Remote FDA Inspection

Increasing Demands of a Digitized World

While the Covid-19 pandemic has delivered challenges across the board when it comes to the production of pharmaceutical goods (among other things), it has also thrown governmental programs into disarray. Nowhere is this more clear than in the FDA's own failure to implement a solution for conducting remote inspections, which has drawn sharp criticism from the pharmaceutical industry.

At issue is the fact that new treatments and drugs cannot be certified unless the FDA is able to perform an on-site inspection of the production facilities. While the FDA does technically have the ability to bypass or adjust these requirements, thus far it has not seemed inclined to do so. This has caused the deferral or outright rejection of drugs for certification that could otherwise be rolling into production; while the agency has made some allowances for drugs and treatments considered "mission critical" will receive in-person inspections regardless of the pandemic, manufacturers feel there is no real definition as to what products merit that consideration.

Fewer Inspections, Fewer Drugs

The FDA had, in August 2020, stated it intended to use "other tools" at its disposal in order to perform inspections, which would theoretically include the use of video and audio equipment to conduct inspections remotely, but thus far there has not been a movement on this front. This delay in inspection not only stops the rollout of new treatments and drugs which are needed for everything from cancer to Covid-19, but it also means there is a very real risk of drug shortages.

This issue raised its head back in November, when the FDA delayed action on a novel cancer therapy application for Liso-cell, a new lymphoma treatment. This treatment would theoretically demonstrate a "substantial improvement over available therapies" and "[have] the potential to address unmet medical needs," both of which are part of the FDA's own definition of what constitutes a mission critical treatment. Instead, the inspection was deferred because inspectors could not travel to the facility where the drug is produced due to the pandemic. It was not until this month that the FDA finally approved use of the drug.

A US-specific Issue?

Standing in stark contrast to the sluggish operations of the FDA are the European Medicines Agency and the Therapeutic Goods Administration in Australia, both of which have conducted remote assessments of new production facilities in the months since the onset of the pandemic. Remote assessments are also utilized in Canada and the UK – the UK has, in fact, been using remote inspections since a few weeks into the pandemic. The FDA has continued to resist implementation of remote or virtual inspections, preferring instead to utilize extensive document requests which are far more time consuming and complex – particularly for facilities located in foreign countries that need to first formulate responses and then translate them into English. Even more frustrating for manufacturers are the size limitations on files that can be transmitted to the FDA, meaning that larger documents need to be broken down into multiple chunks before the system will accept them.

Pressure Continues

While the installation of a new administration in the United States government does promise the possibility the FDA will come around to the idea of remote inspections, it is currently anybody's guess as to when – or if – the administration will ever perform them. Until then, manufacturers are just hoping for at least an upgrade to the technology used by the FDA for its document request submissions. Until then, the FDA will continue to lag behind its contemporaries and pharmaceutical manufacturers will have to soldier on as best they can.

Further reading on this topic:

- FDA Fiddles With Remote Inspections While Pharma Burns

- FDA Chooses Not to Perform Virtual Inspections in Contrast to Non-US Agencies