Category: PORTAL Round-Up

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

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

Ameet Sarpatwari Leave a comment

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

Ameet Sarpatwari 1 Comment

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.

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Photograph of a stack of magazines on a chair

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

Ameet Sarpatwari Leave a comment

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

Ameet Sarpatwari Leave a comment

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

Ameet Sarpatwari Leave a comment

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

Ameet Sarpatwari Leave a comment

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.

PFC Spotlight Series: Faculty Affiliate Ameet Sarpatwari

Ameet Sarpatwari Leave a comment

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

Ameet Sarpatwari Leave a comment

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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of March. The selections feature topics ranging from the characteristics and follow-up of post-marketing studies or conditionally authorized medicines in the European Union; to changes in prescription drug, over the counter drug, and dietary supplement use among older adults in the United States; to an assessment of the logic of Amarin’s off-label promotion of Vascepa. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion. PLoS Med. 2016 Mar 15;13(3):e1001978.
  2. Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of post-marketing studies of conditionally authorised medicines in the EU. Br J Clin Pharmacol. 2016 Mar 18. [Epub ahead of print].
  3. Kapczynski A. Free Speech and Pharmaceutical Regulation-Fishy Business. JAMA Intern Med. 2016 Mar 1;176(3):295-6.
  4. Massey PR, Wang R, Prasad V, Bates SE, Fojo T. Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting. 2016 Mar;21(3):261-8.
  5. Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011. JAMA Intern Med. 2016 Mar 21. [Epub ahead of print]
  6. Yeh JS, Sarpatwari A, Kesselheim AS. Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels. Drug Saf. 2016 Mar 21. [Epub ahead of print]

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

Ameet Sarpatwari Leave a comment

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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of August. The selections feature topics ranging from the impact of Florida’s pill mill and prescription drug monitoring program laws on opioid prescribing and use, to the FDA’s revised guidance on direct-to-consumer marketing, to trends in Medicaid reimbursement for insulin products.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chambers JD, Chenoweth M, Thorat T, Neumann PJ. Private Payers Disagree With Medicare Over Medical Device Coverage About Half The Time. Health Aff (Millwood). 2015 Aug 1; 34(8):1376-82.
  2. Djulbegovic B. Value-Based Cancer Care and the Excessive Cost of Drugs. JAMA Oncol. 2015 Aug 27. [Epub ahead of print].
  3. Greene JA, Watkins ES. The Vernacular of Risk – Rethinking Direct-to-Consumer Advertising of Pharmaceuticals. N Engl J Med. 2015 Aug 19. [Epub ahead of print].
  4. Luo J, Avorn J, Kesselheim AS. Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014. JAMA Intern Med. 2015 Aug 24. [Epub ahead of print].
  5. Luo J, Kesselheim AS. The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines. JAMA. 2015 Aug 20. [Epub ahead of print].
  6. Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA. 2015 Aug 11; 314(6):604-12.
  7. Robertson CT. New DTCA Guidance – Enough to Empower Consumers? N Engl J Med. 2015 Aug 19. [Epub ahead of print].
  8. Rutkow L, Chang HY, Daubresse M, Webster DW, Stuart EA, Alexander GC. Effect of Florida’s Prescription Drug Monitoring Program and Pill Mill Laws on Opioid Prescribing and Use. JAMA Intern Med. 2015 Aug 17. [Epub ahead of print].
  9. Schick A, Miller KL, Lanthier M, Woodcock J. Regulatory watch: What drives differences in review times among CDER divisions? Nat Rev Drug Discov. 2015 Aug 21. [Epub ahead of print].