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