The most-shunned word around FDA has always been “when?” In January, the reason was glaringly apparent to industry negotiators on medical device user fees, and to those waiting for an answer on the three-decades-old dental amalgam controversy.In both cases, FDA did it again: It missed a promised deadline and, in doing so, demonstrated why its officials habitually avoid giving an explicit time for when they will do something. They have always known that too many things can go wrong on their way to meet a commitment.

Jim Dickinson

January 18, 2012

4 Min Read
CDRH Misses User Fee, Amalgam Deadlines

In both the case of the user fees and dental amalgam, FDA did it again: It missed a promised deadline and, in doing so, demonstrated why its officials habitually avoid giving an explicit time for when they will do something. They have always known that too many things can go wrong on their way to meet a commitment. 

And lately they have come to know about a new factor that can throw a monkey wrench in the works: political interference, as in December’s highly public, first-ever reversal by an HHS secretary of an FDA approval decision for a nonprescription emergency contraceptive pill.

In the case of the agency’s missed January 15 deadline for submitting to Congress an agreement with the medical device industry on new user fees, the cause was reportedly the two sides’ inability to bridge a gap in the total amount to be paid. In the confidential negotiations, FDA supposedly wanted as much as $805 million over the next five years to pay for new staff to speed up its reviews, while industry wanted to pay only $447 million. 

According to FDA draft minutes of its December 6 meeting with industry, both sides “remain far apart regarding an appropriate level of resources to support the draft commitment letter. FDA indicated that they have conducted thorough analyses of what is needed to meet the draft commitment letter and therefore any counter-offer would not differ significantly in resource needs from what they have previously presented. Industry restated their position that the draft commitment letter should not be changed to reduce resource needs. Both sides expressed concern with how long it is taking to reach agreement on appropriate funding levels but pledged to continue to look for ways to close the gap.”

FDA would say nothing publicly about the missed deadline, but an AdvaMed spokeswoman said “progress” was still being made in the negotiations. With Congress hovering the wings to take over the matter amid election-year campaign fever, politics was an additional pressure point.

Developments regarding Mercury Dental Amalgam

In the case of smaller, more focused and presumably much easier matter of whether the 50% mercury content of dental amalgam is safe for infants under six years of age and developing fetuses, CDRH director Jeffrey Shuren let his self-imposed “by the end of the year” informal deadline for a decision pass unmet.

When asked what the new timeline goal is, FDA spokesperson Morgan Liscinski responded that there isn’t one.
FDA’s history of regulating dental amalgam is tortuous. For 32 years it refused to publicly warn about its neurotoxic risks until compelled in 2009 by federal court action to classify it. Even then, the agency’s action — declaring it as safe under Class 2 for everyone over age 6 who is not allergic to mercury — was immediately faulted by dental activists as weak and based on selective reading of the scientific literature on the topic.

Within two months of the rule’s publication in the Federal Register, two citizen petitions asked the agency to reconsider it, and a month later a World Health Organization expert group agreed in concept for a worldwide phasing down of dental amalgam. Goaded by such pressures, FDA eventually agreed to ask an advisory panel in December 2010 to examine the latest science; it voted to recommend a ban on amalgam’s use in children.

Still the agency hesitated, sending Shuren to a series of town hall meetings around the country at which he heard so much criticism of the agency’s amalgam policy that he began saying he hoped for agency action on it by the end of 2011.
Liscinsky’s comment suggests that after waiting 35 years on the amalgam safety issue, FDA sees no need to hurry now.

National counsel for Consumers for Dental Choice Charlie Brown commented:

At Jeff Shuren’s Center for Devices, politics wins. Science loses. Thirteen months ago, FDA’s own advisory panel of handpicked scientists told FDA to stop amalgam use for children and pregnant women.

“But Shuren fails to heed the scientists — even though, since September, he repeatedly announced that he intended to act on amalgam in 2011. Every day that Shuren fails to act, more children are subjected to this mercury product, which — FDA’s own rule concedes — can have ‘neurotoxic effects’ on the ‘developing neurological systems’ of children and unborn babies.”

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