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Psst! Industry Has Taken over FDA

Psst! Industry Has Taken over FDA
Is Robert Califf, nominated to be FDA commissioner, too close to industry?

Is Robert Califf, nominated to be FDA commissioner, too close to industry?

Jim Dickinson

By nominating cardiologist Robert M. Califf to be FDA’s next commissioner, the Obama Administration has taken a giant step away from the agency’s traditional avoidance of even the suspicion of coziness with the industries it regulates.

This is a good thing, even though shocking to the traditionalists. It owns up to the reality that FDA is now beholden to its regulated industries who have quietly “come inside” its decision-making processes to an extent that has never been publicly admitted.

Just six years ago, the industry-at-arm’s-length tradition held sway—as it had throughout FDA’s history—when Califf was passed over in Obama’s hunt for a commissioner.

The reason? The Duke University researcher of numerous drug industry clinical trials was then viewed as being too close to the pharmaceutical industry—the same reason that had for decades kept other similarly situated candidates from being chosen to lead the world’s premier health regulatory agency. New York health commissioner Margaret Hamburg was chosen instead.

Actually, her selection wasn’t the pure-as-the-driven-snow alternative to Califf that it seemed at the time. A month after being sworn in she had to recuse herself from the agency’s 2009 rulemaking on dental amalgam safety due to her prior board membership at the country’s largest amalgam distributor, Henry Schein, and divest substantial income from that and other FDA-regulated companies.

Hamburg wasn’t the first FDA commissioner to be embarrassed by being too close to regulated industry. Before her, former commissioner Andrew von Eschenbach was publicly criticized by congressional investigators over his choice of a pharmaceutical industry PR firm, Shaw Science Partners, to develop an FDA Web site for consumers about drug ads and for removing an employee without sufficient cause based on a drug company’s complaints.

And before him, former commissioner Lester Crawford was found to have concealed his ownership of stock in regulated companies while in office and agreed to pay a $50,000 fine instead of going to jail.

These sorts of distractions from FDA’s mission not only consume taxpayer dollars as they are investigated and resolved, but they detract from what has often been called the “FDA gold standard” and actually contribute to public distrust of government.

Califf’s nomination, if it isn’t stalled by political gamesmanship on Capitol Hill, offers an opportunity for public examination of the diverse ways regulated industry can and does influence FDA decision-making.

Stockholding in regulated industry is clearly prohibited by conflict of interest laws, so he will have to divest any stocks in such companies that he and his immediate family possess.

But what do you do about the more subtle forms of influence that may flow from long-held personal relationships and intellectual sympathies developed over years of research assignments with regulated companies?

As the public charges against both von Eschenbach and Hamburg indicated, the issue of at least subliminal pro-company biases in an FDA commissioner is a real one, and something that is not easily addressed by passing a law against it.

No matter how sincere a commissioner might be—and Hamburg was—in divesting him or herself from all potential appearances of possible conflicts of interest before taking on the job, suspicions will linger in the minds of people and groups ready to provoke investigations that cost taxpayer dollars.

That is exactly what seems to be developing in the case of Califf’s nomination.

In a press release, Public Citizen said the Senate should reject it because of Califf’s close ties with industry over the years. “During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few,” the group said. “Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed.”

Public Citizen argued that Califf’s appointment would “accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry, rather than those of public health and patients. The Senate should reject Califf and demand that the president nominate someone who has not been so closely connected to FDA-regulated industries and is therefore better suited to protect public health.”

Echoing similar concerns, National Center for Health Research president Diana Zuckerman said Califf could have a bias toward industry after working in tandem with companies that funded clinical research at Duke.

When Califf joined the agency last February as deputy commissioner for medical products and tobacco—a step widely seen as grooming him to become commissioner—Zuckerman told Time that his “interdependent relationships” may bring into question his “objectivity and distance.” In the Time article, she pointed out that research has shown that scientists may unknowingly be swayed by their industry relationships.

And such credibility- and prestige-shaking suspicions aren’t confined to choosing FDA commissioners. They are also present in the statute-sanctioned user fee process, where accusations occasionally are made that FDA employee attitudes toward sponsors have been made less skeptical and objective in a user fee-influenced internal culture evoking a “he who pays the piper calls the tune” syndrome, at least subconsciously.

Indeed, there have been complaints by FDA whistleblowers in the recent past that managers have encouraged reviewers to regard device sponsors as the agency’s “customers.”

Building “customer satisfaction” has become official CDRH policy, albeit perhaps not in those exact words. It may not be a huge step from that objective to the well-worn mantra from the world of everyday normal commerce: “The customer is always right.”

The inroads industry has made at FDA are not always viewed with apprehension, however.

Califf’s nomination was welcomed enthusiastically by Francis Collins, the director of FDA’s sister agency, the National Institutes of Health. He told The Wall Street Journal he has worked with Califf for years, and called it “a fantastic nomination. . . . I hope that Congress will respond quickly . . . He has such a wealth of experience in how to do research.”

And Friends of Cancer Research chair Ellen Sigal strongly supported the nomination, saying in a statement that her organization looks forward to working with Califf on “vital issues that directly impact patients’ lives.” Sigal said that with Califf’s “diverse background, and his exemplary knowledge of clinical and translational medicine, he will continue to improve the FDA's drug approval process while ensuring that patients are receiving the safest and most effective treatments as quickly as possible.”

FDA’s independence from the industries it regulates has throughout its 109-year history been largely taken for granted.

That has changed in recent years, obscured by the agency’s growing penchant for secrecy in its internal administrative deliberations and communications with individual product sponsors.

The Califf confirmation process in the Senate, with its arena of contestants for and against, is likely to cast a spotlight on how much of FDA’s thinking has been taken over by industry influence.

Jim Dickinson is MD+DI's contributing editor. 

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[Image courtesy of XEDOS4/FREEDIGITALPHOTOS.NET]

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