Delay of FDA rule prevents Lockport company's growth: Hochul pushes FDA to clarify rule so business can expand .
LOCKPORT, NY - August 22, 2012
Representative Kathy Hochul (NY-26) toured Gooding
Company's Lockport facility on August 22, to spotlight how delays in
implementation of a Food and Drug Administration (FDA) mandate is adversely affecting job creation in Lockport. In a meeting with company
leadership, Hochul discussed her efforts to compel the FDA to offer
certainty in the face of these potential new regulations.
"Manufacturers like Gooding Company are suffering due to the uncertainty caused by the delayed rulemaking of the FDA. This ambiguity precludes them from securing investments and loans for expansion and the creation of new local jobs," Rep. Hochul said. "I will continue to urge the FDA to clarify the implementation of this mandate to help provide certainty to Gooding Company and business like it."
By delaying the proposal to mandate electronic distribution of prescribing information for prescription drugs over printed inserts, the FDA is creating uncertainty for Gooding Company. The Lockport business prints inserts and outserts for the pharmaceutical and medical industries and is unable to expand until the implementation for this mandate is clarified.
"As a business whose customers are subject to FDA regulations, and a significant employer in Representative Hochul's district, we are eager to work with our elected federal representatives to support our employees, strengthen our company, and to further the interests of our region," said President of Gooding Company, Jerry Hace.
Rep. Hochul sent a letter
to Margaret A. Hamburg, M.D., Commissioner of the Food and Drug
Administration (FDA), requesting clarification on the delayed FDA
proposal. This mandate was intended to go into effect December of 2011.
Rep. Hochul also expressed concerns to Dr. Hamburg regarding the distribution of prescribing information electronically in rural areas.
"In addition to the adverse impact this rule could have on one of our local employers, I am also concerned that seniors will not receive critical information regarding side effects of their drugs. The FDA rule would shift the information pharmacies and health care providers receive from paper to electronic prescription information, leaving residents in rural areas, particularly seniors, at risk," Rep. Hochul added.
Rep. Hochul has consistently worked to support local businesses as part of both her Revitalizing our Economy through Business (REBUILD) Western New York plan and her Make It In America plan.
Click here for photos of Rep. Hochul's visit to Gooding Company.