Sanofi-Aventis received a warning letter from the FDA’s division of drug marketing, advertising, and communications after the company distributed a misleading promotional card for Uroxatral, an alpha1-blocker used to treat urinary problems caused by an enlarged prostate.

The tent card in question doesn’t list risk information on the front and neglects to caution patients with liver or kidney problems. In its letter the FDA states, “In the absence of the full indication, these statements misleadingly imply that UROXATRAL is approved for use in the treatment of any condition that keeps the patient in the bathroom, such as overactive bladder.  However, UROXATRAL is only approved for use in the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The omission of the indication on the front side of the tent card may encourage the use of UROXATRAL in circumstances other than those for which the drug has been shown to be safe and effective.”

 The card allegedly omits warning information related to the drug and Intraoperative Floppy Iris Syndrome (IFIS), a complication that may be suffered by those undergoing cataract surgery. The FDA requests Sanofi-Aventis cease using the promotional materials in question, and the company is required to respond to the warning letter stating whether they will comply with the letter’s guidance to discontinue use of the flawed Uroxatral tent cards by November 6.

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Sure, prescription information for Sanofi-Aventis's Uroxatral appears on the back of the tent card, but how can consumer?s see it if it's mounted to a pharmacy wall?

Sanofi Warned for Misleading Tent Card

The US Government Accountability Office (GAO) on Monday released a 71-page 

 citing FDA for taking too long to review postmarket trials of drugs through its expedited approval process.

Drugs go onto the accelerated schedule because they are used to treat conditions that are severe or deadly, and are usually given to patients that don’t have many treatment options, such as cancer, HIV/AIDS, and Anthrax. GAO examined 90 applications that went through the fast-track process between 1992 and 2008. The report stated that of the 144 studies requested by FDA, only 64 had been performed to the agency’s specifications, and are labeled “closed.” Many, however, are still open; GAO feels that the feds are slacking off in monitoring the postmarket studies. The committee also argues that FDA also has never used its power to withdraw a drug from the market if the treatment doesn’t prove effective in trials.

In response, the agency states that GAO is downplaying the success of the accelerated approval program, and claims that most of the clinical trials have been completed on time.

“FDA developed the accelerated program with full recognition of the risk that drugs might be approved and later found not to confer clinical benefit to patients,” said Andrea Palm, acting assistant secretary for legislation. “After much input from stakeholders, FDA determined that this was a risk worth taking because patients with life-threatening illnesses and their physicians are willing to accept more risk when making treatment decisions.”

FDA noted the case of ProAmatine, in which extended time was warranted to examine the results of trials. The drug is the only approved treatment for orthostatic hypotension, a debilitating condition. FDA said that even though clinical trials did not “confirm clinical benefit” it didn’t warrant pulling the treatment from patients prematurely.

“FDA must carefully balance exercising its regulatory authority versus considering the best interests of patients with this disease or condition,” Palm stated in the letter. 


The view of the agency appears to be a popular one among physicians and experts interviewed.

“I strongly believe the amount of oversight by the FDA is superb,” rheumatologist Nathan Wei told Pharm Exec. “Yes… the public hears the horror stories. But the reality is that studies conducted at clinical trials centers that know what they’re doing, that follow good clinical practices, and that have well-laid standard operating procedures do an excellent job. Every lab abnormality is scrutinized and accountability is not delegated… it is mandatory.”

Sheila Weiss Smith, director of the Center for Drug Safety at the University of Maryland School of Pharmacy, explained that once a drug is on the market it isn’t easy to get clinical trials conducted. “That’s not something you can just blame on the pharma company,” she said. “The issue is that it is almost impossible sometimes to recruit patients. Ideally, the trials would be done expediently and we would get answers, but in the real world that doesn’t always happen. It would be a shame to lose important new medicines because of things that are beyond control.”

According to Gary Slatko, chief medical officer at ParagonRx, the view that postmarketing follow up by FDA in the past has been problematic or incomplete is one reason Congress legislated FDAAA in 2007, which granted FDA significant new authorities including risk evaluation and mitigations strategies (REMS). 

“FDAAA provides FDA with much greater authority to extend its postmarketing vigilance activities for up to seven years following approval,” Slatko said in an email statement. “Through implementation of REMS, FDA has been exercising its new authority, requiring many REMS and other postmarketing commitments along with the safety communications that REMS outline and define. Beyond that, FDA has been even more proactive in communicating risks to physicians and patients, above and beyond the FDAAA mandate to ensure patient safety.” 

The US oversight arm scripted a hefty report complaining that FDA is not moving fast enough when it comes to screening clinical trials data for drugs green lit through its expedited approval program.

Pharmaceutical Executive-10-29-2009

Sanofi Warned for Misleading Tent Card

GAO Accuses FDA of Tardy Trial Data