Insights Into the Decision Making of Advisory Groups to the Italian Medicines Agency

Abstract

The Italian Medicines Agency (AIFA) is enhancing a strong transparency-oriented policy to improve information exchange and decision making with stakeholders. To this end, a questionnaire titled "Survey AIFA 2013" was sent to the 72 selected contacts on February 17, 2013 (closing date April 3, 2013), to assess influence on committees and secretariats' opinions and decisions. The survey was divided into 2 sections (17 questions) with a 10-minute time limit. The results show that external resolutions have little influence on internal advisory groups, whereas internal ones carry more weight. So-called intellectual bias needs careful monitoring, as it can potentially condition decisions.

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

“…The two surveys described by McIntyre et al (2012) and Marangi et al (2014), which studied the decision making of the US FDA and the Italian AIFA Advisory Committees regarding how the members prepare for meetings and what influences their decision-making, interestingly both concluded a number of similar findings. Those included a diverse range of practices utilized by the members as well as potential biases that influence the decision making that may subsequently need closer monitoring.…”

“…This study was part of an initiative to enhance a transparency-oriented policy and improve information exchange as well as decision making with stakeholders (Marangi et al, 2014). …”

“…A total of 72 participants from AIFA committees, secretariats, and subcommission members took part in the study (Marangi et al, 2014). This qualitative survey can be completed in a short timeframe, but the development of the questions was not described.…”

“…An examination of the seven techniques developed specifically to assess decision making in the area of medicines' development, regulatory review, or HTA demonstrated that a number of were developed to meet the needs of a particular organization, for example to increase transparency of regulatory advisory committee meetings within AIFA and US FDA (McIntyre et al, 2012; Marangi et al, 2014). Nevertheless, although these two surveys are practical for their purpose and are characterized by low resource intensity, their design was not described and their latitude for generalizability and measurement against the QDMPs is limited due to their specific scope.…”

Penidioxolanes A and B, 1,3-Dioxolane Containing Azaphilone Derivatives from Marine-derivedPenicilliumsp. KCB12C078

“…The EtOAc-soluble portion of the fungal extract was purified using silica gel chromatography and ODS flash column chromatography followed by reverse-phase HPLC to afford two novel fungal metabolites named penidioxolanes A (1, 1.3 mg) and B (2, 0.9 mg), together with compounds 3 (406.0 mg), 4 (0.6 mg), 5 (508.2 mg), and 6 (0.8 mg). Compounds 3-6 were identified to isochromophilone IX (3), 14 isochromophilone VI (4), 15 sclerotiorin (5), 16,17 and chloroisotiorin (6), 18 respectively, by comparing the spectroscopic data in the literature (Fig. 1).…”