May 2005 – Pharmaceutical Companies Feeling Pressure to Comply
According to the May 20, 2005 issue of Rx Compliance Report, pharmaceutical companies across the United States are feeling compliance challenges as state legislation addressing pharma sales and marketing continues to be a “moving target.” According to Karmen Hanson of the National Conference of State Legislatures, “there are at least 48 ‘disclosure-related bills’ in over 23 states and Washington, DC, during the current 2005 legislation session.
In California “drug and device companies are scrambling to comply with California’s new law mandating compliance with the HHS OIG guidance and the PhRMA code, which take effect in six weeks. “ Without direction from California, manufacturers are faced with determining how to comply.
Compliance changes have been headed toward the pharmaceutical industry for a number of years. In July 2002, the Executive Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA) adopted a new marketing code to govern the pharmaceutical industry’s relationships with physicians and other healthcare professionals. This voluntary code took effect on July 1, 2002.
The main points of the PhRMA code include:
- A pharmaceutical company’s general interaction with healthcare professionals should focus on providing scientific and educational information.
- Interaction between pharmaceutical companies and healthcare professionals should not include entertainment.
- Pharmaceutical companies may provide support to a continuing education conference sponsor but may not fund individual participants.
- Pharmaceutical companies may use healthcare professionals for legitimate consulting or advisory arrangements, not as a reward or inducement for prescribing.
- Pharmaceutical companies may not offer or provide educational and practice related items that would interfere with the independence of the healthcare professional’s prescribing practices.
Of importance to the healthcare and pharmaceutical industries:
- California is leading the pack. It is likely that the California law could be used to cite violations in other jurisdictions—and other states are expected to follow suit.
- Though California passed legislation mandating that pharmaceutical companies comply with these guidelines as well as the Federal Sentencing Guidelines in November 2004, the July 1 compliance deadline came quickly to the pharmaceutical industry. In other states compliance is voluntary. Because compliance is complex and multi-layered, complying sooner rather than later could save other pharmaceutical companies potential frustration.
