While I was preparing a DSCSA resource list to be handed out at the Systech Uniquity event in Mumbai next week I stumbled across a document that the FDA recently posted on their website. It is a template for a DSCSA-specific information sharing agreement that is aimed at state agencies, like state boards of pharmacy and probably state’s attorneys’ offices and state bureaus of investigation, etc. The DSCSA contains several clauses that imply data sharing between the FDA and “…appropriate Federal or State official[s]”.
The problem is, the data that would likely need to be shared with those state officials might be confidential information, in some cases, provided in the heat of a recall or an investigation into suspect product. This could include the results of laboratory analysis of a suspect product performed by a manufacturer or other entity. This kind of information will need to be kept confidential until the FDA determines the appropriate action to take, whether it be a recall, a public notice, a referral to the Justice Department or some other action—maybe no action at all.
The new template can be found on the FDA’s webpage called “The DSCSA: Resources for State Officials”. The PDF file is called “DSCSA Long-Term 21 CFR §20.88 Information-Sharing Agreement Templates: DSCSA only”. The site offers a companion template file designed for both the DSCSA and data shared under the Compounding Quality Act called “Combined DSCSA and Compounding Agreement”.
The introduction to the DSCSA-only template says:
“Under this confidentiality agreement, you are committing, on behalf of your State agency, to protect the nonpublic information that FDA shares with individuals in your agency. This may include information for which public disclosure is prohibited by law, and information compiled for enforcement purposes. Any request to share this information outside of your agency must be approved in advance by FDA.”
Then, within the actual confidentiality agreement, we learn the type of information that may be exchanged by these agencies under the agreements:
“FDA is putting a number of new processes into place as part of its overall strategy to implement the Drug Supply Chain Security Act (DSCSA) […] Among these new processes are streamlined procedures for sharing nonpublic information under 21 CFR 20.88(d) and (e) to allow this information to be exchanged more efficiently while still adhering to Freedom of Information Act (FOIA) and disclosure laws. Under the streamlined procedures, FDA can rapidly share non- public information concerning drug supply chain security matters, including confidential commercial information and pre-decisional information, with State agencies and officials responsible for overseeing the security of the drug supply chain in their State. Information that can be shared under this agreement includes information pertaining to inspections and regulatory actions, including inspection reports (omitting trade secrets), warning letters, and enforcement actions.”
“In an effort to enhance regulatory and enforcement cooperation between FDA and State government officials who perform counterpart functions to FDA, FDA promulgated a regulation under 21 CFR 20.88 governing the communication of non-public information with State government officials. 21 CFR 20.88 permits FDA, on a discretionary basis, to release non-public predecisional, confidential commercial, and/or other non-public information regarding FDA-regulated products to State officials. As long as the requirements in 21 CFR 20.88 have been met at the time of the release, FDA’s release of non-public information to a State government is not a public disclosure and does not compel FDA, if requested, to release such information to the public. Non-public information that FDA shares with a State government agency is FDA’s property, loaned for the purpose for which it was requested or for other cooperative law enforcement efforts. FDA may take steps to retrieve the information shared with a State government agency at any time and it may initiate judicial proceedings if necessary [see United States v. Napper, The City of Atlanta, et al., 887 F.2d 1528 (1989)].”
If these passages concern you, I recommend that you read through the entire agreement template.
I don’t want to confuse anyone, these agreements will be executed between the FDA and various state agencies around the country. They are not for companies in the supply chain. But I think this new posting is a good indication that things are progressing at the FDA surrounding the DSCSA, and it is also a good indication that the DSCSA will result in closer relationships between the FDA and state enforcement agencies. Those relationships are likely to have a positive effect on tightening the security of the U.S. pharma supply chain.
I hope to see you at the Uniquity event in Mumbai.