California Compliance Policy Summary and Declaration

Compliance Policy Summary

It is the policy of Akrimax Pharmaceutical, LLC (“Akrimax”) to comply with all applicable laws and regulations and industry standards, including the PhRMA Code on Interactions with Healthcare Professionals and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG Guidance”). Our Comprehensive Compliance Program incorporates the following elements from the OIG Guidance:

  • Written Policies and Procedures

  • Compliance Committee

  • Effective Training and Education

  • Effective Lines of Communication

  • Internal Monitoring and Auditing

  • Enforcement Through Discipline Pursuant to Published Guidelines; and

  • Prompt Response and Corrective Action for Detected Problems

Akrimax sales and marketing personnel interact with healthcare professionals to provide them with information about Akrimax products and other relevant educational or scientific topics. Akrimax believes that these interactions provide educational value to healthcare professionals and help benefit patients. In connection with certain of these interactions, Akrimax may provide promotional materials, or educational items intended to benefit a patient or related to a healthcare professionals’ practice. Akrimax may also on occasion offer modest meals to healthcare professionals in connection with educational presentations. The PhRMA Code allows pharmaceutical companies to provide “items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities.” On occasion Akrimax may approve the distribution of an educational item to a healthcare professional in accordance with the PhRMA Code standards. Akrimax’s Comprehensive Compliance Program is designed to ensure that these activities are conducted in lawful manner.

California Health and Safety Code §§ 119400-119402 requires pharmaceutical companies to make available their Comprehensive Compliance Program and to set an annual aggregate limit on certain promotional expenditures provide to a healthcare professional as defined under the California law.

Annual Spend Limit

Subject to this California law, Akrimax has determined that the annual aggregate limit on covered promotional expenditures in California is set at $500.00 per covered healthcare professional for each calendar year. This limit may be revised by Akrimax from time to time. It is important to note that this annual dollar limit is an upper limit. It is not an accurate representation of the average value of gifts, promotional materials, items or activities that Akrimax may provide generally to a healthcare professional. The average could be a lower amount. In accordance with the law, certain items and payments are excluded in determining whether the annual limit has been met. The annual limit does not include the value of:

  • Drug samples provided to healthcare professionals intended for free distribution to patients;

  • Financial support for continuing medical education forums;

  • Financial support for health educational scholarships; and

  • Payments for legitimate professional services, including professional speaking, advising, consulting, training or market research services, that are based on the fair market value of the services provided.

Declaration of Compliance

Akrimax declares, in good faith, that Akrimax is in substantial compliance with its Comprehensive Compliance Program and the requirements of California Health and Safety Code §§ 119400-119402. Our declaration is based upon information available during the twelve month period from January 1, 2016 through December 31, 2016. The next declaration will be based upon information captured beginning January 1, 2017.

Conclusion

As appropriate and consistent with applicable law, Akrimax will amend and make conforming changes to its Comprehensive Compliance Program. Akrimax is committed to assessing ongoing compliance with its Comprehensive Compliance Program. A copy of the Comprehensive Compliance Program and this written declaration can be requested by calling 973-597-6202.