FDA Week on the Rehberg Amendment

‘Hard Science’ Approps Amendment Stemmed From Antibiotic Concerns

Posted: June 2, 2011

The full House Appropriations Committee’s approval of an amendment to the FDA spending bill Tuesday (May 31) that would mandate the agency base its guidance or regulations purely on “hard science” stems from a lawmaker’s concerns that FDA might limit antibiotic use in animals based on contentions that utilization of these drugs on the farm promotes antimicrobial resistance of bugs in humans. The measure garnered substantial opposition from key Democrats, FDA and many other stakeholders, with the amendment possibly set to be stripped from the bill before it hits the floor because it is not germane to appropriations and would better suit consideration by an authorizing committee.

While the “hard science” measure cleared the appropriations panel, the language is expected to garner significant pushback before it hits the floor, sources said. The overall spending bill was passed late Tuesday cutting FDA’s fiscal 2012 budget by $285 million, representing an 11.5 percent reduction from fiscal 2011 levels and 20 percent less than the president’s request. A total of 12 amendments were adopted during the markup, but only one directly pertained to FDA.

The amendment, proposed by Rep. Denny Rehberg (R-MT), passed the committee 29-20 and states that funding for all FDA rules, regulations or guidance “intended to restrict the use of a substance or a compound” should be based on “hard science,” such as risk assessments and toxicological or epidemiological evidence showing that the substance is more harmful than beneficial, instead of factors such as cost or consumer behavior.

Rehberg told FDA Week in an emailed statement that a key concern the amendment is designed to address is that FDA will act on assertions by interest groups that antibiotic use in animals spurs resistance in humans to these drugs, and he contended that there is “no scientific data” to back up that claim. “If we’re going to preserve the integrity of the FDA, we’ve got to ensure that their action addresses real threats grounded in science, not scare campaigns manufactured by focus groups and ad agencies,” he said. “For years, a few special interest groups have claimed that the use of antibiotics in livestock is detrimental to the health of humans.”

Supporters of limits on antibiotic use in animals point to several studies that demonstrate a link between resistant bacteria in animals with similar resistant bugs in humans, while the drug industry and its supporters contend the science is flawed.

“American producers — including those in Montana — give their livestock antibiotics to keep them healthy and help feed the world,” Rehberg said. “If the FDA decides to restrict their ability to do so, the threshold for such a limitation must be a lot higher than unsubstantiated scare tactics.”

But advocates of preserving antibiotics say such concerns do not accurately represent the science behind antimicrobial resistance, which they say has been thoroughly validated with substantial data. “Four decades of rigorous science and research confirm that the routine use of antibiotics in food animal production promotes the development of dangerous drug-resistant bacteria that can spread to humans,” said Laura Rogers of the Pew Campaign on Human Health and Industrial Farming.

FDA said the amendment would restrict its ability to ensure the safety of products under its purview and inhibit many of its ongoing activities. “The amendment will interfere with the many ways FDA acts to protect American patients and consumers, whether at the border to stop the importation of unsafe products or by issuing rules to improve the safety of food and medical products,” an FDA official said in an email.

A slew of key Democrats are also already pushing back against the language and vowed that it will not pass the House floor. Additionally, an informed source said the House Rules Committee may knock out the amendment before it can be taken up on the House floor on the basis that it legislates on an appropriations bill.

House Energy and Commerce Committee ranking member Henry Waxman (D-CA) said in a statement on Wednesday (June 1) that he has significant concern that the language would undermine FDA’s authority in a variety of areas and contended that he intends to ensure it is not passed on the floor.

“This amendment ties FDA’s hands and will prevent the agency from taking basic steps to protect us from highly lethal threats, like tainted foods and drugs. Simply put, it will endanger American lives,” he said. “I intend to strip this irresponsible language from the bill when it goes to the House floor, and I urge all members to support me in this effort.”

The informed source added that the language appears to be modified from a House Resolution introduced earlier this Congress, H. Res 98, by Rep. Stephen Lee Fincher (R-TN). It calls for FDA to “give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences.” Fincher’s resolution has 31 cosponsors, including Rehberg.

However, the source said there is an important difference between the resolution language and the amendment, as the latter would require that all FDA funds be used for “hard science.”

Sources said they expected an amendment to address tobacco products and were surprised at the broad language that was proposed during Tuesday’s markup. A letter sent on Tuesday to appropriators from a slew of key medical groups, including the American Medical Association and the American Cancer Society, expressed concern about any legislative language that would limit the ability for FDA to regulate tobacco.

“We are especially concerned about any attempt to weaken the authority of [FDA] to restrict tobacco marketing or require changes in tobacco products, such as the reduction or removal of ingredients,” the letter states. “We also oppose any attempt to limit the type of scientific evidence the FDA can consider or the setting of a higher standard of proof that the FDA must meet before taking action, such as the removal of substances that result in an increase in the use of tobacco products.”

However, Rehberg contended during the markup that it is not his intention to specifically address tobacco products through the amendment language.

House FDA appropriations subcommittee chair Jack Kingston (R-GA) backed the measure and said he is concerned about FDA “wandering from [its] path.”

However, the amendment was opposed by key Democrats, who noted that it was never discussed during appropriations committee hearings. Appropriations Committee ranking member Norm Dicks (D-WA) stated that no one on the panel had viewed the language and the concept is outside of the purview of the appropriations panel. “This is something the authorizers should be dealing with,” he said, which in this case would be the Energy and Commerce Committee. “This needs to have comprehensive hearings. This is a big mistake,” Dicks added.

Rep. Rosa DeLauro (D-CT) also contended that an appropriations bill is not the correct vehicle for the discussion and that the authorizing committee should instead consider the proposal. She added that there are already existing standards in law with regard to regulating drugs, devices and tobacco products. “Are we now suggesting those should be undone?” she questioned. — Sara Ditta

1 comment. Leave a Reply

  1. Anonymous

    “Rehberg told FDA Week in an emailed statement that a key concern the amendment is designed to address is that FDA will act on assertions by interest groups that antibiotic use in animals spurs resistance in humans to these drugs, and he contended that there is “no scientific data” to back up that claim.”
    I beg to differ. Read this article, http://healthland.time.com/2011/06/03/watch-out-for-the-cows-they-might-be-carrying-a-new-strain-of-mrsa/

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