Source: https://www.portalresearch.org/literature-scan.html
Timestamp: 2019-04-22 08:32:55+00:00

Document:
Each month, we review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues at the intersection of regulation, therapeutics and law.
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Major Events in the Life Course of New Drugs, 2000-2016.
Beall RF, Hwang TJ, Kesselheim AS.
N Engl J Med. 2019 Mar 14;380(11):e12.
Out-of-pocket Spending on Orphan Drug Prescriptions Among Commercially Insured Adults in 2014.
J Gen Intern Med. 2019 Mar;34(3):338-340.
Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.
Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ.
PLoS Med. 2019 Mar 13;16(3):e1002763. eCollection 2019 Mar.
Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing.
Fleischman W, Auth D, Shah ND, Agrawal S, Ross JS.
JAMA Netw Open. 2019 Mar 1;2(3):e191340.
US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?
​Trends in Medicaid Prices, Market Share, and Spending on Long-Acting Insulins, 2006-2018.
Hernandez I, Good CB, Shrank WH, Gellad WF.
2. Hernandez I, Good CB, Cutler DM, Gellad WF, Parekh N, Shrank WH. The Contribution of New Product Versus Existing Product Inflation In The Rising Costs of Drugs. Health Aff (Millwood). 2019 Jan;38(1):76-83.
6. Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS. Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes. JAMA. 2019 Jan;321(4):374-384.
8. Schwartz LM, Woloshin S. Medical Marketing in the United States, 1997-2016. JAMA. 2019 Jan 1;321(1):80-96.
​1. Beall RF, Kesselheim AS, Sarpatwari A. New Drug Formulations and Their Respective Generic Entry Dates. J Manag Care Spec Pharm. 2019 Feb;25(2):218-224.
2. Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS. Impact Of The Priority Voucher Program On Drug Development For Rare Pediatric Diseases. Health Aff (Millwood). 2019 Feb;38(2):313-319.
3. Rollman JE, Heyward J, Olson L, Lurie P, Sharfstein J, Alexander GC. Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products. JAMA. 2019 Feb 19;321(7):676-685.
​5. Sarpatwari A, Curfman G. Mitigating Health Risks of Prescription Drugs: Lessons From FDA Oversight of Opioid Products. JAMA. 2019 Feb 19;321(7):651-653.
​1. Beall RF, Darrow JJ, Kesselheim AS. A Method for Approximating Future Entry of Generic Drugs. Value Health. 2018 Dec;21(12):1382-1389.
​2. Danzon PM. Differential Pricing of Pharmaceuticals: Theory, Evidence and Emerging Issues. Pharmacoeconomics. 2018 Dec;36(12):1395-1405.
5. Shaw DL, Dhruva SS, Ross JS. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval. J Manag Care Spec Pharm. 2018 Dec;24(12):1230-1238.
2. Cutler DM. Extending the User Fee Approach to Pharmaceuticals. JAMA. 2018 Oct 16;320(15):1525-1526.
3. Feldman WB, Hey SP, Kesselheim AS. A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway. Health Aff (Millwood). 2018 Oct;37(10):1605-1614.
​1. Avorn J, Kesselheim A, Sarpatwari A. The FDA Amendments Act of 2007 - Assessing Its Effects a Decade Later. N Engl J Med. 2018 Sep 20;379(12):1097-1099.
4. Nishikawa G, Prasad V. Diagnostic expansion in clinical trials: myocardial infarction, stroke, cancer recurrence, and metastases may not be the hard endpoints you thought they were. BMJ. 2018 Sep 19;362:k3783.
5. O'Connor JM, Fessele KL, Steiner J, Seidl-Rathkopf K, Carson KR, Nussbaum NC, Yin ES, Adelson KB, Presley CJ, Gross CP. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials. JAMA Oncol. 2018 Aug 1;4(8):e180798.
6. Sacks CA, Lee CC, Kesselheim AS, Avorn J. Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents. JAMA. 2018 Aug 21;320(7):650-656.
4. Hernandez I, Prasad V, Gellad WF. Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy. JAMA Oncol. 2018 Jul 1;4(7):994-996.
8. Puthumana J, Wallach JD, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation. JAMA. 2018 Jul 17;320(3):301-303.
5. Gerrity MS, Prasad V, Obley AJ. Concerns About the Approval of Nusinersen Sodium by the US Food and Drug Administration. JAMA Intern Med. 2018 Jun 1;178(6):743-744.
2. Gill J, Obley AJ, Prasad V. ​Direct-to-Consumer Genetic Testing: The Implications of the US FDA's First Marketing Authorization for BRCA Mutation Testing. JAMA. 2018 May 18.
3. ​Luo J, Kesselheim AS. Delayed Generic Market Saturation After Patent Expiration--A Billion-Dollar Problem. JAMA Intern Med. 2018 May 1;178(5):721-722.
4. Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barbard RT, Darrow JJ, Kesselheim AS. Precision Medicines Have Faster Approvals Based On Fewer and Smaller Trials Than Other Medicines. Health Aff (Millwood). 2018 May;37(5):724-731.
5. Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS. Evaluating the Impact of the Orphan Drug Act's Seven-Year Market Exclusivity Period. Health Aff (Millwood). 2018 May;37(5):732-737.
7. Sinha MS, Kesselheim AS. The Next Forum for Unraveling FDA Off-Label Marketing Rules: State and Federal Legislatures. PLoS Med. 2018 May 8;15(5).
8. Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket Studies Required by the US Food and Drug Administration For New Drugs and Biologics Approved Between 2009 and 2012: Cross Sectional Analysis. BMJ. 2018 May 24;361.
9. Woloshin S, Schwartz LM. Overcoming Overuse: The Way Forward is Not Standing Still. BMJ. 2018 May 22;361.
1. Corrigan-Curay J, McKee AE, Stein P. Breakthrough-Therapy Designation--An FDA Perspective. N Engl J Med. 2018 Apr 12;378(15):1457-1458.
2. Darrow JJ, Avorn J, Kesselheim AS. The FDA Breakthrough-Drug Designation--Four Years of Experience. N Engl J Med. 2018 Apr 12;378(15):1444-1453.
3. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018 Apr 3;361.
4. Goldman AL, McCormick D, Haas JS, Sommers BD. Effects of the ACA's Health Insurance Marketplaces on the Previously Uninsured: A Quasi-Experimental Analysis. Health Aff (Millwood). 2018 Apr;37(4): 591-599.
5. Gupta R, Henkel A, Forman HP, Ross JS. The Impact of Off-Patent Drug Acquisitions on Prices. J Gen Intern Med. 2018 Apr 23.
7. Sampat BN, Shadlen KC. Indian pharmaceutical patent prosecution: The changing role of Section 3(d). PLoS One. 2018 Apr 2;13(4).
1. DeLoughery EP, Prasad V. The US Food and Drug Administration's use of regulator approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation. Ann Oncol. 2018 Mar 1;29(3):527-529.
2. Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study. BMJ. 2018 Mar 19;360.
3. Hwang TJ, Tomasi PA, Bourgeois FT. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study. PLoS Med. 2018 Mar 1;15(3).
4. Lee TT, Kesselheim AS, Kapczynski A. Legal Challenges to State Drug Pricing Laws. JAMA. 2018 Mar 6;319(9):865-866.
6. Wagner J, Marquart J, Ruby J, Lammers A, Mailankody S, Kaestner V, Prasad V. Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study. BMJ. 2018 Mar 7;360.
​​1. Beall RF, Kesselheim AS. Tertiary Patenting on Drug-Device Combination Products in the United States. Nat Biotechnol. 2018 Feb 6;36(2):142-145.
2. Bothwell LE, Avorn J, Khan NF, Kesselheim AS. Adaptive Design Clinical Trials: A Review of the Literature and ClinicalTrials.gov. BMJ Ope. 2018 Feb 10;8(2):e018320.
6. Powers JH, Evans SR, Kesselheim AS. Studying new antibiotics for multidrug resistant infections: Are today's patients paying for unproved future benefits? BMJ. 2018 Feb 22;360:k587.
8. Wallach JD, Ross JS. Gabapentin approvals, off-label use, and lessons for postmarketing efforts. JAMA. 2018 Feb 27;319(8):776-778.
​4. Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis. JMIR Public Health Surveill. 2018 Jan 5;4(1).
5. Sommers BD, Kesselheim AS. Massachusett's Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage? N Eng J Med. 2018 Jan 11;378(2):109-111.
6. Woloshin S, Schwartz LM, Bagley PJ, Blunt HB, White B. Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications. JAMA. 2018 Jan 23;319(4):404-406.
Darrow JJ, Beall RF, Kesselheim AS. Will Inter Partes Review Speed US Generic Drug Entry? Nat. Biotechnol. 2017 Dec 8;35(12):1139-1141.
Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding--From PDUFA I to PDUFA VI. N Engl Med. 2017 Dec 7;377(23):2278-2286.
Dave CV, Hartzema A, Kesselheim AS. Prices of Generic Drugs Associated with Numbers of Manufacturers. N Engl J Med. 2017 Dec 28;377(36):2597-2598.
Hwang TJ, Darrow JJ, Kesselheim AS. The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics. JAMA. 2017 Dec 5;318(21):2137-2138.
Miller JE, Wilenzick M, Ritcey N, Ross JS, Mello MM. Measuring Clinical Trial Transparency: An Empirical Analysis of Newly Approved Drugs and Large Pharmaceutical Companies. BMJ Open. 2017 Dec 5;7(12). Epub ahead of print.
Fralick M, Kesselheim AS, Avorn J, Schneeweiss S. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. 2017 Nov 20. Epub ahead of print.
Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA. 2017 Nov 13. Epub ahead of print.
Horton DB, Gerhard T, Davidow A, Strom BL. Impact of the Black Triangle Label on Prescribing of New Drugs in the United Kingdom: Lessons for the United States at a Time of Deregulation. Drug Saf. 2017 Nov;26(11):1307-1313.
Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Reuglatory Authority: Implications of Amgen v HHS. JAMA. 2017 Nov 8. Epub ahead of print.
Rutkow L, Vernick JS. Emergency Legal Authority and the Opioid Crisis. N Engl J Med. 2017 Nov 15. Epub ahead of print.
Gordon N, Stemmer SM, Greenberg D, Goldstein DA. Trajectories of Injectable Cancer Drug Costs After Launch in the United States. J Clin Oncol. 2017 Oct 10. Epub ahead of print.
Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. J Manag Care Spec Pharm. 2017 Oct;23(10): 1066-1076.
Jonker CJ, van der Berg HM, Kwa MSG, Hoes AW, Mol PGM. Registries Supporting New Drug Applications. Pharmacoepidemiol Drug Saf. 2017 Oct 6. Epub ahead of print.
Sarpatwari A, Choudhry NK. Recalibrating Privacy Protections to Promote Patient Engagement. N Engl J Med. 2017 Oct 19;377(16):1509-1511​.
Bucher Bartelson B, Le Lait MC, Green JL, Cepeda MS, Coplan PM, Maziere JY, Wedin GP, Dart RC. Changes in Misuse and Abuse of Prescription Opioids Following Implementation of Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy. Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1061-1070. Epub 2017 Jul 31.
Hey SP, Cohen IG, Adashi EY, Kesselheim AS. Influence, Integrity, and the FDA: An Ethical Framework. Science. 2017 Sep 1;357(6354):876-877.
Kesselheim AS, Sinha MS, Avorn J. Determinants of Market Exclusivity for Prescription Drugs in the United States. JAMA Intern Med. 2017 Nov 1;177(11):1658-1664. Epub 2017 Sep 11.
Mostaghim SR, Gagne JJ, Kesselheim AS. Safety Related Label Changes from New Drugs After Approval in the US through Expedited Regulatory Pathways: Retrospective Cohort Study. BMJ. 2017 Sep 7;358:j3837.
Woloshin S, Schwartz LM, White B, Moore TJ. The Fate of FDA Postapproval Studies. N Engl J Med. 2017 Sep 21;377(12):1114-1117.
Kashoki M, Lee C, Stein P. Letter to the Editor: FDA Oversight of Postmarketing Studies. N Engl J Med. 2017 Sep 21;377(12):1201-1202.
Alexander GC, Ballreich J, Socal MP, Karmarkar T, Trujillo A, Greene J, Sharfstein J, Anderson G. Reducing Branded Prescription Drug Prices: A Review of Policy Options. Pharmacotherapy. 2017 Aug 14. Epub ahead of print.
Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Ann Intern Med. 2017 Aug 1;167(3):145-151.
Horton DB, Gerhard T, Davidow A, Strom BL. Impact of the Black Triangle Label on Prescribing of New Drugs in the United Kingdom: Lessons for the United States at a Time of Deregulation. Pharmacoepidemiol Drug Saf. 2017 Aug 31. Epub ahead of print.
Hwang TJ, Franklin JM, Kesselheim AS. Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development. Clin Pharmacol Ther. 2017 Aug;102(2):290-296.
Naci H, Smalley KR, Kesselheim AS. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. JAMA. 2017 Aug 15;318(7):626-636.
Sommers BD, Gawande AA, Baicker K. Health Insurance Coverage and Health--What the Recent Evidence Tells Us. N Eng J Med. 2017 Aug 10;377(6):586-593.
Zheng SY, Dhruva SS, Redberg RF. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. JAMA. 2017 Aug 15;318(7):619-625.
Fralick M, Avorn J, Kesselheim AS. The price of crossing the border for medications. N Eng J Med. 2017 Jul 27;377(4):311-313.
Jain N, Hwang TJ, Franklin JM, Kesselheim AS. Association of the priority review voucher with neglected tropical disease drug and vaccine development. JAMA. 2017 Jul 25;318(4):388-389.
Kemp R, Prasad V. Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused? BMC Med. 2017 Jul 21;15(1):134.
Miller JE, Ross JS, Moch KI, Caplan AL. ﻿Characterizing expanded access and compassionate use programs for experimental drugs.﻿ BMC Res Notes. 2017 Jul 28;10(1):350.
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials. 2017 Jul 18;18(1):333.
Chimonas S, DeVito NJ, Rothman DJ. Bringing Transparency to Medicine: Exploring Physicians' Views and Experiences of the Sunshine Act. Am J Bioeth. 2017;17(6):4-18.
Dong K, Boehm G, Zheng Q. Economic Impacts of the Generic Drug User Fee Act Fee Structure. Value Health. 2017;20(6):792-8.
​ Hey SP, Franklin JM, Avorn J, Kesselheim AS. Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors. Circ Cardiovasc Qual Outcomes. 2017 Jun;10(6).
‘t Hoen EFM, Boulet P, Baker BK. Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation. J Pharm Policy Pract. 2017 Jun 28;10:19.
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA. 2017 May 9;317(18):1854-1863.
Gellad WF, Kesselheim AS. Accelerated Approval and Expensive Drugs - A Challenging Combination. N Engl J Med. 2017 May 25;376(21):2001-2004.
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017 May 3;357:j1680.
Sacks CA, Avorn J, Kesselheim AS. The Failure of Solanezumab - How the FDA Saved Taxpayers Billions. N Engl J Med. 2017 May 4;376(18):1706-1708.
Sommers BD, Maylone B, Blendon RJ, Orav EJ, Epstein AM. Three-Year Impacts of the Affordable Care Act: Improved Medical Care and Health Among Low-Income Adults. Health Aff (Millwood). 2017 Jun 1;36(6): 1119-1128.
Davies BJ, Hwang TJ, Kesselheim AS. Ensuring Access to Injectable Generic Drugs – The Case of Intravesical BCG for Bladder Cancer. N Engl J Med. 2017;376(15):1401-3.
Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents – FDA versus EMA, 2011-2015. N Engl J Med. 2017;376(14):1386-7.
Gyawali B, Prasad V. Drugs that Lack Single-Agent Activity: Are They Worth Pursuing in Combination? Nat Rev Clin Oncol. 2017;14(4):193-4.
Polinski JM, Howell B, Gagnon MA, Kymes SM, Brennan TA, Shrank WH. Impact of CVS Pharmacy’s Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014). Am J Public Health. 2017;107(4):556-62.
Califf RM. Warning About Shortcuts in Drug Development. J Am Heart Assoc. 2017 Mar 21;6(3).
Hey SP, Kesselheim AS. Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations. Hastings Cent Rep. 2017;47(2):16-20.
Layton JB, Kim Y, Alexander GC, Emery SL. Association Between Direct-to-Consumer Advertising and Testosterone Testing and Initiation in the United States, 2009-2013. JAMA. 2017;317(11):1159-1166.
Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open. 2017;7(2):e014582.
Luo J, Kesselheim AS, Greene J, Lipska KJ. Strategies to improve the affordability of insulin in the USA. Lancet Diabetes Endocrinol. 2017;5(3):158-159.
Spelsberg A, Prugger C, Doshi P, Ostrowski K, Witte T, Hüsgen D, Keil U. Working Group on Health and Working Group on Freedom of Information, Transparency International Deutschland eV. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ. 2017;356:j337.
Wong J, Motulsky A, Abrahamowicz M, Eguale T, Buckeridge DL, Tamblyn R. Off-label indications for antidepressants in primary care: descriptive study of prescriptions from an indication based electronic prescribing system. BMJ. 2017;356:j603.
Ahn R, Woodbridge A, Abraham A, Saba S, Korenstein D, Madden E, Boscardin WJ, Keyhani S. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ. 2017;356:i6770.
Kesselheim AS, Treasure CL, Joffe S. Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage. PLoS Med. 2017;14(1):e1002190.
Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, et al. Transforming Evidence Generation to Support Health and Health Care Decisions. N Engl J Med. 2016;375(24):2395-2400.
Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone – Risks to Efforts to Stem Overdose Deaths. N Engl J Med. 2016;375(23):2213-2215.
Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan. Clin Pharmacol Ther. 2016;100(6):626-632.
Knopf K, Baum M, Shimp WS, Bennett CL, Faith D, Fishman ML, Hrushesky WJ. Interpretation of surrogate endpoints in the era of the 21st Century Cures Act. BMJ. 2016;355:i6286.
Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016;375(24):2313-2315.
Sinha MS, Kesselheim AS. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorg Med Chem. 2016;24(24):6446-6451.
Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016;31(12):1482-1489.
Abola MV, Prasad V. Industry Funding of Cancer Patient Advocacy Organizations. Mayo Clin Proc. 2016;91(11):1668-1670.
Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended-Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016;170(11):1103-1104.
Doshi P. Is this trial misreported? Truth seeking in the burgeoning age of trial transparency. 2016;355:i5543.
Sommers BD, Blendon RJ, Orav EJ, Epstein AM. Changes in Utilization and Health Among Low-Income Adults After Medicaid Expansion or Expanded Private Insurance. JAMA Intern Med. 2016;176(10):1501-9.
Bouvy JC, Huinink L, De Bruin ML. Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012. Pharmacoepidemiol Drug Saf. 2016;25(9):1004-14.
Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016;176(9):1391-3.
Kleijnen S, Lipska I, Leonardo Alves T, Meijboom K, Elsada A, Vervölgyi V, d’Andon A, Timoney A, Leufkens HG, De Boer A, Goettsch WG. Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries. Ann Oncol. 2016;27(9):1768-75.
Mailankody S, Prasad V. Thinking Systematically About the Off-Label Use of Cancer Drugs and Combinations for Patients Who Have Exhausted Proven Therapies. Oncologist. 2016;21(9):1031-2.
Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016;316(10):1093-103.
Chang HY, Lyapustina T, Rutkow L, Daubresse M, Richey M, Faul M, Stuart EA, Alexander GC. Impact of prescription drug monitoring programs and pill mill laws on high-risk opioid prescribers: A comparative interrupted time series analysis. Drug Alcohol Depend. 2016;165:1-8.
Chambers JD, Rane PB, Neumann PJ. The impact of formulary drug exclusion policies on patients and healthcare costs. Am J Manag Care. 2016;22(8):524-31.
Doshi JA, Lim R, Li P, Young PP, Lawnicki VF, State JJ, Troxel AB, Volpp KG. A Synchronized Prescription Refill Program Improved Medication Adherence. Health Aff. 2016;35(8):1504-12.
Fleischman W, Agrawal S, King M, Venkatesh AK, Krumholz HM, McKee D, Brown D, Ross JS. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. BMJ. 2016;354:i4189.
Hey SP, Kesselheim AS. The FDA, Juno Therapeutics, and the ethical imperative of transparency. BMJ. 2016;354:i4435.
Kesselheim AS, Avorn J, Sarpatwari A. The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. JAMA. 2016;316(8):858-71.
Sarpatwari A, Gagne JJ. Balancing benefits and harms: privacy protection policies. Pharmacoepidemiol Drug Saf. 2016;25(8):969-71.
Gabler NB, Duan N, Raneses E, Suttner L, Ciarametaro M, Cooney E, Dubois RW, Halpern SD, Kravitz RL. No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals. Trials. 2016;17(1):320.
Gagne JJ, Han X, Hennessy S, Leonard CE, Chrischilles EA, Carnahan RM, Wang SV, Fuller C, Iyer A, Katcoff H, Woodworth TS, Archdeacon P, Meyer TE, Schneeweiss S, Toh S. Successful comparison of US Food and Drug Administration Sentinel analysis tools to traditional approaches in quantifying a known drug-adverse event association. Clin Pharmacol Ther. 2016 Jul 14. [Epub ahead of print].
Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016 Jul 18. [Epub ahead of print].
Haffner ME. The history of orphan drug regulation – US and Beyond. Clin Pharmacol Ther. 2016 Jul 9. [Epub ahead of print].
Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU. Br J Clin Pharmacol. 2016;82(1):213-26.
Luo J, Kesselheim AS. Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad. AMA J Ethics. 2016;18(7):727-35.
Mailankody S, Prasad V. Implications of Proposed Medicare Reforms to Counteract High Cancer Drug Prices. JAMA. 2016;316(3):271-2.
van Staa TP, Goldacre B, Buchan I, Smeeth L. Big health data: the need to earn public trust. BMJ. 2016 Jul 14;354:i3636.
Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard–Lessons from the History of RCTs. N Engl J Med. 2016;374(22):2175-81.
Hwang TJ, Sokolov E, Franklin JM, Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016;353:i3323.
Kesselheim AS, Gagne JJ, Eddings W, Franklin JM, Ross KM, Fulchino LA, Campbell EG. Prevalence and Predictors of Generic Drug Skepticism Among Physicians: Results of a National Survey. JAMA Intern Med. 2016;176(6):845-7.
Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients’ Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med. 2016;31(6):609-14.
Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):713-8.
Sarpatwari A, Kesselheim AS. Navigating the Dermatological Drug Cost Curve. JAMA. 2016;315(24):2724-5.
Sarpatwari A, Avorn J, Kesselheim AS. State Initiatives to Control Medication Costs–Can Transparency Legislation Help? N Engl J Med. 2016;374(24):2301-4.
Eichler HG, Hurts H, Broich K, Rasi G. Drug Regulation and Pricing–Can Regulators Influence Affordability? New Engl J Med. 2016 May 12;374(19):1807-9.
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