A couple weeks ago, I posted about a recent HHS report on the increasing number of foreign clinical trials that received no FDA oversight. The HHS report found that 80% of all drugs approved in the US in 2008 relied on some foreign trial data, 78% of all study enrollees were at foreign sites, and 10 new drugs had no US derived data at all. Some members of Congress and others consider that to be a dangerous situation.
A similar situation unfolds when you look at the manufacture of active pharmaceutical ingredients (APIs) made in foreign facilities. According to the SOCMA website, many of these are rarely inspected by the FDA, especially in the case of ingredients going into OTC drugs. The majority of foreign facililties manufacturing APIs used in generics rarely see an FDA inspector after the initial inspection.
To help address the situation, SOCMA created the Bulk Pharmaceuticals Task Force (BPTF) to provide guidance to companies seeking foreign outsourcing partners. The BPTF several months ago put together a standardized quality agreement for general manufacturers of APIs. Now, the BPTF announced that it has put together a very similar quality agreement for CMOs and its customers.
BPTF Chairman Brant Zell of Cherokee Pharmaceuticals LLC says, "With today's supply chain issuesand the potential for misunderstandings in a global environment, a quality agreement is the best way to ensure compliance and meet FDA's expectations and filing requirments."
See Quality Template - Download Final-Quality-Agreement-Custom-Template-7-6-10-clean-protected
It is good to see that people, companies, organizations and even governments are now playing closer attention to the integrity of the supply chain. BPTF's role is very valuable in seeking to clarify the current regulatory requirements and to interact with government agencies on emerging issues that impact its members and the public.
Documents like the template rely on the collective wisdom of BTPF members and serve to standardize and educate users on drafting appropriate quality documents for their situation. Hopefully this guidance also helps streamline the process for the industry.
Posted by Bruce Lehr July 7th 2010.