FDA: Innovation Spoken Here

From digital submissions to integrated document control, the agency moves into the lean arena

Taran March @ Quality Digest

November 14, 2018

These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest has kept an eye on the FDA’s progress toward these goals. How well has it done? For a sprawling bureaucracy, marvelously.

One of the first pieces QD published this year was a declaration of intent from FDA chief Scott Gottlieb, who said the agency has recognized “when scientific innovations warrant new, more flexible regulatory approaches.” A number of specific changes that would speed products safely to market have been approved and developed, including harmonizing global standards, supporting electronic submissions, and clarifying and promoting a “least burdensome” approach to premarket reviews. The FDA has also embraced the idea of continuous manufacturing to help drug manufacturers and their customers save money.

“We must continually adapt our regulations to enhance efficiency and improve our effectiveness,” says Gottlieb. To that end, the FDA is updating its requirements for accepting foreign clinical data that are used to bring new medical devices to market. Gottlieb says this should “reduce the compliance burden on industry because it will harmonize with the standards currently used in drug regulation.”

Along those eye-opening lines was an August announcement by the International Organization for Standardization (ISO) that the FDA plans to use ISO 13485 —“Quality management systems—Requirements for regulatory purposes” for regulating medical devices. The U.S. Office of Information and Regulatory Affairs has placed the project on its docket.

“The FDA intends to harmonize and modernize the Quality System regulation for medical devices,” the office reported. “The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.”

Learn how digital compliance solutions can help you respond to new FDA and ISO regulations.

Get your free FDA/ISO Compliance toolkit now

On the digital front, the FDA has launched a new framework that allows the agency and manufacturers to come to terms electronically with new-device submissions. Its Electronic Submissions Gateway (ESG) enables secure submission of premarket and postmarket regulatory information for review. The ESG complies with secure hypertext transfer protocol (HTTP) messaging standards and uses digital certificates for secure communication.

The notion of a least burdensome approach has been hatching within the FDA since 1997, when the Food and Drug Modernization Act became law. In 2016, the 21st Century Cures Act clarified and expanded the concept. “The Cures Act extended the least burdensome provisions and their application to the premarket review process in new ways,” wrote Gottlieb and Jeffrey Shuren in February 2018. “It streamlined the FDA’s ability to remove the 510(k) submission burden where no longer needed for certain lower-risk devices.”

The updated clearance process makes use of science-based consensus standards and FDA-developed performance criteria as comparators when reviewing “certain well-understood technologies.”

The FDA calls it “continuous manufacturing,” but manufacturers will recognize (and surely welcome) that the agency has dsicovered lean concepts and is favorably impressed. As Gottlieb explains, continuous manufacturing methods “integrate traditional step-wise manufacturing processes into a single system that’s based on modern process monitoring and controls. This enables a steady output of finished drug products even as raw materials are continuously added to the closed system. The closed and continuous nature of these manufacturing systems means that the process is easier to control. These systems also require smaller footprints to operate.”

No real news to manufacturers, but it’s worth noting that the agency now champions continuous manufacturing for advanced domestic drug manufacturing, an industry that has traditionally been regulated to a walking pace.

“Drug makers won’t switch to these systems until we create a clear path toward their adoption and provide more regulatory certainty that changing over to a new manufacturing system won’t be an obstacle to either new or generic drug approvals,” he wrote in August 2018. “The FDA recognizes that it’ll require additional investment in policies and programs that’ll provide regulatory clarity to enable these new methods to be more quickly and widely adopted.”

Nothing reinforces a position like money, and Gottlieb also disclosed that the federal fiscal year 2019 budget has earmarked $58 million to accelerate “the development of the regulatory and scientific architecture needed to progress this technology.” And there’s money to be saved by drug manufacturers, he adds. “Continuous manufacturing technologies could save 30 percent in manufacturing costs. This estimate does not include the savings from potential future technologies. That totals $60 billion per year in savings in the United States. This can help reduce drug costs.”

At this year’s Master Summit, sponsored by MasterControl, QD’s Ryan Day spoke with Bryant Hedley, the FDA’s quality management information systems (QMIS) business manager and program director. MasterControl specializes in integrated quality management software systems, and Hedley was there on behalf of the FDA as a satisfied user.

Walking the talk: Bryant Hedley, the FDA’s quality management information systems (QMIS) program director, says the agency is meeting the standards it asks of others.

“We’re making sure that our document control is there, that we have good configuration management within our own system,” he told Day. “You can't go out there and actually audit somebody without having your own house in place. So that’s really what treatment we’re doing: making sure that we’re meeting those standards that we’re asking others to meet.”

Although Hedley is not one of the FDA auditors that manufacturers would meet face to face, he does provide support for them by ensuring a user-friendly experience with FDA documentation. “What we provide them from our side—my side—is a technical solution, working through MasterControl, and creating that quality management informational system that allows them to use the reports, the forms, the training modules, whatever it may be, that they need to be successful.”

It’s encouraging to know that a huge governmental entity is working to meet quality management system practices in much the same way as the companies it regulates. Given the FDA’s scale and focus, this can’t be a simple task. Hedley had this to say to manufacturers staring down the regulatory gun barrels:

“It’s amazing what the little wins will do for any organization, be it a government organization or industry. Those little wins are an important piece, and people sometimes think, ‘Let’s get to the bigger solution’—no! Think about, concentrate on, the little ones. Make those better, and eventually it will escalate into one big one. Don’t bite off too much.”

About The Author

Taran March @ Quality Digest’s picture

Taran March @ Quality Digest

Taran March is Quality Digest’s editorial director. A 30-year veteran of publishing, March has written and edited for newspapers, magazines, book publishers, and universities. When not plotting the course of QD with the team, she usually can be found clicking around the internet in search of news and clues to the human condition.