Global Regulatory Dissonance A Case Study of Industry Views on the Development of Drugs for Postmenopausal Osteoporosis

• Published in: Therapeutic innovation & regulatory science Vol. 49; no. 2; pp. 269 - 278
• Main Authors: Storm, Neal E., Richmond, Frances J.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.03.2015; Springer International Publishing; Springer Nature B.V
• Subjects: Bone density; Drug Safety and Pharmacovigilance; Global Perspectives; Osteoporosis; Pharmaceutical industry; Pharmacotherapy; Pharmacy; Product development; United States > US; divergence; precedents; convergence; guidance; dissonance; guidelines; alignment; strategy; harmonization
• ISSN: 2168-4790; 2168-4804
• DOI: 10.1177/2168479014558276

Background: The footprint of drug distribution is multinational, but the regulatory frameworks supporting drug development, review, and approval remain largely regional. As a result, industry faces regulatory standards that may be complementary, additive, or contradictory, resulting in global regulatory dissonance (GRD). Methods: Global regulatory dissonance was explored through a case study of drug development (postmenopausal osteoporosis) using survey methodology. Results: In the feedback received, respondents generally agreed that GRD increases the complexity, timelines, and size of registration studies. Dissonant regulatory feedback on proposed labeling, applications, and benefit-risk assessments was also reported. Multiple causes of GRD were identified, including dissonant drug regulatory authority advice, guidelines, benefit-risk assessments, drug approval precedents, medical standards of care, and health technology assessments. Harmonization of guidelines, scientific advice, benefit-risk procedures, and expanded use of mutual recognition agreements were identified as mechanisms thought to reduce GRD. Conclusions: The results suggest that global access to new drugs may be enhanced through a greater understanding of GRD.