Source: American Enterprise Institute
Dr. Scott Gottlieb, the new head of the Food and Drug Administration (FDA), gave his first address to employees yesterday providing insight into the direction he wants to take the agency in.
His remarks echoed similar statements previously made by President Trump about streamlining the FDA’s operations to get new drugs and medical devices to market more quickly while also exploring options for keeping prices lower.
“Scientific advances also give us better tools to do our regulatory work. Many of these tools and resources are being developed right here at FDA, in our labs, and at places like NCTR (National Center for Toxicological Research). Twenty-first century challenges require us to modernize how we do our own work to take advantage of advances that can help us better protect consumers and promote health by making the regulatory process, itself, more modern and efficient,” said the commissioner.
Part of that plan will involve a change at the agency’s Office of Regulatory Affairs, reported Bloomberg.
The publication cited an internal FDA memo noting Gottlieb will implement a Program Alignment initially proposed four months ago making the staff of 4,000 investigators focus on overseeing specific product areas instead of activities in geographic regions.
The 20 district offices previously reported to five region heads, but staff will now report to six product-specific offices focused on areas like pharmaceutical quality, medical devices, tobacco, and food.
Another part of this regulatory reform effort will include implementing the 21st Century Cures Act, which was legislation passed at the end of the Obama Administration designed to open new avenues for enhancing investments in cancer research and similar fields.
Gottlieb also discussed drug prices in his speech emphasizing the need to accelerate approval and availability for low-cost alternative treatments like generics and biosimilars to give consumers more options.
Also, the commissioner pledged to combat opioid abuse adding that it was a public health crisis of staggering human and economic proportion.
“The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in giving health care providers the tools to reduce exposure to opioids to only clearly appropriate patients, so we can also help reduce the new cases of addiction. Addressing this tragedy is going to be one of my highest initial priorities,” he said.
He concluded his speech calling for staff to be patient-centric and science-based in every task they perform while ensuring they maintain the gold standard for regulatory science and independent decision making.
Gottlieb was officially confirmed by the Senate on May 9th. He was a physician-turned-health consultant who previously served as deputy commissioner of the FDA under the George W. Bush administration.
Filed Under: Drug Discovery
