- The FDA is urging healthcare stakeholders to provide input on how reshaping the agency’s complex regulations could better help the industry meet its most pressing public health needs, says Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis.
Feedback from the community, including those most affected by rules impacting the FDA’s many areas of oversight, will be critical for crafting a modern, equitable, and effective framework to ensure the safety and health of Americans.
“We’re at a moment of extraordinary opportunity to improve the public health,” Abram said in a blog post on FDA Voice. “New innovations are giving us fundamentally better ways to address disease. At the same time, we also face a lot of new challenges.”
“As part of our commitment to protect and promote the public health, we’re undertaking a comprehensive review of our regulations. Our aim is to ensure that our policies and regulations keep pace with the challenges we face in protecting consumers, and the opportunities we have to improve their lives. As in all our actions, science will remain FDA’s North Star when it comes to our role in devising regulatory policy.”
The 21st Century Cures Act is one of the primary catalysts for the broad restructuring effort, FDA Commissioner Dr. Scott Gottlieb said earlier in the summer. The bi-partisan legislation, aimed at modernizing the pharmaceutical development, testing, and research ecosystem, requires the FDA to take a new approach to governance of the quickly-expanding precision market.
“We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions,” Gottlieb wrote in July. “To build upon such opportunities, FDA will soon unveil a comprehensive Innovation Initiative.”
“It will be aimed at making sure our regulatory processes are modern and efficient, so that safe and effective new technologies can reach patients in a timely fashion.”
The FDA is exploring how to ensure that patients have access to the best – and safest – new therapies at reasonable costs, added Abram.
“We’re looking at places where FDA’s rules concerning new drugs are being used in ways that may create obstacles to the timely entry of generic competition,” she wrote. “We want to make sure our policies aren’t being misused in ways that thwart the competition that Congress intended when it created the modern generic drug framework.”
“We know that vigorous generic competition can help benefit patients by lowering drug costs, which improves access to medicines. It’s one example of where a closer analysis of our existing policies can help make sure our regulations are having their intended purpose.”
Creating a safe but competitive pharmaceutical development environment will likely require a rethink of regulations that may inhibit scientific advancement or inadvertently prevent developers and patients from benefitting from new breakthroughs.
“We need policies that are as modern as the products that we’re being asked to evaluate, and a regulatory framework that uses efficient tools to achieve our vital consumer protection role,” stated Abram.
Public input will play a major part in this process, she added, as the agency reviews the more than 4000 pages of rules included in the Code of Federal Regulations.
“We are opening a number of public dockets to solicit feedback from patients, consumers, health providers, caregivers, industry, health groups, academia, as well as state, local and tribal governments, and public health partners,” said Abram.
“We’re also exploring other opportunities to solicit input from stakeholders on this effort. We believe that engaging both internal and external stakeholders are critical to focusing our attention on where our policies might need updating; to ensure FDA’s work maximizes our public health purpose.”
The FDA has also developed a checklist of deliverables, including guidance, public meetings, and reports to Congress, that will contribute to this ongoing process.
“Our approach also aligns our efforts with the Administration-wide goal for federal regulatory reform to improve how government serves the American people,” Abram concluded.
“At FDA, we take seriously our responsibility to protect and promote the public health. This will be our guiding principle. We’ll use this opportunity to make sure our regulations reflect the new benefits that science and technology offer to advance opportunities for patients to improve their lives, and to strengthen our mandate to protect consumers. We look forward to your input and will continue to communicate our plans as we move forward on this endeavor.”