Ethical Challenges of Developing New Drugs Overseas

Geographic shifts away from the United States to other countries in developing and testing new drugs create challenges for protecting research participants and ensuring data integrity.

Although the United States once dominated early-stage drug development, it now shares the leading role in this rapidly expanding field with China. In 2024 there were 18,999 drug-development programs worldwide, compared with 10,417 in 2015, an 82.4% increase, according to a 2026 study in JAMA. From 2015 to 2024, however, the percentage of programs originating in the United States declined from 48.2% to 37.4%, while China’s share increased from 8.0% to 32.3%; the share of programs in other high-income countries also declined.[1] Phase 1 clinical trials are conducted more rapidly in China than in the United States, and at lower cost.[2] The changes in the location of drug development are evident in all areas of medicine and most pronounced for biologics and cancer therapeutics.[3]

This shift has captured the attention of the Food and Drug Administration (FDA). The FDA is seeking to make domestic earlyphase
clinical trials more efficient and less costly, and to provide incentives for companies to develop and manufacture more new drugs in the United States.[4] In September 2026 the agency launched the Expedited Investigational New Drug Pilot, which seeks to decrease the time from when a potential new drug is identified until a first-in-human clinical trial is completed.[5]

In an August 2026 commentary, the agency also issued a strong warning to research sponsors about new drug applications that rely on clinical studies conducted outside the United States and the agency’s “greater scrutiny on whether those data are reliable, inspectable, and ethically derived.”[6] Four senior FDA officials reiterated the agency’s commitment to the transparency of findings from inspections at research sites outside the United States and oversight of clinical studies (and sites) “where conditions raise concerns about data integrity or genuine informed consent.”[7]

The senior officials said the FDA was “particularly concerned” about early-phase studies in countries “where geopolitical conditions make informed consent difficult to ensure, or where documented human rights concerns create a heightened risk that consent
was not freely and voluntarily given. Audits of clinical trial conduct (across trial phases) have revealed instances of fabricated participants, falsified health conditions, falsified laboratory results and concealed adverse events.”[8]

A related concern is that the efficacy and safety results of clinical trials without U.S. participants may be less likely to generalize to the U.S. patients for whom the treatments are intended. It has been known for years that new drugs and biologics should be tested in the intended populations, including people of various ages, genders, races and ethnicities.

At a time when the FDA often seems to have lost its way, it is refreshing to see senior agency officials speak out about the core regulatory issues of good clinical practices, high standards, research ethics and humansubject protections. The FDA must now promptly follow through on its commitments. The world is watching.

References

[1] Kang S, Ji Y. Geographic shifts in early-stage biopharmaceutical innovation. JAMA. 2026:335(15):1355-1357. https://jamanetwork.com/journals/jama/fullarticle/2846875. Accessed September 9, 2026.

[2] Pazdur R, Usdin S. The geography of pharmaceutical innovation. JAMA. 2026;335(15):1309-1310. https://jamanetwork.com/journals/jama/fullarticle/2846877. Accessed September 9, 2026.

[3] Kang S, Ji Y. Geographic shifts in early-stage biopharmaceutical innovation. JAMA. 2026:335(15):1355-1357. https://jamanetwork.com/journals/jama/fullarticle/2846875. Accessed September 9, 2026.

[4] Food and Drug Administration. FDA actions to support and strengthen domestic drug manufacturing. July 21, 2026. https://www.fda.gov/industry/fda-actions-support-and-strengthen-domestic-drug-manufacturing#:~:text=The%20FDA%20is%20taking%20decisive,to%20safe%2C%20effective%2C%20high%2Dquality%20medicines. Accessed September 9, 2026. 

[5] Food and Drug Administration. FDA expeditated investigational new drug (IND) pilot program. September 15, 2026. https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development/fda-expedited-investigational-new-drug-ind-pilot-program?utm_medium=email&utm_source=govdelivery. Accessed September 15, 2026.

[6] Davis M, Mikhail B, Tarver M, de Claro RA. Good clinical practices are not optional: the FDA’s commitment to human subject protections and gold standard science in an era of global clinical research. FDA Voices.  September 2, 2026. https://www.fda.gov/news-events/fda-voices/good-clinical-practices-are-not-optional-fdas-commitment-human-subject-protections-and-gold-standard. Accessed September 9, 2026.

[7] Ibid. 

[8] Ibid.