Last month, the Food and Drug Administration, the European Commission, and the European Medicines Agency announced that they had signed confidentiality commitments to facilitate sharing non-public information related to establishment inspections. The commitments tie in with the regulators’ broader initiative to recognize each other’s current good manufacturing practice inspections.
Press reports about these commitments have focused on FDA’s new commitment to share trade secret information with its EU counterparts. This development is not insignificant, but FDA’s authority to share the information is subject to notable limitations.
What else is noteworthy about these commitments? FDA’s agreement not to publicly disclose certain categories of information it receives from the EU regulators. This development is of interest because, as of 2012, FDA has had the authority not to publicly release certain non-public information received from foreign governments that it would otherwise have to release under the Freedom of Information Act (FOIA). As a result, FDA is authorized, and arguably has committed, to withhold certain non-public information it receives from its EU counterparts, even if the information forms the basis of an enforcement or regulatory action, such as a warning letter issued for failure to comply with cGMP or a response to a citizen petition. The Agency has yet to announce that it intends to exercise this authority; however, its potential implications should be on stakeholders’ radar as FDA begins to recognize the inspections of EU regulators as part of its Mutual Reliance Initiative.
FDA’s Commitment to Share Trade Secret Information with EU Regulators
FDA has long shared non-public information, including confidential commercial information, with its EU counterparts, pursuant to FDA regulations. FDA regulations do not authorize the sharing of trade secret information; however, as of the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in July 2012, FDA has had the authority to share certain trade secret information with foreign governments under limited circumstances, under Section 708(c) of the Federal Food, Drug, and Cosmetic Act. The confidentiality commitments signed last month mark the first time FDA has entered into an agreement to use this new authority to share trade secret information with a foreign regulator.
What information can FDA now share and in what circumstances? As long as FDA has a confidentiality commitment in place that meets statutory requirements, the Agency can share trade secret information:
The first category of trade secret of information is subject to a major limitation: it is constrained to trade secret information that the foreign government already has the authority to obtain. If a foreign government lacks the authority to obtain trade secret information from an establishment, it will be unable to receive that information from FDA.
The second category of trade secret information that FDA can share with a foreign government is limited to circumstances in which FDA believes that a drug has a reasonable probability of SAHCODHA, and then only “as part of an inspection” or to alert foreign governments to the potential need for an investigation.
Section 708(c) of the Act does not contain broad authority for FDA to provide trade secret information to foreign governments; however, this new information sharing pathway does has the potential to be useful. For example, even if a foreign government already has the authority to obtain information by other means, FDA’s ability to share unredacted inspectional observations or conclusions with the foreign government could prevent delays in its access to safety-related information.
If FDA wants to share trade secret information with foreign regulators, it must document that each of the requisite statutory criteria have been met. For example, if FDA shares trade secret information with one of its EU counterparts, it will need to have documented, among other things, its determination that the foreign regulator already has the authority to obtain the information and the basis for that determination. Or, in another example, if FDA wants to share trade secret information with a foreign regulator because it believes that a drug has a reasonable probability of causing SAHCODHA, it will need to document its support for that determination. The administrative records for at least some of these determinations likely will need to be made on a case-by-case basis. The Agency has yet to announce how and whether it intends to develop, maintain, and make available the administrative records supporting these determinations.
Finally, it is important to note that the confidentiality commitments referenced above do not cover sharing the information with individual countries that are members of the EU; FDA still needs to enter into commitments with those countries for the types of trade secret information at issue to be shared.
To enter into such a commitment with another country, the FDA Commissioner him or herself has to certify that the government of that country has the “authority and demonstrated ability to protect trade secret information from disclosure.” FDA has not articulated how it might make that type of certification for member countries. The foreign government also has to commit to protect the information exchanged from public disclosure, unless the sponsor gives written permission to disclose, or the Secretary of HHS makes a specific type of public health emergency declaration.
FDA’s Commitment to Withhold Non-Public Information It Receives from EU Regulators
As noted above, the newly signed confidentiality commitments also include FDA’s agreement not to publicly disclose certain non-public information it receives from EU regulators, without the written authorization of the owner of the information. This aspect of the commitments is significant, especially given FDA’s new authority to withhold from the public certain information received from foreign governments.
Section 708(b) of the Federal FD&C Act, added by FDASIA, provides that FDA does not have to release under the FOIA “any information relating to drugs,” that a foreign government voluntarily gives FDA, on certain conditions:
Section 708(b) also provides that the written agreement between FDA and the foreign regulator must specify the time period within which FDA agrees to withhold the shared information. If no time period is specified, then, after 36 months, FDA has to use the FOIA for determining whether information must be released publicly.
It is not clear whether FDA intends to use its Section 708(b) authority to withhold information received from EU regulators pursuant to the confidentiality commitments signed last month. The commitments do not explicitly call out Section 708(b) and do not include a time period within which FDA must keep the information non-public.
Most of the types of non-public information cited in the commitments as examples of information FDA might receive from the EU regulators include information FDA would generally have the authority to withhold under FOIA; however, the commitments do cite to certain types of information—e.g., national security information, law enforcement information, and internal, pre-decisional information—that FDA arguably would not have the authority to withhold under FOIA if received from a foreign government. FDA would have to invoke Section 708(b) to withhold records it could not otherwise withhold under FOIA. (For you FOIA experts out there, Section 708(b) is an Exemption 3 statute, so FDA would cite to Exemption 3 as a basis for withholding such records.)
What are the implications of FDA’s agreement to withhold non-public information received from its EU counterparts? As noted above, they could be significant, especially as FDA begins to recognize the cGMP inspections of EU regulators as part of its Mutual Reliance Initiative. If FDA is authorized, and has agreed, to withhold certain information it receives from EU regulators, it could obscure Agency transparency in a variety of ways. For example, FDA could withhold information that forms the basis, in whole or in part, of an Agency action. FDA could also choose to withhold certain types of information received from a foreign regulator that FDA would not ordinarily consider withholdable under FOIA—given, for example, FOIA's presumption of disclosure for deliberative process and certain law enforcement agency documents—but that the foreign regulator does. As such, stakeholders should be aware of the contours of this authority and its potential implications.
In November, I will be speaking on a panel at the FDANews Inspections Summit entitled “US/EU Mutual Recognition of Drug GMP Inspections: Practical Consequences for Manufacturers,” which likely will cover these and other issues. Join me and my fellow panelists there!