仿制药标签后续及“首仿”定义考量
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仿制药标签后续及“首仿”定义考量
笔记 2014-11-20 Lachman CONSULTANTS 经过将近一年的来自工业界、消费者团体、公众和仿制药协会的抗议，FDA决定在对标签拟议规定定稿（或但愿可以放弃）之前，对许多评论进行更深入的研究，该标签拟议规定允许ANDA持有人修改或增加标签警告。面对最高法院的两个决定和许多负面评论（见往期相关资讯），FDA表示将有关标签拟议规定的任何定论延迟至2015年9月。也许FDA会变魔术般的使该规定更可被接受，也许FDA在等高等法院在未来几个月内提供更多的指导。即便如此，有缓和空间总是好的，希望FDA对评论的更多考虑能带来比拟议规定好些的结果。 在其它研发方面，为了实施和进一步阐明《MaPP 5240.3 Rev.I》中“首仿”的术语，19日联邦公报(FR)（请见此处）发表了关于术语“首仿”标准的进一步规定。在GDUFA承诺函中，FDA承认：“(1)对第1年队列和第2年队列（即，分别指2013、2014财年递交的ANDAs）首日递交的任何有效的有关第IV段专利药物申请（首个立卷ANDA）的ANDA加快审评；(2)争取对所有首个立卷的ANDA，在提交后30个月内审评和采取行动，以免无意间没收了符合《联邦食品、药品和化妆品法案》505(j)(5)(D)(i)(IV) (21 U.S.C. 355(j)(5)(D)(i)(IV))而应有的180天专营期；(3)对没有封锁性专利和专营期的“首仿”ANDAs加快审评。” 在上述联邦公报通告中，FDA指出，关于“首仿”术语真正包含的ANDA，出现了一些混乱。FDA曾针对这一问题和指南接收到的评论举行过公开会议， “首仿申请”是指任何接收的ANDA满足：“(1)符合180天专营期的首个立卷ANDA，或没有封锁性专利和专营期的首个立卷ANDA，以及(2)之前没有针对相同的产品已获批ANDA。” “FDA相信这些拟定的标准，合理地将FDA的资源集中在尽快批准，供患者使用的新的安全有效的仿制药产品。FDA还相信这些标准与GDUFA承诺函的适用范围一致，并普遍地反映了工业界的预期。最后，当专利或专营期形势变化而导致ANDA可被批准的日期改变，这些标准使FDA优先审评未决ANDA。” 因为令仿制药申请成为“首仿”的情况会随时间变化，并且这些变化多数超出FDA的控制，FDA正在针对关于FDA是否应对在审评过程中不再满足“首仿”标准的ANDA改变审评优先级的问题征询意见。 对仿制药办公室（OGD）来说，保持对审评优先级的跟踪将是很难的。你能想象不得不在审评过程中改变认定和优先级吗？目前，OGD的做法是，一旦ANDA被认定为优先审评，将保持优先审评直至被批准。因形势变化，在审评中改变优先审评的认定，将导致更多的问题，甚至将导致FDA因不公平竞争环境而被起诉。如果FDA将在审评期间中改变产品的优先审评认定，这一标准必须得水晶般清澈透明。到现在为止，正如我们的业界评论中看到，清晰明确是难以实现的。 Lachman CONSULTANTS - Bob Pollock先生 2014-11-19 识林www.shilinx.com版权所有，未经许可不得转载。如需使用请联系admin@shilinx.com Generic Labeling Issue Is Off the Table until 2015; FDA Asks for Input on What Constitutes a First Generic Application After almost a year of protests from the industry, consumer groups, the public and GPhA, the FDA has decided to take a deeper dive into the many comments before finalizing (or hopefully abandoning) their proposed rule on permitting ANDA holders to revise or add label warnings. In the face of two Supreme Court decisions and lots of negative comments (see previous posts) the FDA has indicated that it will now delay any final decision on the Proposed Rule until September 2015. Perhaps FDA has some trick up its sleeve to make the Rule more palatable or perhaps they are waiting to see if the Federal Courts will provide some additional guidance over the next few months. Nonetheless, the breathing room is welcomed and the FDA's additional consideration of the comments hopefully will bring a better result than the Proposed Rule. In other developments today, the Federal Register (FR) contained a publication today (here) that further defined the criteria for the term “first generic” for the purposes of implementing and further clarifying that term in MaPP 5240.3 (here). In its GDUFA commitment letter, the FDA agreed to: “(1) Expedite review of ANDAs in the year 1 and year 2 cohorts (i.e., those ANDAs submitted in fiscal year (FY) 2013 and FY2014, respectively) that are submitted on the first day that any valid paragraph IV application for the drug in question is submitted (first-to-file ANDA); (2) strive to review and act on all first-to-file ANDAs within 30 months of submission to avoid inadvertent forfeiture of 180-day exclusivity eligibility under section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)); and (3) expedite review of “first generic” ANDAs for which there are no blocking patents or exclusivities.” In the FR notice cited to above, FDA says, that there appeared to be some confusion as to what the term “first generic” really encompassed. FDA also held a public meeting on the issue and from the comments received to the Guidance and at the public meeting and has “a first generic application as any received ANDA: “(1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.” “FDA believes that these proposed criteria appropriately focus FDA's resources on approving as quickly as possible, new safe and effective generic drug products for patient use. The Agency also believes that these criteria are consistent with the broad scope of the Commitment Letter, and generally reflect industry intent. Finally, these criteria enable FDA to prioritize review of a pending ANDA when the date on which the ANDA can be approved alters due to changes in the patent or exclusivity landscape.” Because the circumstances made a generic application a first generic may change over time and because these changes are mostly outside of the Agency's control, FDA is seeking comment on whether FDA should change the review prioritization for an ANDA that no longer meets the “first generic” criteria during its review. Keeping track of prioritization of review is going to be difficult enough for OGD- can you imagine having to change the designation and prioritization as the review progresses? Right now, the OGD practice is that, once an ANDA is designated as prioritized, it remains that way until it is approved. Changing the designation during the review due to changes in the landscape could result in more problems than it solves and could even lead to charges of an un-level playing field. If FDA will change the designation of a prioritized product during the review period, the criteria must be crystal clear. As we see from the industry comments so far, clarity is something that has been hard to achieve. 标签拟议规定相关的往期资讯
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