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.
- 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.
- Djulbegovic B. Value-Based Cancer Care and the Excessive Cost of Drugs. JAMA Oncol. 2015 Aug 27. [Epub ahead of print].
- 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].
- 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].
- Luo J, Kesselheim AS. The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines. JAMA. 2015 Aug 20. [Epub ahead of print].
- 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.
- Robertson CT. New DTCA Guidance – Enough to Empower Consumers? N Engl J Med. 2015 Aug 19. [Epub ahead of print].
- 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].
- 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].