Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of August. The selections feature topics ranging from the characteristics of pre- and post-approval studies for drugs granted accelerated approval by the FDA, to a review of policy options to reduce brand-name drug prices, to characteristics of clinical studies used for FDA approval of high-risk medical device supplements. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Reducing Branded Prescription Drug Prices: A Review of Policy Options. Alexander GC, Ballreich J, Socal MP, Karmarkar T, Trujillo A, Greene J, Sharfstein J, Anderson G. Pharmacotherapy. 2017 Aug 14. [Epub ahead of print]
  2. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. Ann Intern Med. 2017 Aug 1;167(3):145-151.
  3. 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. Horton DB, Gerhard T, Davidow A, Strom BL. Pharmacoepidemiol Drug Saf. 2017 Aug 31. [Epub ahead of print]
  4. Effect of US Food and Drug Administration’s Cardiovascular Safety Guidance on Diabetes Drug Development. Hwang TJ, Franklin JM, Kesselheim AS. Clin Pharmacol Ther. 2017 Aug;102(2):290-296.
  5. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. Naci H, Smalley KR, Kesselheim AS. JAMA. 2017 Aug 15;318(7):626-636.
  6. Health Insurance Coverage and Health – What the Recent Evidence Tells Us. Sommers BD, Gawande AA, Baicker K. N Eng J Med. 2017 Aug 10;377(6):586-593.
  7. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. Zheng SY, Dhruva SS, Redberg RF. JAMA. 2017 Aug 15;318(7):619-625.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from the characteristics of expanded access programs, to the association of the priority review voucher with neglected tropical disease drug and vaccine development, to the use of surrogate outcomes in oncology. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bonnie RJ, Kesselheim AS, Clark DJ. Both Urgency and Balance Needed in Addressing Opioid Epidemic: A Report from the National Academies of Sciences, Engineering, and Medicine. 2017 Jul 13. [E-pub ahead of print]
  2. Fralick M, Avorn J, Kesselheim AS. The Price of Crossing the Border for Medications. N Engl J Med. 2017;377(4):311-313.
  3. Hwang TJ, Kesselheim AS, Sarpatwari A. Value-Based Pricing and State Reform of Prescription Drug Costs. 2017 Jul 10. [E-pub ahead of print]
  4. Jain N, Hwang TJ, Franklin JM, Kesselheim AS. Association of the Priority Review Voucher with Neglected Tropical Disease Drug and Vaccine Development. 2017;318(4):388-389.
  5. 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;15(1):134.
  6. Miller JE, Ross JS, Moch KI, Caplan AL. Characterizing Expanded Access and Compassionate Use Programs for Experimental Drugs. BMC Res Notes. 2017;10(1):350.
  7. 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. 2017;18(1):333.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariMichael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from physicians’ views of the Sunshine Act; to a biomarker-based drug development case study of CETP inhibitors, to the potential return on public investment in detecting adverse drug effects. A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. Dong K, Boehm G, Zheng Q. Economic Impacts of the Generic Drug User Fee Act Fee Structure. Value Health. 2017;20(6):792-8.
  3. 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;10(6).
  4. Huybrechts KF, Kesai RJ, Park M, Gagne JJ, Najafzadeh M, Avorn J. The Potential Return on Public Investment in Detecting Adverse Drug Effects. Med Care. 2017;55(6):545-51.
  5. 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;36(6):1119-28.
  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;10:19.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of May. The selections feature topics ranging from post-approval safety events among novel drugs approved between 2001 and 2010, to the failure of the Alzheimer’s drug Solanezumab, to the three-year impacts of the Affordable Care Act among low-income adults. A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. Gellad WF, Kesselheim AS. Accelerated approval and expensive drugs – a challenging combination. N Engl J Med. 2017 May 25;376(21):2001-2004.
  3. 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.
  4. 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.
  5. 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.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from the effect of a shortage of baclle Calmette-Guérin (BCG) on treatment costs for bladder cancer, to a comparison of regulatory review of new therapeutic agents by the FDA and the EMA, to the impact of CVS pharmacy’s discontinuance of tobacco sales on cigarette purchasing. A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. 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.
  3. Fralick M, Kesselheim AS. FDA Approval of Desmopressin for Nocturia. JAMA. 2017 Apr 6. [Epub ahead of print]
  4. 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.
  5. 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.
  6. Sharfstein J. Déjà Vu at the FDA. Milbank Q. 2017 Apr 4. [Epub ahead of print]

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of February. The selections feature topics ranging from the effect of reminder devices on medication adherence, to the relationship between industry sponsorship and research outcomes, to the contribution of industry funded post-marketing studies to drug safety. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Choudhry NK, Krumme AA, Ercole PM, Girdish C, Tong AY, Khan NF, Brennan TA, Matlin OS, Shrank WH, Franklin JM. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 27. [Epub ahead of print]
  2. Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS. Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence. Drugs. 2017 Feb 8. [Epub ahead of print]
  3. 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.
  4. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033. [Epub ahead of print]
  5. 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.
  6. Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov. 2017 Feb 24. [Epub ahead of print]
  7. 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.
  8. 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.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from pharmacist-industry relationships, to returns from six-month market exclusivity extensions, to financial conflicts of interest among patient advocacy organizations. A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. Califf RM. Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance. JAMA. 2017 Jan 20. [Epub ahead of print]
  3. Hakim A, Ross JS. High Prices for Drugs With Generic Alternatives: The Curious Case of Duexis. JAMA Intern Med. 2017 Jan 23. [Epub ahead of print]
  4. Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers. Health Aff (Millwood). 2017 Jan 18. [Epub ahead of print]
  5. 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.
  6. Rose SL, Highland J, Karafa MT, Joffe S. Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest. JAMA Intern Med. 2017 Jan 17. [Epub ahead of print]
  7. Saavedra K, O’Connor B, Fugh-Berman A. Pharmacist-industry relationships. Int J Pharm Pract. 2017 Jan 18. [Epub ahead of print]

PFC Spotlight Series: Faculty Affiliate Ameet Sarpatwari

Learn more about the Petrie-Flom Center’s work through our Spotlight Series, which features interviews with Student and Academic Fellow alumni, as well as current Faculty Affiliates.

sarpatwari_peopleThis week’s post features Ameet Sarpatwari, J.D., Ph.D., who is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL). His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

Read the article to learn more about his contributions to the Center and its mission!

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from the rising price of the opioid reversal agent naloxone, to the interpretation of surrogate endpoints in the era of the 21st Century Cures Act, to a comparative assessment of pharmaceutical licensing and reimbursement in the European Union, United States, and Japan. A full posting of abstracts/summaries of these articles may be found on our website.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Robertson C, Kesselheim AS. Regulating Off-Label Promotion – A Critical Test. N Engl J Med. 2016;375(24):2313-2315.
  6. Sinha MS, Kesselheim AS. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorg Med Chem. 2016;24(24):6446-6451.
  7. 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.