首页 > 资讯 > 两议员就仿制药标签变更规定拷问行政管理和预算办公室

出自识林

2014-06-28 Lachman CONSULTANTS

FDA拟议规定允许仿制药ANDA持有者单方面变更药品安全性警告，这一极具争议的拟议规定一经提出便引来百家争鸣，参议院健康教育劳工与养老委员会副主席、参议员Lamar Alexander，以及司法委员会主席、众议员Bob Goodlatte两人，要求白宫信息及法规事务办公室(Office of Information and Regulatory Affairs, OIRA) 的行政管理及预算办公室对于FDA在此事中的立场做出些许解释。

两位议员要求解释：FDA是如何得出结论，说明这项拟议规定并未与Hatch-Waxman法案中的“同一性”条款背道而驰；经济影响分析是如何忽略掉像法律责任开支和其他拟议规定带来的标签开支这样看起来如此巨额的事项；自从Hatch-Waxman法案通过，在Mensing案的非当事人意见陈述、各类公民请愿回复、以及过去30年签发的各种指南文件中，FDA长期以来的立场就是不允许仿制药申请者变更标签，那么究竟是什么使他们改变了主意？

两位议员还申请OIRA召开吹风会，以解决信中提到的问题。

完整的信件请见此处。

所以，一场新的国会听证会拉开帷幕，江山易改本性难移，但FDA究竟是如何改弦易帜？让我们拭目以待。让我们期待有足够多的努力能够悬崖勒马，阻止这一拟议规定可能会为美国公众和业界带来的悲剧吧。

Lachman CONSULTANTS - Bob Pollock先生 2014-06-26
校译：识林-柯 2014-06-28

识林www.shilinx.com，版权所有，如需转载请注明出处

Senator Alexander and Representative Goodlatte Grill OMB on Proposed Generic Drug Labeling Rule
Written by Bob Pollock • June 26, 2014

In the latest salvo fired over the controversial FDA proposed rule that would permit generic drug ANDA holders to unilaterally change their drug product warnings, Senator Lamar Alexander, Ranking Member, Committee on Health, Education, Labor & Pensions and Congressman, and Bob Goodlatte, Chairman of the Judiciary Committee asked the Office of Management and Budget's Administrator of the Office of Information and Regulatory Affairs (OIRA) to explain a few things about the FDA position.

They asked for an explanation of how the FDA could reach a conclusion that the proposed rule does not violate the “sameness” provisions of the Hatch-Waxman Act, how the economic impact analysis appeared to ignore certain big ticket items like liability expenses and other labeling costs associated with the proposed rule, as well as why the FDA really changed its mind about its own long-held position that generic applicants were not permitted to do so, which it has stated over and over ever since the passage of the Hatch-Waxman Act, in its Amicus brief in the Mensing case and in various petition responses and Guidance documents the Agency has issued over the last 30 years.

They also asked for a briefing by OIRA to address the issues raised in the letter.

A complete copy of the letter is here.

So another Congressional inquiry is now open to see just how and why the FDA changed its stripes on this tiger. Let's hope enough is being done to undo the potential damage of this proposed rule to the American public and the industry.