Next FDA head faces tough road as criticism increases

No matter who becomes the next FDA commissioner, that person is in for a difficult battle to raise its credibility in the wake of recent controversies.

No matter who becomes the next FDA commissioner, that person is in for a difficult battle to raise its credibility in the wake of recent controversies.

The Food and Drug Administration is once again without permanent leadership, and whoever becomes the next commissioner will face a challenge in rebuilding the agency's reputation and credibility.

Facing mounting pressure over controversies ranging from drug safety to teen contraceptive use, Dr. Lester Crawford resigned as the agency's commissioner on September 23, after only two months in office.

Dr. Andrew von Eschenbach is now serving as acting commissioner, but his appointment is expected to be temporary.

"I think what you have is the perfect storm of the FDA's communications nightmare," says Peter Pitts, SVP of global health affairs at MS&L and former FDA associate commissioner for external affairs.

Pitts notes that, while the public still holds the FDA in high regard, the agency has dropped in esteem inside the Beltway.

"The agency has a much harder time asking for money from Congress and using the bully pulpit for its own purposes," he says.

The FDA now finds itself in an unfamiliar position: at the center of a sensitive and polarizing political battle - one that the agency has been reluctant to address head-on, instead opting to wait out the storm.

The situation may only intensify as President Bush seeks another candidate to fill Crawford's post.

Paul Clark, director of crisis media at Hill & Knowlton, notes that the FDA has a long road ahead of it before another commissioner is installed.

"[Whomever the President nominates] will be vetted by the administration," he says, drawing a comparison to the Supreme Court confirmation hearings and adding that Congress will be on alert for cronyism. "You are trying to do that for a highly controversial position."

But PR pros agree that installing a new leader is the first step for the FDA to increase trust in the agency.

"There's been a lack of leadership," says Kym White, MD of Ogilvy's New York office and former head of the healthcare practice. "I don't think the resignation itself is all that well-explained."

Pitts similarly points to the need for a quick confirmation, adding that an acting commissioner doesn't have the same authority or confidence as a leader who has been approved by Congress, a key audience for the FDA's lobbying efforts.

Von Eschenbach has already faced conflict-of-interest concerns that forced him to temporarily step down as director of the National Cancer Institute, Pitts notes.

"You can't have those sorts of crises and not have an image problem," says Fleishman-Hillard SVP Mark Senak, an attorney who counsels clients on bringing drugs to market. "Putting in a strong figure ... provides an opportunity for rehabilitation here."

Responding to detractors

Even after a new commissioner is confirmed, the FDA must still respond to criticism that it cares more about politics than science.

The FDA approval process has long been regarded as the "gold standard" worldwide, Senak notes. "You have an agency that two years ago was described in glowing terms ... and confidence levels were really high," he says.

But lately it has suffered from the fallout from controversies including the Vioxx recall, the flu vaccine shortage, high-profile resignations, and the morning-after pill debate.

Pitts notes that the FDA has typically responded to crises by waiting for them to blow over. In this case, however, he notes that a wait-and-see approach might not be the most prudent.

He suggests that the FDA has become a scapegoat for politicians looking to "grab headlines" and benefit from recent controversies. "What you don't have is people working together," he says.

And he notes that outreach will need to be directed toward doctors in particular. "The FDA needs doctors to have faith in what they're doing."

The agency has undertaken a number of transparency initiatives, including setting up a Drug Watch website, distributing product information sheets to patients and doctors, and establishing an independent Drug Safety Oversight Board.

It's also changed its message to position itself less as an agency that has the final say on the safety of a drug than one that gives patients and doctors enough information to make informed decisions.

An FDA public affairs representative was not immediately available for comment.

Senak notes that the FDA also needs to take steps to indicate that it has learned from some of its past mistakes.

"The FDA is trying very hard to do a more diligent job than ever," he says in reference to last year's controversies over antidepressants and cox-2 inhibitors (painkillers commonly used to treat arthritis) that raised questions about whether the agency could effectively monitor drugs post-approval.

But becoming too strict is likely to create the same sort of crisis the FDA saw a decade ago, when AIDS activists clamored for speedy drug approval, Ogilvy's White notes.

"We must make sure that the FDA doesn't tighten up the ship ... and [also] make sure that people do have access to life-saving therapies," she explains. "The next FDA commissioner will need to show that creativity and flexibility."

She adds that the next FDA commissioner must have a strong public profile.

"We would benefit from a strong FDA commissioner who has widespread public recognition along the lines of former Surgeon General C. Everett Koop," she says. "The new FDA commissioner will need to be seen as both vigilant and creative to win over Americans who have lost faith in the system."

Some of the most damaging criticism against the FDA has come from within its own walls, and internal communications must be a significant focus going forward, Senak notes.

Pitts categorizes the internal conflict as "discontented employees settling old scores."

In the aftermath of the Vioxx recall, drug reviewer Dr. David Graham blew the whistle on the agency, calling it "incapable of protecting America."

Less than a year later, in the wake of the morning-after pill controversy, Dr. Susan Wood resigned from her post as the head of the Office of Women's Health and left no doubt about why she was leaving.

"Scientific and clinical evidence," she wrote in an e-mail that abortion-rights advocates sent to the Associated Press, "has been overruled."

Morning-after controversy

The debate over the morning-after pill's status has been particularly damaging to the FDA's image as a science-guided agency.

Senak calls a decision on over-the-counter status for the morning-after pill "critical" to moving past that controversy.

That fight in particular had "a very public viewing," and the public saw politics "trumping the scientific process," he notes.

H&K's Clark, however, disagrees. "If they take on those issues head on ... I think that will be unfortunate," he says. "That's not where you want to go first. At this point, you don't want to take on a controversial issue without leadership."

As the FDA works to repair its damaged credibility, White notes, lower confidence "creates an atmosphere of distrust that runs through the entire healthcare system."

She adds, "When consumers doubt the FDA, they rely more heavily on other sources - their doctors, their pharmacists, mass media, friends, and family."

But Senak notes that the agency is on track this year to nearly double the number of MedWatch drug advisory alerts it issued last year.

"I don't think that there's anything to indicate that there is [an impact on drug] quality."

He says the crisis reflects more on the state of trust in Washington than on the state of the public's trust in healthcare companies.

"You see more of a crisis in government than a crisis in industry," he says.

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