Drug Pricing - The Next Compliance Waterloo

Whitelaw, Seth; Fiorentino, Nicodemo; and O'Leary, Jennifer (2018) "Drug Pricing—The Next Compliance Waterloo," Mitchell Hamline Law Review: Vol. 44 : Iss. 4 , Article 2

40 Pages Posted: 27 Feb 2018 Last revised: 14 Oct 2018

See all articles by Seth Whitelaw

Seth Whitelaw

Mitchell Hamline School of Law

Nicodemo Fiorentino

Life Science Compliance Update

Jennifer O'Leary

Mitchell Hamline School of Law, Students

Date Written: October 8, 2018

Abstract

The current drug pricing war pits the pharmaceutical companies against doctors, hospitals, insurers, regulators, and consumers. The pharmaceutical industry has been fighting this war for more than two decades and is now engaged in a rearguard action. Their actions may delay the tidal wave of regulatory efforts, but, ultimately, the legislators, payers, and public will prevail. It is only a matter of time.

While legislative efforts continue to evolve, some form of transparency or disclosure is at the heart of all these efforts. Thus, the discussion has shifted from whether there should be disclosure to what information is needed and who will have access to the information. While the current landscape is tumultuous and unsettled, drug pricing transparency is not a topic that is going to fade away.

In the short term, for the pharmaceutical manufacturers facing an onslaught of pricing legislation, it comes down to trust, and trust is something that compliance professionals know a great deal about. Compliance professionals also have the tools and processes to help companies demonstrate social responsibility and trustworthiness. In other words, tools that will allow drug companies to demonstrate that they understand the "social contract." This radically new landscape, similar to physician payment transparency, is something compliance professionals have encountered before.

This paper explores the drug pricing transparency landscape and the role the compliance professionals can play in helping pharmaceutical companies handle the uncertainty.

Keywords: drug pricing, transparency, pharmaceuticals, pharmaceutical manufacturers, compliance, compliance officers, disclosure

Suggested Citation

Whitelaw, Seth and Fiorentino, Nicodemo and O'Leary, Jennifer, Drug Pricing - The Next Compliance Waterloo (October 8, 2018). Whitelaw, Seth; Fiorentino, Nicodemo; and O'Leary, Jennifer (2018) "Drug Pricing—The Next Compliance Waterloo," Mitchell Hamline Law Review: Vol. 44 : Iss. 4 , Article 2. Available at SSRN: https://ssrn.com/abstract=3127733 or http://dx.doi.org/10.2139/ssrn.3127733

Seth Whitelaw (Contact Author)

Mitchell Hamline School of Law ( email )

875 Summit Ave
St. Paul, MN 55105-3076
United States
2152751556 (Phone)

Nicodemo Fiorentino

Life Science Compliance Update ( email )

United States

Jennifer O'Leary

Mitchell Hamline School of Law, Students ( email )

875 Summit Ave
St. Paul, MN 55105-3076
United States

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