Drugs

FDA Denies Drug-Device Parkinson’s Petition

FDA has denied a US WorldMeds 7/21/15 petition asking that the agency require specific conditions for any application for a drug-device combination product containing apomorphine, intended for use in the advanced Parkinson’s disease population. Specifically, the petition asked that FDA:

require applicants to demonstrate that their drug-device combination products are supported by a device-use training program designed and proven through human factors testing to ensure that patients and care partners can safely and effectively use apomorphine as intended;
require applicants to demonstrate that the product is designed to account for the physical limitations and special needs of the advanced Parkinson’s disease population;
require that ANDA applicants demonstrate that their devices are the same as the reference-listed drug’s with respect to device-drug training and key design attributes and performance; and
require 505(b)(2) applicants to demonstrate that their products are supported by comparable device-use training programs as the listed drug relied upon and are designed to be safe and effective for use specifically by advanced Parkinson’s disease patients.

The agency denial letter says that in general, the need for training and the characteristics of such training are product-design specific determinations and it expresses the concern that categorically requiring a formal training program for any NDA-approved apomorphine-device combination product “could constrain the development of such products with user interfaces that reduce or eliminate the need for user training or retraining to the detriment of the public health.”

The letter also notes that FDA did not require the type of training program requested in the petition as a condition of approval for US WorldMeds’ Apokyn, the reference-listed drug.

FDA says it denied the requested action for ANDA applicants because it recognizes that a potential applicant with a proposed generic drug-device combination product may develop a user interface that has certain differences from that approved for the reference-listed drug. “FDA may accept such differences if they are adequately analyzed, scientifically justified, and do not preclude approval in an ANDA,” the letter says.

Finally, the agency says the request involving 505(b)(2) applicants was denied because the agency to date has not required any drug-device combination containing apomorphine and intended for use in the advanced Parkinson’s disease population to be supported by a validated user training program and does not agree with the petition’s request to categorically require all applicants to include such a training program.

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