An unsolicited request is a question about a medicine or device, most often about a use the label does not include, that a healthcare professional or other person raises with the company on their own, without being prompted by the company or anyone acting for it. The distinction matters because FDA allows a company to answer an unsolicited request for off-label information with truthful, balanced scientific information, while the same information offered unprompted could be treated as promotion of an unapproved use.
Quick answer: Under FDA's 2011 draft guidance, a request is unsolicited only if it comes from someone completely independent of the company. If the company or its representatives prompted it in any way, it is solicited. A private unsolicited request can be answered privately, tailored to the exact question, by medical or scientific staff separate from sales and marketing. A request made in public should get a public reply that only gives contact details and notes that the question concerns an unapproved use.
How FDA defines an unsolicited request
FDA set out its approach in the draft guidance Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, issued in December 2011 and still a draft. It says unsolicited requests are initiated by people or organizations completely independent of the firm. That can include healthcare professionals, health systems, academics, formulary committees, patients, and caregivers. Any request the company or its representatives prompted, however indirectly, is solicited.
The guidance splits unsolicited requests into two kinds. A non-public request is made privately, one to one, such as a call or email to the medical information team. A public request is made in a forum others can see, such as a question asked during a live presentation or posted on a website or discussion board.
| Situation, from FDA's examples | How FDA classifies it |
|---|---|
| A physician calls or emails medical information about an off-label use | Unsolicited, non-public |
| Someone asks the company's representative about an off-label use during a live presentation others can hear | Unsolicited, public |
| Attendees ask for more information after a company-sponsored promotional dinner | Solicited |
| A promotional piece invites readers to call or send a reply card for off-label information | Solicited |
How companies respond
For a private request, the draft guidance recommends that the answer go only to the person who asked, be tailored to the specific question, and come from medical or scientific staff who are independent of sales and marketing. If a question is broad, the team should narrow it before answering. Sales representatives who receive an off-label question should pass it to the medical function rather than answer it themselves.
Most companies answer common questions with approved, versioned documents. How those are built and kept current is covered in scientific response documents. Those documents are non-promotional and are usually reviewed through a medical process rather than MLR review for promotional materials.
For a public request, the public reply should be limited to contact details for the medical team and a note that the question concerns an unapproved or uncleared use. The scientific answer then goes privately to the person who follows up. This applies online too, which is why companies brief anyone who posts for them, including paid digital opinion leaders, on what to do when an off-label question appears.
Unsolicited requests in the field
MSLs receive many unsolicited questions during scientific exchange. The question itself is usually not the problem. What matters later is whether the record shows that the HCP raised it without prompting, who else was present, and what was provided. How an MSL documents that is covered in how an MSL records a scientific exchange.
A question raised at a joint visit with a sales representative, or after a promotional program, may be treated as solicited, so it should be routed through medical information and classified by compliance rather than answered on the spot. Every request, whatever its source, follows the same medical information request workflow: intake, triage, response, and a record, with any adverse event mentioned in it passed to safety.
Unsolicited requests and SIUU communications
In January 2025, FDA issued a separate final guidance on scientific information on unapproved uses (SIUU). It covers communications the company starts itself, such as sharing a published study on an unapproved use with HCPs, and sets out the disclosures and separation from promotion FDA expects. FDA's cover page says it is not for current implementation while parts of it are under review by the Office of Management and Budget. The 2025 guidance refers back to the 2011 draft for unsolicited requests, so the two cover different situations: one where the HCP asks, and one where the company chooses to share.
Routing the request
When a request becomes a case, it needs to be classified, answered from an approved source, and recorded. TikaMedInfo routes each request by on-label, off-label, and adverse-event or product-quality language, keeps versioned standard responses, and leaves a person to read the request and send the response. A more general definition of the request itself is in the glossary entry on the medical information request.
Frequently asked questions
What is an unsolicited request in pharma?
An unsolicited request is a question about a product, often about an off-label use, that comes from someone completely independent of the company and was not prompted by the company or its representatives. FDA's 2011 draft guidance allows companies to answer such requests with truthful, balanced, non-promotional information.
What makes a request solicited instead of unsolicited?
A request is solicited if the company or anyone acting for it prompted it in any way. FDA's examples include questions from attendees at a company-sponsored promotional event and requests generated by promotional pieces that invite readers to ask for off-label information.
Who should respond to an unsolicited request for off-label information?
Medical or scientific staff who are independent of sales and marketing. FDA's 2011 draft guidance recommends that sales representatives refer such questions to the medical function, and that the response go only to the person who asked, tailored to the specific question.
How should a company respond to an off-label question asked in public?
The public reply should give only the medical team's contact details and say that the question concerns an unapproved use, without any off-label information. The scientific answer is then provided privately to the person who makes contact.
If your team wants to see how a request is classified, answered from an approved response, and recorded, we can walk through it with a question your team received this month.
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Sources
- U.S. Food and Drug Administration. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. Draft guidance, December 2011.
- U.S. Food and Drug Administration. Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers. Final guidance, January 2025. Not for current implementation pending OMB review.
Glossary
November 1, 2026
