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

By Ameet Sarpatwari, Charlie Lee, 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from the cost of delayed generic entry in Medicaid, to challenges with false negative tests for SARS-CoV-2 infection, to difficulties in implementing and enforcing state opioid prescribing laws. A full posting of abstracts/summaries of these articles may be found on our website.

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Large pile of amber prescription pill bottles

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

By Ameet SarpatwariCharlie LeeFrazer Tessema, 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 pharmaceutical law and policy.

Below are links to the papers identified from the month of May. The selections feature topics ranging from the association between clinical benefit of approved cancer drugs and their prices in the U.S. and Europe, to an assessment of how commercial health plans cover biosimilars relative to their reference products, to a commentary on how children should be included in clinical trials evaluating COVID-19 therapies. A full posting of abstracts/summaries of these articles can be found on our website.

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

By Ameet SarpatwariCharlie LeeFrazer Tessema, 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from increases in Internet searches for hydroxychloroquine following promotional remarks by the President, to an evaluation of health gains from orphan drugs, to an assessment of clinical trials supporting new FDA drug approvals. A full posting of abstracts/summaries of these articles can be found on our website.

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Stacks of books against a burgundy wall

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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.

Below are the abstracts/summaries for papers identified from the month of March. The selections feature topics ranging from the utilization and cost of naloxone for patients at high risk of opioid overdose, to off-label and compassionate drug use in the COVID-19 pandemic, to public-sector financial support and sponsorship for gene therapy trials in the U.S. A full posting of abstracts/summaries of these articles may be found on our website.

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Stacks of books against a burgundy wall

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

By Ameet SarpatwariCharlie LeeFrazer Tessema, 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 of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School.

Below are the abstracts/summaries for papers identified from the month of February. The selections feature topics ranging from the compliance of manufacturers with clinical trial reporting requirements, to estimation of possible savings that could be attained for diabetics purchasing insulin, to documentation of how frequently pharmaceutical industry-sponsored charity patient assistance programs cover off-label uses of a drug. 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, Charlie Lee, Frazer Tessema, 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 of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School.

Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from the evolution of drug regulation in the US, to establishing a population health-based framework for value-based drug pricing, to the limited utilization of biosimilar infliximab in the US. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 Jan 14;323(2):164-176.
  2. Desai RJ, Sarpatwari A, Gautam N, Lii J, Fischer MA, Gagne JJ. Changes in Utilization of Generic Angiotensin Receptor Blockers Following Product Recalls in the United States. JAMA. 2020;323(1):87-89.
  3. Hu Y, Eynikel D, Boulet P, Krikorian G. Supplementary protection certificates and their impact on access to medicines in  Europe: case studies of sofosbuvir, trastuzumab and imatinib. J Pharm policy Pract. 2020 Jan 14;13:1.
  4. Jung EH, Sarpatwari A, Kesselheim AS. Novelty of Active Ingredients in High-Cost Brand-Name Drugs. J Gen Intern Med. 2020 Jan 2. [Epub ahead of print].
  5. Kaltenboeck A, Calsyn M, Frederix GWJ, Lowenthal J, Mitchell D, Rector B, Sarpatwari A. Grounding Value-Based Drug Pricing in Population Health. Clin Pharmacol Ther. 2020 Jan 17. [Epub ahead of print].
  6. Kim SC, Sarpatwari A, Landon JE, Desai RJ. Utilization and Treatment Costs of Tumor Necrosis Factor Inhibitors after the Introduction of Biosimilar Infliximab in the U.S. Arthritis Rheumatol (Hoboken, NJ). 2020 Jan 13. [Epub ahead of print].
  7. King AC, Schwartz LM, Woloshin S. A National Survey of the Frequency of Drug Company Detailing Visits and Free Sample Closets in Practices Delivering Primary Care. JAMA Intern Med. 2020 Jan 27. [Epub ahead of print].
close up of an open book

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 potential Medicare savings on inhaler prescriptions through use of negotiated prices and a defined formulary, to evaluation of the REMS for extended-release/long-acting opioids, to the costs of medication non-adherence in adults with atherosclerotic cardiovascular disease in the US. A full posting of abstracts/summaries of these articles may be found on our website. Read More

Stacks of books against a burgundy wall

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 November. The selections feature topics ranging from the impact of state laws restricting opioid duration, to Medicare spending on drugs and biologics not recommended by the international health technology assessment agencies, to a randomized study of providing evidence context to mitigate physician misinterpretation from off-label drug promotion. A full posting of abstracts/summaries of these articles may be found on our website. Read More

Stack of colorful books in front of a wood paneled wall

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 September. The selections feature topics ranging from the contributions of academia and industry to lung cancer survival gains, to the savings from the EpiPen authorized generic, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

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Photograph of a gavel and three open books

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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.

Read More