Pharma on the Hot Seat
Document Type
Article
Publication Date
2007
ISSN
1526-2472
Publisher
American Health Lawyers Association
Language
en-US
Abstract
The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act’s statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital industry faced when Medicare promulgated major reimbursement modifications. The Article proposes that the pharmaceutical industry, in the face of such intense scrutiny and uncertainty, should implement more rigorous self-regulation. Without more stringent self-regulation, this intense interest in the pharmaceutical industry may result in a regulatory push that establishes unanticipated and cumbersome measures for the industry.
Recommended Citation
Nicole Huberfeld,
Pharma on the Hot Seat
,
in
40
Journal of Health Law
241
(2007).
Available at:
https://scholarship.law.bu.edu/faculty_scholarship/1936
