Recent Developments in Monitoring and Verification
Both the Federal Sentencing Guidelines and the OIG Compliance Program Guidance for Pharmaceutical Manufacturers have
noted that effective compliance programs should include periodic monitoring of high risk areas too verify compliance. Recent
Corporate Integrity Agreements, as well as the PhRMA Code on Interactions with Healthcare Providers, have fleshed out and
highlighted monitoring and verification activities, which provides some insight into emerging trends and best practices for a
Effective 2009, PhRMA amended its Code on Interactions with Healthcare Providers. In addition to tighter restrictions on
gifts, meals, continuing medical education programs and prescriber data, PhRMA also emphasized the need for greater
transparency and compliance with the code. To that end, PhRMA posts annual certifications, signed by signatory companies'
Chief Executive Officers and Chief Compliance Officer, confirming that they have policies and procedures in place to comply
with the Code. (The AdvaMed code contains a similar provision).
Beyond the annual CEO and Chief Compliance Officer certification, the PhRMA Code encourages companies "to seek external
verification periodically, meaning at least once every three years, that the company has policies and procedures in place to
foster compliance with the Code. PhRMA will prepare general guidance for such external verification and will identify on its
web site if a company has sought and obtained verification of its compliance policies and procedures from an external
source." Prudent manufacturers might want to start an interim verification process, so that it can address potential outstanding
issues before the three year certification is due.
On August 31, 2009, Pfizer Inc entered into a five year Corporate Integrity Agreement (CIA) with the Office of Inspector
General, Health and Human Services, resulting from alleged off-label promotion and anti-kickback violations.. In addition to
requirements regarding policies and procedures, training, Indepehent Review Organization, risk assessment and other matters,
the CIA imposes substantial monitoring and verification requirements, including:
Speaker Monitoring. Pfizer must conduct live audits of 200 speaker programs per year (roughly four per week),
selected based on both risk and random sampling. The audit includes review of slides and other materials, speaker
statements and sales representative activities.
Field Observations. Pfizer legal and/or compliance personnel must conduct at least 60 full day ride alongs with sales
representatives each year (a little more than once per week), throughout the year. Representatives are selected based on
Pfizer's judgment, taking into account each therapeutic area and actively promoted product, to determine whether the
oral messages and written materials are consistent with law and policy.
Records Reviews. For each year, Pfizer must conduct Records Reviews associated with at least three high risk
Government Reimbursed Products. The review includes records relating to the activities of sales representatives in
every separate district and/or region (as applicable) who promoted the products under review. These records include:
1) records relating to field sales representatives' interactions withhealthcareprofessionalsand institutionsrelating
to promotional speaker program activities, starters, travel andentertainment, payments to healthcare
professionals, and requests for medical information;
2) message recall studies or other similar records (such as Verbatims) reflecting the details ofrepresentatives'
interactions withhealthcare professionals and institutions
3) field sales representative call notes;
4) field sales representatives' e-mails and other electronic records; and
5) recorded results of the Field Observations, coaching guides, and district manager notes(as applicable).
Consultant Programs. For each year, Pfizer must conduct at least 50 reviews of consultant programs, consisting of at
least 35 non-advisory boards and 15 advisory boards. The monitoring includes review business rationale forms,
consultant contracts, and materials relating to the program (including a verification that the work product resulting
from any consultant-related program or event or otherwise generated by the consultant is consistent with the stated
business need set forth on the business rationale form or elsewhere), in order to assess whether the programs and
arrangements were conducted in a manner consistent with policies.
Publication Activities. For each year, Pfizer must conduct audits of at least 30 publication activities, selected on a risk-
based targeting approach and on a random sampling approach. The audit includes a review of needs assessment
documents, contracts, and materials relating to the publication activities (including work product resulting from these
activities), and general compliance with policies.
Medical Education and Charitable Grants. Each year, Pfizer must review at least 50 medical education grant request
and 10 charitable contribution request. Programs are selected based on both a risk-based targeting approach and on a
random sampling approach. The audit includes a review of grant and charitable contribution requests, documents
relating to the internal review of the requests, and documents and materials relating to the grants, charitable
contributions and any events or activities funded through the grants or contributions in order to assess whether the
activities were conducted in a manner consistent with Pfizer's policies.
The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding
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