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 promoting patient interests in implementing the federal right to try act; to the percentage of US patients with cancer who benefit from genome-driven oncology, to Medicare spending on brand-name combination medications and their generic constituents. A full posting of abstracts/summaries of these articles may be found on our website.

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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 June. The selections feature topics ranging from the utilization of medical devices necessary to detect post-approval safety differences, to evidentiary standards and regulatory tradeoffs in the FDA’s expedited approval programs, to the president’s plan to address high drug prices. A full posting of abstracts/summaries of these articles may be found on our website.

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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 April. The selections feature topics ranging from experience with the FDA breakthrough drug designation pathway; to the impact of off-patent drug acquisitions on prices; to the Indian pharmaceutical patent prosecution. A full posting of abstracts/summaries of these articles may be found on our website.

  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:k1180.
  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. 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. [Epub ahead of print]
  6. Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines. J Clin Oncol. 2018 Apr 24. [Epub ahead of print]
  7. Sampat BN, Shadlen KC. Indian pharmaceutical patent prosecution: The changing role of Section 3(d). PLoS One. 2018 Apr 2;13(4):e0194714.

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 March. The selections feature topics ranging from the FDA’s regular approval of cancer drugs based on single-arm studies; to delays in the completion and reporting of clinical trials under the Paediatric Regulation in the EU, to legal challenges to state drug pricing laws. A full posting of abstracts/summaries of these articles may be found on our website.

  1. DeLoughery EP, Prasad V. The US Food and Drug Administration’s use of regular 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:k831.
  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):e1002520.
  4. Lee TT, Kesselheim AS, Kapczynski A. Legal Challenges to State Drug Pricing Laws. JAMA. 2018 Mar 6;319(9):865-866.
  5. ‘t Hoen EF, Veraldi J, Toebes B, Hogerzeil HV. Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016. Bull World Health Organ. 2018 Mar 1;96(3):185-193.
  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:k668.

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 February. The selections feature topics ranging from tertiary patenting of drug-device combinations; to off-label promotion and adherence to FDA guidelines among direct-to-consumer advertisements; to the impact of FDA label changes. A full posting of abstracts/summaries of these articles may be found on our website.

  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 Open. 2018 Feb 10;8(2):e018320.
  3. Chang HY, Murimi I, Faul M, Rutkow L, Alexander GC. Impact of Florida’s prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis. Pharmacoepidemiol Drug Saf. 2018 Feb 28. [Epub ahead of print]
  4. Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS. Application and impact of run-in studies. J Gen Intern Med. 2018 Feb 15. [Epub ahead of print]
  5. Klara K, Kim J, Ross JS. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. J Gen Intern Med. 2018 Feb 26. [Epub ahead of print]
  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.
  7. Sobel RE, Bate A, Marshall J, Haynes K, Selvam N, Nair V, Daniel G, Brown JS, Reynolds RF. Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System’s analytic tools. Pharmacoepidemiol Drug Saf. 2018 Feb 2. [Epub ahead of print]
  8. Wallach JD, Ross JS. Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Efforts. JAMA. 2018 Feb 27;319(8):776-778.

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 January. The selections feature topics ranging from the savings possible from greater generic substitution in Medicare; to proposed federal right to try legislation; to the characteristics of interim publications and final publications from RCTs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Egilman AC, Wallach JD, Ross JS, Dhruva SS. Medicare Spending and Potential Savings on Brand-Name Drugs with Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015. JAMA Intern Med. 2018 Jan 16. [Epub ahead of print]
  2. Fuse Brown EC, Sarpatwari A. Removing ERISA’s Impediment to State Health Reform. N Eng J Med. 2018 Jan 4;378(1):5-7.
  3. Joffe S, Lynch HF. Federal Right-to-Try Legislation—Threatening the FDA’s Public Health Mission. N Eng J Med. 2018 Jan 10. [Epub ahead of print]
  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. Massachusetts’ Proposed Medicaid Reforms – Cheaper Drugs and Better Coverage? N Engl 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.