Sina Pharma's 2022 Forecast Can the FDA Reduce Its Drug Manufacturing Regulatory Review Backlog?

In 2021, U.
S.
lawmakers, government officials and top FDA officials all appear to be racking their brains to try to resolve the huge backlog of regulatory review of drug manufacturing that the agency faces
.
However, although the slow and inefficient US FDA has now begun to rectify the domestic regulatory dilemma, these problems will continue to exist in foreign countries.

1.
The progress of domestic review is expected to be accelerated

The backlog in the U.
S.
FDA will not only lead to delays in approving new drugs, but it will also lead to other problems for drugmakers, such as the fact that these manufacturers must pass a series of FDA inspections before they can be cleared of warning letters or import alerts
.
In an update to its inspection resilience roadmap in mid-November, the FDA disclosed that it reported a cumulative 52 new drug application delays due to the review backlog caused by the COVID-19 pandemic, up from 48 reported in May

In terms of domestic manufacturing inspections next year, the FDA will likely need to complete its backlog
.
Given the progress the FDA has made at home, Denigan Macauley, director of health care at the U.

Macauley added that while the agency has made inspection improvements at home, things are very different abroad
.
Given the problems the FDA has faced in this regard, some of which actually predate the COVID-19 outbreak, it seems even more elusive that the FDA can reduce its foreign inspection backlog, Macauley also asserts, "certainly next year.

2.
FDA review strategy needs to be revised urgently

The FDA basically resumed normal operations in July
.
By November, the FDA said it had completed 1,139 of the 3,229 outstanding inspections of medical products and devices

McMeekin said the agency does not yet have data on the number of domestic inspections completed since the November update, but the FDA plans to share that information at some point in the future
.
The U.

3.
Overseas regulatory difficulties may continue

In addition to the backlog in the domestic market and the inefficient and slow review strategy that needs to be improved, the regulatory dilemma of the US FDA in overseas markets also needs to be resolved urgently
.
In 2022, the problems the FDA faces overseas may remain insurmountable

However, Macauley noted that the outbreak of the COVID-19 Omicron variant could derail the implementation of these plans, but there is no doubt that the FDA's roadmap to resiliency is moving in the right direction
.
McMeekin explained that the foreign surveillance inspection program will rely on U.

The U.
S.
Government Accountability Office said earlier in 2021 that from March to October 2020, the FDA conducted only three critical regulatory task inspections overseas, compared with the agency's annual ability to conduct inspections under normal circumstances.
About 600 foreign inspections
.
The situation improved in 2021 as the outbreak eased, but inspection activity remained relatively light
.
Between April and September 2021, regulators conducted only 37 foreign drug inspections, 3 foreign animal drug inspections, 4 foreign medical device inspections, and 2 foreign biologics inspections
.

Like many organizations during the pandemic, the FDA has opted for a combination of digital technology and remote tools
.
Macauley added that while remote inspection tools are an important resource during the pandemic, in-person inspections are a key step in the agency's oversight efforts
.
FDA ultimately needs to use these alternative oversight tools (such as remote inspections, requesting records, and reliance on certain other regulatory agencies abroad) to complement, not replace, its traditional inspection process
.

4.
There are many difficulties and the improvement of the plan is limited

In fact, when it comes to foreign inspections, the U.
S.
FDA has struggled since before the pandemic
.
Staff vacancies and language barriers are the two main issues, Macauley said
.
The good news, though, is that the FDA is actively addressing these issues, as she pointed to a pilot program the regulator plans to launch in 2022 to improve translation capabilities for foreign drug inspections
.
Macauley added that the staffing level of investigators is key to the agency's ability to effectively complete regulatory reviews, and regulators are actively hiring
.

McMeekin said the FDA is specifically looking for foreign professional employees who will be based in the U.
S.
but travel to foreign countries for on-site inspections
.
Looking ahead, the FDA said it will continue to prioritize "mission-critical work" as well as other "higher-level inspection needs," such as causal inspections for safety incidents (eg, drugs containing carcinogenic impurities)
.

In July, the agency also launched the FDA Inspection Affairs Committee (FIAC) to develop a multi-year action plan around inspections, information sharing and other processes to accelerate the evaluation and potential integration of new oversight methods and tools
.
One of FIAC's responsibilities is to develop agency-wide policies and procedures for remote regulatory assessment
.
McMeekin said the FDA has learned from experience to date and discussions with foreign counterparts that remote assessments present meaningful technical challenges that require more resources than expected, some of which include difficulties surrounding time zone differences and live streaming tapes.
unavoidable network technology problems
.

The FDA has relied on these alternatives to enhance its surveillance review efforts during COVID-19, but remote reviews fall far short of the actual requirement that surveillance inspections require in-person reviewers
.
By moving to digital, the FDA can reduce the number of review delays, but it will still be subject to hundreds of surveillance inspections that require in-person contact
.

Ideally, on-site inspections would be complemented by other tools, including records and remote interactive assessments, McMeekin said.
The combination of the two would provide the FDA with the most in-depth information.
The information obtained through remote assessments could be used to support regulatory decisions, including applications.
approval, and regulatory action including warning letters
.
In this regard, both Macauley and McMeekin also pointed out that the FDA needs to adopt a combined inspection mode that combines old and new review methods
.

Reference source:

2022 forecast: Can the FDA whittle down its manufacturing site inspection backlog next year?