Breaking News on Contract Research, Manufacturing & Clinical Trials

Service Sectors > Bulk ingredients

Overseas FDA offices bring benefits but planning needed

By Nick Taylor+

28-Oct-2010

Overseas FDA offices have realised immediate benefits but strategic planning is needed to ensure the ventures, critical aspects of the agency’s ability to ensure drug quality, are long-term successes according to the GAO.

Globalisation of the supply chain, and high-profile contamination cases, prompted the US Food and Drug Administration (FDA) to set up offices overseas. Now, almost two years after the first office opened, the US Government Accountability Office (GAO) has assessed their progress .

A positive development of setting up offices in China, India, Europe and Latin America has been improved relationships with foreign regulators. This was an initial goal and is viewed by the FDA as a key step towards better understanding foreign regulatory processes and sharing information.

Responses to earlier crises emphasises the importance of having close ties to overseas regulators. For instance, the GAO writes that it took the FDA a month to identify their Chinese regulatory counterparts during the melamine crisis.

Now, the FDA has begun to build personal relationships with foreign stakeholders which would have been hard to achieve without an overseas presence. This has been welcomed by the FDA and their counterparts in overseas regulatory agencies.

However, relationship building has been slower than expected in some countries, notably India where regulators must obtain permission from the government before meeting with the FDA.

Resources have also been taken up by tasks outside the remit of the FDA, such as contributing to trade discussions involving US industries or federal agencies located abroad. High regard for the FDA makes it a useful presence in these talks but they may take time away from core activities.

Workload challenges

The GAO report highlights a number of other areas that may stretch the resources of overseas FDA offices in the future. A number of these areas concern are part of efforts to build the capacity of foreign stakeholders.

As part of work in this area FDA overseas offices have been working to ensure agency policies are translated into foreign languages. The FDA views this as integral to its overseas strategy but it is “also an expensive and time-consuming process”.

Overseas office employees are also answering queries from the foreign counterparts. Some officials involved in answering queries “anticipate future workload challenges” and the Latin America team said “it is likely to become unmanageable” as more people hear about the office.

Recommendations

The GAO makes two recommendations for the overseas offices: develop a set of performance goals and measures that can demonstrate contributions to long-term outcomes; and create a strategic workforce plan.

Staff work at the overseas offices on two-year rotations and the GAO is concerned about the impact turnover could have on operations. “Without a comprehensive workforce plan, the agency has little assurance that it will be equipped to address future staffing challenges”, wrote the GAO.

Related products

Key Industry Events

Interphex 2014

New York, NY 10001 / Conference and exhibition

Read more

Access all events listing