The FDA — the agency responsible for protecting Americans from unsafe and ineffective drugs — has been captured by the industry it is supposed to regulate. Consumer Reports and the FDA's own internal documents reveal the extent of this capture.

Regulatory Capture Defined

Regulatory capture occurs when a regulatory agency comes to serve the interests of the industry it is supposed to regulate, rather than the public interest. The FDA exhibits classic signs of regulatory capture:

  • Funded by user fees paid by the pharmaceutical industry
  • Staffed by former industry employees and future industry employers
  • Approves drugs based primarily on industry-funded trials
  • Suppresses internal dissent from scientists who question drug approvals

The User Fee Problem

The FDA's drug approval division (CDER) is funded approximately 65% by user fees paid by pharmaceutical companies. This creates a structural conflict of interest: the FDA depends on the industry it regulates for its operating budget.

The user fee system was introduced in 1992 with the stated goal of speeding drug approvals. It has succeeded in speeding approvals — but at the cost of approving more drugs that later prove harmful.

The FDA depends on the pharmaceutical industry for 65% of its drug approval budget. This is not a regulator — it is a partner.

The Revolving Door

Former FDA officials routinely take jobs in the pharmaceutical industry after leaving government service. A 2016 study found that 55% of FDA reviewers who left the agency between 2001 and 2010 took jobs in the pharmaceutical industry.

Conversely, many FDA officials previously worked in the pharmaceutical industry. This revolving door creates a culture of accommodation rather than regulation.

Consumer Reports' Investigation

Consumer Reports' 2012 investigation "Too Many Meds?" found:

  • The FDA approved 20 drugs in 2011 that were later found to have serious safety problems
  • 32% of drugs approved between 2001 and 2010 received post-approval safety communications
  • The FDA relies almost entirely on industry-funded trials for approval decisions
  • Independent verification of trial data is rare

The Internal Dissent Problem

FDA scientists who raise concerns about drug safety face retaliation. Multiple whistleblower cases have documented FDA management suppressing safety concerns to approve drugs. The FDA's own scientists have written to Congress complaining of a culture that prioritizes speed of approval over safety.