d U.S. Food and Drug Administration 2019 https:\/\/fis.fda.gov\/sense\/app\/d10be6bb-494e-4cd2-82e4-0135608ddc13\/sheet\/7a47a261-d58b-4203-a8aa-6d3021737452\/state\/analysis."},{"key":"e_1_2_9_63_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-016-0455-4"},{"key":"e_1_2_9_64_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f2217"},{"key":"e_1_2_9_65_1","unstructured":"\u201cFree to Choose Medicine \u201d The Heartland Institute November 8 2020 https:\/\/www.heartland.org\/Center-Health-Care\/free-to-choose-medicine\/index.html; \u201cRight to Try \u201d U.S. Food and Drug Administration 2019 https:\/\/www.fda.gov\/patients\/learn-about-expanded-access-and-other-treatment-options\/right-try; Conditional Approval Act H.R. 5497 (introduced 2019) https:\/\/www.congress.gov\/bill\/116th-congress\/house-bill\/5497."},{"key":"e_1_2_9_66_1","unstructured":"Eyal \u201cReconciling Informed Consent.\u201d"},{"key":"e_1_2_9_67_1","doi-asserted-by":"publisher","DOI":"10.1097\/GCO.0000000000000019"}],"container-title":["Hastings Center Report"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fhast.1195","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hast.1195","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/hast.1195","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hast.1195","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,22]],"date-time":"2024-08-22T17:21:09Z","timestamp":1724347269000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.1195"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11]]},"references-count":68,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2020,11]]}},"alternative-id":["10.1002\/hast.1195"],"URL":"https:\/\/doi.org\/10.1002\/hast.1195","archive":["Portico"],"relation":{},"ISSN":["0093-0334","1552-146X"],"issn-type":[{"value":"0093-0334","type":"print"},{"value":"1552-146X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,11]]},"assertion":[{"value":"2020-12-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}