Human Factors Studies

Transcription

1 Human Factors Studies Generic Combination Products Moderator: David M. Fox, Partner Hogan Lovells, US LLP Panelist: Kirsten H. Paulson, Sr. Director Pfizer Inc. Global CMC-Medical Devices Panelist: Dick Horst, President UserWorks, Inc. Panelist: Tor Alden, Principal and CEO HS Design, Inc. FDAnews June 2017

2 Generic Drug-Device Combination Products: Guidance Documents Comparative Analyses and Related Comparative Use Human Factor Studies for a Drug-Device Combination Product Submitted in an ANDA (Draft, Jan. 2017) (ANDA Combination Product Draft Guidance). Considerations in Demonstrating Interchangeability With a Reference Product (Draft, Jan. 2017) (Biosimilar Interchangeability Draft Guidance). Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (June 2013). 2

3 FDA s Prior and Current Thinking What does it mean to be a therapeutically equivalent substitutable generic when the product incorporates a functional device component? [P]atients in an emergency situation can use the [proposed generic] product safely and effectively in accordance with instructions provided for the RLD without additional physician intervention or retraining prior to use. FDA-2007-P-0128, FDA P-0040 (July 29, 2009) (King Petition ) (emphasis added). Has evolved to... FDA does not necessarily expect for approval that a generic combination product be used in according to the RLD labeling per se, but rather it is critical that the generic combination product can be substituted for the RLD without additional physician intervention and/or retraining prior to use. ANDA Combination Product Draft Guidance at n. 12 (emphasis added). 3

4 Threshold Analyses: Compare Generic and RLD Devices FDA Recommends: Labeling side-by side comparison Comparative Task analysis Physical comparison of delivery devices If analyses show that user interface differences between generic and RLD products might not be minor: Consider changing the generic design, or Conduct Comparative Human Factors Study measuring error rates 4

5 Key Standard The objective of the comparative use human factors studies described in this guidance is to demonstrate that the use error rate, associated with a change in an external critical design attribute for the proposed user interface, does not preclude approval of the proposed product in an ANDA. A comparative use human factors study... should be designed to provide sufficient data to confirm that the use error rate, for the critical task(s) as impacted by the differing external critical design attribute of the delivery device constituent part for the proposed generic combination product, is not worse than the corresponding use error rate for the RLD when used by patients and caregivers in representative use scenarios and use environments consistent with the labeled conditions of use. ANDA Combination Product Draft Guidance at

6 What are the Human Factor issues or biggest challenges you see with Comparative Analysis & Comparative User Studies submitted in an ANDA? Integration of Delivery Device? Lack of adoption by healthcare services? Constraints of IP vs improvements to delivery? Increased budget / management oversight? Lack of Device Improvements? 6

7 Are there strategies you have developed for implementing Comparative User Studies? How do you decide what user population is required Does your company have a methodology to understand user needs vs new technology? Guidelines for testing? IFU s vs existing user population? 7

8 How does the new FDA s new guidance recommendations of Generic & RLD devices effect Threshold Analyses? Labeling side-by-side comparison Competitive Task Analysis Physical Comparison of delivery devices 8

9 Recommendations What do you do if the Analysis shows that the UI differences between the proposed generic and the RLD may not be minor? What are your best practices? What have you tried or are currently trying? Does the FDA or AAMI need to provide further standardization? 9

10 Open for Questions 10