The European Fine Chemicals Group (“EFCG”), a sector of the European Chemical Industry Council (“CEFIC”), and the Society of Chemical Manufacturers and Affiliates (“SOCMA”) have urged FDA to take a more active role in the regulation of foreign API manufacturers. Citing, among other reasons, “[t]he accelerating globalization of the industry,” as well as “[t]he slow pace of adjustment by governmental bodies charged with oversight . . .,” the comments submitted by EFCG and SOCMA advocate both improvements to the current compliance and oversight regime and a publicly-accessible database that would hold noncompliant entities accountable.
EFCG and SOCMA are lead trade associations in Europe and the United States, respectively. EFCG is a sector of CEFIC, which represents 29,000 companies and accounts for one third of the world’s chemical production. SOCMA represents approximately 300 companies and encompasses over 2,000 manufacturing sites. Members of both trade groups manufacture APIs, excipients and intermediates.
FDA recently opened a second comment period in relation to its generic drug user fee plan, which aims to expedite review times for generic drug applicants through the collection of user fees. CEFIC and SOCMA posit that (along those same lines) all API manufacturers, particularly foreign manufacturers, whose products enter the U.S. market should submit to FDA inspections on a regular basis. In order to fund said inspections, FDA should impose registration and inspection fees for all relevant API manufacturers. The proposal further envisions a comprehensive online database that would make GMP certificates publicly available, similar to the EudraGMP database run by the European Medicines Agency.
The proposal aims to promote public safety, but also to level the playing field amongst API manufacturers. Due to the challenges inherent in increased inspections of foreign facilities (see our previous blog on the topic here), API manufacturers are thus incentivized to establish operations in areas where inspections are less frequent. EFCG and SOCMA submit that their proposal “would be a giant step forward in rebalancing the competitive environment.” Both trade groups have expressed willingness to comply with the measures they propose.