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Brightening Up: The Effect of the Physician Payment Sunshine Act on Existing Regulation of Pharmaceutical Marketing

Published online by Cambridge University Press:  01 January 2021

Extract

In 2008 pharmaceutical companies spent over $12 billion on product promotion and detailing aimed at U.S. health care practitioners. Drug and device manufacturers rely on a workforce of detailers and physician speakers to reach health care practitioners and nudge their prescribing habits. To prevent undue influence and protect the public fisc, a number of states began regulating these marketing practices, requiring companies to disclose all gifts to practitioners, prohibiting the commercialized sale of prescription data, and prohibiting certain gifts altogether. The 2010 enactment of the Physician Payment Sunshine Act (PPSA) marks the first Congressional involvement in the regulation of disclosure related to pharmaceutical marketing. Overall, the Act improves transparency in pharmaceutical marketing to physicians and expands the regulation of disclosure of pharmaceutical marketing activities in important substantive ways.

Type
Independent
Copyright
Copyright © American Society of Law, Medicine and Ethics 2013

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References

See Congressional Budget Office, “Promotional Spending for Prescription Drugs,” Economic and Budget Issue Brief, December 2, 2009. This amount excludes the retail value of free product samples, direct-to-consumer advertising, and other expenditures such as research grants related to product use that may have promotional value.Google Scholar
See Wilson, D., “Data on Fees to Doctors is Called Hard to Parse,” New York Times, April 13, 2010, at B3.Google Scholar
Except Vermont.Google Scholar
Ross, J. Lackner, J. Lurie, P. Gross, C. Wolfe, S., and Krumholz, H., “Pharmaceutical Company Payments to Physicians: Early Experiences with Disclosure Laws in Vermont and Minnesota,” JAMA 297, no. 11 (2007): 12161223.Google Scholar
Paid to Prescribe? Exploring the Relationship Between Doctors and the Drug Industry, Before the Special Committee on Aging, 110th Cong. 253 (2007) (statement of Lurie, Peter M.D. MPH, deputy director of Public Citizen's Health Research Group, Washington, DC).Google Scholar
105 C.M.R. §§ 970.000, et seq.Google Scholar
Minn. Stat. Ann. § 151.461.Google Scholar
18 V.S.A. § 4631a.Google Scholar
Cal. Health & Safety Code § 119402.Google Scholar
CT ST § 21a-70e.Google Scholar
Nev. Admin. Code §§ 639.616 – 639.619.Google Scholar
D.C. Mun. Regs. tit. 17, §§ 8300, et seq.Google Scholar
Colorado Constitution, Art. XXIX, § 3. (Amendment 41).Google Scholar
Cal. Health & Safety Code § 119402; CT ST § 21a-70e.Google Scholar
IMS Health Inc. v. Mills, 616 F.3d 7 (1st Cir. 2010); IMS Health Inc. v. Ayotte, 550 F.3d 42 (1st Cir. 2008); IMS Health Inc. v. Sorrell, 630 F.3d 263 (2d Cir. 2010).Google Scholar
Sorrell v. IMS Health, Inc., 131 S.Ct 2653 (2011).Google Scholar
Eli Lilly Press Release. Lilly Set to Become First Pharmaceutical Research Company to Disclose Physician Payments, September 24, 2008.Google Scholar
Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119 (2010).Google Scholar
Sec. 6002. Transparency Reports and Reporting of Physician Ownership or Investment Interests (codified as 42 U.S.C.A. § 1320a-7h).Google Scholar
42 U.S.C.A. § 1320a-7h(e)(2).Google Scholar
42 U.S.C.A. § 1320a-7h(e)(5).Google Scholar
42 U.S.C.A. § 1395x(r).Google Scholar
42 U.S.C.A. § 1320a-7h(d)(3).Google Scholar
42 U.S.C.A. § 1320a-7h(d)(3)(B)(iv).Google Scholar
Proposed Rule, Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests, 76 Fed. Reg. 78742 (Dec 19, 2011).Google Scholar
Note that although reporting of NPI is reported, it will not be made available in the public data. We are unsure why this number will be withheld; the names of the physicians will be still be reported so they are identifiable.Google Scholar