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.
Below are the citations for papers identified from the month of July. The selections feature topics ranging from a discussion of issues related to FDA’s approval of aducanumab for the treatment of Alzheimer’s disease, to an analysis of the communication of survival data in cancer drug labels, to an evaluation of public-sector contributions to novel biologic drugs. A full posting of abstracts/summaries of these articles may be found on our website.
- Alexander GC, Knopman DS, Emerson SS, Ovbiagele B, Kryscio RJ, Perlmutter JS, Kesselheim AS. Revisiting FDA Approval of Aducanumab. N Engl J Med. 2021 Jul 28. Epub ahead of print.
- Benning TJ, Shah ND, Inselman JW, Van Houten HK, Ross JS, Wyatt KD. Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation. Clin Trials. 2021 Jul 16:17407745211030683. Epub ahead of print.
- Darrow JJ. Government Pharmaceutical Development to Address High Prices: Challenges Ahead. Ther Innov Regul Sci. 2021 Jul 14. Epub ahead of print.
- Gyawali B, Ross JS, Kesselheim AS. Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway: The Need for Reforms. JAMA Intern Med. 2021 Jul 13. Epub ahead of print.
- Lalani HS, Avorn J, Kesselheim AS. US Taxpayers Heavily Funded the Discovery of COVID-19 Vaccines. Clin Pharmacol Ther. 2021 Jul 9. Epub ahead of print.
- Naci H, Guan X, Woloshin S, Xu Z, Wagner AK. Communication of Survival Data in US Food and Drug Administration-Approved Labeling of Cancer Drugs. JAMA Intern Med. 2021 Jul 12:e213505. Epub ahead of print.
- Nayak RK, Lee CC, Avorn J, Kesselheim AS. Public-sector Contributions to Novel Biologic Drugs. JAMA Intern Med. 2021 Jul 19. Epub ahead of print.
- Powell K, Lythgoe MP, Prasad V. The Oncologic Drugs Advisory Committee Votes of April 2021-Implications for the Fate of Accelerated Approval. JAMA Oncol. 2021 Jul 8. Epub ahead of print.
- Sharma S, Booth CM, Eisenhauer EA, Gyawali B. Do Editorialists With Industry-Related Conflicts of Interest Write Unduly Favorable Editorials for Cancer Drugs in Top Journals? J Natl Compr Canc Netw. 2021 Jul 29:jnccn20459. Epub ahead of print.
- Vokinger KN, Hwang TJ, Daniore P, Lee CC, Tibau A, Grischott T, Rosemann TJ, Kesselheim AS. Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe. JAMA Oncol. 2021 Jul 1:e212026. Epub ahead of print.
- Walsh BS, Sarpatwari A, Rome BN, Kesselheim AS. Frequency of First Generic Drug Approvals With “Skinny Labels” in the United States. JAMA Intern Med. 2021 Jul 1;181(7):995-997.