Healthy Skepticism Library item: 14076

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

US Congress slams FDA for off-label promotion control failures
Pharma Times 2008 Aug 3
http://www.pharmatimes.com/WorldNews/article.aspx?id=14054&src=EWorldNews

Full text:

The US Food and Drug Administration has been rapped by Congressional watchdog the Government Accountability Office (GAO) for failing to track the promotional materials which it is responsible for reviewing to ensure that they do not promote off-label uses of prescription medicines.

Sheer volume prevents the FDA from reviewing all the promotional materials which are submitted to it by drug companies, so it prioritises its reviews in order to examine those with the greatest potential impact on human health, the agency has told the GAO. However, the Office has concluded that the FDA does not prioritize its reviews in a systematic manner but, instead, relies on its staff to sort through large volumes of material and select submissions for review.

The GAO’s criticisms come in the final report of its investigation, conducted at the request of Republican Senator Chuck Grassley, into how the FDA tackles the promotion of off-label uses of prescription drugs. The investigation has also found that the FDA has no system to enable it to track consistently the receipt and review of materials submitted to it by drugmakers, and the GAO points out that, while it called on the agency back in 2006 to address these shortcomings, it has still not done so.

Moreover, says the GAO, monitoring and surveillance activities undertaken by the FDA to identify violations that cannot be identified through these reviews – such as discussions between doctors and sales representatives – are limited because the agency cannot observe all off-label promotion activities. These can take many forms and occur in a “myriad of places,” it says.

US doctors can prescribe drugs for off-label indications, but it is illegal for drug companies to promote such uses, and the FDA is empowered to tackle violations through regulatory actions or enforcement action with the Department of Justice (DoJ). The GAO report finds that, during 2003-7, the FDA issued 42 regulatory letters requesting drug companies to stop disseminating materials which were found to promote off-label use, but the agency took an average of seven months to issue these letters from the time it first drafted them. In addition, drug companies cited for more serious violations took an average of four months to take the corrective actions requested, it says.

Moreover, while the FDA did not refer any of these violations to the DoJ for enforcement during 2003-7, the Department settled 11 cases, both civil and criminal, involving off-label promotion which were identified by sources other than the FDA, it says.

Before it published its report, the GAO sent a draft of its findings to the Department of Health and Human Services (HHS), which responded that that a tracking system would not improve the agency’s ability to identify promotional violations. “We disagree,” said the Office: “we continue to believe that a tracking system would help ensure that staff systematically prioritize all materials and would provide key information for managing the programme.”

“We found that FDA does not screen all of the tens of thousands of final promotional materials it receives per year to determine which ones need to be reviewed. Without a systematic application of FDA’s criteria to every submission, the agency cannot be certain that it is reviewing the highest-priority materials submitted or that violative materials are not being circulated,” concluded the GAO.

Local reports quote Sen Grassley as commenting that the Office’s findings show the FDA is failing to keep track of how drugs are marketed for off-label use, even though such marketing is illegal and it is the agency’s job to enforce that law. “As a result, drugmakers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished,” he added.