Legislative fixes are required for the Food and Drug Administration 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 authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive 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.
Plan Has Been Discussed Before
The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that 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 that resources can be used more effectively.
Increases in medical products that are imported into the United States 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," Ms. 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. The formal announcement coincided with the release of an agency report describing the circumstances the 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.
FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.
Forming a Regulators Coalition
The 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.
The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.
The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.
But Mr. 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.
This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.