Outrage of the Month: Agency Insiders Recount FDA’s Cozy Relationship with Industry

Health Letter, August 2018

By Michael Carome, M.D.

outrage

If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

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Image: Kirill Kurashov/Shutterstock.com

Time and again over the last 47 years, Public Citizen’s Health Research Group has harshly criticized the Food and Drug Administration (FDA) for approving new prescription medications — or allowing already approved drugs to remain on the market — when the available evidence demonstrated that the drugs’ risks of serious harms outweighed their benefits.

The FDA’s increasingly lax oversight of prescription drugs no doubt has been driven by the agency’s much too cozy relationship with the pharmaceutical industry — a relationship that FDA leadership in recent years routinely has trumpeted as a “partnership.” Underpinning this partnership, in which FDA decision makers too often place the industry’s interests over the protection of public health, have been the exorbitant user fees paid by drug companies for the FDA’s review of their products. Agency budget documents reveal that industry user fees to the FDA’s Center for Drug Evaluation and Research now total more than $1 billion annually.

The reality of the deeply entrenched industry-friendly culture within the FDA was underscored in a remarkable exposé, “FDA Repays Industry by Rushing Risky Drugs to Market,” that was published by ProPublica on June 26, 2018. The piece highlighted the agency’s growing emphasis on speed over safety when reviewing applications for approval of new drugs.

ProPublica reported that according to former agency employees, as the FDA became more reliant on industry user fees to pay for drug reviews, the agency showed an increasing inclination to approve new drugs. For example, Dr. Tom Marciniak, a former FDA medical team leader who has been a long-time critic of how drug companies conduct clinical trials, told ProPublica, “You don’t survive as a senior official at the FDA unless you’re pro-industry. 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.” Marciniak further noted to ProPublica that FDA staff know that you “don’t get promoted unless you’re pro-industry.”

One particularly revealing indication of the FDA’s pro-industry tilt can be found in the annual internal awards given to drug review teams. Marciniak and another anonymous former FDA employee recounted to ProPublica never having seen an award granted to a review team that rejected a new drug application. FDA leaders would congratulate review teams when drugs were approved, whereas “[n]obody gets congratulated for turning a drug down, but you get seriously questioned.”

With industry capture of the agency, the FDA no longer follows the precautionary principle necessary for protecting public health. Thus, the independent drug reviews provided by Worst Pills, Best Pills News are now more important than ever.