The Revised PhRMA Code, CME & Industry
Pamela Mason, CCMEP, FACMEDirector of the Medical Education Grants Office
AstraZeneca PLP
AOA CME ConferenceJanuary 9, 2009
From FDA to OIG to Transparency
Setting the Stage for the
Revised PhRMA Code
Guidelines, Standards, Codes and Policy
Dec 1990 Mar 1992 Dec 1997
Jul 2002 Apr 2003 Nov 2003 Jan 2004 May 2007 Aug 2007 July 2008
AMA Guidelines on Gifts to Physicians ACCME Standards for Commercial Support (SCS) FDA Final Guidance on Industry-Support
Scientific and Educational Activities PhRMA Code – Interactions with HCPs OIG Compliance Program Guidance AdvaMed Code Revised ACCME SCS US Senate Report Ed Grants and Pharma ACCME Revised Policies Revised PhRMA Code – Interactions with HCPs
Independent vs Promotional Education
FDA does not differentiate between education and promotion
FDA does not seek to regulate industry-supported activities that are independent and non-promotional
Basically, educational programs that have not been designed independently from company control are categorized as promotional and regulated as such
Must meet the FDA Guidance (12 factors) to be designated as independent.
Independent Certified CME vs. FDA-regulated, Promotional
EducationEducation Promotion Independent
Oversight Guidelines
FDA, OIG, PhRMA ACCME, AAFP, AOA, (+ FDA, OIG, PhRMA for industry)
Funding Sponsored by Company Sponsored by Provider – may be supported by a Commercial interest
Origin of Need Market driven Independent assessment documenting learners needs
Content Creator Company ACCME accredited provider, AAFP, AOA
Content Focus Product – limited by labeling Disease State – limited by scientific data
Fair Balance Based on Regs – safety & efficacy data
Based on all information - therapy options – peer review
Faculty Selection Sponsoring company Provider selects faculty independently
Conflict of Interest ID by faculty to audience Resolved by Provider through transparent process
Off label Faculty may respond to unsolicited question based on experience and state which areas are off-label
Faculty may address off label issues as long as they are evidenced based. Free scientific exchange of information
Learner Motivation New products, faculty Learning methods – faculty – CME credits
Recommendations from the OIG regarding commercial supporters in 2003
• Separate grant decision-making function from sales & marketing• Establish policies and internal controls
• Establish objective criteria that do not take into account volume or value of referrals
• No manufacturer control over speaker or content• Support bona fide educational activities – establish rigorous review and
approval process
• Documentation• Agreements in writing• Maintain documentation• Regular monitoring
OIG requirements for grants in recent CIAs
2005 Serono CIA Establish policies and
internal procedures and controls
Document agreements in writing
Retain & track information – make available to OIG
Establish criteria on grant selection
Document review & approval process
Internal audit – report reviewed by Compliance
External audit Respond to suspected
violations
2007 BMS CIA Support of activities will
be transparent Internal audit - Quarterly
documentation review of 10 randomly selected grants in all TAs
Assess processes and procedures used to approve grants
Confirm that the activity actually occurred and funds were used as stated
Maintain records of CIA review for OIG inspection and include summary report in Annual Report
OIG requirements for grants in recent CIAs
Cephalon CIA 2008 Defines “third party
educational activity” = CME, IME, disease awareness or other scientific, educational or professional program, meeting or event (symposia at medical conferences)
Discloses financial support and any financial relationships with faculty, speakers or organizers at such Activity
Third party has to agree to disclose as a condition of funding
Support contingent on provider’s commitment to provide information that is fair and balanced, accurate & not misleading
Recent State Agreements & CME (IME)
Lilly judgment 2008 Disclose supported grants Maintain information on LGO
website for at least 2 years Readily accessible format for
review by the States upon written requests for 5 years
Separate grant function from sales & marketing
Contractually require provider to disclose Lilly’s support & any financial relationship with faculty
Require provider to identify URL of Lilly website as a reference
If know speakers promoting off-label, then can not provide funding for same program or additional funding
Pfizer judgment 2008 Comply with ACCME SCS Contracted speakers agree to
disclose to provider & participants nature of relationship (same therapeutic area & within 12 months
Can not fund CME activity if have knowledge at time of decision that a speaker has been a promotional speaker for Pfizer in past 12 months related to same class of drugs to be discussed in the CME.
Must have a separate grants office Shall not use grants to advantage
or promote products. S&M: Should not initiate on behalf of
customers No involvement in selection of
grantees Not measure or track prescribing
Transparency
Move towards greater transparency by many companies.
Education grants & contributions Eli Lilly posted in May 2007 In Feb 2008, Grassley requested positions on
transparency from 15 companies Companies responded (letters posted April 2008)
10 companies had plans; 5 had no plans at this time
Some companies have posted (Pfizer, Amgen, AstraZeneca, MedImmune, J&J, Merck)
Other companies have announced their plans to post (Abbott, BMS, GSK, Shire, etc).
Key Changes to the PhRMA Code on Interactions with Healthcare Professionals
PhRMA Code Basics Revised Code released July 10, 2008; effective
January 2009
Preamble: explains the need for a code
Body of Code 15 sections E.g., Presentations, Consultants, CME, Use of Prescriber Data, etc.
Question & Answer Section Clarifies PhRMA’s position on common questions Provides PhRMA’s only “interpretation” of the Code
Key Changes to Code Prohibits distribution of non-educational items (pens, mugs and other “reminder”
objects) to healthcare professionals Prohibits company field sales representatives from providing restaurant
meals to healthcare professionals Sales representatives may provide occasional, modest meals only in physician office or
hospital settings in conjunction with educational presentations As in 2002 Code, “dine and dash” meals in offices still prohibited
Provides additional guidance on speaker and consultant arrangements Provides more detailed standards on support of CME Strengthens Code adherence provisions New sections include
Speaker and Consultant conflict of interest Use of prescriber data Sales representative training
Pharmaceutical Company Support for Continuing Medical Education Financial support is appropriate:
Should be provided to event sponsor, not individual healthcare professionals
Control over independent events should reside with the organizers
Should support a full range of treatment options and not promote a particular medicine- NEW
Support should not be used for travel, lodging or other expenses of non-faculty attendees.
Meals and receptions at CME may not be provided.- NEW
Pharmaceutical Company Support for Continuing Medical Education
Grant making decisions should be separate from sales and marketing.-NEW
Companies should respect independent judgment of CME provider and should follow standards for commercial support established by ACCME or other entity that accredits CME provider accrediting entity.-NEW
No company input to CME providers on content or faculty, even if asked by provider. - NEW
Consultants and Speakers
Spells out compensation should be reasonable and based on fair market value.
Decisions regarding the selection or retention of consultants or speakers should be made based on defined criteria such as general medical expertise and reputation, or knowledge and experience regarding a particular therapeutic area.
Meetings should not be held at resorts and should not include entertainment, even if incidental to business purpose of meeting.
Speakers – New Provisions Utilization: Company should develop policies addressing the appropriate
use of speakers, including appropriate utilization after training and appropriate number of engagements for any particular speaker over time.
Monitoring: Company should periodically monitor speaker programs for compliance with FDA regulatory requirements.
Caps: Each company individually and independently should establish an annual cap on the total amount it will pay to a healthcare professional in connection with speaking arrangements.
Transparency about speaker programs v. CME Company and speakers should be clear about the distinction between
promotional speaker program and independent medical education. Speakers and their materials should clearly identify the company that is
sponsoring their presentation and that the speaker is presenting information that is consistent with FDA guidelines.
PhRMA Code Compliance Mechanism: Greater Transparency Regarding Company
Commitments 2002 Code: Code is voluntary with no compliance
mechanism. Revised Code: Annual Self-Certification Regarding
Compliance: All companies that engage in pharmaceutical marketing should:
1) publicly state their commitment to abide by the Code;2) self-certify annually with signatures of CEO and Chief
Compliance Officer that they have policies and procedures to foster compliance; and
3) authorize PhRMA to post names and contact information for company Compliance Officers
PhRMA Code Compliance Mechanism: Greater Transparency Regarding Company
Commitments
Companies are encouraged to obtain periodic, external verification of their compliance policies and procedures.
PhRMA will post on its website: names of companies that indicate commitment to abide by
Code, status of annual certification, when company has sought and obtained external verification of
compliance policies and procedures.
Implications and Challenges
Reasons Why Pharmaceutical Industry
Supports CME Mission includes improving patient care through
research and education Pharmaceutical and Device companies are core
members of the healthcare system and are evidence-based
Industry has a responsibility to ensure safe and appropriate use of products through education that is: Fair and balanced In the full context of available therapeutic options Evidence-based Independent of commercial bias
Why Is CME So Important? An avenue to address the healthcare gaps…
Important way for physicians and healthcare providers to keep current on: New Guidelines New Research New Technology and Skills Emerging new therapies Potential practice gaps How to translate data into practice improvements
Required for re-licensure and maintenance of certification
Support from Industry
Independent Medical
EducationGrants
CorporateSponsorships
Research
Charitable Contributions
Exhibits
Need to differentiate types of support requested:Specific restrictions for each type
Areas of concern for us……….Areas of concern for us……….
Indication of non-independence Conflict of interest not being resolved Learning objectives do not match needs
assessment Excessive amount of time on off-label discussion Recreation time vs. education time Venues giving the appearance of recreation focus Excessive budget amounts
(honoraria, travel, meals, administrative costs) Medical education company doing both promotional
and independent programs for company
Reasons for “Not Funded” Decisions
Not enough time to review grant application (Less than 45 days from program date)
Needs assessment and learning objectives do not match our criteria for funding
Not an area of educational interest Budget limitations Emerging area of interest and funding not fully
established Not consistent with policies and practices as
established by AstraZeneca
Thank you
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