| Drug/device combination products raise compliance | | | | associated with drug/device combination product |
| and regulatory issues in the pharmaceutical industry. | | | | compliance. They first determine the drug/device |
| On their own, each drug and device has their own | | | | product's "primary mode of action." The OCP |
| specific type of marketing and good manufacturing | | | | analyzes what is the "most important therapeutic |
| practices regulation. However, when drugs and | | | | action of a combination product." Based on this |
| devices are combined together, they pose a new | | | | "primary mode of action," the OCP directs these drug |
| compliance question - how will this new combined | | | | device products to the following Centers based on |
| product be regulated as a whole? Pharmaceutical | | | | their analysis. The responsibility lies on the following |
| consultants point out there isn't one easy solution. | | | | FDA centers: Center for Biologics Evaluation and |
| Combination products consist of the following: | | | | Research (CBER), Center for Drug Evaluation and |
| products that are combined with two or more | | | | Research (CDER), and Center for Devices and |
| regulated drugs, devices or biologics (i.e. drug/device, | | | | Radiological Health (CDRH). |
| biologic/drug, or drug/device/biologic). Because of the | | | | Because of the regulatory complications associated |
| diversity of these drug/device combinations, a | | | | with combination products, the FDA created an |
| one-size-fits-all approach doesn't always work. For | | | | effective way to handle this problem. The OCP |
| example, these drug/device products may consist of | | | | wrote a SOP for IntercenterConsultative |
| either drugs packaged along with devices, or the | | | | Collaborative Review Process. It outlines the |
| drugs coated on devices. Another combination is | | | | necessary procedures and processes that the three |
| drugs and devices that are packaged separately. | | | | Centers must follow when reviewing combination |
| These separate drugs and devices may be produced | | | | products. |
| by different manufacturers. | | | | The FDA also consults with applicants and assists |
| Another issue that arises is the complexity of drug | | | | them with marketing applications. According to the |
| device combinations. Combined products could be as | | | | FDA, single marketing applications for combination |
| simple as a syringe pre-filled with drugs. They also | | | | products usually work for clearance. Dependent upon |
| could be as complex as chemotherapeutic drugs | | | | the combination product, the FDA may recommend |
| combined with monoclonal antibodies. | | | | two separate marketing applications. The FDA |
| The U.S. Federal Drug Administration (FDA) has made | | | | advises applicants to contact the OCP to discuss the |
| it a top priority to address these ongoing compliance | | | | appropriate marketing application based upon their |
| issues. They developed the Office of Combined | | | | drug/device combination. |
| Products (OCP) which was a result of the Medical | | | | Pharmaceutical consultants agree that the FDA's OCP |
| Device User Fee and Modernization Act of 2002 | | | | has made great strides over the past few years with |
| (MDUFMA). The OCP has taken the mystery out of | | | | compliance issues for drug/device products. The OCP |
| the compliance process for drug/device combinations, | | | | conducts trainings for both staff and applicants |
| and has proved successful. | | | | throughout the year to resolve combination product |
| The OCP's main priority is to ensure that these | | | | issues. |
| combined products are sent to the appropriate FDA | | | | If you liked this article, tell all your friends about it. |
| Centers. They oversee timely premarket reviews of | | | | They'll thank you for it. If you have a blog or |
| combination products. The OCP also oversees | | | | website, you can link to it or even post it to your |
| consistent, effective post-market regulations. | | | | own site (don't forget to mention as the original |
| However, OCP doesn't handle the entire process | | | | source. |