News Feature | July 23, 2014

FDA's $10 Million Deal To Intensify South American Pharma Regulation

By Lori Clapper

The U.S. Food and Drug Administration (FDA) has penned a five-year, $10 million contract with the Pan American Health Organization (PAHO) to strengthen medical product regulatory monitoring systems in South American regions. By working more closely with global regulators, the FDA hopes to ultimately protect U.S. citizens.

This latest strategy is a proactive step by U.S. and global regulators to bust illicit or sub-standard pharmaceuticals before they even enter the supply chain, and potentially reach patients in the U.S. In addition, if local or regional regulators notice any questionable activities or product issues, that information could be useful to U.S. officials.

According to the Regulatory Affairs Professional Society (RAPS), the FDA wants PAHO to help develop South American regulatory systems.

The organizations originally started this process in May 2012, and officially awarded the contract to help "foster regulatory collaboration and strengthen regulatory capacity throughout the Americas" to the PAHO in July 2013. In doing so, the FDA and PAHO will collaborate on monetary resources, staff expertise, and authority.

In order for the two agencies to establish the working relationship in regards to regulatory oversight, the FDA said the PAHO is prepared to do the following:

  • Ensure awareness of quality standards
  • Facilitate the exchange of regulatory information
  • Evaluate regulatory authorities
  • Provide necessary training and support
  • Circulate scientific materials as it concerns regulation
  • Boost monitoring of falsified and substandard products regionally
  • Increase capacity as a component of WHO's prequalification programs.

The FDA says that, “These activities help to strengthen regulatory systems which, in this era of globalization, where the supply chain of medicines has become a global network, and as national, regional, and global health programs work to scale up access to medicines and health products, strong regulatory systems are imperative.”