The US Food and Drug Administration (FDA) can be a driving force for industry innovation but the agency needs a strong and talented workforce, Robert Califf, the recently confirmed FDA commissioner, said at the Food and Drug Law Institute's Annual Conference in Washington, DC, on Thursday.
"FDA can be the lynchpin between good ideas and good progress, and while I appreciate the often seemingly miraculous nature of some current scientific and medical developments, know that many promising new technologies fail when put to the test," Califf said.
He also noted that he had plenty of opportunity to reflect on such failures during the proceedings leading up to his confirmation in February.
"I had to make a list of all the trials that I led, a total of 64. The bad news is the majority were either neutral or negative for the sponsor of the study," he said.
However, Califf believes FDA can be a driver of innovation that leads to successful new technologies for both patients and companies.
"I've seen this first-hand," Califf said. Earlier in his career, as the director of a coronary care unit at Duke University Medical Center, Califf said he saw a high number of heart attack survivors dying within a month of having a heart attack.
"One in three people died in the first 30 days after a heart attack. Early in that first year [as director of the unit], some courageous cardiologist did the first angiogram showing a blood clot in the coronary artery. With a therapeutic target clearly identified, we developed global networks of clinical investigators who worked with industry, academia and FDA to develop and evaluate new drugs, biologics and devices. Although the vast majority of candidate therapies failed, we found a combination of therapies that cut the risk of death from heart attack by over 50%."
Califf said he attributes part of that success to FDA pushing for strong evidence to back the new therapies.
"The FDA plays a critical role—and played a critical role—in holding the line when zealous advocates claimed that good trials couldn't be done because of the emergency nature of the problem, and this insistence on high quality evidence guided the industry into effective innovations," he said.
"I truly believe this progress is a result of the guidance of the FDA, combined with the incessant ingenuity and drive to develop solutions by the biologists, doctors and engineers, and the huge number of people like you who, want to make the healthcare system work for the benefit of individuals and public health," Califf said, referring to the many drug and device lawyers and consultants in the audience.
However, Califf stressed that a strong FDA workforce is necessary for that type of collaboration to continue. An FDA official told Focus that there are more than 900 vacancies in CDER.
"We can't accomplish our mission and deliver on the promise of science with data-driven results and rigorous scientific research and analyses without sustaining, solidifying and strengthening our talented workforce," he said.
That, Califf said, is why strengthening FDA's workforce is his "number one priority" as commissioner.
Califf isn't alone in making this call. In March, Senate HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) introduced a bill known as the FDA and NIH Workforce Authorities Modernization Act, which would help the two agencies attract top talent.