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Animal Drug User Fees, Drug Safety Bills Pass

by Britt E. Erickson , Glenn Hess
December 23, 2013 | A version of this story appeared in Volume 91, Issue 51

Credit: Shutterstock
Recently weaned piglets are routinely given antibiotics in their water to prevent bacterial infections.
This is a photo of piglets drinking from water lines.
Credit: Shutterstock
Recently weaned piglets are routinely given antibiotics in their water to prevent bacterial infections.


Animal Drug User Fees, Drug Safety Bills Pass

In what was a rare occurrence this year, Congress cleared two bills related to drug safety and use.

The first of these bills was passed in June and it reauthorizes the Food & Drug Administration to collect fees from manufacturers of animal drugs. The Animal Drug & Animal Generic Drug User Fee Reauthorization Act of 2013 allows FDA to collect more than $21 million annually for five years in fees from the animal drug industry.

FDA relies on user fees to supplement its annual congressionally approved appropriations. Such fees have enabled the agency to reduce its review time for new animal drugs and bring medications to market faster.

Both the House of Representatives and the Senate passed the bill without amendments, despite pressure from public health advocacy groups for a provision that would have required FDA to track the sale and use of antibiotics in animals.

Studies showing that drug-resistant bacteria can be transmitted from livestock to workers strengthened congressional efforts this year to push for legislation that would ban the use of antibiotics in healthy animals. The studies also prompted some lawmakers to call for measures to force FDA to make animal antibiotic use data publicly available.

Rep. Louise M. Slaughter (D-N.Y.), who has repeatedly introduced legislation in the House to restrict the use of antibiotics in animals, introduced the Preservation of Antibiotics for Medical Treatment Act (H.R. 1150) in March.

Sen. Dianne Feinstein (D-Calif.) introduced similar legislation in the Senate in late June. That bill, the Preventing Antibiotic Resistance Act (S. 1256), would require animal producers to show that antibiotics are used to treat diseases, not enhance the growth of livestock. Such restrictions would apply only to antibiotics that are used in humans. Producers would be able to use any antibiotic to treat sick animals.

Neither bill saw any movement this year.

The second drug-related bill to clear Congress was the Drug Quality & Security Act. Passed in November, the measure is designed to prevent public health crises related to counterfeit and contaminated prescription drugs. It establishes a national system for tracking prescription drugs throughout the supply chain and boosts federal oversight of large-scale compounding pharmacies that act as drug manufacturers.

Meanwhile, efforts are also under way in the Senate to make so-called pay-for-delay patent dispute settlement agreements between brand-name pharmaceutical companies and generic drug makers presumptively illegal. The Senate Judiciary Committee is considering the bill (S. 214), which addresses a practice in which a brand manufacturer pays a generics company to drop its patent validity challenge in court and stay out of the market until shortly before the patent expires.



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