The OCP is essentially an oversight body, assigning a combination product to the most appropriate center—CDRH, CDER, or CBER—based upon the primary mechanism of action. For most combination products, a second center is designated the consulting center. The OCP does not perform the actual regulatory reviews.
Where there is no clear regulatory path for a combination product, a manufacturer can file a request for designation (RFD) with the OCP, recommending the center it proposes for primary review authority. In the RFD, the company can provide justification for its position, including product information, proposed indications for use, any completed test results, and dose and method of administration for a drug or biologic. Experts suggest that manufacturers must take an active role in guiding the regulatory path for their products, even at the initial development stage; if they do not, "significant time and costs can be added to the approval process.'' [9. Lewin N. Faster approvals seen for drug and device combination products. BBI Newsletter 2003; 26(9):249.]
FDA review requirements are significantly more stringent for a combination product compared to a stand-alone device. A combination product assigned to CDRH rather than CBER or CDER "will significantly shorten the time to market for the product and decrease the costs.'' [10. Lewin N. Faster approvals seen for drug and device combination products. BBI Newsletter 2003; 26(9):248.] A comparison of some of the device and drug/biologic regulatory processes is illustrative:
• a device can use a prototype in a clinical trial, a drug/ biologic cannot;
• in vitro assessment is easy with a device, difficult with a drug/biologic;
• devices usually require only one full-scale clinical trial, drugs/biologics require two;
• the extent of required clinical data is low for devices, high for drug/biologics;
• the average number of patients in a clinical trial is hundreds for devices, thousands for drugs/biologics. [11. Lewin N. Faster approvals seen for drug and device combination products. BBI Newsletter 2003; 26(9):250.]
These are examples of where certain combination products fall in the new OCP regulatory scheme:
• Primary Approval Center CDRH (devices) and Consulting Center CDER (drugs): drug-eluting stent and bone cement containing antimicrobial agent.
• Primary Approval Center CDRH (devices) and Consulting Center CBER (biologic): recombinant human bone and catheter that delivers angiognesis gene to heart muscle.
• Primary Approval Center CDER (drugs) and Consulting Center CDRH (devices): prefilled syringe and dermal patch.
• Primary Approval Center CBER (biologic) and Consulting Center CDRH (devices): vacuum assisted blood collection systems and blood mixing devices and blood weighing device.
• Primary Approval Center CDRH (devices) and Consulting Center None (Device and Drug as separate entities): drug delivery pump and/or catheter infusion pump for implantation and devices that calculate drug dosages. [12. Intercenter Agreement between the Center for Drug Evaluation and Research and the Center for Devices and Radiologic Health http://www.fda.gov/oc/ ombudsman/drug-dev.htm (accessed October 2005).]
The OCP is a new agency, and snags in the regulatory process will continue to be worked out as more and different types of combination products are submitted. An important factor in the genesis and continued operations of the OCP is the active involvement of manufacturers and trade organizations, working cooperatively with the OCP and the respective centers (CDRH, CBER, and CDER) in all stages of the regulatory pre- and postmarket approval process.
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