Big Pharma’s worst nightmare? FDA now exposes drug harms in real time

• The FDA will now publish daily drug injury reports after years of deliberate delays that left patients uninformed about medication dangers.
• Critics argue the change comes only after mounting public distrust due to scandals like the opioid crisis and COVID vaccine cover-ups.
• VAERS still lags behind, with thousands of vaccine injury reports—including deaths—hidden from the public for years.
• Passive reporting systems like VAERS and FAERS fail to capture most adverse events, leaving Americans vulnerable to unchecked drug and vaccine risks.
• True transparency requires real-time VAERS updates, full access to hidden databases, and an end to FDA-Pharma conflicts of interest.

For years, Americans who suffered devastating side effects from prescription drugs or vaccines were forced to wait months—and sometimes years—for the FDA to release injury reports to the public, but all that is about to change. In a rare victory for medical transparency, the FDA announced last week that it will begin publishing daily updates on drug-related adverse events through its FAERS (FDA Adverse Event Reporting System) database, ending an era of deliberate delays that left patients in the dark about the dangers of their medications.

The move comes after decades of criticism from health freedom advocates, independent researchers, and even some lawmakers who accused the agency of hiding critical safety data while fast-tracking dangerous drugs to market. FDA Commissioner Marty Makary, in a refreshing break from bureaucratic doublespeak, admitted what we’ve all known for years: “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public.”

So why the sudden change of heart? The answer may lie in the growing public distrust of federal health agencies—distrust fueled by scandals like the opioid crisis, the COVID vaccine cover-ups, and the revolving door between Big Pharma executives and FDA regulators. With more than 2 million adverse drug reactions reported annually, the agency can no longer afford to drag its feet while Americans suffer.

A step forward… but what about vaccines?

While the FDA’s new policy is a long-overdue win for transparency, glaring questions remain: Why doesn’t the vaccine injury reporting system VAERS get the same treatment?

Children’s Health Defense (CHD) has been sounding the alarm for years about VAERS’ shocking lack of accountability. In a scathing letter to the CDC earlier this year, CHD revealed that more than 5,000 vaccine injury reports, including 795 deaths, were never made public, despite being logged internally. That’s right: while the FDA is now updating drug injuries in real time, the CDC has been sitting on thousands of vaccine-related deaths and injuries, releasing them only when forced—or not at all.

Health Secretary Robert F. Kennedy Jr. has pledged “radical transparency” at federal health agencies, calling out VAERS as a “system designed to fail” that captures fewer than 1% of actual vaccine injuries. But will his reforms survive the deep-state resistance? The recent firing of CDC Acting Director Susan Monarez after clashes with Kennedy over vaccine policy suggests the battle is far from over.

Why we’re still flying blind on drug and vaccine risks

Here’s the dirty little secret about FAERS and VAERS: they’re both “passive” systems, meaning they rely on doctors, patients, or drug companies to voluntarily report injuries. As any whistleblower will tell you, most adverse events never get reported—either because patients don’t know how, doctors dismiss their concerns, or (let’s be honest) Big Pharma pressures them to stay silent.

Hooker points to a 2011 Harvard Pilgrim study that proved automated, active surveillance using electronic health records to flag post-vaccination injuries could work. So why hasn’t the FDA implemented it? “The lame excuse… is always privacy issues,” Hooker said, “but it would be easy to de-identify patient records.”

The real reason? Follow the money. The FDA gets 45% of its budget from pharmaceutical companies through “user fees.” The CDC owns over 50 vaccine patents and rakes in billions from vaccine sales. Conflict of interest, anyone?

Will this actually protect Americans, or is it just damage control?

The FDA’s new “real-time” reporting is a step in the right direction, but let’s not pop the champagne yet. FAERS still doesn’t include over-the-counter drugs, supplements, or—most critically—vaccines. And as CHD’s Tom Yengst warned, VAERS continues to withhold thousands of reports, raising serious questions about what else they’re hiding.

If the FDA is truly committed to “radical transparency,” here’s what needs to happen next:

• Daily VAERS updates. No more sitting on death reports for months.
• Full public access to the Vaccine Safety Datalink (VSD), the CDC’s secretive database that’s been off-limits to independent researchers for decades.
• Mandatory, automated injury tracking. No more relying on voluntary reports that get “lost” in the system.
• An end to FDA-Pharma collusion. No more fast-tracking dangerous drugs while burying the side effects.

For too long, federal health agencies have operated in the shadows, protecting pharmaceutical profits over public health. The FDA’s new policy is a small but meaningful crack in the wall of secrecy, but it’s not enough. Not when 1.5 million COVID vaccine injuries have been reported to VAERS since 2020. Not when thousands of deaths remain hidden from the public. Not when Big Pharma still enjoys legal immunity for vaccine injuries.

The American people deserve full, unfiltered access to the truth—about drugs, about vaccines, about the real risks they’re being forced to take. The FDA’s move is a start. Now let’s see if they have the courage to finish the job.

Sources for this article include:

ChildrensHealthDefense.org

MedicalXpress.com

FDA.gov