Kyle Faget discusses Montana’s post-Phase I drug access law and its implications for FDA oversight

In a recent appearance on Health Care Network, Kyle Faget unpacked Montana’s new law allowing physicians to prescribe drugs after Phase I safety testing — well before FDA approval.

Kyle explained that the law builds on the federal Right to Try Act and FDA’s expanded access program, but departs from them in a critical way: unlike those programs, which limit manufacturers to recovering direct costs, Montana’s framework allows drug makers to monetize post-Phase I products without the disease-state restrictions that apply federally. She noted that oversight is comparatively light, resting on a facility licensure structure funded by an annual fee and a share of revenue, with no mandate by the state that insurers cover the products.

Kyle cautioned that the law carries real risk for sponsors. While Montana itself may not require reporting adverse events to FDA, sponsors with active FDA applications remain independently obligated to report safety signals — creating a back-channel link to federal oversight that could trigger a clinical hold on a broader trial program if a serious safety issue emerges. She also pointed out that sponsors will have far less control over which providers ultimately administer their investigational products than they do with traditionally vetted clinical investigators, a dynamic she expects could lead to market stratification between risk-tolerant early-stage companies and larger, more conservative sponsors.

Zooming out, Kyle framed Montana’s move as part of a broader trend of states stepping in where they perceive FDA’s regulatory posture as uncertain or politicized. She noted that federal preemption remains a live issue given the interstate commerce implications of drug supply chains.