On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.” This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order to maximize the possibility that the drug and device will be approved and cleared in close temporal proximity.
AST devices are useful both on a personal level—informing the appropriate clinical use of antimicrobial drugs—and on a societal level—identifying the emergence of drug resistance and monitoring overall antimicrobial susceptibility changes. FDA has not traditionally considered ASTs or other microbiology diagnostics to be companion diagnostic devices (which are essential for the safe and effective use of a drug).
Suggested Co-Development: FDA recommends that drug sponsors, during the early drug development stages, discuss coordinated development opportunities with AST device manufacturers for multiple reasons. First, this provides device manufacturers access to biological samples and provides drug sponsors access to AST device technology which may be useful during clinical trials. Second, availability of the drug to multiple device manufacturers for AST device development may increase the number of AST devices that are available after approval of the drug.
Coordination of Review and Approval: In order to have the best chance of obtaining drug approval and device clearance at around the same time, FDA suggests the following steps be taken:
- The drug sponsor and device manufacturer should submit their coordinated development plans to CDER and CDRH (respectively) for review and comment—the drug submission to CDER should be made via CDER’s pre-IND consultation program for the Office of Antimicrobial products, and the device submission should be made via CDRH’s pre-submission program.
- Companies that are co-developing antimicrobial drugs and ASTs should request a joint meeting that would include the drug sponsor, device manufacturer, and personnel from both CDER and CDRH.
- The device manufacturer should, in its 510(k) submission, provide appropriate permissions to FDA from the drug sponsor to cross-reference information in the drug sponsor’s NDA to facilitate AST device review.
Nevertheless, the process is still dependent on CDRH’s communication with CDER during CDRH’s pre-submission process, as well as each center’s review processes. FDA makes clear that the drug and device will be reviewed independently and, therefore, there is no guarantee that approval and clearance will be close in terms of timing.
FDA requests that comments be submitted by November 21, 2016. If you have any questions about the draft guidance or would like to submit comments, please feel free to contact one of the Hogan Lovells attorneys listed above.