A Retrospective on the Evolution of Pharmacovigilance




To understand where we are going, we need to understand where we’ve been. In this interview with Pharma IQ, Paul Beninger, Vice President, Global Patient Safety and Risk Management at Genzyme and speaker at the upcoming IQPC Pharmacovigilance North America Conference, takes a look at where the pharmaceutical industry is now, where we have been, and what the future looks like in Pharmacovigilance.

Pharma IQ: What lessons has the pharmaceutical industry learned from the past?

P Beninger:
Much has happened in the last century. One way to look at the outcomes of the tragedies and disasters is the following:

1) activities that were once optional have become mandatory
- e.g., use of Informed Consent and IRBs

2) those that were once individualized have become standardized
- e.g., templates for PSURs and RMPs

3) those that were once local or national have become regional or global
- e.g., development of uniform standards for adverse event reporting

4) those that were only descriptive have become quantitative
- e.g., use of data mining methodologies for detecting adverse events for marketed products

5) those programs that were created in reaction to crises have become proactive
- e.g., Kefauver-Harris Amendments of 1962 vs Safety and Innovation Act of 2012
Still, much needs to be done.

Pharma IQ: Can you give us an update on the state of drug safety at the present time?

P Beninger: The Safety and Innovation Act of 2012 is the latest of the five-yearly Congressional legislations that prospectively offer solutions to looming problems before they become crises or catastrophes.

The broad areas addressed in this legislation include the following:

– User fee programs that have been expanded to include drugs and biologics, devices, generic drugs and biosimilars

– Review process enhancements

– Regulatory science modernization measures

– Pediatric permanency of BPCA and PREA

– Post-market safety surveillance strengthening

– Drug supply shortages

– Supply chain integrity

The last three are of special concern to safety. In particular, safe-guarding the integrity of the supply chain through establishing upstream and downstream pedigrees of manufactured products is of crucial importance since the heparin catastrophe of 2008.
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Pharma IQ: What are potential areas of concern in the future?

P Beninger: The relentless pressures on increasing efficiencies, including globalization, will have lasting effects in three areas:

1st: processes
2nd: organizations
3rd: professionals

1st: Processes will continue to take into account outsourcing as a paradigm;

2nd: Vertically integrated organizations will continue to de-integrate, allowing more and more specialized CROs to take root and allowing more experimentation with collaborations among companies and with other stakeholders, including academics;

3rd: Professionals will continue to develop new and varied skill sets, such as manufacturing liaison and communications

Paul Beninger is a speaker at the upcoming IQPC Pharmacovigilance North America Conference, October 22 to 24, 2012 in Boston. For more information or to register, visit Pharmacovigilance North America.

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