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Regulatory Focus™ > News Articles > Government Report Says FDA Could Do a Better Job at Leveraging Adverse Event Data

Government Report Says FDA Could Do a Better Job at Leveraging Adverse Event Data

Posted 19 March 2013 | By Alexander Gaffney, RAC

A new report published by the US government Accountability Office (GAO), a intra-government watchdog that assesses programmatic weaknesses, has informed the US Food and Drug Administration (FDA) that it could be doing a better job at utilizing the information it collects on adverse events for dietary supplement products.


The 18 March 2013 report reflects a complicated regulatory area for the agency, in which products-some of which contain pharmaceutical or pharmaceutical-like ingredients-are regulated not as drugs, but as food products.

Even as the products skirt pre-market regulatory hurdles put in place for their pharmaceutical counterparts, they are still subject to similar post-market requirements, including voluntary reporting procedures for adverse events and the potential for FDA investigators to come in to investigate a facility.

And though FDA receives far fewer adverse event reports for dietary supplement products than it does for pharmaceutical products, it still receives enough of them that it ought to be doing something with them, GAO's report argues.

In the four-year period preceding 2012, FDA received 6,307 adverse event reports for supplements, of which 71% came from industry. "Most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals, or were otherwise not classified within FDA's product categories," GAO explained.

The High Costs of Getting Data

There's a problem with that number, though: government investigators know there's a huge amount of under-reporting due to consumer confusion. While most doctors know to report an adverse reaction to FDA, because most dietary supplements are taken outside of the direction of a doctor, a large portion of consumers will instead contact poison control if they have a problem.

So large a portion, in fact, that the various poison control centers actually received about 16% more adverse event reports than FDA did during the same four-year period. And that's problematic for FDA for one simple reason: It can't get that data without purchasing it from poison control centers at a significant cost-a cost it has been unwilling to assume. That comes despite the federal government's fiscal support for the centers.

The cost to have FDA access that data: $800,000, per a May 2012 quote. That more than double FDA's entire allocated budget for supplement surveillance, GAO explained. Negotiations have since stalled, and GAO said this remained a sticking point between the agency's ambitions and being able to achieve them.

Reports Trending Upward

While it's widely acknowledged that only a small fraction of all adverse events are reported, the number of adverse events reported to FDA has increased dramatically in recent years. That increase has been driven largely by mandatory reporting by supplement manufacturers, whose reporting numbers essentially tripled from 2008 through 2011.

And that's not by accident, GAO explains. Instead, it's the result of increased FDA enforcement efforts against non-compliant manufacturers, who are required by law to report adverse events reported to them and include information on how and where to report events on the product's labeling. So, too, have a large number of lawsuits against companies by personal injury firms resulted in increased reporting vigilance on the part of companies.

Still, GAO's report notes that the industry has a long way to go if it is to become fully compliant. A recent report by the Office of the Inspector General for the Department of Health and Human Services (DHHS) found that 20% of a sample did not have contact information listed to enable reporting.

Recommendations for FDA

But what can regulators do to shore up their own capabilities and encourage further reporting? GAO's report explains that the agency needs to do more to utilize what data it does collect, saying it could "draw on such information to assess whether AERs are being used to their fullest extend for consumer protection."

In addition, the agency could better use electronic reporting, which could in turn reduce its costs to analyze the data. This would require the agency to allow firms to submit data electronically, which they currently cannot do. FDA said it plans to have these capabilities in place by mid-2014.

Other suggestions include promoting fuller reporting of adverse events data and better communicating safety risks to the public on a regular basis.

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