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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

The Revised PhRMA Code, CME

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Page 1: The Revised PhRMA Code, CME

The Revised PhRMA Code, CME & Industry

Pamela Mason, CCMEP, FACMEDirector of the Medical Education Grants Office

AstraZeneca PLP

AOA CME ConferenceJanuary 9, 2009

Page 2: The Revised PhRMA Code, CME

From FDA to OIG to Transparency

Setting the Stage for the

Revised PhRMA Code

Page 3: The Revised PhRMA Code, CME

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

Page 4: The Revised PhRMA Code, CME

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.

Page 5: The Revised PhRMA Code, CME

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

Page 6: The Revised PhRMA Code, CME

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

Page 7: The Revised PhRMA Code, CME

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

Page 8: The Revised PhRMA Code, CME

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

Page 9: The Revised PhRMA Code, CME

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

Page 10: The Revised PhRMA Code, CME

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).

Page 11: The Revised PhRMA Code, CME

Key Changes to the PhRMA Code on Interactions with Healthcare Professionals

Page 12: The Revised PhRMA Code, CME

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

Page 13: The Revised PhRMA Code, CME

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

Page 14: The Revised PhRMA Code, CME

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

Page 15: The Revised PhRMA Code, CME

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

Page 16: The Revised PhRMA Code, CME

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.

Page 17: The Revised PhRMA Code, CME

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.

Page 18: The Revised PhRMA Code, CME

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

Page 19: The Revised PhRMA Code, CME

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.

Page 20: The Revised PhRMA Code, CME

Implications and Challenges

Page 21: The Revised PhRMA Code, CME

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

Page 22: The Revised PhRMA Code, CME

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

Page 23: The Revised PhRMA Code, CME

Support from Industry

Independent Medical

EducationGrants

CorporateSponsorships

Research

Charitable Contributions

Exhibits

Need to differentiate types of support requested:Specific restrictions for each type

Page 24: The Revised PhRMA Code, CME

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

Page 25: The Revised PhRMA Code, CME

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

Page 26: The Revised PhRMA Code, CME

Thank you