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brbrSyracuse Pharmaceutical Company, Hanford, Was Stuck in Holding Pattern Could Not Expand Without FDA Rebate for Drug Fees; Schumer Successfully Pushed for Expedited Rebate to Fund Hanfords Proposed ExpansionbrbrHanford Now Plans Construction of New Filling Suite in Syracuse In Addition to Construction Jobs, Expansion Would Create 20 Additional Jobs Downtown by 2014Schumer: FDA Rebate Spurred Hanford Expansion and thats a Prescription for Jobsbrbr


Today, U.S. Senator Charles E. Schumer announced that he has helped Hanford Pharmaceuticals, located in downtown Syracuse since 1846, receive a longdelayed FDA rebate, which will now allow them to begin construction on a proposed expansion of their Syracuse facility. This $176,000 Animal Drug User (ADUFA) rebate for Fiscal Year 2012 comes after Senator Schumer urged the FDA to expedite Hanford's request for a waiver, which they requested in June 2012. Hanford could not consider expansion without this rebate. With the Senator's push this year, the FDA granted the waiver earlier than Hanford officials had hoped, allowing their construction plans for a planned expansion to move forward ahead of schedule.

"To put it simply: this FDA rebate is like writing a prescription for jobs," said Schumer. "I am pleased that the FDA has heeded my call and granted the rebate to Hanford, allowing them to begin construction on the expansion of their facility, which will create jobs in downtown and boost this company's growth in Syracuse," said  Senator Schumer.


"Senator Schumer was quick and effective when he learned we were waiting on an ADUFA fee rebate, a rebate critical to our expansion plan," said George Hanford, CEO of Hanford Pharmaceuticals. "He  understood what having this money inhand would mean for our larger plan: to continue to provide quality drugs to the marketplace and to grow our highly skilled workforce right here in the city."   


Hanford is preparing to build a new filling suite to produce human and veterinary oral suspensions, and tablets.  Their initial customer for the suite has already purchased and committed over $1,000,000 of equipment to the project.  It will cost them roughly $220,000 to build the filling suite itself. With the $176,120 refund from the FDA, Hanford can now start the construction and expansion this month. Hanford expects to employ 10 new hires by the end of 2013 year, for a total of 20 by the end of 2014.  

The  Animal Drug User Fee Act (ADUFA) of 2003, which amends the Federal Food, Drug, and Cosmetic Act (FFDCA), authorizes the FDA to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of animal drugs. These additional resources support FDA's responsibilities under the FFDCA to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption. On August 14, 2008, President Bush signed the Animal Drug User Fee Amendments of 2008 (ADUFA). The new amendments extend ADUFA until 2013.


Hanford qualified for a waiver from the ADUFA fees due to a provision in the law that exempts small businesses whose ADUFA fees exceed the costs of production, in this case two penicillin drugs made by Hanford. Because Hanford Pharmaceuticals, a small business with roughly 100 employees, manufacturers two drugs with FDA fees that exceed production costs, Hanford qualifies for an FDA waiver. After Hanford applied for a waiver for their ADUFA Fees, Senator Schumer pushed the FDA to expedite the rebate process.


Hanford Pharmaceuticals is a small, family owned sixth generation, downtown Syracusearea pharmaceutical company that was established in 1846. They currently employ 101 employees. In FY 2011, Hanford's ADUFA fee was $161,570, and they applied for a waiver for 100% of that amount, but it took a calendar year to receive the rebate. They submitted the request in March 2011 and waited over a full year for their rebate.  Last year, FY 2012, their ADUFA fee was $176,120 and they submitted the request for a waiver in June 2012, receiving it just one week after Schumer stepped in.   


Schumer urged the FDA to deliver a quick refund so that Hanford, who wanted to being an expansion this month, could move forward with plans to renovate their facility. Schumer also asked the FDA to work with small businesses like Hanford to make sure these rebates are delivered in a timely manner in the future. For many small businesses, these sometimes sixfigure rebates account for a large percentage of net revenue dollars, and business plans may be put on hold until confirmations of rebates like Hanford's are received.