Agency Best Practice in Regulatory Compliance - Pharmaceutical Executive

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Agency Best Practice in Regulatory Compliance


Pharmaceutical Executive


The support and commitment of senior management is key, if regulatory compliance problems are to be prevented, or at least resolved. To that end, agencies must fund internal protocols to assure that there is an infrastructure for proper regulatory and legal review of all programs and materials sent to clients.

Invest in Compliance Education

Today the cost of doing business must include a line item for compliance training. For agencies, ongoing internal education for executive, senior, and mid-level staffers is critical to assuring that their regulatory knowledge is current. It's not enough to have only one or two individuals in-house who understand regulatory matters. All staff should be schooled on the basics, with management taking additional time to further expand its own level of knowledge.

"Internal education is the price of doing business in healthcare communications," says Susan Torroella, president and CEO of Columbia MedCom Group. "As one of the first medical education agencies to separate its accredited and non-accredited subsidiaries, we intimately understand that know-how in regulatory compliance must apply to both promotional and educational arms of the company."

Robin Winter-Sperry, MD, president, Scientific Advantage, concurs, "One of the best forms of risk reduction is education." She should know: Her company creates and trains medical-science liaisons (MSL) and medical-affairs teams, which play a key role in information exchange between companies and healthcare providers. "In essence, they can be models for compliance and professional ethics," says Winter-Sperry.

Consult Regulatory Counsel

Agencies should have access to regulatory insights from a team of experts with intimate knowledge of advertising, PR, advocacy, public affairs, and medical education. Program execution is becoming increasingly integrated, with various disciplines working together on large campaigns, so one-dimensional counsel may be inadequate. Compliance counsel is beneficial for both new business development and current client engagements.

Understand Compliance Systems

Reaching out to clients on a systematic basis will enable agencies to gain a better understanding of their own internal policies and procedures. Each client company will view the regulatory environment somewhat differently, so it is important for agencies to understand their clients' internal clearance process and how they must interact with them.

By the same token, marketers should insist that their agencies have processes to educate staff about the government regulations and policies, so that energy and time need never be wasted on themes, programs, or language that will not be used. Not far off in the future: a new standard of agency selection where agency-of-record status will be predicated on a mandatory level of regulatory training and certification.

Certainly an industry-wide policy that sets compliance as a goal for communications agencies—similar to the policy PhRMA has established for the pharmaceutical companies themselves—will fuel increased investment in compliance education.

For clients, keeping agencies informed of corporate regulatory policies is time-consuming. Pharmaceutical companies would benefit from programs for educating agencies about the company's position on compliance. Turn-key electronic training solutions can simplify the process so that frequency of interaction remains high, and costs low.

Clients must also set realistic expectations for their promotional materials, and not ask their agencies to do something that could later be construed as violative. Companies and agencies must discuss their attitudes toward government compliance during the materials-development process.

This is clearly not a time for agencies to be watching the evolution of public policy from the sidelines. Instead, they should be actively engaged in getting their own houses in order. Recognizing the challenges faced by their clients, they must work to stay ahead of the curve. Nor is this a time when pharmaceutical marketers should be testing the limits of government authority or patience. Instead, they should be well grounded in the realities of the enforcement environment. They must act accordingly and expect those around them to do the same.

Wayne L. Pines (
) is president of regulatory services and healthcare at APCO Worldwide. Ilyssa Levins (
) is president of HCIL Consulting.


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