The U.S. Food and Drug Administration, the agency charged with protecting public health, is hampering innovation in the health care sector, according to former Oklahoma Sen. Tom Coburn.
The family physician and three-time cancer survivor called for a new national health care innovation strategy at the Westchester County Association”™s recent Health Tech ”™16 conference at the DoubleTree Hilton in Tarrytown.
“We currently have a regulatory environment that was built for the 1960s, and we have science that”™s cascading before our eyes with new innovation, new technology and an inability for government agencies to keep up with it,” he said.
Coburn, who serves as an advisor to the Manhattan Institute”™s Project FDA, an initiative that aims to reform the Food and Drug Administration, said at the Sept. 28 conference that discrepancy must be given more attention.
“Every year tens of thousands of people are dying that should not be dying and it”™s our inability to have a regulatory environment and a leadership system that would solve that problem,” he said.
One way to bring that number of deaths down, Coburn said, is to shorten the delay between the time a new drug is developed and when it is made available to the public. Coburn also called for enhanced funding to the FDA, which he said would make life-saving drugs available in a more timely manner.
“The limitations of new drugs is one of the things that really hurts us,” he said.
Coburn also proposed that the system of clinical trials should be modified and open to patients with less severe symptoms of certain diseases.
“The sicker patients are the ones involved in the clinical trials, therefore what we see in clinical trials isn”™t representative of the nation as a whole in a certain disease,” he said. “It”™s the sickest patients.”
Coburn said the FDA”™s inability to keep pace with new changes and advances in technology partly stems from the fact that it cannot compete with private entities in hiring prospective talent.
“There has to be a different way for us to figure out how we can actually compete in that area to give the agency the tools they need to work in terms of new drug approvals,” he said.
Another problem with the current system is the lack of data sharing between health care organizations, one that could be solved if sharing that data was incentivized, Coburn said.
“If we had an independent forum where we had data-sharing, you could participate knowing that you could get compensated if somebody makes a breakthrough from parts of your data and their data,” Coburn said, adding that the organizations could then share the intellectual property rights. “That sounds big and hard, but it”™s not big and hard. It”™s not nearly as hard as creating a chronic disease out of HIV.”Â
Coburn said the FDA’s regulatory review process must be modified with respect to the approval process for new drugs and to allow outside companies to develop treatments outside of the protocol.
“The goal in the future for our country and the saving of these tens of thousands has to be based on applied direction,” he said. “It cannot be based on the assumption that whoever is trying to help people has to prove they”™re innocent of any malfeasance before they can move forward.”
