Taking on too much responsibility
Although these initiatives are altruistic, this author wonders whether USP is reaching a little too far from home in its pursuit
of global pharmacopeial dominance. Perhaps some of these international resources could be redirected to continue and speed
up the harmonization of monographs and testing requirements with the European and Japanese Pharmacopeias, a goal that has been on USP's plate for some time. Or better yet, the true altruistic action for this standard-setting body
would be to provide the other pharmacopeias assistance, staff, and funding to enhance their national compendia, or to work
in a more collaborative manner with the World Health Organization to develop additional monographs for the International Pharmacopoeia.
Disrespecting industry input
One philosophy that has not seemed to change is USP's reluctance to accept that the USP–National Formulary (NF) is a compilation of the hard work and intellectual input of regulatory filings of US proprietary and generic pharmaceutical
companies. Representatives from these companies belong to trade organizations. These trade organizations make up the members
of USP's Prescription/Nonprescription Stakeholders Forum (PNP–SF). In the May 19, 2011 PNP–SF meeting, USP announced to the
attendees that they were re-evaluating the need and purpose of these meetings. USP proposed reducing its interaction with
the industry trade organizations that make up the PNP to a once-a-year webinar instead of the current two face-to-face meetings.
In addition, USP opened the planning committee for these meetings by posting a call for interested parties on its website
and asking these volunteers to nominate a chair person.
If all that wasn't enough, USP summarily dismissed the current PNP–SF industry member's suggestions to form new project teams
in an effort to help USP achieve some of its 2010 resolutions and to avoid such issues as the recall of USP 33–NF 28, the monograph redesign project, the confusing implementation of residual-solvents testing, the number of errors in the
Pharmacopeial Forum and the potential confusing implementation of the revised USP <231> Heavy Metals General Chapter. These situations have left industry with a sense that USP is losing touch of its responsibility
to the US pharmaceutical and medical communities. The only project team that USP intends to keep is the Compendial Process
Improvement Team, whose charter is to address how USP can streamline and speed up its process for getting monographs and making
information available. What USP fails to recognize is that the majority of the people who are representing the industry at
the PNP–SF meetings have scientific backgrounds and can offer constructive and valuable insight regarding technical issues
facing the USP.
Conclusion
In summary, there are two issues that are of concern to this author: the apparent globalization of USP without sufficient
harmonization and the dichotomous position of wanting the US industry to provide its technical information for monographs
but discouraging input when it comes to assisting in improving the scientific information contained in USP. It seems that USP is trying to find a new identity that focuses beyond US borders, an approach that conflicts with what
should be USP's main focus: providing current and accurate monographs for use by the US pharmaceutical industry. Let's hope
the pharmacopeia can figure out its true identity before it ends up with no identity at all.
Susan J. Schniepp is vice-president of quality at OSO Biopharmaceuticals, susan.schniepp@osobio.com
.
Reference
1. USP website,
http://www.usp.org/.
The author served on the PNP–SF and on a USP expert committee from 2000 to 2005. She chaired a USP expert committee from 2005
to 2010.
* See USP's response on next page
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