FDA wants to expand its information sharing with the European Medicines Agency, but is not ready to say that it could rely only on foreign data to approve manufacturing facilities.

By using EMA inspection reports to determine whether a facility is acceptable, FDA stands to save millions of dollars, which could be redirected to inspection operations elsewhere.

FDA also has the statutory authority to implement such a policy with EMA. But FDA officials said they still are working on it.

When asked whether FDA could make an approval decision for a facility it has never seen based on EMA inspection information, the agency said it remains up in the air.

“Once you trust … then it doesn’t matter if [the inspection is] positive or negative,” EMA’s Anabela Marcal.

“I think that’s a consideration for the scope of the agreement,” said Dara Corrigan, FDA associate commissioner for global regulatory policy, during a Sept. 28 session at the Parenteral Drug Association-FDA Joint Regulatory Conference. “It has not been decided.”

FDA and EMA already share some inspection information, but FDA by law cannot transmit confidential commercial information to EMA. That means FDA inspection reports sent to EMA have redacted sections, unlike the EMA reports that FDA receives.

The 2012 FDA Safety and Innovation Act allowed the agency to give reports with trade secrets to another regulator if it has the ability to protect the information Also see "FDA Could Release GMP Data To Prod Manufacturing Improvements" - Pink Sheet, 16 July, 2013..

Corrigan said FDA still is trying to figure out the best way to use the statute with European Union countries.

Both FDA and EMA have different inspection methods and are trying to determine which differences matter.

“You look at [an inspection report] and you see whether our experts can look at that and know that they have the information they would need to make their own decision,” Corrigan said.

“What does reliance mean? Doing fewer inspections that we don’t need to duplicate or do so that resources are used in the right way and in the best way we can.”

Mutual reliance is one of the goals of FDA’s plans to deal with the globalization of the pharmaceutical industry.

FDA wants to develop a cadre of trusted regulators around the world in order to share the inspection workload and allow resources to be directed where they are needed most Also see "FDA Globalization Capacity, Shortage Monitoring Remain Concerns, GAO Says" - Pink Sheet, 11 February, 2015..

Globalization efforts also will be aided by a reorganization of FDA’s Office of Regulatory Affairs to align that staff more closely with various FDA centers.

The reorganization will create drug-specific inspection groups, moving away from the domestic geographically based field offices. Some drug inspectors also may have sub-specialties ([A#14150929002]).

FDA's Inspections In EU Actually Going Up

Some progress on mutual reliance with EU already appears in the works.

FDA may begin making adjustments to reduce inspections in the region going forward.

EMA decreased inspections in the US about 25% to 30% last year. But FDA increased its inspections in the EU 20% during that time.

FDA is changing its risk model for determining what facilities need to be visited, which likely will affect its EU inspections, said Karen Takahashi, a senior policy advisor in CDER's Office of Pharmaceutical Quality Office of Policy for Pharmaceutical Quality.

“Hopefully, in the next year they’ll start to be sort of tweaking the way the assignments are handed out,” Takahashi said. “[The risk model is] being re-assessed and part of that model is our reliance on other inspections from some of our regulatory colleagues.”

The potential benefits already are evident.

Corrigan said during the meeting that nearly half of FDA inspections, 43%, now are done in EU countries.

The high percentage is somewhat surprising given the headlines generated by manufacturing violations discovered in Asia, such as the problems found at a Ranbaxy Laboratories Ltd.’s facility in India ([A#28140124007]).

And the fallout from contaminated heparin made in China still resonates today ([A#00140908003]).

Corrigan said $18.5m in inspection costs could be used elsewhere if FDA did not inspect facilities in the EU, not including costs for attorneys and other related items.

FDA certainly could use the additional funding. In its fiscal year 2016 budget request, the agency said it would reduce some low-priority field operations so it could focus on more high-priority activities Also see "FDA Field Operations Would Endure Reductions Under Budget" - Pink Sheet, 9 February, 2015..

More Comfort With Negative Decisions?

Once an agreement is in place, there are industry concerns that FDA will not place as much weight on the positive inspection results it receives as the negative results.

Corrigan said the agency wants to have incentives for companies to improve and its system to recognize the good as well as bad facility inspections.

FDA's Ingrid Markovic, a biologist in the Center for Biologics Evaluation and Research, said during the conference that all inspection information is valuable, whether it is positive or negative.

EMA already has several mutual-reliance agreements in place with other countries where its staff will not inspect facilities there.

Anabela Marcal, head of the EMA Compliance and Inspections Department, said during the conference that its agreements include a fail-safe clause giving EMA inspectors the option to look over a facility in a mutual-reliance country if there is a major concern despite the inspection result.

But Marcal said that clause is not invoked often.

“Once you trust, once you have done all these assessments, then it doesn’t matter if [the inspection is] positive or negative,” she said.

FDA has initiated a number of pilot programs with EMA and other regulators to learn how each conducts inspections Also see "GMP Oversight Collaboration Helps FDA Plan, But Not Avoid, Foreign Inspections" - Pink Sheet, 8 August, 2011..

FDA Mutual Reliance With EU On Inspections Is Slow Going

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