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The Role and Responsibilities of a Sponsor’s Authorized Representative

November 19, 2015 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting

A person does not have to work in the field of US Regulatory Affairs for any meaningful length of time before needing to complete a Form 1571. Virtually all regulatory submissions pertaining to INDs include this document, which can be viewed as a tabular cover letter describing the contents of the submission.

Line 17 of the form identifies a person as the “Sponsor or Sponsor’s Authorized Representative” and, ultimately, that person signs the form.

The Role of the Sponsor’s Authorized Representative

We all understand that an IND is a request of the FDA to allow a Sponsor to initiate clinical trials with an experimental therapeutic agent. This fact often gets lost during the construction of the IND, however, as toxicology reports, CMC data, and clinical plans all get finalized, seemingly at the last minute.

When the dust starts to settle, the project team compares the checklist of documents to be submitted to the checklist of documents in-house, and when both match, the dossier is sent to the publisher for submission.

Usually, the person signing Form 1571 is a senior regulatory affairs professional, whose signature identifies that person to the FDA as the point person acting on behalf of the Sponsor. The signer has just acknowledged that he or she accepts the responsibilities of the Sponsor as detailed in 21CFR312.50.

Responsibilities of the Sponsor’s Authorized Representative

This sounds fairly straightforward, but as with all legal documents, the Authorized Representative should know exactly what obligations he or she assumes by signing the document. Without belaboring the issue, the Sponsor is responsible for:

  • selecting qualified Investigators;
  • providing Investigators with the information they need to conduct an investigation properly;
  • ensuring proper monitoring of the investigation;
  • ensuring that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND;
  • maintaining an effective IND with respect to the investigations; and,
  • ensuring that FDA and all participating Investigators are promptly informed of significant new adverse effects or risks with respect to the drug.

Except for very small companies, usually all of these functions are not the responsibility of a single individual, yet one person, by signing the form, assumes responsibility for all of these tasks.

Who Should be the Sponsor’s Authorized Representative?

Fortunately, very few INDs, if any, are submitted by Sponsors with no previous experience. In large and small pharmaceutical companies, the “C-level” and Director-level personnel have been involved in other drug development programs and they understand the requirements inherent in the submission of an IND.

The leaders of start-up and virtual biotechnology companies usually are seasoned industry veterans, but even those who are comparatively new to the industry understand the value of using experienced people for this vital task.

In all of these situations, the formation of strong project teams assures that each aspect of a drug development program is being attended to with confidence by appropriately trained and competent people.

Outside of the United States?

It is important to note that if the person signing the application does not reside/have a place of business within the United States, the submission must be countersigned by an authorized official who resides/has a place of business within the United States.

To some, this requirement seems to be unnecessarily xenophobic, but it has a much more practical function.

If, for any reason, the clinical program is shown to be out of compliance with US regulations, the FDA has already identified the person within US borders to go after!

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Image courtesy of Imgur

Wrap-up

Obviously, nobody wants to find himself in the latter situation. To avoid this possibility, the person signing Form 1571 as the Sponsor’s Authorized Representative must be aware of the requirements of the Sponsor and be confident that each requirement is being addressed by fully-competent colleagues.

The lead Regulatory Affairs professionals at IMPACT have the experience needed to assure that your IND submission meets the current expectations of the FDA. If you have any concerns about your program, give us a call at 919-899-9248 to arrange for a review.

Category: Regulatory Affairs, Drug Development Consulting
Keywords: Sponsor’s Authorized Representative, IND, Form 1571

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