In the latest part of its “beyond our borders” scheme, the US FDA is asking drugmakers to volunteer supply chain information for drugs and APIs sourced outside the USA.
The pilot plan, whose launch coincides with today’s opening safety offices in India, will assess the importation practices of 100 applicant drugmakers to determine the feasibility of setting up a supply chain monitoring network.
At present, more than 80 per cent of the active pharmaceutical ingredients (API) sold in the US are sourced from overseas according to government statistics, with the majority coming from manufacturers in India and China.
Michael Chappell, the Food and Drug Administration’s (FDA) acting associate commissioner of regulatory affairs, explained that: "It is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don't meet the FDA's standards and violate US laws."
Deborah Autor, director of the office of compliance in FDA's Center for Drug Evaluation and Research (CDER) agreed, commenting that: "This initiative creates incentives for drug makers to develop and maintain secure supply chains," stressing that "this is one of several agency initiatives to enhance drug product safety."
Drugmakers wishing to participate in the two-year scheme must meet certain requirements, with the main criteria being an ability to demonstrate complete supply chain security from source to final destination in the US.
Secondly, participants in the programme must be able to show that foreign and US factories receiving drugs and APIs for processing or packaging comply with FDA good manufacturing practice (GMP) regulations.
In addition, firms wishing to include finished drugs in the scheme must hold FDA-approval for that product or must be the foreign manufacturer identified in the approved application. Furthermore, the imported API must exclusively be used in the manufacture of approved pharmaceuticals.
Steve Silverman, assistant director of the FDA’s compliance office, told Reuters that: "We're asking for a very robust and comprehensive description of the process by which the products come into the country," and added that this would help border inspectors focus on other medicines that may be more of a risk.
With criticism for its role in the heparin crisis and the October call for “country of origin” labelling still fresh in its memory, the FDA will hope that the new scheme improves its somewhat tarnished reputation.
Whether these efforts will be sufficient to answer Representatives Bart Stupak and John Dingell’s November accusations that recent FDA efforts are merely “posturing” in an effort secure its position under the incoming US administration remains to be seen.