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By: Barclay Butler, Ph.D., Deputy Commissioner for Operations and Chief Operating Officer

When Americans look to the U.S. Food and Drug Administration, they are expecting to see the "Gold Standard" of regulatory review—the rigorous scientific scrutiny that determines whether a new therapy, medical device, or food process is safe and effective. Behind every one of these critical decisions lies one of the world’s most sensitive repositories of intellectual property and personal data.

In an era defined by radical transparency, the FDA operates at a unique crossroads. As public servants, the staff of the FDA are driven by the principle that the American people deserve openness regarding decisions that affect their health. The FDA remains committed to evolving policies that aim for more transparency and taking steps to support innovation through greater transparency and predictability. At the same time, the integrity of that very process—and the life-saving innovation we oversee—depends on the agency’s ability to act as a fortress for the sensitive information entrusted to us.

The FDA must maintain a delicate balance: being a model of openness regarding the scientific basis of its decisions, while safeguarding the proprietary secrets of the industries it regulates. This isn't just a bureaucratic preference, it is a legal mandate. While the Freedom of Information Act (FOIA) promotes disclosure, other laws like the Trade Secrets Act and the Privacy Act mandate strict confidentiality.

Violations of these protections must not be taken lightly. Improper disclosure can lead to individual criminal liability, disciplinary action, or lawsuits against the agency. Most importantly, it undermines the "duty of trust" essential to a functioning government.

To understand how the FDA protects the public and the economy, it helps to see what typically stays behind closed doors and why:

1. Trade Secrets: The "DNA" of Innovation

   A single manufacturing process or chemical formula can represent decades of research and billions of dollars in investment. If the FDA cannot appropriately secure these secrets, the incentive to innovate vanishes. This "lock and key" ensures that when a company submits its most valuable assets for review, they remain their assets alone.

2. Confidential Commercial Information (CCI)

   This includes proprietary, non-public information that provides a company a competitive edge and would cause substantial harm if disclosed. It includes financial data, customer lists, marketing strategies, employee records, and much more. Protecting CCI prevents competitors from gaining an unfair advantage and maintains a stable marketplace.

3. Personal Privacy Information

   The FDA is a steward of deeply personal data, including the identities of consumers or physicians who report adverse events and related medical records. Protecting this "sacred" data ensures that patients and providers feel safe sharing the information necessary to catch safety issues before they become crises.

4. Privileged Intra-agency Documents

   For the FDA to make sound decisions, experts must be able to argue and vet ideas candidly. The Deliberative Process Privilege protects the raw, pre-decisional advice of scientists, helping ensure decisions are based on data rather than external political or commercial pressure.

5. Law Enforcement Records

   Information compiled for investigations, such as inspection reports, must often be shielded to protect an ongoing investigation, investigative techniques, and the identity of confidential sources.

The responsibility to protect information has real-world economic consequences. Because FDA information has the power to move markets, leaked information or recommendations could cause a company's stock to soar or plummet in seconds.

To ensure a level playing field, the FDA enforces strict insider trading and ethics protocols. Employees are prohibited from using nonpublic information for private gain or "tipping" off others. This vigilance is an important defense against the erosion of institutional integrity and maintains the fairness of U.S. financial markets.

The FDA provides a massive amount of data to the public through FOIA and on its own initiative. However, every page is meticulously reviewed to redact specific sensitive categories as appropriate:

The FDA’s commitment to confidentiality is what allows the private sector to share its most sensitive data with the government. By acting as a vigilant guardian of this information, the FDA doesn't just protect "data"—it protects the very cycle of innovation that brings new treatments to the bedside and safe food to the table.