FDA’s tech overhaul is underway

FDA’S TECH OVERHAUL IS UNDERWAY — The agency is pulling inspiration everywhere from the Pentagon to agile tech companies in a push to modernize its IT infrastructure and data strategies, FDA Principal Deputy Commissioner Amy Abernethy told POLITICO.

The oncologist, who joined the FDA a little under a year ago from the Roche-owned health tech company Flatiron Health, is heading up a three-pronged tech modernization plan aimed at overhauling the agency’s mountains of data and eventually speeding up review processes.

FDA used the Pentagon as a model for its new data storage and management techniques as the agency shifts toward cloud-based data that can be used and exchanged rapidly in the future, Abernethy said in an interview. “But culturally, we are looking to look more like a solid-looking technology company that is able to pull together teams in a very efficient way,” she said. “Governments tend to be pretty hierarchical and fixed.”

The modernization plan is a priority for new commissioner Stephen Hahn. “That is where Dr. Hahn’s interests and excitement lies. As we build a robust and durable technical organization, it allows us to do a number of things.”

The potential starts with a speedy safety data reporting plan that the agency is phasing in over two years after a five-company pilot program proved a success.

“If we can start receiving safety data that way, think about all the other kinds of information we can receive directly from industry and in other places,” she said. “It starts to set the stage for moving from massive applications that are 300-page PDFs to now, component information that can be more rapidly analyzed.”

AND A DATA CHALLENGE  FDA Monday announced a challenge that will allow scientists to use its data to detect possible drug-related adverse event patterns. The contest, which starts Friday and ends Feb. 28, offers no cash award, but is intended to bolster FDA’s existing data mining and case review approach to finding safety problems.

The full announcement will be available on Friday here. To attract talent it should be publicized widely not only among data scientists but also social scientists who may have good ideas for detecting anomalies, said Raj Ratwani, director of the MedStar Health National Center for Human Factors in Healthcare.

“Drug safety events don’t occur in a vacuum, and FDA data is only one piece of the puzzle,” said Ben Moscovitch, who leads EHR safety efforts at the Pew Charitable Trusts. “Other factors—such as the design, implementation, and use of EHRs—can lead to the harm.”

FDA KICKS OFF STRING OF PAIN DRUG ADCOMS — The FDA will review a handful of pain medications this week, including some new opioids, as the country continues to struggle with misuse and addiction to narcotics.

Members of Congress have criticized the FDA in recent years for approving new opioids. But the agency defended the role of drugs in the treatment of chronic pain in documents prepared by the agency in advance of today’s meeting to consider Nektar Therapeutics’ oxycodegol. FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will consider the drug to manage chronic low back pain in adults who require around-the-clock, long-term treatment for whom other treatment options are inadequate. They will also consider approving the drug more generally for chronic pain.

Rigoberto Roca, acting director of FDA’s addiction medicine and pain medicine division, pushed back against claims that opioids are not proven to be effective beyond 12 weeks, the typical length of clinical trials testing for effectiveness. “An absence of evidence has been misinterpreted as evidence of an absence of effect,” he wrote. Roca also rejected the idea of “absolute limits” on the total daily dose of opioids for pain management.

Diana Zuckerman, a drug safety expert at the National Center for Health Research, said the panel should reject oxycodegol. The key trial for the drug had a high dropout rate and it performed only marginally better than placebo, she said. “Instead of comparing it to over-the-counter pain medications they compared it to nothing and yet it had little impact for a small amount of time,” she said.

… On Wednesday, the advisory committees will discuss two more. The morning docket holds Esteve Pharmaceutical’s application for a drug combination of the opioid tramadol and the anti-inflammatory celecoxib, to treat acute pain in adults. Esteve says the pill offers a safer alternative to other pain relievers by including lower-than-recommended doses of each drug, according to FDA materials for the meeting, but the company presented no data to conclude that the combination is better or worse than other approved pain relievers. Tramadol was less frequently implicated in prescription opioid misuse than hydrocodone and oxycodone, but overdose deaths involving it increased from 2011 to 2017.

In the afternoon session the committees will discuss Aximris XR, an extended-release oxycodone pill designed to make it hard to crush the drug so it can be snorted or injected. The committee voted 22-1 to reject an earlier version submitted in 2017 under the name Rexista; at the time it contained a blue dye that was released when the pills were crushed. But the dye hadn’t been tested for safety and some panel members felt that rather than discouraging use, blue lips might make the drug attractive to abusers. Like the older version, the new drug contains a material that makes it gel in an unappealing way when crushed.

On Thursday the Anesthetic and Analgesic Drug Products panel considers Durect’s bupivacaine, a non-opioid anesthetic, proposed for post-surgical pain.


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