Before August 2014, a total of only five companies had ever received warning letters from the U.S. Food and Drug Administration (FDA) regarding failure to pay generic drug user fees. On August 7, 2014, FDA added three additional companies to its list of non-compliers: Colgate, Explora Laboratories, and Korea United Pharm. The FDA warning letters to the companies state:
“Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded. 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii). It is a violation of federal law to ship misbranded products in interstate commerce, which includes causing such products to be imported into the United States. 21 U.S.C. § 331(a). Such violations can result in injunctions or seizures of the misbranded products. See 21 U.S.C. §§ 332 and 334. Products that appear to be misbranded may also be denied entry into the United States. 21 U.S.C. § 381(a)(3).”
FDA also warned the non-paying companies that any new generic drug submissions referencing those companies would not be received if they did not pay the fees within twenty days.
Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. If you receive an FDA warning letter or have questions about FDA drug regulations, Registrar Corp can assist you. Call us at 1-757-224-0177 or receive online Live Help 24 hours a day from our regulatory specialists at https://www.registrarcorp.com/livehelp.