Diagnostics, Dietary Supplement Reforms on FDA Legislative Agenda

FDA legislative and policy staff continue to have their sights on urging Congress to take up reforms for medical diagnostics, dietary supplement listing/registration, and supply chain information updates. These are some of the top priorities the agency’s legislative staff are working on this year, FDA deputy commissioner for policy, legislation and international affairs Andi Fristedt told an Alliance for a Stronger FDA 1/13. She said a likely vehicle to which these reforms could be attached might be an upcoming bill on reauthorizing the Pandemic and All-Hazards Preparedness Act.

Provisions on diagnostics and dietary supplement reforms were noticeably missing in the year-end omnibus legislation that added many other FDA policy reforms, such as accelerated approval modifications (see earlier story). The agency had been hoping the omnibus could include the Verifying Accurate Leading-edge IVCT Development (VALID) Act that would have clarified its authority over lab-developed tests, but it and a dietary supplement listing mandate were omitted due to “opposition from stakeholders (including academic medical centers) as well as a reluctance by certain members to increase FDA’s authority,” according to a summary by the law firm Arnold & Porter.

This year, diagnostics and dietary supplement reforms continue to be legislative priorities for FDA, Fristedt told the Alliance. “We have really committed Congressional champions on both of these, and I think that we will see continued interest in thinking about how to advance these priorities on the hill.” She said Covid made it clear that diagnostics are an important part of the agency’s pandemic response, adding that diagnostics reforms added to the Pandemic and All-Hazards Preparedness Act reauthorization would not be a surprise.

Fristedt noted that FDA commissioner Robert Califf believes that the current situation with diagnostics is “untenable, and we have made clear that everything really remains on the table for the agency in terms of making sure that we are moving to a place where providers and patients can really have confidence in the diagnostics that they’re using, and that they’re accurate and reliable. And so, we’ll certainly be continuing that work inside the agency as well.”

With dietary supplements, Fristedt reiterated why the agency would like mandatory listing authority. “FDA does not have a systematic way to know, for example, when a new dietary supplement is marketed,” she told the Alliance. “This is compounded by the globalization of the supply chain and the explosion of the internet as a retail and distribution channel… And so that is a place that we will certainly continue to do really significant work.”

And regarding a supply chain information mandate, Fristedt said this continues to be something that her office’s global and policy work is largely focused on, such as “building” the agency's access to information being such an important part of supply chain considerations. “I think that there can be a bit of a misunderstanding about how much information and data FDA is entitled to under the law,” she said, adding that her shop will “certainly continue to work with Congress and thinking about what it looks like for FDA to really continue to sort of gain insight into the supply chains across the commodities that we regulate.”