In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials. “We have processes in place to make sure that the Centers are protected from any outside pressure, and that they’re focused solely on looking at the science and the data,” Hahn said. “I have absolute faith and confidence in those decisions.”

Hahn assumed leadership of the FDA on Dec. 17, 2019, just four weeks before the U.S. identified its first case of the novel coronavirus and China confirmed human transmission of the virus. During that month, he said he learned to “trust the career scientists. Trust the FDA. That has been a guidepost for me throughout the last year.”

When it comes to ensuring safe products and particularly the eagerly awaited vaccine, he urged the attendees at his virtual chat to do the same. “The incredible expertise, the commitment to public health, to protecting Americans is written in the DNA of FDA staff, and it’s helped us help the public through the pandemic.”

Hahn reiterated that the guidelines for vaccine testing laid out in June will guide the decision-making process and the timing. The agency expects to see mature safety and effectiveness of clinical data as well as manufacturing and quality data from a phase III trial that compares any candidate vaccine to placebo. The Vaccine and Related Biological Products Advisory Committee will review the data in public sessions, and they will advise the career scientists. He noted that the FDA will look to vaccine sponsors to decide whether they want to apply for emergency use authorization (EUA) or a biologics license application (BLA).

When pressed on the likely timing of authorization or approval of a vaccine by moderator Scott Whitaker, president and CEO of Advamed, Hahn reiterated, “We don’t know from an agency perspective when those data will be available. We are looking forward to receiving applications, but from a timing perspective, I don’t have a crystal ball; I can’t predict that.”

Hahn praised the public-private partnerships that enabled the rapid development of diagnostic tests and production of a sizable stockpile of ventilators. “The urgency everyone felt. Nobody was talking about cutting corners. Everyone was talking about how do we work together to get to the right place, understanding that the science and the data had to be behind it in order for FDA to authorize moving forward.”

The FDA recognized early on that streamlining emergency use authorizations was critical to facilitating public-private collaboration. That awareness led to creation of an EUA template for laboratory testing that identified the data elements needed for the agency to make the best decision quickly and adoption of a rolling review process that enhanced ongoing dialogue with companies to provide feedback to help construct data needed to get authorization. Adaptive trial design also sped the process by enabling quicker rejection of therapies that might not be effective and accelerating the process for those that looked to be more effective.

Diversity panel

After Hahn, the fireside chat moved to a panel format for a discussion of the other crisis that the pandemic has highlighted – disparities in health care. The devastating impact of COVID-19 on communities of color illuminated the need for greater diversity in med tech and health care and focused attention on how longstanding and long-ignored differences in underlying health conditions, access to care, and social determinates of health care influence clinical outcomes.

Patrick Hines, founder and CEO of Functional Fluidics, prompted the panel to look at the issue a little differently. He pointed out that ignoring communities of color had negatively affected all patients and led to another health care crisis that’s being exacerbated by the pandemic. Sickle cell disease, which primarily affects individuals of sub-Saharan African origin, was identified more than 70 years ago, but treatment for the disease has seen little innovation until recent years. Given that individuals with the disease suffer from chronic pain, earlier development of strategies to manage and diagnose their disease could have benefited all patients who experience chronic pain and perhaps giving physicians tools would have helped the country avoid the opioid epidemic, he observed.

Ashley McEvoy, executive vice president, worldwide chairman, medical devices at Johnson & Johnson, advocated Advamed’s top-down initiative, which she expected to be rolled out in the next 60 to 90 days, to unite stakeholders to join forces to effect lasting change by improving access to care and patient outcomes. In counterpoint, Carl St. Bernard, CEO of Celonova Biosciences Inc., noted that he was part of a bottom-up effort at GE Healthcare in the 1990s to “stitch together” the connections that could address disparities in health care for people of color much as Advamed now proposes. Thirty years later, he said, “the call to action is pretty clear. Just connecting people may not be enough. ... It’s high time that we really got going on this.”

St. Bernard also noted that thinking about global problems can quickly become overwhelming and encouraged attendees to consider what their companies are uniquely qualified to provide. “We have a deep, deep bench in educating physicians” and a “treasure trove of outcomes from common procedures.” Large med-tech companies could employ the data, people, metrics, skillsets and experience in their patient access and reimbursement programs to close the disparities gap by putting together targets for people of color and women, he said.

Hines took the idea a step further, urging large institutions and academic centers to pursue cross-institutional collaborations that leveraged their resources, technology and innovative approaches to address the critical issues in areas with greatest disparities in health care by joining with smaller, well connected community programs and providers. He also suggested that greater participation by people of diverse backgrounds in the development of devices and solutions could make sure that companies are thinking about addressing disparities in patients.

Changing how and where money flowed could also reduce these issues. Hines observed that “innovation tends to follow investment,” so that if investors place a higher priority on improving disparities in health care, the industry would see a change in the type of technologies that got to market. Similarly, if payers made covering therapies that reduced disparities or improved health for communities of color a priority, such as recently FDA-approved therapies for sickle cell, that would also have an impact.

In a return to the impact of the pandemic, panel moderator Kwame Ulmer, principal at Ulmer Ventures, asked what the panel thought about Wayne A.I. Frederick, the president of Howard University, encouraging African Americans to enroll in COVID-19 clinical trials at the university’s hospital. Hines noted that these communities are severely impacted by COVID, yet are still wrestling with the legacy of mistrust of medical systems arising from experiences of racism like the highly unethical Tuskegee experiment that began in 1932. Frederick’s appeal identifies a way for historically Black colleges and universities (HBCUs) to build trust between health care institutions and the community and to increase comfort with the safety of the technology itself.

As to the larger issue of diversity in med tech and commitment to eradicating disparities in care, Hines captured the sense of the panel: “The moral piece of this we all understand. Making the business case for integrating it into the DNA of these companies is the challenge of our lifetime.”