Let us think with reason and logic. You are paid to regulate an industry, but 45% of your payment comes directly from the industry you are supposed to regulate. Is that a conflict of interest? The FDA has the highest responsibility to the public as it is charged to make certain the products we consume, and the medications we take are safe. This agency receives 45% of its budget ($2.7 billion) directly from the very industry it is supposed to regulate. This is from a fact sheet released by the FDA in November 2020. This wasn’t always the case; but since these so-called industry “user fees” started funding close to half of the FDA’s budget, some alarming facts have come to light.
In the years that followed after fees were introduced, several drugs approved by the FDA came under scrutiny. Pharmaceutical giants promoted drugs that were later connected with extremely dangerous and life threatening side effects. In 2004, Merck as an example, withdrew Vioxx from the market, after discovery that it increased both the risk of heart attack and stroke. David Graham, who is an FDA safety official, along with other researchers estimated Vioxx had caused at least 139,000 heart attacks and sudden deaths. Infuriatingly to all of us who depend on the integrity of the agency, it was put on record that permission to publish their findings in a medical journal was withheld! This is what David Graham testified to during a 2004 Senate hearing.
A spokesperson for the FDA Michael Felberbaum said to USA today that “User fees provide instrumental funding for the FDA’s independent review of medical products that make a difference in the lives of all Americans, without compromising the agency’s commitment to scientific integrity, public health and regulatory standards, patient safety and transparency,”. Can we believe the word of someone not underoath after the sworn testimony given by Graham? I don’t know how a logical person could not see a problem here. Is there a systemic problem within the FDA? Graham stated “I was ordered to withdraw the paper or ‘face severe consequences’—which I interpreted to mean that I would be fired,” to The Los Angeles Times .
So who is telling the truth? A spokesperson, or Graham during the 2004 Senate hearing who spoke on the culture at the FDA saying that the agency “views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and it seriously undervalues, disregards and disrespects drug safety”.
Does this give you confidence in the FDA and its ability to ensure safety of the products it approves? Or does it persuade you that an independent regulatory body ought to investigate the FDA and hold the agency accountable for any wrongdoing, or at the very least restore public confidence in the agency’s integrity.