Washington Insider -- Monday

Complications for Antibiotic Regulations

Here's a quick monitor of Washington farm and trade policy issues from DTN's well-placed observer.

Talks Regarding Continuing Resolution Well Advanced

House Republican and Senate Democratic leaders last week said they are discussing the likelihood they will pass a continuing resolution to ensure federal government spending well into the next fiscal year.

With just four days before Congress begins its five-week summer recess and no progress on completing work on even one of the regular appropriations bills, it is clear that a continuing resolution will be needed to keep the government funded from the beginning of the 2015 fiscal year (Oct. 1) until Congress reconvenes after the November elections.

The plan appears to be for the CR to take shape during the recess and for it to be brought up for votes in September. House Speaker John Boehner, R-Ohio, told reporters last week that he and other Republicans already are planning to move a CR to ensure no funding lapse when the fiscal year ends Sept. 30.

In the Senate, Assistant Majority Leader Dick Durbin, D-Ill., said Democrats see a continuing resolution as inevitable. Durbin told reporters Democrats also believe the best strategy is to pass one CR long enough to cover the fall's campaign season and a post-election session.

If past performance is any guide, a post-election session will not result in the passage of all 12 regular appropriations bills, although one or two might make it through. Thus the odds of yet another continuing resolution this December –– funding the government into next March, perhaps –– appear to be rather good.

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Senate Finance Subcommittee to Hold KORUS Hearing

A Senate Finance subcommittee has scheduled a hearing for Wednesday that likely will address the growing U.S. trade deficit with South Korea. The hearing will examine U.S.-Korea Free Trade Agreement (KORUS) and the effects it has had during the two years it has been in effect.

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Since the implementation of KORUS on March 15, 2012, South Korea's exports to the United States amounted to $121 billion, up 10.3% from $109.7 billion logged during two years prior to the implementation, according to Seoul's trade ministry.

U.S. exports to South Korea, on the other hand, shrank 3.8% to $84.4 billion during the two-year period since the implementation of the trade pact.

The hearing is likely to give more ammunition to senators who already are skeptical about the benefits that free trade agreements have for the United States.

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Washington Insider: Complications for Antibiotic Regulations

Few public concerns have deeper or more controversial roots than those regarding the growing bacterial resistance to modern drugs. Because much of the nation's drug use is for livestock, many activist groups have been pressing the Food and Drug Administration for tougher regulations. However, a recent federal appeals court decision reversed two lower court rulings and appears to make bans on antibiotics in livestock less likely.

The decision came as a surprise to many observers, and certainly appears to support FDA's strategy of building voluntary programs to curb antibiotics overuse by livestock operations.

The decision itself was by the US Court of Appeals for the Second Circuit in New York. Specifically, it means FDA is no longer required to proceed with hearings to determine whether to withdraw approval of medically important antibiotics use in livestock feed. Earlier district court rulings would have required the hearings.

The fight over antibiotic use by livestock has been long and contentious. As early as the 1970s, FDA determined that penicillin and tetracycline, used routinely by livestock producers, were no longer safe. The agency issued two hearing notices that would have required new evidence of the drugs’ safety, but never actually held the hearings.

It is not completely clear why FDA did not go forward with hearings, but it is clear that proposals to largely prohibit livestock antibiotic use were enormously unpopular among livestock producers and their supporters in Congress. Important Congressional committees said they wouldn’t approve the hearing process unless they had conclusive evidence linking overuse of antibiotics in livestock to human health. So far, experts conclude, that evidence has not been found.

In 1999 and 2005, activist groups petitioned the agency to go forward with hearings for the two drugs, as well as other classes of medically important antibiotics. FDA rejected the petitions and took the position that an alternative strategy for combating the ill effects of sub-therapeutic use of antibiotics in animal feed would be more efficient than pursuing an effort to withdraw approval for all such uses,” the recent decision says. “By way of explaining its decision, the FDA stated that proceedings to withdraw drug approvals are very costly and lengthy.”

The appeals court found that a “decision whether to institute or terminate a hearing process that may lead to a finding requiring withdrawal of approval for an animal drug is a discretionary "prudent choice" of the FDA. However, Judge Robert Katzmann disagreed, noting that, under the majority’s reading, “the FDA is never statutorily required to initiate or continue withdrawal proceedings for a drug – no matter how terrifyingly unsafe that drug might be.” Katzmann wrote that the decision “allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw the approval of that drug.”

FDA argues that the voluntary route it has chosen is, in fact, effectively regulating livestock drug use. Last December, the agency published guidance that is prompting the animal drug industry to remove growth promotion claims from its product labels, effectively making it illegal to use the drugs for that purpose.

A number of critics charge the current FDA guidance still allows livestock producers to widely use the drugs for disease prevention as well as disease treatment. Thus, the next fight over livestock antibiotics likely will focus on whether the "growth promotion" uses now prohibited overlap too much with the "disease prevention" uses still permitted in some settings.

So, it appears that at least one federal court has endorsed the current voluntary FDA approach, and believes it is effectively reducing livestock drug use. And, this court decision suggests that the voluntary approach is likely to be more effective--and, more acceptable to Congress-- than alternative, more interventionist approaches.

Still, the problem of drug resistant bacteria is so dangerous and so widely feared by the public that livestock drug use, even though declining, is likely to remain in the policy cross-hairs of many activist groups for the foreseeable future. The more concrete steps the livestock industry can take to insure that the new drug guidance rules are effective, the less likely future, perhaps more restrictive, intervention becomes, Washington Insider believes.


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