Since he’s having trouble getting his own bill passed, he’s trying a different approach to get the same results. New Action Alert!
For weeks we have been telling you about Sen. Dick Durbin’s disastrous Dietary Supplement Labeling Act, which attempts to impose harsh limits on supplement availability by giving the FDA major new powers to make arbitrary standards and rules that will curtail supplement sales.
Initially it orders the FDA to compile, with help from the Institute of Medicine, a list of dietary ingredients (read: supplements) that could lead to adverse events or are otherwise deemed risky in some way. But creating lists of “bad” ingredients or “bad” doses based on completely arbitrary or non-existent standards is a slippery slope.
Now Sen. Durbin has proposed an amendment to an appropriations (budget) bill, which is a sneaky way of getting controversial laws passed without too much attention. The amendment would have the Government Accountability Office (GAO) assess the effectiveness and utility of the FDA’s adverse event reporting (AER) system, and report to Congress on what actions FDA is taking to ensure that dietary supplement manufacturers are reporting adverse events; how the AER system “informs the public” of FDA’s efforts to protect consumers; and, most especially, whether FDA has implemented the recommendations GAO made in its 2009 report on dietary supplements.
Buried in the GAO’s recommendations in its 2009 report are some of the same provisions that are also in Durbin’s unpopular Dietary Supplement Labeling Act. In our article on the report, we noted that the GAO recommended:
- increased supplement labeling regulations—one of the Durbin bill’s main goals;
- a clear delineation to be made between food and supplements—a first step toward treating supplements as drugs—this is also in the Durbin bill, and it’s the particular clause we feared he would slip into the appropriations bill; and
- an increase in AER requirements: currently only severe adverse events must be reported, but this would force AERs to be filed even for the most minor events.
The GAO undermined its own recommendation in the report by acknowledging that “FDA officials told us that the current regulatory framework is sufficient to identify and act on safety concerns regarding foods with added dietary ingredients.” This supports ANH-USA’s assertion that the FDA is already well equipped and needs no additional authority to do its job.
Furthermore, the number of supplement AERs is quite low—only 1,080 in 2008. And keep in mind that over half the US population (at least 154 million individuals) take nutritional supplements, according to data from 2007 National Health Interview Survey. The supplement AER figure is even lower when compared to the 526,527 prescription drug AERs in 2008. In other words, for every adverse event from supplements, there are 488 adverse events from prescription drugs!
Remember that it took the deaths of 55,000 Americans before FDA considered pulling Vioxx off the shelves.
The fact that Sen. Durbin has suggested this appropriations amendment indicates that he no longer has high hopes for the Durbin bill. Thanks to all the messages you’ve been sending Congress, he is having a difficult time gaining support for it—he has only been able to find one senator so far who is willing to co-sponsor his bill—and so he’s trying to pressure FDA into implementing the bill’s goals via the regulatory system. We believe it is also an attempt to lay stronger groundwork to push his bill through legislatively, once he gets the ball rolling and FDA starts to treat supplements more like drugs.
We should also note that Sen. Durbin was the architect of the current AER system, but he was unhappy with the political compromise that was struck when the law was passed originally—Sens. Hatch and Harkin agreed to a reporting system so long as it was only for severe events. Now we see Durbin pushing a requirement to have all adverse events be reported, no matter how minor.
What Sen. Durbin clearly wants is for every supplement to be approved by the FDA before it is sold. Everything he does is intended to move things in that direction.
There are fundamental objections to this. First, the FDA is biased in favor of drugs, probably because drugs pay the FDA’s bills. Since the agency sees supplements as competition for drugs, not many will be approved. Second, the agency will demand supplement trials just like drug trials—which is not appropriate for supplements. Supplements are like food: it is the combination and balance of what you take that matters, not just the effect of one pill. Third, the cost of complying with the pre-approval process will make supplements, already beyond many people’s budget, too expensive for all but the rich.
If this powerful senator can’t win using the direct approach, he’ll try an end-run. It may be politics as usual, but when it affects your family’s health, it’s time to fight back. We’ll keep you posted on the maneuvering around appropriations bills.
In the meantime, if you haven’t yet sent a message to Congress about the Durbin bill, please do it now! But just as important, the appropriations bill is scheduled to be voted on by next Monday, October 31, at which time Sen. Durbin will try to add his amendment. Please write your senators today and stop this language dead in its tracks!
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