Massachusetts Gets First Look at Gift Ban Rules

Bas van der Brugge

December 1, 2008

5 Min Read
Massachusetts Gets First Look at Gift Ban Rules

Sommer: Time for consideration.

Massachusetts life sciences organizations are continuing to work with authorities to develop implementing regulations for the state's new ‘gift ban' law, but not everyone is enthusiastic about the results so far.

Earlier this month, the Massachusetts Department of Public Health released its proposed regulations relating to the gift ban law, and now formalized as the “Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct.” Release of the proposal marked something of a victory for life sciences organizations, which had argued that the department's original plan to issue emergency regulations that would take effect on January 1, 2009, would not provide sufficient time for companies to gear up for compliance.

Instead, the new rules proposed by the DPH carry a compliance date of July 1, 2009, with the first reporting date of July 1, 2010.

“This new compliance date will provide additional time for medical device companies to develop procedures and processes related to collecting data on ‘reportable activities',” said Thomas J. Sommer, president of the Massachusetts Medical Device Industry Council (MassMedic; Boston).

MassMedic has been working closely with DPH, the Massachusetts Life Sciences Center, and the state's Executive Office of Housing and Economic Development to ensure that the proposed regulations address specific concerns of the medical device industry.

The proposed regulations suggest that the provisions of the ‘gift ban' law will apply only to sales and marketing activities at life science companies, and not to clinical trials or product development projects.

In addition, the proposed regulations allow medical device companies to pay for meals associated with technical training at corporate facilities that approximate a hospital setting. The language that expands meals payment restrictions is included in the first section of the draft regulations.

To bring its members up to speed on the proposed requirements of the code, MassMedic contacted the law firm of Foley Hoag (Boston) to prepare an analysis of the regulations.1 The analysis was prepared by three of the firm's attorneys: Colin J. Zick, counsel; Pat A. Cerundolo, associate; and Tad Heuer, associate. In their summary, the attorneys write:

  • First, the regulations establish a marketing code of conduct that applies to pharmaceutical and medical device companies. In developing this code, DPH declined to establish two separate codes of conduct for the pharmaceutical and device industries. Instead, the regulations apply the code differently to the industries in certain limited situations.

  • Second, the regulations mandate the implementation of certain training and compliance programs and related certifications to DPH for both pharmaceutical and medical device manufacturers.

  • Third, the regulations require pharmaceutical and medical device manufacturers to disclose certain payments and other benefits provided to certain health care providers, and clarify that disclosures are limited to sales and marketing activities. The disclosures will be publicly available for review on a dedicated Web site.

Cerundolo: Up to speed.

“These new rules will add to a growing list of initiatives that Massachusetts has undertaken to support quality and control costs in health care.” said Massachusetts DPH Commissioner John Auerbach in a press release. “Our goal in drafting these regulations was to uphold the intent of the law passed by the legislature and signed by Governor [Deval L.] Patrick last August; namely, to curb any inappropriate influence of industry sales and marketing activities on the independent clinical judgment of healthcare providers in the Commonwealth.

“We also wanted to strike a balance by promoting broad transparency of financial dealings between the industry and health care providers, while at the same time recognizing important and legitimate research occurring in Massachusetts,” Auerbach said.

Nevertheless, healthcare activists have expressed dissatisfaction with the shape of the proposed rules, which would place restrictions and reporting requirements on manufacturer payments for meals, but would permit manufacturers to provide healthcare practitioners with “reasonable compensation or expense reimbursements for genuine research or clinical trials pursuant to a written agreement,” without requiring any reporting of the relationship.

In a press release, the Massachusetts Prescription Reform Coalition (MPRC), a group focused on eliminating industry marketing practices that it believes inflate the cost of prescription drugs, expressed concern that DPH's proposed regulations do not provide adequate consumer protections. “MPRC is concerned that failure of DPH to require full disclosure of all payments to healthcare providers, as called for under the legislation, will adversely impact consumers. The draft regulations do not require companies to disclose fees for research and other consulting arrangements despite evidence that these payments are often exorbitant and strongly influential.”

DPH will hold two public hearings on the proposed regulations, on January 9, 2009, in Boston and on January 12, 2009, in Worcester. MassMedic has announced that it intends to present oral testimony at the public hearings before the Massachusetts Public Health Council on January 9, and will file written comments on the proposed regulations based on membership feedback.

“There are several areas of this proposal that need to be reexamined,” says MassMedic's Sommer. “A 60-day comment period and two public hearings will allow MassMedic to bring these issues up to DPH rule makers and offer alternative language.

Reference

1. CJ Zick, PA Cerundolo, and T Heuer, “Summary of Proposed DPH Regulations 105 CMR 970.000; Pharmaceutical and Medical Device Manufacturer Conduct (Boston: Foley Hoag, 2008); available from Internet: http://www.foleyhoag.com/newscenter/publications/alerts/life-sciences-alerts/life-sciences-alert-121508.aspx?ref=1.


© 2008 Canon Communications LLC

Return to MX: Issues Update.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like