Book contents
- The Cambridge Handbook of Compliance
- The Cambridge Handbook of Compliance
- Copyright page
- Contents
- Figures
- Tables
- Contributors
- 1 Introduction: Compliance as the Interaction between Rules and Behavior
- Part I Compliance Concepts and Approaches
- Part II Deterrence and Incapacitation
- Part III Incentives
- Part IV Legitimacy and Social Norms
- Part V Capacity and Opportunity
- Part VI Compliance and Cognition
- Part VII Management and Organizational Processes
- Part VIII Measuring and Evaluating Compliance
- Part IX Analysis of Particular Fields
- 55 Strengthening Tax Compliance by Balancing Authorities’ Power and Trustworthiness
- 56 Compliance in Occupational Safety and Health
- 57 Intellectual Property Compliance: Systematic Methods for Building and Using Intellectual Property
- 58 Insider Trading Compliance Programs
- 59 Antitrust Compliance: Collusion
- 60 Understanding AI Collusion and Compliance
- 61 HIPAA Compliance
- 62 Biopharmaceutical Compliance
- 63 Transnational Anti-Bribery Law
- 64 Data Security, Data Breaches, and Compliance
- 65 Doping in Sports: A Compliance Conundrum
- 66 Food Safety Compliance
- 67 Global Supply Chain Auditing
- 68 Corporations, Human Rights and Compliance
- 69 Aiming for Integrity with Integrity
- References
62 - Biopharmaceutical Compliance
from Part IX - Analysis of Particular Fields
Published online by Cambridge University Press: 07 May 2021
Book contents
- The Cambridge Handbook of Compliance
- The Cambridge Handbook of Compliance
- Copyright page
- Contents
- Figures
- Tables
- Contributors
- 1 Introduction: Compliance as the Interaction between Rules and Behavior
- Part I Compliance Concepts and Approaches
- Part II Deterrence and Incapacitation
- Part III Incentives
- Part IV Legitimacy and Social Norms
- Part V Capacity and Opportunity
- Part VI Compliance and Cognition
- Part VII Management and Organizational Processes
- Part VIII Measuring and Evaluating Compliance
- Part IX Analysis of Particular Fields
- 55 Strengthening Tax Compliance by Balancing Authorities’ Power and Trustworthiness
- 56 Compliance in Occupational Safety and Health
- 57 Intellectual Property Compliance: Systematic Methods for Building and Using Intellectual Property
- 58 Insider Trading Compliance Programs
- 59 Antitrust Compliance: Collusion
- 60 Understanding AI Collusion and Compliance
- 61 HIPAA Compliance
- 62 Biopharmaceutical Compliance
- 63 Transnational Anti-Bribery Law
- 64 Data Security, Data Breaches, and Compliance
- 65 Doping in Sports: A Compliance Conundrum
- 66 Food Safety Compliance
- 67 Global Supply Chain Auditing
- 68 Corporations, Human Rights and Compliance
- 69 Aiming for Integrity with Integrity
- References
Summary
Abstract: The global pharmaceutical market is projected to approach $1170 billion by the year 2021; the US market alone currently accounts for 45 percent of the market, at nearly $500 billion. International legal frameworks share fundamental characteristics governing the development, evaluation, and approval of drugs and biological products, including clinical trials demonstrating safety and efficacy; good laboratory, clinical, and manufacturing practices; appropriate labeling; and robust reporting and post-market surveillance. This chapter explores regulatory compliance in the pharmaceutical industry drawing from recent scholarship, federal agency reports and materials, and publicly available corporate resources. Coverage will focus specifically on the US market, with general discussion of international trends as well.
- Type
- Chapter
- Information
- The Cambridge Handbook of Compliance , pp. 909 - 923Publisher: Cambridge University PressPrint publication year: 2021
References
Ayres, Ian, and Braithwaite, John. 1992. Responsive Regulation: Transcending the Deregulation Debate. Oxford University Press.Google Scholar
Chrai, Suffly S., and Burd, Michelle. 2004. “Consent Decrees: Effects on Consumers, Companies, and Investors.” Pharmaceutical Technology 28: 168–82.Google Scholar
Deloitte Center for Regulatory Strategy, Americas. 2019. Leading in Times of Change: Life Sciences Regulatory Outlook 2019, www2.deloitte.com/content/dam/Deloitte/us/Documents/regulatory/us-insurance-regulatory-outlook-2019.pdf.Google Scholar
Glicksman, Robert L., and Earnhart, Dietrich. 2015. “Coercive vs. Cooperative Enforcement: Effect of Enforcement Approach on Environmental Management.” International Review of Law & Economy 42: 135–46.Google Scholar
Goldstein, Wendy C., and Snyder, Lynn Shapiro. 2003. “The OIG’s Draft Compliance Guidance for Pharmaceutical Manufacturers: One More Compliance ‘Script’ for the Healthcare Industry.” Food and Drug Law Institute Update 26–30.Google Scholar
Green, Michael D. 1997. “Statutory Compliance and Tort Liability: Examining the Strongest Case.” University of Michigan Journal of Legal Reform 30: 461–510.Google Scholar
Hale, Andrew, Borys, David, and Adams, Mark. 2011. “Regulatory Overload: A Behavioral Analysis of Regulatory Compliance.” Working Paper No. 11–47, Mercatus Center: George Mason University, 1–31.Google Scholar
Hans, Mohit, and Gupta, Suresh Kumar. 2018. “Comparative Evaluation of Pharmacovigilence Regulation of the United States, United Kingdom, Canada, India, and the Need for Global Harmonized Practices.” Perspectives in Clinical Research 9(4): 170–4.Google Scholar
Hindin, David A., and Silberman, D.. 2016. “Designing More Effective Rules and Permits.” George Washington Journal of Energy and Environmental Law 7: 103–23.Google Scholar
Miller, Jennifer E., Wilenzick, Marc, Ritcey, Nolan, Ross, Joseph S., and Mello, Michelle M.. 2017. “Measuring Clinical Trial Transparency: An Empirical Analysis of Newly Approved Drugs and Large Pharmaceutical Companies.” British Medical Journal Open 7: e017917. https://bmjopen.bmj.com/content/7/12/e017917.Google Scholar
Niedelman, Steven M. 2005. “Remarks at the Food and Drug Law Institute’s 48th Annual Conference.” Food and Drug Law Journal 60: 117.Google ScholarPubMed
Noah, Lars. 2000. “Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability.” Georgetown Law Journal 88: 2147–65.Google Scholar
Olson, Mary K. 1995. “Regulatory Discretion Among Competing Industries: Inside the FDA.” Journal of Law, Economics and Organization 11: 379–405.Google Scholar
Olson, Mary K. 1996. “Substitution in Regulatory Agencies: FDA Enforcement Alternatives.” Journal of Law, Economics and Organization 12: 376–407.Google Scholar
Olson, Mary K. 1999. “Agency Rulemaking, Political Influences, Regulation, and Industry Compliance.” Journal of Law, Economics and Organization 15: 573–601.CrossRefGoogle Scholar
Page, Robert A. Jr. et al. 2015. “Sustainability and Stratified Noncompliance in the Pharmaceutical Industry.” Journal of International Business Disciplines 1: 18–40.Google Scholar
Poska, Richard, and Graham, Ballard. 2009. “FDA 483 Responses-Suggestions for Industry.” Journal of Validation Technology 57–62.Google Scholar
Prayle, Andrew P., Hurly, Matthew N., and Smyth, Alan R.. 2012. “Compliance with Mandatory Reporting of Clinical Trials Results on ClinicalTrials.gov: Cross Sectional Study.” British Medical Journal Open 344: d7373. www.bmj.com/content/bmj/344/bmj.d7373.full.pdf.Google Scholar
Rabin, Robert L. 2000. “Reassessing Regulatory Compliance.” Georgetown Law Journal 88: 2147–65.Google Scholar
Sclar, David, and Keilty, Gary. 2012. “Sunshine and Strategy: Managing and Monitoring Compliance with PPACA’s Sunshine Provisions – Evolving Legal Requirements and Operational Considerations.” Health Lawyer 24: 14–24.Google Scholar
Tyler, Ralph S. 2013. “The Goals of FDA Regulation and the Challenges of Meeting Them.” Health Matrix 22: 423–6.Google Scholar
Wiktorowicz, Mary E. 2003. “Emergent Patterns in the Regulation of Pharmaceuticals: Institutions and Interests in the United States, Canada, Britain and France.” Journal of Health Politics, Policy, and Law 28(4): 615–58.Google Scholar