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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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

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

Photograph of a stack of magazines on a chair

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 July. The selections feature topics ranging from the price increases of protected-class drugs in Medicare Part D, to the impact of price regulation on the availability of new drugs in Germany, 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 stack of magazines on a chair

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

By Ameet Sarpatwari, 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 June. The selections feature topics ranging from premarket development times for biologics versus small-molecule drugs, to the characteristics of trials and regulatory pathways leading to U.S. approval of innovative vs. non-innovative drugs, to generic and brand-name thyroid hormone drug use among commercially insured and Medicaid beneficiaries. 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 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.