Many countries look to the US FDA for guidance on approval decisions. In fact the FDA will sometimes find and test drugs and vaccines whose primary market is in less developed countries. Fexinidazole, for example, is a drug to treat African trypanosomiasis, i.e. sleeping sickness. We don’t get many cases of sleeping sickness in the US but there are many such cases in the Democratic Republic of Congo.
Therefore, the US FDA provides a useful service, both to US pharmaceutical firms and especially to developing countries. That’s good. But Jacob Trefethen of OpenPhil notes that for unusual administrative and legal reasons we are redoing much of the information that might be useful to countries that will use these therapies. Here, for example, is an excerpt from the Fexinidazole approval decision:
The strangest thing here is that as far as Trefethen, or I, I would say, no one wants this! The FDA has no reason to hide this information, the company submitting the proposal certainly wants as much information as possible sent to the countries where it will eventually need to get approval (remember that these are successful applications!) and medical agencies in developing countries would like to get context so they can have confidence in the FDA’s decisions. Instead, it appears that these drugs are caught in laws meant to protect pharmaceutical firms in some cases. Thus, Trefethen makes two proposals:
let’s build a track for products on the Neglected Tropical Diseases list, share testing with few or no delays through the WHO Pre-Qualification (PQ) program, and allow PQ to share those documents further with regulators in partner countries.
Such an authorization track already exists in the EU:
[The EU] have a track record of approving products that will be widely used elsewhere. If you apply using that track, they enter the controllers from those countries as well. They share your clinical data validation documents and your manufacturing facility assessment with the WHO prequalification (PQ) team – a team with a stamp of approval that speeds things up in many countries with less experienced national regulators. Gavi and the Global Fund require pre-qualified product to purchase through UN procurement agencies (eg UNICEF, for childhood vaccines).
Even outside of the approval track there are some small changes in priority and emphasis that can improve information sharing. The FDA is not aware of these information sharing issues, for example, and there are procedures in place for confidentiality agreements with other countries. Trefethen suggests that these may be given higher priority.
FDA leadership should set strong goals to complete two-way Confidentiality Obligations with low- and middle-income country regulators.
Broaden the scope of existing obligations, where they are limited, to allow sharing in many areas – especially related to drug approval.
Extend 708(c) authority to additional national agreements, not just those of European countries, to allow sharing of full documents covering trade secrets.
I have been advocating peer recognition for a long time, Trefethen is stepping into the grass to show some ideas to make this idea more useful, especially in developing countries. See Trefethen for more ideas!
Source link