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Disclosing Information About Drugs and Fostering CDER’s Transparency Efforts

CDER’s Office of Regulatory Policy’s (ORP) Division of Information Disclosure Policy (DIDP) works to make CDER materials available to the public, all while adhering to relevant statutes, such as the Freedom of Information Act (FOIA), and other applicable disclosure laws. DIDP Deputy Director Darshini Satchi, JD, discusses how the division develops and implements CDER’s disclosure activities, including proactively releasing content related to drug approvals and responding to external requests for information.

Darshini Satchi

Darshini, can you describe ORP’s Division of Information Disclosure Policy (DIDP)? What is the purpose and mission of the division?

DIDP is CDER’s gateway to release information consistent with applicable disclosure laws which allows important drug information to be made available to the public. Disclosure work involves reviewing all types of CDER documents related to the drug review and approval process. DIDP document reviews determine whether, before being made available to the public, drug information should be redacted, in part or in its entirety, under FOIA. While CDER strives to be as transparent as possible, we are required under the law to review and protect certain information from being released to the public such as confidential commercial information, trade secrets, and personal privacy information, from documents before we publicly share them.

The FOIA statute plays a key role in advancing government transparency—it allows the public to know “what the government is up to” by giving people the right to request access to federal agency records or information. While FOIA is intended to increase transparency, it does not provide access to all government documents. Often, our division needs to make complex decisions about what information can be released to the public. There are times when we are legally restricted in what we can publicly release, for example we are limited in disclosing information on pending drug approval applications.

Given the volume of documents CDER creates and the high-level of public interest in CDER activities, DIDP has its hands full. We maintain CDER’s portfolio of routine, proactive disclosure efforts (based on FOIA and statutory obligations) -- for example, reviewing and publicly posting drug approval packages, warning letters, and untitled letters. Our proactive efforts allow people access to important drug information without the need of having to make a FOIA request. Disclosing these documents helps patients as well as health care providers make potentially life-saving decisions.

We also evaluate thousands of external requests for information under FOIA. We’re talking about requests seeking an amount of documents that could fill football stadiums across the country. Plus, we respond to requests for CDER documents from: Congress; foreign, state, and local governments; and other federal agencies. These efforts help to increase collaboration among governing agencies and partners to benefit public health in the development and approval of life-saving drugs.

In addition, DIDP directs the overall policy direction on disclosure issues for CDER, providing disclosure advice on a wide variety of scientific and policy matters, including advisory committee meetings and drug safety communications.

Can you elaborate on DIDP’s tasks related to CDER drug approvals?

We understand the public is keenly interested in drug approval documents and DIDP’s Proactive Disclosure Branch (PDB) focuses on this effort. The PDB releases information that is required to be disclosed under the law as quickly as possible after a drug is approved, such as reviews of original New Drug Applications (NDAs) and Biologics License Applications (BLAs). The PDB also reviews hundreds of other types of documents for proactive disclosure, including NDA and BLA efficacy supplement approval letters, requests for pediatric studies and pediatric reviews, and ANDA approval letters especially for first generic approvals.

In addition, the Food and Drug Administration Amendments Act of 2007 requires that New Molecular Entities (NME)/New Biological Entities (NBE) action packages be published on CDER’s web page within 30 days after approval. Certain drugs are classified as NMEs for purposes of FDA review. Many of these products contain active moieties -core molecules or ions of a drug that is responsible for the physiological or pharmacological action of a drug substance - that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients.

Can you talk about any challenges brought on by the COVID-19 global pandemic?

The pandemic presented many challenges for DIDP, as it did for CDER and FDA at large. For one, we saw a substantial increase in FOIA requests for COVID-19-related documents. CDER also has a proactive transparency program for review documents supporting CDER-led Emergency Use Authorizations (EUA) that requires us to quickly redact and release these review documents to the public. DIDP believes that health care providers, patients, and the scientific community benefit from public disclosure of CDER’s scientific reviews of the data and information supporting EUAs and we have been very successful in getting this information to the public quickly.

We have also seen an increase in requests from foreign governments and other federal agencies during the pandemic, which all required DIDP to shift resources to meet this new volume of work. We are passionate about international information sharing and collaboration during the COVID-19 global pandemic, such as information about drug safety and effectiveness and FDA’s decision-making process of drugs.

Given the challenges you faced with the pandemic, it looks like DIDP was still very successful in releasing a large volume of information to the public. Can you talk about what DIDP accomplished?

Like all offices in CDER, DIDP was all hands on deck in 2021 and worked around the clock to not only assist in our response to COVID-19, but also continue our important work in other areas. Here’s a sampling of our accomplishments last year:

  • Posted action packages for NME/NBEs containing scientific reviews supporting their approvals;
  • Reduced the average time from approval to publication of NME/NBE action packages;
  • Posted action packages for non-NME NDAs;
  • Posted action packages for supplemental NDAs for high-priority approvals;
  • Posted drug approval letters;
  • Posted Pediatric reviews;
  • Posted non-compliance letters and sponsor-response letters;
  • Responded to and completed FOIA requests;
  • Posted COVID-19-related warning letters; and
  • Posted non-COVID-19 warning letters.

What does the future for hold for DIDP in general and your transparency efforts?

Given the importance of disclosure work in many aspects of CDER’s mission, DIDP’s portfolio continues to expand and we’re ready to take on the challenge. DIDP has a role in many of CDER’s ongoing initiatives of strategic importance. One of our goals is to lead and help CDER efforts on sharing information in the spirit of cooperation and transparency. DIDP will continue its critical work in responding to information requests as quickly and diligently as we can.

 
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