Biopharmaceutical Innovation

The “South Meets North” Summit will bring together leading local and international experts in Buenos Aires to exchange effective strategies in innovation-related policies.

A cornerstone of U.S. biopharmaceutical leadership, PDUFA has dramatically accelerated drug approvals and patient access, but looming FDA budget cuts threaten to unravel three decades of progress.

Continued innovation and investment is vital to maintaining the U.S.'s leadership in the biopharma sector.

Universities play a pivotal role in America’s technology economy, serving as a crucial source of research, inventions, patents, start-up technology companies, and regional economic and employment growth. The Bayh-Dole Act has played an instrumental role in spurring academic technology transfer activities that serve as vital drivers of American innovation.

Following the FDA's announcement to unleash AI and harness big data as core new priorities, ITIF released the following statement from Senior Policy Manager Hodan Omaar and Vice President for Global Innovation Policy Stephen Ezell.

President Trump has announced his intention to regulate U.S. drug prices. But the arguments in favor of doing so are wrong. Price controls reduce development of new treatments and cures, and hurt U.S. biopharmaceutical competitiveness.

Microgravity could be the next big breakthrough in drug development, but only if policymakers act now to turn space-based research from potential into progress.

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.