The U.S., EU and other developed jurisdictions are beefing up their pharmaceutical regulatory operations to protect against counterfeit or substandard products from areas with weak oversight. Perhaps the best way to tackle the problem would be to make it a priority to help low- and middle-income countries do the same.
That is the thinking of three staff members from the FDA International office, Charles Preston, Mary Lou Valdez and Katherine Bond. Writing this week in the open access, peer-reviewed publication PLoS Medicine, they argue that with globalization, more products are coming from low-income countries, so improving regulations there will be helpful to developed nations.
They also point out that the value of efforts to provide more cost-effective treatments to these countries is reduced if they don't have the regulatory capacity to do the kind of post-market evaluation necessary to assure quality. And, of course, solid manufacturing and post-market oversight will save lives. They point to a case in Niger where in 2005, a counterfeit meningitis vaccine led to 3,000 deaths. There was also the 2008 case in the U.S. where patients died after getting heparin made with an API from China that was tainted.
There are some programs that can serve as early steps, like the President's Emergency Plan for AIDS Relief (PEPFAR) program, in which the FDA uses its own "tentative approval" process to pre-qualify drugs for purchase through the program. But the article says the real impact will be realized when countries have the mechanisms and expertise to qualify drugs themselves and are capable of following them through the full regulatory gauntlet. This will happen much sooner if developed countries make that a health and development priority, which they say it so far has not been.
Their belief is that systems in areas like sub-Saharan Africa don't have to meet the level of say Canada or Europe but need three elements to be successful. They need a rule-making process that allows comment on proposed regulations; a protocol for different regulatory agencies to share information; and oversight along the supply chain with a method to identify when action is needed. "Efforts must be targeted and prioritized, with an end goal of sustainability in mind."
The FDA members are not alone in their assessment. Roger Bate at the American Enterprise Institute has authored some research this year pointing to substandard manufacturing of medications that are paid for primarily by Western aid programs. He points out that the lack of oversight in many countries receiving this aid makes it impossible for them to test for quality. He has suggested that the World Health Organization test drugs for the programs and kick out any manufacturers whose drugs fail quality tests three times.
The proposal also comes as the FDA is expanding its international staff to increase inspections of foreign plants, using money being generated through new generic drug user fees. It also is working with some other jurisdictions to share inspection responsibilities in plants each are visiting.
- here's the PLoS Medicine story