类似的，另一企业认为“该调查虽然有助于FDA指导监管政策，但实际上属于国家药房部（State Boards of Pharmacy）所管辖的范畴”。FDA重申调查的目的仅是了解医护人员与患者对外观区别的看法，或许有助于指导针对患者或医师的教育项目，规避问题开启对话机制，而不是“意在指导药房运营工作”。
一评论者表示收集这些信息可能引发《健保流通与责任法案》（Health Insurance Portability and Accountability Act，HIPAA）相关问题。FDA对此保证，该研究得到了有关部门的批准，并交由熟悉程序的学术机构进行，并表示任何FDA人员都不会接触其中的个人信息。
As we reported in October of 2014 (here), the FDA announced that it was proposing to conduct a study of pharmacist and patient perception of changes in the physical attributes of generic products. This study is being designed by an academic institution to measure the impact of changes in shape, size and color of generic products. With 85% of all products being dispensed generically, and with new first time generics or different suppliers of generic products being dispensed, changes in the physical attributes of the product the patient receives may impact compliance rates, cause confusion in the patient and in some instances even stop the patient from taking their medication altogether.
When FDA first published the Federal Register (FR) notice announcing the proposed study they asked for comments and today, as a prepublication in the FR the FDA repeated its goal in conducting the study and outlined the comments received and provided their responses to those comments.
This is an important issue as FDA has issued guidance on size and shape of solid oral dosage forms and has hinted at the possibility of further changes or requirements. The industry should review the survey results carefully and provide their comments on any FDA report associated with the findings of the survey.
The Agency’s goal is stated as follows: To provide additional information that may help guide regulatory policy or pharmacy business practices, we intend to conduct surveys of pharmacists and patients about their perceptions about and experiences with generic drug product pill appearance change. These surveys are intended to further our understanding of the relationship between changes in pill appearance and non-adherence to prescribed therapeutic regimens. The surveys may enable us to investigate factors that may explain the association between changes in pill appearance and nonadherence, including which factors could be modified to improve the safe and effective use of generic drugs.
There were 10 comments received in response to the initial FR notice. Some of the more relevant comments are summarized below along with a summary of the FDA response.
Two companies addressed the issue of potential trade dress issues should the findings suggest that there should be no difference in appearance of brand and generic drugs. Interestingly, FDA responded that their goal is to obtain the perceptions of healthcare providers and patients, but not to mandate sameness in appearance or change any legal precedent or legal issue.
In a similar vein, one commenter noted “that the survey findings may be used by FDA to guide pharmacy business practice, which is the jurisdiction of the State Boards of Pharmacy.” The FDA reiterated its position that the goal of the survey is to obtain perceptions relative to changes that may provide guidance as to educational programs for patients and practitioners to help avoid problems and to open the dialog and that they had “no intent on guiding pharmacy business practice”.
One commenter expressed concern about gathering of data and potential HIPAA issues. FDA assured the commenter that the study is being conducted under approval of an institutional review board (IRB) and is being conducted by an academic institution familiar with appropriate procedures and indicated that no FDA staff will have access to personal information.
One comment noted that variances in shape, color, or other physical appearance characteristics could actually help patients and pharmacists avoid confusion. FDA acknowledged this fact and noted that it has decided to include additional questions to address this issue.
A full list of comments and the full FDA responses can be accessed here.
