FDA制定2018年政策優先事項
FDA Plots Policy Priorities for 2018
FDA制定2018年政策優先事項
來源RAPS
作者Zachary Brennan
編譯 Tony
The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency』s workforce.
美國食品藥品監督管理局(FDA)周四宣布了其2018年政策活動的優先事項，其中包括減少阿片類藥物的錯用和濫用，促進仿製葯和生物類似葯的競爭，為醫療器械創建一個完整的產品生命周期辦公室，推進數字健康技術和增強該機構的工作人員隊伍。
「Our work is taking place during an inflection point in both science and policy,」 FDA Commissioner Scott Gottlieb said in a statement. 「We have more opportunity to deliver on the promises of science than at any time before. Gene- and cell-based therapies hold the opportunity to treat a wider range of debilitating disorders, and deliver outright cures to intractable diseases.」
FDA局長Scott Gottlieb在一份聲明中說：「我們的工作是在科學和政策的轉折點上進行的。我們比以往任何時候都有更多的機會兌現科學的承諾。基於基因和細胞的療法擁有治療範圍更廣的衰弱性疾病的機會，並能徹底治癒難治性疾病。」
Opioids
阿片藥物
As the number of opioids sold to pharmacies, hospitals and doctors』 offices nearly quadrupled from 1999 to 2010, and deaths from immediate-release opioids have more than quadrupled since 1999, FDA said in the roadmap that it needs 「to make sure that patients are prescribed these drugs only when properly indicated, and that when prescriptions are written, they are for dosages and durations of use that comport closely with the purpose of the prescription.」
由於從1999年到2010年，向藥房、醫院和醫生辦公室出售的阿片藥物數量幾乎翻了兩番，而自1999以來，因速釋阿片藥物而死亡的人數增加了兩倍多，FDA在路線圖中表示，它需要「確保患者只有在正確的指示下才能得到這些藥物的處方，而且當處方開具時，它們的劑量和使用時間與處方的目的密切相關」。
The agency will also look to help push the US to use opioid drugs with improved formulations that are harder to manipulate and abuse, advance other drugs and devices that can treat pain and are less likely to be addictive, and create new paths for the development and approval of better treatments for addiction.
該機構還將尋求幫助來推動美國通過改進配方來使用阿片類藥物，使其更難操作和濫用，促進其他藥物和裝置的開發，這些藥物和裝置可以治療疼痛，並且不太可能使人上癮，並為開發和批准更好的治療成癮的藥物開闢新途徑。
Generic Competition
仿製葯競爭
In addition to establishing an inter-agency working group with the Federal Trade Commission to better stop companies from gaming the patent and exclusivity system, the agency said it will issue new draft guidance in the first quarter of this year on its process for determining whether to grant a waiver for adopting a single, shared-system risk evaluation and mitigation strategy (REMS).
除了與聯邦貿易委員會建立一個機構間工作組，更好地阻止公司利用專利和排他權制度，該機構表示將在今年第一季度發布新的指導意見草案，內容涉及其決定是否批准放棄採用單一共享系統風險評估和減低策略(Rems)的程序。
「We expect that this guidance will be helpful in situations where the negotiations of a single, shared-system is lengthy, complex, or otherwise creates a burden for stakeholders. We will also advance draft guidance on the development of shared-system REMS, to make the process for developing a shared REMS more efficient,」 the roadmap said.
路線圖講到，「我們希望，在單一共享系統的談判冗長、複雜或以其他方式給利益攸關方造成負擔的情況下，這一指南將有所幫助。我們還將提出關於開發共享系統REMS的指南草案，以提高開發共享REMS的過程的效率。」
FDA also said it will also issue new guidance on how to more efficiently handle citizen petitions, including so-called 「blocking」 petitions that are subject to section 505(q) of the Food, Drug & Cosmetics Act. In the past week, the agency has denied three such petitions.
FDA 還表示, 它還將發布新的指南, 說明如何更有效地處理公民請願, 包括所謂的 "阻止" 請願書, 受《食品、藥品和化妝品法》 505 (q) 條的限制。在過去的一周里, 該機構拒絕了三次此類請願。
「While the record shows that citizen petitions have rarely delayed specific generic drug approvals, there is no doubt that the deadlines associated with 505(q) petitions can add to resource burdens on the generic review process. We expect our new guidance will allow for a more efficient approach to 505(q) petitions, and allow us to focus more reviewer resources on the approval of generic drugs,」 the roadmap said.
他說：「雖然紀錄顯示市民的上訴很少延遲批准特定的仿製葯，但與505(q)上訴有關的最後期限，無疑會增加非專利審查程序的資源負擔。」我們期望我們的新指南將使我們能夠更有效地處理505(q) 上訴，並使我們能夠將更多的審查資源集中在批准非專利藥品上。「路線圖說。
And as previously discussed in November, FDA is also looking to address complex generics, and to focus 「on the overall efficiency of our generic drug review program.」
正如之前在11月討論過，FDA也在尋求解決複雜的仿製葯，並專註於「我們的仿製葯審評項目的總體效率」。
On the biosimilars front, FDA noted that it will make the process for developing and approving biosimilar drugs more efficient.
在生物類似藥方面，FDA指出它將使開發和批准生物類似葯的過程更加有效。
「As part of these efforts, we will create better incentives for the adoption of safe, effective, and high-quality biosimilar drugs. These policies will be part of a new Biosimilar Innovation Plan (BIP) that we will advance over the coming year,」 the roadmap said.
「作為這些努力的一部分，我們將為採用安全、有效和高質量的生物類似葯創造更好的激勵措施。這些政策將成為新的生物類似葯創新計劃(BIP)的一部分，我們將在未來一年推進這項計劃。」
Devices
醫療器械
The roadmap』s highlights for medical device companies include: Creating a new Total Product Life Cycle Office in CDRH, first discussed in September, to minimize 「organizational layers of review throughout the device life-cycle, achieving more efficient work processes and allowing employees to better leverage their knowledge of pre- and post-market information to optimize decision-making.」
該路線圖對醫療器械公司的重點包括：在CDRH中創建一個新的產品全生命周期辦公室，第一次討論是在九月，以最小化「整個醫療器械生命周期的組織層審查，實現更有效的工作流程，並允許員工更好地利用他們對上市前和上市後信息的了解來優化決策。」
The roadmap also discusses the advancement of an alternative 510(k) pathway for reviewing medical device submissions, through legal experts have questioned the legality of such a pathway.
通過法律專家質疑這一途徑的合法性，該路線圖還討論了一個替代的 510 (k) 途徑的進展，該途徑用以審查醫療設備的提交。
The agency also said it will advance a new framework to balance pre- versus post-market requirements for devices targeted to significant unmet medical needs and it will develop and advance the use of in silico tools and models to evaluate device performance and patient outcomes as part of the Medical Device Innovation Consortium.
該機構還表示，它將推進一個新的框架，以平衡針對重大未被滿足的醫療需求的醫療器械在市場前和市場後的需求，並將開發和推動使用In Silo工具和模型來評估設備性能和患者療效，作為醫療器械創新聯盟的一部分。
Digital Health and Workforce
數字健康和勞動力
Building off its work on the precertification pilot project, FDA said it is seeking to develop a more tailored approach to accommodate the rapid pace of digital innovation while still taking a risk-based approach.
在預認證試點項目的基礎上，fda表示它正在尋求一種更有針對性的方法，以適應快速的數字創新步伐，同時仍採取基於風險的方法。
In addition, FDA said it will embrace new predictive toxicology methods and computational modeling across the agency』s product centers and making new investments in the FDA』s high-performance, scientific computing.
此外，FDA表示它將在整個機構的產品中心採用新的預測毒理學方法和計算模型，並對FDA的高性能、科學計算進行新的投資。
And the roadmap noted several efforts already underway to build and retain FDA』s workforce.
路線圖還指出了在建立和留住 FDA 員工方面已經進行了幾項努力。
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