Product Overview
Indications and Information from the IFU (Instructions for Usage)
- Classification: OsteoBoost® is an osteoconductive, synthetic bone graft
- Usage: Intended to fill bone voids and gaps not intrinsic to the stability of the bone
- Cleared for usage in extremities, spine, pelvis and cranium
- It may be shaped, injected or made into beads
Contraindications
- Not to be used to provide structural support
- Do not implant into an avascular site (site with no blood flow)
On-Label vs Off-Label Usage
- On-Label promotion: FDA monitors activities for all drugs and devices, including labeling, related to their approved / cleared indications for use. All labeling should be consistent with its approval / clearance.
- Physicians (Healthcare providers) are permitted to utilize devices in an off-label manner (in a way that is outside of the IFU prescribed labeling). FDA does not regulate the practice of medicine. Physicians take an oath to do no harm and utilize their own judgement for how they choose to use products.
- Industry is not allowed to “promote” or encourage the usage of products in ways that are outside of the IFU labeling or that is considered “Promoting Off-Label” which has serious implications.
Unsolicited vs Solicited Requests for Information
- FDA definition: Unsolicited Requests are those initiated by persons or entities that are completely independent of the relevant firm and are not solicited in any way by the distributor/representatives
- Requests that are prompted in any way by a manufacturer or representatives of the company are “solicited requests”
- FDA considers requests for off-label information that are prompted in any way by a manufacturer, representatives of the company, to be solicited which is “promoting off-label” and has serious consequences
- Mentioning any usage of OsteoBoost® not reflected in the IFU and prompting a surgeon/prescriber to request more information is considered a solicited request or promoting off-label as well
- Sharing information, suggesting new ways to use a product, discussing experimental data from studies, from industry meetings, other countries, anything not contained in the IFU or corporate brochure is considered promoting “off-label” or soliciting
Responding to Unsolicited Requests for Off-Label Information
- FDA states that Information distributed in response to an unsolicited request should be truthful, non-misleading, accurate and balanced, tailored specifically to the scope of the question.
- It should be responded to by the OMA
- If a question is very broad, it needs to be narrowed to what the surgeon/prescriber is asking and sent into the Office of Medical Affairs (OMA)
- The OMA will send out a scientific informational packet via email to the surgeon/prescriber directly, sharing the information that is in response to the request
- A direct email will be sent to the surgeon/prescriber with the packet and a response to their request for information within 24-48 hours
What information should be gathered for an unsolicited request?
- The unsolicited request that will be handled by the Office of Medical Affairs (OMA) will contain scientific data and documentation and will be emailed directly to the surgeon/prescriber
- Provide the following information:
- Full name and title (i.e. Dr. John Brown, surgeon/prescriber)
- Direct email address
- Hospital name, city, state
- The question(s), as closely paraphrased as possible and should be as specific as possible
How to submit an Unsolicited Request?
- Fill out the Form on behalf of the surgeon/prescriber
- Email to [email protected]
UNSOLICITED REQUEST FORM
ACCESSIBLE UPON PASSING
COMPLIANCE QUIZ