{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:57:09Z","timestamp":1777420629140,"version":"3.51.4"},"reference-count":38,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2013,12,5]],"date-time":"2013-12-05T00:00:00Z","timestamp":1386201600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2014,3]]},"abstract":"<jats:p>Objective: To review the successes and omissions of the Food and Drug Administration (FDA) pediatric exclusivity incentive. Data Sources: Pediatric drug development receives less attention and funding than drug development targeting adults resulting in fewer appropriately labeled pediatric drugs. Newly introduced legislation aims to correct this deficit using market exclusivity incentives. Under the Food and Drug Administration Modernization Act (FDAMA, 1997), the FDA established the exclusivity principle. This legislation was renewed and amended in 2007 under Food and Drug Administration Amendments Act (FDAAA) allowing drug companies to receive a 6-month patent extension for initiating clinical investigation in pediatric populations. Fostering improved knowledge in pediatric indications and dosing is the motivating force behind this program. Study Selection and Data Extraction: We examined drugs granted exclusivity through FDA published database as well as relevant drug labeling and postmarket safety studies. Our examination shows that studies conducted in support of patent protection are often not designed to meet current pediatric needs. Conclusion: Amendments to FDAAA are needed to ensure that studies approved for exclusivity strive to meet the following requirements: relevant pediatric clinical indication ; disease addressed should represent a significant disease burden to the appropriate population; important age ranges should be covered; studies should not be allowed when a safety signal is identified prior to initiation of the study; and trials where endpoints are successfully achieved providing considerable contribution to pediatric dosing knowledge or result in labeling changes may gain an additional incentive.<\/jats:p>","DOI":"10.1177\/1060028013514031","type":"journal-article","created":{"date-parts":[[2014,2,28]],"date-time":"2014-02-28T20:02:58Z","timestamp":1393617778000},"page":"369-379","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":14,"title":["Pediatric Exclusivity"],"prefix":"10.1177","volume":"48","author":[{"given":"Donna R.","family":"Rivera","sequence":"first","affiliation":[{"name":"University of Florida, Gainesville, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abraham G.","family":"Hartzema","sequence":"additional","affiliation":[{"name":"University of Florida, Gainesville, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2013,12,5]]},"reference":[{"key":"bibr1-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. OTC cough and cold products: not for infants and children under 2 years of age. http:\/\/www.fda.gov\/forconsumers\/consumerupdates\/ucm048682.htm. Accessed April 12, 2012."},{"key":"bibr2-1060028013514031","unstructured":"Harris G. FDA urges ban on medicine for child colds. New York Times. http:\/\/www.nytimes.com\/2007\/10\/20\/washington\/20fda.html?pagewanted=all. Accessed April 12, 2012."},{"key":"bibr3-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. FDA basic video: Dianne Murphy discusses effective and proper uses of medicines and devices in children. http:\/\/www.fda.gov\/AboutFDA\/Transparency\/Basics\/ucm228249.htm. Accessed April 12, 2012."},{"key":"bibr4-1060028013514031","unstructured":"Frattarnelli DAC. Testimony before the Committee on Health, Education, Labor, and Pensions, United States Senate: July 21, 2010. http:\/\/www2.aap.org\/advocacy\/washing\/7_21_10_AAP_Frattarelli_help_testimony.pdf. Accessed April 12, 2012."},{"key":"bibr5-1060028013514031","first-page":"133","volume":"40","author":"Breslow LH","year":"2003","journal-title":"Harvard J Legis"},{"key":"bibr6-1060028013514031","first-page":"16","volume":"14","author":"Tabor E","year":"2009","journal-title":"Regulatory Focus"},{"key":"bibr7-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. Pediatric exclusivity granted: October 2013. http:\/\/www.fda.gov\/downloads\/Drugs\/DevelopmentApprovalProcess\/DevelopmentResources\/UCM223058.pdf. Accessed November 9, 2013."},{"key":"bibr8-1060028013514031","doi-asserted-by":"publisher","DOI":"10.1161\/01.HYP.0000142248.54761.56"},{"key":"bibr9-1060028013514031","unstructured":"NYU Langone Medical Center: Pediatric Heart Disease. http:\/\/cvi.med.nyu.edu\/conditions-we-treat\/conditions\/pediatric-heart-disease. Accessed November 15, 2011."},{"key":"bibr10-1060028013514031","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2008.05.001"},{"key":"bibr11-1060028013514031","unstructured":"Olitsky S. Pediatric glaucoma. http:\/\/www.childrensmercy.org\/content\/view.aspx?id=1564. Accessed November 15, 2011."},{"key":"bibr12-1060028013514031","unstructured":"Friedman DS, Congdon N, Kempen J, Vision problems in the U.S. prevalence of adult vision impairment and age-related eye disease in America: National Eye Institute and Prevent Blindness America. http:\/\/www.preventblindness.net\/site\/DocServer\/VPUS_2008_update.pdf. Accessed April 12, 2012."},{"key":"bibr13-1060028013514031","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)61965-6"},{"key":"bibr14-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. FDA Announces new safety recommendations for high-dose simvastatin. http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm258338.htm. Accessed April 12, 2012."},{"key":"bibr15-1060028013514031","unstructured":"American Academy of Pediatrics. Safer medicines for children: the need to renew pediatric drug testing laws. http:\/\/www.aap.org\/advocacy\/washing\/therapeutics\/docs\/coalitionbpcaprea.pdf. Accessed November 15, 2011."},{"key":"bibr16-1060028013514031","unstructured":"Agency for Health Care Research and Quality. Selected findings on child and adolescent health care from the 2004 National Healthcare Quality\/Disparities reports. http:\/\/archive.ahrq.gov\/qual\/nhqrchild\/nhqrchild.htm. Accessed April 12, 2012."},{"key":"bibr17-1060028013514031","volume-title":"Pediatric Drug Development: Concepts and Applications","author":"Mulberg AE","year":"2011"},{"key":"bibr18-1060028013514031","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.82.3.364"},{"key":"bibr19-1060028013514031","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2008-2869"},{"key":"bibr20-1060028013514031","first-page":"18228","volume":"76","author":"Department of Health and Human Services, National Institutes of Health","year":"2011","journal-title":"Fed Regist"},{"key":"bibr21-1060028013514031","unstructured":"Department of Health and Human Services, National Institutes of Health. Best Pharmaceuticals for Children (BPCA) priority list of needs in pediatric therapeutics. http:\/\/bpca.nichd.nih.gov\/about\/process\/upload\/2011_Priority_List_and_Summary_for_web_posting_04_07_11.pdf. Accessed April 12, 2012."},{"key":"bibr22-1060028013514031","unstructured":"Drugs.Com. Pharmaceutical sales 2010: top 200 drugs for 2010 by units sold. Verispan. http:\/\/www.drugs.com\/top200_units.html. Accessed April 12, 2012."},{"key":"bibr23-1060028013514031","unstructured":"US National Institutes of Health, ClinicalTrials.gov. www.clinicaltrials.gov. Accessed November 30, 2012."},{"key":"bibr24-1060028013514031","unstructured":"Clinical Pharmacology. http:\/\/www.clinicalpharmacology.com\/. Accessed November 30, 2012."},{"key":"bibr25-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. Breakdown of FDAAA completed pediatric studies. http:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/DevelopmentResources\/ucm190622.htm. Accessed December 20, 2012."},{"key":"bibr26-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. Guidance for industry: qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act. http:\/\/www.fda.gov\/downloads\/Drugs\/DevelopmentApprovalProcess\/DevelopmentResources\/UCM049924.pdf. Accessed November 15, 2011."},{"key":"bibr27-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. New pediatric labeling information database. http:\/\/www.accessdata.fda.gov\/scripts\/sda\/sdNavigation.cfm?filter=&sortColumn=1d&sd=labelingdatabase&page=1. Accessed April 12, 2012."},{"key":"bibr28-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. Pediatric studies characteristics. http:\/\/www.accessdata.fda.gov\/scripts\/SDA\/sdNavigation.cfm?sd=fdaaadescriptorssortablewebdatabase. Accessed April 12, 2012."},{"key":"bibr29-1060028013514031","unstructured":"Medco Health. Estimated dates of possible first time generic\/Rx-to-OTC market entry. http:\/\/www.medcohealth.com\/art\/corporate\/anticipatedfirsttime_generics.pdf. Accessed April 12, 2012."},{"key":"bibr30-1060028013514031","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2008-0585"},{"key":"bibr31-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. One year post-pediatric exclusivity adverse event review: rofecoxib (Vioxx). http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/05\/briefing\/2005-4180b_07_01_Vioxx%20AE_reviewed.pdf. Accessed April 12, 2012."},{"key":"bibr32-1060028013514031","unstructured":"Martinez B, Matthews AW, Lublin JS, Merck pulls Vioxx from market after link to heart problems. Wall Street Journal. http:\/\/finance.wharton.upenn.edu\/~acmack\/merck0.pdf. Accessed November 15, 2011."},{"key":"bibr33-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. FDA drug safety communication: FDA recommends against the continued use of Meridia (sibutramine). http:\/\/www.fda.gov\/drugs\/drugsafety\/ucm228746.htm#safety_announcement. Accessed April 12, 2012."},{"key":"bibr34-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. One year post-pediatric exclusivity adverse event review: rosiglitazone (Avandia). http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/06\/briefing\/2006-4254b_05_01_RosiglitazoneSafetyreviewRedacted_D040849_0.pdf. Accessed April 12, 2012."},{"key":"bibr35-1060028013514031","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-003-1134-0"},{"key":"bibr36-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. Pediatric exclusivity granted: October 2013. http:\/\/www.fda.gov\/downloads\/Drugs\/DevelopmentApprovalProcess\/DevelopmentResources\/UCM223058.pdf. Accessed November 9, 2013."},{"key":"bibr37-1060028013514031","unstructured":"Department of Health and Human Services, US Food and Drug Administration. Breakdown of FDAAA completed pediatric studies. http:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/DevelopmentResources\/ucm190622.htm. Accessed April 12, 2012."},{"key":"bibr38-1060028013514031","unstructured":"Department of Health and Human Services U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension. Available at: http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm317123.htm. Last Accessed: February 6, 2013."}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1060028013514031","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1060028013514031","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1060028013514031","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:14:45Z","timestamp":1777374885000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1060028013514031"}},"subtitle":["Evolving Legislation and Novel Complexities within Pediatric Therapeutic Development"],"short-title":[],"issued":{"date-parts":[[2013,12,5]]},"references-count":38,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2014,3]]}},"alternative-id":["10.1177\/1060028013514031"],"URL":"https:\/\/doi.org\/10.1177\/1060028013514031","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,12,5]]}}}