首页 > 资讯 > FDA警告9企业未能自我认定或支付GDUFA费

出自识林

2014-09-30 Lachman CONSULTANTS

2014年到目前为止，FDA已经对未支付仿制药使用者付费法案（GDUFA）费用的企业发出9封警告信。最近的两封于2014年8月26日发出，但发布到CDER网页上的日期为9月8日和16日。所有9封警告信可以在这里查看。

有趣的是警告信中2封与未能自我认定相关，另外7封与未支付设施费相关。如GDUFA中规定，未能支付费用可能导致FDA发现“在未能支付所需设施费或未能提交所需自我认定信息的设施中生产、制备、传递、混合或加工的任何药品或API，或含有在此类设施中生产、制备、传递、混合或加工的药物活性成分的药品，均为冒牌产品。21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii). 在州际贸易中发送冒牌产品，包括将此类产品进口到美国，违反联邦法律。21 U.S.C. § 331(a)”（重点强调）。冒牌产品受到FDA强制行动管制，包括禁制令或没收，或拒绝进入美国境内。未能支付费用的设施将被列在一份可公开获得的拖欠名单中。并且对于申请持有人最重要的是，FDA将拒绝审评任何含有任一未能支付此类费用的设施信息的申请。此外，如果在申请中引用的设施尚未支付费用，FDA将拒绝接收任何和所有申请。

未缴费不再是无关紧要的事，如果你是申请持有人，别人的未能支付可能令你的申请沉没。请保证预先进行尽职调查，检查拖欠清单并从任何外部付费机构获得他们目前支付的凭证。一着不慎，满盘皆输！

Lachman CONSULTANTS - Bob Pollock先生 2014-09-30
校译：识林-椒 2014-09-30

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Agency Warns 9 Firms for Failure to Self-Identify or Pay GDUFA Fees
Written by Bob Pollock • September 30, 2014

In 2014, to date, FDA has issued 9 Warning Letters to firms for failure to pay their Generic Drug User Fee Act (GDUFA) fees. The latest two letters were issued on August 26, 2014, but were posted to the CDER web page on September 8 and 16, respectively. All 9 Warning Letters can be found here.

It is interesting to note that 2 of the Warning Letters relate to failure to self-identify and the other 7 relate to failure to pay facility fees. As outlined in GDUFA, failure to pay fees may result in the FDA finding that “[A]ny 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)” (emphasis added). Misbranded drugs can be subject to FDA enforcement actions including injunctions or seizures, or denied entry into the US. Facilities failing to pay fees will be placed on a publically available arears list and, most importantly for application sponsors, FDA will refuse to review any application that contains information that any facility for which a fee may be due fails to pay such fee. In addition, FDA will Refuse-to-Receive any and all applications if a fee has not been paid for a facility cited in an application.

Failure to pay fees is no laughing matter, and, if you are a sponsor, someone else’s failure to pay a fee may sink your application. Make certain you preform your due diligence and review the arears list and obtain a certification from any outside fee-paying entities that they are current with their payments. One mistake could really cost you!