FDA Foot Dragging – Three Months After Expert Panel Urged “Black Box” Warnings for Antidepressants, No Action

Thu, 23 Dec 2004

Why is the FDA failing to enforce the "Black Box" warnings on SSRI antidepressant drug labels?

When questioned by the NJ Star Ledger, Robert Temple, director of the FDA’s Office of Medical Policy, said:

“I’m sympathetic to the idea that you don’t want to let a lot of time go by. But we ask the companies to modify labeling that they own. … The right to disagree (over the wording) is reasonable.”

Reasonable? After antidepressant drug manufacturers have been caught concealing vital safety information, engaging in fraudulent marketing, ghostwriting reports in scientific journals, and exposing children’s lives to severe harm – even suicide – it is reasonable and appropriate for the FDA to enforce the "Black Box" warning – as written by the FDA.

Children’s lives will not be protected merely by Dr. Temple’s claim that he is "sympathetic." The time for action is long overdue. Why is the agency failing to enforce itsw own safety directive? Who is giving the marching orders at the FDA?

Laurie Yorke, whose son twice attempted suicide while on an antidepressant put it succinctly:

“This is a life-and-death situation that should have been instituted immediately. The fact that we sit here months after the decision only reinforces FDA foot-dragging on a serious public health issue.”

Contact: Vera Hassner Sharav

NJ Star-Ledger
Choosing their words carefully
Thursday, December 23, 2004

Three months after a panel of government scientists called on drug makers to add “black box” warnings to their antidepressants, the changes have yet to be made.

The delay is angering consumer advocates, who say children are being put at risk because the pills are linked to suicide in youngsters. And they say the holdup underscores concerns about the ability of the Food and Drug Administration to monitor drug safety.

They also complain drug makers may unfairly benefit. Despite widespread publicity given the issue, some doctors may not change prescribing habits until the warnings appear.

“If the warnings aren’t being issued fast enough, lives will continue to be lost,” said Vera Sharav of the Alliance of Human Research Protection, who is a frequent FDA critic and has assailed drug makers for failing to disclose links between antidepressants and suicide.

A black-box warning, the most severe warning that can be placed on a drug label, is used to alert doctors to serious side effects. In September, an FDA advisory panel recommended the agency require black-box warnings for antidepressants. The FDA adopted the recommendation and the next month notified drug makers of the change.

Laurie Yorke, a Clark resident whose son twice attempted suicide while on an antidepressant, said: “This is a life-and-death situation that should have been instituted immediately. The fact that we sit here months after the decision only reinforces FDA foot-dragging on a serious public health issue.”

FDA officials said the amount of time that has elapsed is not unusual, because the wording of a black-box warning requires time-consuming reviews and discussions between the agency and each company. Updated labeling should be in place by late January, FDA officials said.

“I’m sympathetic to the idea that you don’t want to let a lot of time go by,” said Robert Temple, director of the FDA’s Office of Medical Policy. “But we ask the companies to modify labeling that they own. … The right to disagree (over the wording) is reasonable.”

For their part, several large drug makers said they responded to the agency’s request for input on labeling and are awaiting further directions. They maintained the amount of time that has elapsed since the FDA order is not unusual, given the complexity of the issue.


The FDA instructed drug makers to add black-box warnings as a result of the protracted controversy over antidepressants.

The agency began examining the issue last year, after British medical authorities urged doctors not to prescribe antidepressants to children. The problem grew still more heated after it became known some drug makers never revealed clinical-trial data showing safety risks.

At a specially convened meeting in September, an FDA advisory panel recommended the government require drug makers to place a black-box warning on all antidepressants. The warning would indicate a risk of suicide for children who took the pills.

By requiring such a warning, which would be prominently placed on package inserts and in physician reference manuals, the goal is to quickly alert doctors to the safety risks of this group of drugs, including Paxil, Zoloft and Effexor.

The FDA followed up by sending drug makers a letter Oct. 15 that contained proposed language for a warning. The wording noted the average risk of suicidal thinking or behavior associated with antidepressants was twice the risk associated with taking a placebo.

Critics of the agency say that by now, the FDA should have ensured black-box warnings had been added to product labeling. The delay, they say, reflects the FDA’s failure to establish firm deadlines for requiring such warnings.

“It’s inexcusable,” said Sidney Wolfe of Public Citizen, who often challenges the FDA over safety issues. “The FDA does not have a rigorous, predictable set of policies for deciding a black-box warning. They’re not dealing with it as urgently as they should be.”

Temple, the FDA official, acknowledged there is no rule that says how fast a warning should appear. But he argued the process is a complicated balancing act. The FDA’s need to protect public health must be reconciled with a drug maker’s legal right to label its products.

If a drug maker refuses to respond, the FDA can declare that a medicine is mislabeled and seek to have the product removed from the market. But Temple said the agency would prefer to avoid such a step if a medication is needed by consumers.

“What we can control is how quickly we can respond, and we’re responding very fast,” said Temple. “Some issues are more complicated than others.”


In this case, the FDA gave drug makers a 30-day deadline to respond to its letter and suggest any changes in the proposed wording for the black-box warning. As of mid-December, Temple said not all drug makers had met the Nov. 15 deadline. He did not specify which companies failed to meet the deadline.

Still, Temple said he expects black-box warnings to be added within several weeks. In addition, a patient medication guide, which the FDA will require to be distributed to patients with each prescription, should be available by late January.

Several big drug makers that sell the most widely prescribed antidepressants said they met the FDA’s Nov. 15 deadline and are now waiting for the agency to reply to their responses to the proposed labeling.

“The ball is back in their court,” said Charles Triano, a spokesman for Forest Laboratories, which sells Celexa.

An official from another large drug maker said the practice of asking companies for commentary was “customary.” He said it may take three to five months altogether to add the warning, maintaining that this was a “reasonable” amount of time.

“In the end, the language will be about the same for everybody,” said Joseph Camardo, senior vice president of medical affairs at Madison-based Wyeth, which sells Effexor. “As for benefiting from any delay, any doctor would be hard-pressed not to know about the warning, given that it’s been so publicly discussed.”

A spokeswoman for Pfizer, which sells Zoloft, also rejected charges drug companies are profiting from the lengthy process for adding the warnings. Pfizer’s Susan Bro added that widespread publicity over the controversy has dampened prescription writing.

However, the total number of prescriptions dispensed each week for all antidepressants at pharmacies nationwide increased slightly between mid-September and early December, according to Verispan, a market-research firm.

Ed Silverman can be reached at (973) 392-1542.

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