Prepare the Generic Drug Enforcement Act statement

What should the GDEA statement address for an abbreviated drug application?

Address the specified convictions during the previous five years involving the applicant and affiliated persons responsible for developing or submitting the application. Establish the covered parties, events and interval before drafting. This disclosure under section 306(k)(2) is separate from the debarment certification under (k)(1); a negative debarment-list search does not establish that there are no responsive convictions.

Before you begin

Application-specific GDEA factual review, including the abbreviated-application conviction disclosure in 21 U.S.C. 335a(k)(2).

What you will prepare: A supported statement or disclosure for authorized regulatory/legal review.

Separate two related factual questions

The statute addresses an application's certification about use of debarred persons and, for an abbreviated drug application, a list of specified convictions during the prior five years involving the applicant and affiliated persons responsible for development or submission. These are not interchangeable checks.

Use the debarment-certification guide for that distinct statement. For the GDEA disclosure, ask the regulatory/legal owner to establish the actual applicant, relevant affiliated-person scope, covered convictions and applicable five-year interval. Do not broaden the statement to every criminal matter everywhere, or narrow it to names currently appearing on an FDA list, without the governing analysis.

Create a traceable factual review before drafting

Prepare a controlled evidence record with the entity/person scope, responsible information owners, questions asked, dates covered, responses received and unresolved issues. Corporate name changes or acquisitions may require additional identity work. A missing response is not a negative finding.

For an identified matter, collect the legal entity/person, jurisdiction, conviction date and nature of the matter for counsel to determine whether and how it is covered. Keep sensitive supporting records in the appropriate controlled location; the public guide supplies no real identities or legal conclusions.

An editorial statement outline is: applicant/application; statutory purpose; established disclosure scope; responsive disclosure or supported conclusion; references/attachments as appropriate; authorized execution. Do not offer a pre-signed “none” declaration.

Worked review: a list search answers the wrong question

Fictional editorial exercise: an author finds no matching names on a debarment list and concludes that there were no reportable convictions in five years. The inference is unsupported: the list and the conviction inquiry serve different purposes.

Obtain the scoped confirmations and resolve any legal interpretation before finalizing. If the application is not an abbreviated application, reassess the specific conviction-disclosure provision rather than copying the ANDA statement. Retain the current source and the actual legal review for the filing; source access limitations in this guide are not a substitute for that assessment.

Turn the legal scope into an answerable factual inquiry

The writer needs a defined inquiry and explicit responses. A broad email asking whether anyone has a “GDEA issue” leaves recipients to interpret the scope differently. Ask the responsible regulatory/legal reviewer to establish the inquiry, then retain the evidence supporting each response.

Section 306(l)(1) uses a meaning of conviction broader than a final judgment after every appeal. It includes an entered Federal or State court judgment despite a pending appeal, an accepted guilty or nolo contendere plea, and participation in specified first-offender, deferred-adjudication or similar programs where judgment has been withheld. Do not ask only whether someone has “served a sentence.” Equally, a complaint, allegation or arrest should not automatically be labeled a conviction. Obtain the actual disposition and have the reviewer determine its significance.

The referenced categories in subsections (a) and (b) are detailed and differ for individuals and entities. Do not reduce them to “all felonies” or “only FDA convictions.” The working record should preserve the facts needed for the legal classification without asking the author to infer it from a case title.

Fictional review exercise: an affiliated contributor answers that there is no conviction because an appeal is pending. The underlying record shows an entered judgment. The writer should not copy that answer as a negative finding: subsection (l)(1) specifically addresses pending appeals. Collect the court record, event dates and role in this application; route the matter for assessment against the covered offense categories and five-year interval. The exercise does not establish that this particular matter must be disclosed without that assessment.

If a filing moves, revisit the interval and factual confirmations. A response that was complete for an earlier proposed submission date may not cover later events. Document the update rather than silently reusing an old signature package.

Keep the debarment certification and the GDEA disclosure reconciled but separately supported. The ANDA basis statement establishes a different question: the regulatory reference for the proposed generic product. None of these documents substitutes for the others.

Source edition: the linked GovInfo compilation was retrieved October 6, 2026. Its cover identifies amendments through Public Law 119–75, enacted February 3, 2026; the PDF carries an August 7, 2026 production date. Those dates have different meanings. The compilation itself is not the official statutory edition. Use its stated revision alongside the official Code source and confirm legal currency for the actual filing.

Frequently asked questions

Sources and revisions

Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.

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