Product News and Recalls

Think the FDA Has Your Best Interests in Mind? You May Want to Think Again.

FDA under fire for industry-friendly approach“Instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.” This is the assessment of Dr. Michael Carome, director of health research for Public Citizen, on the current state of affairs at the Food and Drug Administration.

Earlier this summer, ProPublica published a damning look at the agency responsible for keeping Americans safe from the foods we feed ourselves and the drugs we use to stay healthy and treat illnesses. It tells the story of an agency that is bending over backward to serve its financial overlords and doing everything it can to prove itself worthy of the money that pharmaceutical companies shovel into its coffers every year. After all, most Americans are blissfully unaware that the vast majority of the FDA’s review budget comes not from the tax dollars of those they should be working to protect, but from the companies who have put forth the drugs and medical devices for the agency’s approval in the first place.

And it appears that under the “leadership” of Trump administration commissioner Dr. Scott Gottlieb, this trend is only getting worse. Gottlieb seems to be focused on making it as easy as possible to get new drugs into the marketplace, regardless of their effectiveness. In fact, the agency is rejecting fewer new medications than ever. In 2010, the FDA rejected 59.2 percent of the applications it received for new drugs, biologics, and efficacy supplements. In 2017 that percentage was less than 20.

“You don’t survive as a senior official at the FDA unless you’re pro-industry,” says a former FDA medical team leader quoted in the article. “The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don’t like you.” In the assessment of another former FDA staffer, “Nobody gets congratulated for turning a drug down, but you get seriously questioned. Keep Congress off your back and make your life easier.”

When Big Pharma pays close to a billion dollars a year toward the review budgets for the drugs it wants to see on American shelves – not to mention the money it pays to keep members of Congress in check – what are we supposed to do when it comes time to make independent, informed choices regarding our health and the health of our families?