Relationship between FDA Agencies and the Advisory Committee

Question

This article has the following descriptions;

"Perhaps what is most surprising is that in mid-August, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 1 to recommend the drug for that indication. Although the agency isn't required to follow an advisory committee's recommendation, it usually does."

According to that article, at least two groups are involved in the final stage of the FDA's approval process: the 'Oncologic Drugs Advisory Committee (ODAC)' and the 'agency'.

My question.

• In the final stage of FDA's approval process, what does the 'AGENCY'? What is the role of them? Is this the group writing the review report?
• What kind of Committees or Groups involve the review at the final stage of approval?
• How is the relationship between the groups or committees or ... involved? (In Japan's case, it appears to be as shown in Figure 1 below.)

Fig.1 Review Process for Drug or Medical Device Application in Japan(Quoted from here; it is in the public domain.)

Other article has following description

While the advisory committees’ recommendations are not binding, the FDA typically follows those endorsements when it comes to final approval of a new drug. A recent study conducted by the Milbank Quarterly found that the FDA followed the guidelines of the scientific advisory committees 78% of the time. To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015.

In a previous Q&A, I asked about the entire process from R&D to approval. In this board, I'd like to focus on the final stages (around NDA / BLA) to get approval from the FDA.

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In Japan, according to this PMDA's web site,

• The PMDA reviews all drugs or medical devices to be approved in Japan.
• After PMDA's review, the reasons, logic, rationale, and so on behind the decision to approve a drug or medicine are reported on the PMDA's review reports.
• PMDA's review reports are further reviewed by the 'Pharmaceutical Affairs and Food Sanitation Council'. This Council may be a regularly scheduled gathering of experts.

Answer 1

In the final stage of FDA's approval process, what is the 'agency'? What is the role of them?

The agency is the Food and Drug Administration (FDA). They are an agency within the Department of Health and Human Services. As the article and quote in your question says,

Although the agency isn't required to follow an advisory committee's recommendation, it usually does.

Unfortunately in the instance you mentioned, they didn't, and there can be a number of reasons for that.

In its CRL, the FDA recommended the company run at least one more randomized controlled trial in adults and/or children to generate more evidence of the drug’s effectiveness for SR-aGVHD.

^{* For those who may not know, CRL stands for Complete Response Letter and SR-aGVHD stands for steroid-refractory acute graft versus host disease}

What kind of Committees or Groups involve the review at the final stage of approval? And, what is the relationship between the committees and the FDA?

The FDA advisory committees are critical to the FDA's Product Review Process and the Oncologic Drugs Advisory Committee (ODAC) mentioned in the article you linked and quoted is one of many different committees.

A calendar of FDA committee meetings can be found at https://www.fda.gov/advisory-committees and the calendar mentions the names of the committees involved.

The committees provide FDA with independent advice from outside experts.

In general, advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be added for individual committee meetings as needed. Although the committees provide advice to the agency, FDA makes the final decisions.