Drug Industry to Revise Marketing Code | Medtronic Sprint Fidelis Lead Recall Lawsuit Attorney

Given the growing number of reported problems involving fractures and shocks with the Medtronic Sprint Fidelis leads and the increasing lawsuits filed by Medtronic recall patients throughout the United States it is instructive to look at the drug industry’s latest voluntary marketing guidelines that are expected to be announced this week. Although the guidelines do not apply to medical device companies it reveals the close relationship between the drug and device manufacturers and doctors.

This Thursday the Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors is expected to announce their new marketing code. This voluntary guideline drafted by the industry’s trade association (PhRMA) will ask the chief executives of large drug manufacturers to provide written certification that “they have policies and procedures in place to foster compliance with the code.”

The new marketing code is supposed to ban pharmaceutical marketing campaigns that in the past have provided doctors with gifts such as mugs, pens and pads. The code requires drug companies to set annual limits on the amounts they pay doctors for educational lectures. However, the industry code fails to define any limits on money spent on speaking and consulting arrangement between the drug makers and doctors throughout the country. Furthermore, these new guidelines do not apply to biotechnology or medical device companies.

PhRMA Chairman and Chairman and CEO of Merck & Co., Inc., Richard Clark, stated “Informative, ethical and professional relationships between healthcare providers and America’s pharmaceutical research companies are instrumental to effective patient care”.

Among its changes, the revised Code:

- Prohibits distribution of non-educational items (such as pens, mugs and other “reminder” objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, “may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues.”

- Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.

- Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice — including this Code — that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.

- Provides that each company will state its intentions to abide by the Code and that company CEOs and Compliance Officers will certify each year that they have processes in place to comply, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies’ annual certifications of compliance.

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