Enti regolatori ed istituzioni
Massimo Di Maio
SCDU Oncologia, AO Mauriziano Dipartimento di Oncologia Università degli Studi di Torino
massimo.dimaio@unito.it
Financial interest
of FDA Center for Drug Evaluation and Research
• The study used a data set of voting behavior and reported financial interests of 1379 FDA advisory committee
members who voted in CDER committee meetings that were convened during the 15-year period of 1997–2011.
• Data on 1168 questions and 15739 question-votes from 379 meetings were used in the analyses.
• Multivariable models were used to estimate the relationship between committee members’ financial interests and
their voting behavior.
Pham-Kanter G. The Milbank Quarterly. 2014;92(3):446-470.
Pham-Kanter G. The Milbank Quarterly. 2014;92(3):446-470.
Pham-Kanter G. The Milbank Quarterly. 2014;92(3):446-470.
FDA “waivers”
The FDA states that the agency can issue waivers in the following cases:
1. if an individual’s financial interest is “not so
substantial” that it is likely to affect the individual’s committee service;
2. if the need for an individual’s expertise outweighs the risk of influence;
3. if the individual provides “essential” expertise not otherwise obtainable.
Section 712(c)(2)(B) of the Federal Food Drug and Cosmetic Act and 18 USC § 208(b)
Financial interest
of FDA Center for Drug Evaluation and Research
Pham-Kanter G. The Milbank Quarterly. 2014;92(3):446-470.
Financial tie Difference between financial tie and no financial tie
Odds
ratio 95% CI P value Sponsor only 1.49 1.04 – 2.15 0.032
Competitor only 1.03 0.78 – 1.36 0.829 Both sponsor and
competitor 1.16 0.77 – 1.76 0.481
No financial ties Ref.
All votes (1379 voting participants, 15739 question-votes)
Financial interest
of FDA Center for Drug Evaluation and Research
Pham-Kanter G. The Milbank Quarterly. 2014;92(3):446-470.
Financial tie Difference between financial tie and no financial tie
Odds
ratio 95% CI P value Sponsor only 1.56 1.06 – 2.28 0.023
Competitor only 1.27 0.95 – 1.71 0.105 Both sponsor and
competitor 0.79 0.47 – 1.33 0.369
No financial ties Ref.
Non-unanimous votes (1236 voting participants, 9718 question-votes)
Direct interests in pharmaceutical industry are:
• Employment with a company
• Consultancy to a company
• Strategic advisory role for a company
• Financial interests
Indirect interests in pharmaceutical industry are:
• Principal investigator
• Investigator
• Grant or other funding to an organisation /
institution
The policy focuses on 3 pillars, i.e.:
• robustness
• efficiency
• transparency
Declared interests
In terms of declarations of interests, 3 interest levels can be identified:
• “direct interests declared” (i.e. interest level 3);
• “indirect interests declared” (i.e. interest level 2);
• “no interests declared” (i.e. interest level 1).
Category 1: leading role during previous employment with a pharmaceutical company which results in lifetime non-
involvement, on two possible levels:
• Either executive role within a pharmaceutical company, resulting in lifetime non-involvement for any medicinal product for which that pharmaceutical company is the MAH, irrespective if such involvement relates to a
decision-making or an advisory body.
• Lead role in the development of a medicinal product, resulting in lifetime non-involvement for that medicinal product, irrespective if such involvement relates to a decision-making or advisory body.
Category 2: for certain declared interests, as specified below, it is assumed that the declared interest is
considered over when such interest is no longer present, resulting in full involvement in the Agency’s activities.
− Financial interests.
− Grant or other funding to an organisation/institution.
− Interests related to close family members.
Category 3: for the remaining declared interests, not listed in categories 1 and 2, it is assumed that the declared
interest is considered over following a 3 year cooling-off period.
Mitigating measures will vary depending on whether the involvement of the expert relates to a decision-making or an advisory body, and will depend as well on the role of the expert (chairperson, rapporteur or equivalent
leading/co-ordinating role, formally appointed peer reviewer).
• Involvement in academic trials and in publicly funded
research/development initiatives, as well as membership of an ethics committee should be declared. This will not result in the Agency restricting involvement in its activities, unless a specific interest is identified.
• Attendance at courses and conferences funded by the pharmaceutical industry […] do not need to be declared.
However, in case the expert receives payment by
pharmaceutical industry going beyond reimbursement of
reasonable expenses directly related to a conference/seminar attendance, this needs to be declared and this will be
incompatible with involvement in the Agency’s activities.
Transparency is achieved through:
• Publication on the Agency’s website of the minutes of the scientific committees’ meetings, including – where relevant – restricted involvement of the chairs,
members and experts.
• Publication of the DoIs and CVs on the Agency’s website of all experts, whilst ensuring that personal data legislation is adhered to, as well as publication on the Agency’s website of the assigned interest
levels.
Seguendo i tre principi cardine dell’Appartenenza, Trasparenza e Responsabilità che guidano il
documento strategico di funzionamento dell’Agenzia a partire dal 2012, tutti i dipendenti AIFA e tutti
coloro che collaborano con l’Agenzia a qualunque titolo, inclusi fornitori e membri di Commissioni e
organi di controllo, sono soggetti al regolamento sul conflitto di interesse, pubblicato in G.U. nel maggio del 2015 a seguito di un’apposita delibera proposta dal Direttore Generale al Consiglio
d’Amministrazione e approvata dai Ministeri vigilanti
We recommend that NGS-driven trials and the development of treatment algorithms are further explored, potentially including public-private
partnerships and multi-sponsor collaborations
M. Doherty et al.
Precision Medicine and Oncology: An Overview of the Opportunities Presented by Next-Generation Sequencing and Big Data and the Challenges Posed to Conventional Drug Development and Regulatory Approval Pathways
Ann Oncol first published online April 26, 2016
Confluenze di interesse
Enti regolatori ed istituzioni
Massimo Di Maio
SCDU Oncologia, AO Mauriziano Dipartimento di Oncologia Università degli Studi di Torino
massimo.dimaio@unito.it
