11月4日，美國參議員Elizabeth Warren （D-MA）和Patty Murray （D-WA）在一封致FDA官員的信中表示，他們對FDA重新針對某些醫(yī)療器械實行漸進式審批制度感到擔(dān)憂。

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這封信是寫給FDA代理局長Brett Giroir和醫(yī)療器械與放射健康中心（CDRH）主任Jeffrey Shuren的。鑒于此前FDA前局長Scott Gottlieb于2018年告訴參議員，有條件的批準(zhǔn)途徑不適用于人用醫(yī)療產(chǎn)品，參議員在信中對FDA在器械漸進式批準(zhǔn)方面的態(tài)度大轉(zhuǎn)變提出質(zhì)疑。

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雖然器械的漸進式批準(zhǔn)已經(jīng)討論了多年，但FDA首次正式提出這一途徑是在其2020財年預(yù)算說明中。根據(jù)該提議，某些器械在證明其安全性和性能以及采取其他風(fēng)險緩解措施的情況下，可獲得臨時批準(zhǔn)上市銷售，但在規(guī)定的時間期限后，申請人需根據(jù)上市后數(shù)據(jù)證明產(chǎn)品能夠合理保證其安全性和有效性，然后才能繼續(xù)在市場上銷售這類器械產(chǎn)品。

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針對這一提議，Warren和Murray于6月份致函Shuren和時任FDA代理局長的Ned Sharpless，該提案“令人擔(dān)憂”，同時指出，“從書面上看，該項"臨時批準(zhǔn)"與前局長Gottlieb向國會和公眾保證FDA不會尋求的“有條件批準(zhǔn)”幾乎沒有區(qū)別。

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負(fù)責(zé)立法事務(wù)的FDA副局長Karas Gross在8月份向參議員們做出回應(yīng)，解釋說：“FDA對醫(yī)療器械的看法在不斷演變。”

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Gross寫道:“這一途徑旨在幫助人們獲得能夠治療或診斷威脅生命或不可逆轉(zhuǎn)的衰弱性疾病和狀況的醫(yī)療器械，并幫助解決尚未滿足的醫(yī)療需求，特別是對兒童和其他長期缺醫(yī)少藥的少數(shù)人群。”

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對此，Warren和Murray表示，他們對FDA的有關(guān)說法感到失望，同時還對FDA設(shè)想的漸進式批準(zhǔn)資格標(biāo)準(zhǔn)以及用于完全批準(zhǔn)該途徑下器械的上市后數(shù)據(jù)的“質(zhì)量和完整性”感到擔(dān)憂。

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此外，參議員們還質(zhì)疑，如果在臨時批準(zhǔn)期限到期后，F(xiàn)DA無法證明臨時批準(zhǔn)的器械能夠合理保證其安全性和有效性，那么該機構(gòu)能夠在多大程度上將這些器械從市場上撤出。

In a letter to top US Food and Drug Administration (FDA) officials on Monday, Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) say they are concerned about the agency’s renewed interest in a progressive approval system for certain medical devices.

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The letter, addressed to Acting FDA Commissioner Brett Giroir and Centerfor Devices and Radiological Health (CDRH) Director Jeffrey Shuren, questions the agency’s about-face on progressive approvals for devices after former FDA Commissioner Scott Gottlieb told senators in 2018 that a conditional approval pathway would not be suitable for human medical products.

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While progressive approvals for devices have been discussed for years, FDA first officially proposed the pathway in its FY2020 budget justification. Under the proposal, certain devices could be marketed under a provisional approval based on a demonstration of safety and performance in addition to other risk mitigations for a three-year period. Afterward, the sponsor would be required to demonstrate a reasonable assurance of safety and effectiveness based on postmarket data to continue marketing the device.

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In response to the proposal, Warren and Murray sent a letter to Shuren and then-Acting FDA Commissioner Ned Sharpless in June calling the proposal "alarming"?and noting that "as written, this 'provisional approval'?seems hardly distinguishable from the 'conditional approval'?that former-Commissioner Gottlieb had assured Congress and the public that the FDA would not pursue."

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FDA Associate Commissioner for Legislative Affairs Karas Gross responded to the senators in August, explaining that, "The agency's views with respect to medical devices have continued to evolve."

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"This pathway is intended to help enable access to medical devices which treat or diagnose life-threatening or irreversibly debilitating diseases and conditions and address unmet medical needs, particularly for children and other small and rare populations that remain perpetually underserved," Gross wrote.

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In response, Warren and Murray say they are "disappointed by FDA's clarification"?and continue to have concerns about the agency’s envisioned eligibility criteria for progressive approval and the "quality and completeness" of the postmarket data that would be used to fully approve devices under the pathway.

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The senators also question how well the agency would be able to remove provisionally approved devices from the market if they are unable to demonstrate a reasonable assurance of safety and effectiveness after the provisional approval period expires.