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The Revised PhRMA Code, CME

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  • PhRMA provide slides on the changes to the PhRMA Code on Interactions with Healthcare Professionals.
  • Transcript

    • 1. The Revised PhRMA Code, CME & Industry Pamela Mason, CCMEP, FACME Director of the Medical Education Grants Office AstraZeneca PLP AOA CME Conference January 9, 2009
    • 2. From FDA to OIG to Transparency Setting the Stage for the Revised PhRMA Code
    • 3. 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
    • 4. 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.
    • 5. Independent Certified CME vs. FDA-regulated, Promotional Education Education 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
    • 6. 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
    • 7. 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
    • 8. 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
    • 9. 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
    • 10. 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).
    • 11. Key Changes to the PhRMA Code on Interactions with Healthcare Professionals
    • 12. 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
    • 13. 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
    • 14. 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
    • 15. 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
    • 16. 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.
    • 17. 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.
    • 18. 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
    • 19. 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.
    • 20. Implications and Challenges
    • 21. 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
    • 22. 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
    • 23. Support from Industry Independent Medical Education Grants Corporate Sponsorships Research Charitable Contributions Exhibits Need to differentiate types of support requested: Specific restrictions for each type
    • 24. 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
    • 25. 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
    • 26. Thank you

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