Legislative fixes are required for FDA to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for similar authority over the drug industry that it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventative controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

The bill also likely will include new generic drug and biosimilar user fee programs (Also see ""Mega-UFA" Is Behind Schedule; Combined User Fee Bill Will Be Difficult, But Still Expected" - Pink Sheet, 14 February, 2011.).

Facility inspection fees have been anticipated as part of GDUFA but are a more contentious issue on the brand side (Also see "Is Silence Golden For Brand Companies On Inspection Fees?" - Pink Sheet, 4 April, 2011.). Inspection fees were part of Rep. John Dingell's (D-Mich.) globalization bill in 2009, but were removed from the Senate version, which stalled in that chamber.

PDUFA negotiations have wrapped up and GDUFA and MDUFMA talks are underway, but the agency has not started BsUFA talks yet.

Plan Has Been Discussed Before

The globalization plan will change FDA's thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so resources can be used more effectively.

Increases in medical products imported into the U.S. are outstripping resources and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the office of compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that's something I know Congress has taken a look at," Autor said during the announcement. "With that restriction we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months (Also see "FDA Globalization Efforts Gain Traction Even As Budget Request Emphasizes Old Inspection Model" - Pink Sheet, 21 February, 2011.).

The formal announcement coincided with the release of an agency report describing the circumstances FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan's implementation (Also see "FDA Appropriations Debate Moves To Senate, And From "Hard Science" To Harder Numbers" - Pink Sheet, 16 June, 2011.).

Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John Taylor, acting principal deputy commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming A Regulators Coalition

FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

FDA already has agreements in place with regulators in several countries that allow for information sharing. The agency recently announced it was making a joint-inspection program with the European Medicines Agency and Australian Therapeutic Goods Administration permanent.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared between the three agencies in the hopes of freeing resources for other needs.

But Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency's regulatory experience.

"What we're contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

More Data Sharing And Intelligence Gathering Coming

The agency also will be hoping to establish more data sharing capabilities and the use of third parties in the coming year. That would include a technology platform that can aggregate information from multiple sources and "proactively identify threats," according to the report.

Intelligence gathering and focusing inspections based on risk also are among the tenets of the plan. FDA expects to create a system for validating information gained from private third parties.

The agency is already contemplating adapting an internal certification program for inspectors to help bring contractors and others into the fold (Also see "FDA-EMA-TGA Joint Inspection Program To Be Permanent; Other Collaborations Expand" - Pink Sheet, 21 March, 2011.).

-Derrick Gingery (d.gingery@elsevier.com)

FDA Looks To Capitol Hill For New Authority For Globalization Plan

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