Biopharmaceutical Innovation

Counterfeit drugs are flooding U.S. supply chains—fueled by third-party sellers, drop-shipping, and weak online pharmacy oversight. The fentanyl crisis highlights the danger, but the issue runs deeper. Enforcement alone isn't enough. Congress and regulators must embrace digital solutions like blockchain, RFID tagging, and tamper-proof packaging to secure drug traceability and protect public health.

The Trump administration’s call for “most favored nation” drug price controls will lead to less biopharmaceutical innovation and reduced U.S. drug industry competitiveness. However, the president’s willingness to use tariff negotiations to press other nations to pay their fair share for patented drugs is salutary.

The Trump administration’s “MFN” drug-price proposal would pose a far greater threat to U.S. biopharma innovation than the Inflation Reduction Act, because unlike the IRA’s selective list, MFN could apply across virtually every medicine, multiplying the deleterious impact.

As part of its deregulation efforts, the administration should clarify Bayh-Dole march-in rights; rescind NIH Access Planning Policy; rescind FRA two-person train crew requirements; clarify requirements for manually operated driving controls; protect America’s innovative clean-energy technologies; and streamline regulatory permitting for semiconductors.

Watch now for a summit on Capitol Hill presented by ITIF, Purdue University, and the National Institute for Pharmaceutical Technology and Education (NIPTE) where top leaders in AI, pharmaceutical manufacturing, and public policy will discuss what must be done.

Instead of blanket tariffs, America should focus first on persuading other nations to pay their fair share, and then on supporting public-private investments in novel technologies that will make U.S. pharmaceutical producers more innovative and cost-competitive.

The United States shoulders the cost of global drug innovation—unless wealthy nations pay their fair share, future cures will stall.

To stay ahead in biopharma and ensure new therapies work for everyone, the U.S. must fix the diversity gap in biomedical research.

Follow-on biopharmaceutical innovations deliver substantial health and economic benefits by improving the safety and efficacy of existing therapies, addressing unmet patient needs, expanding therapeutic applications, and enhancing adherence. Supportive policies are essential to sustain progress and ensure broad access to these medical advances.

ITIF’s spring seminar course explores core emerging technologies and issues that are reshaping our world and, in the process, creating public policy challenges and opportunities. The course is open to congressional and federal staff only.