Robert F. Kennedy Jr. is the Health Secretary. He wants pharmacies to make special medicines called peptides. But FDA scientists say these medicines are not safe.

小羅伯特·甘迺迪是衛生部長。他希望藥局能製造稱為「胜肽」的特殊藥物。但 FDA 的科學家表示這些藥物並不安全。

Secretary Kennedy wants to change the rules. He thinks pharmacies can make these medicines safely. He says this is better than buying them from bad shops.

甘迺迪部長想要修改規定。他認為藥局可以安全地製造這些藥物。他表示這比從劣質商店購買更好。

FDA scientists do not agree. They say there is no proof from tests on people. They say these medicines might not work. They say there are other safe medicines for these problems.

FDA 的科學家並不認同。他們表示缺乏人體試驗的證明。他們認為這些藥物可能沒有效果，且針對這些問題已有其他安全的藥物。

The FDA has a group of experts. This group will meet in July. Many new members of this group work with the companies that sell these medicines.

FDA 有一個專家小組。該小組將在七月開會。這個小組的許多新成員在銷售這些藥物的公司工作。

The expert group will meet in late July. They will decide if these seven medicines are safe to use.

專家小組將在七月下旬開會，決定這七種藥物是否安全可用。

Health Secretary Robert F. Kennedy Jr. wants to allow compounding pharmacies to produce certain synthetic peptides, even though FDA experts claim there is not enough clinical data from human trials to prove they are safe.

衛生部長 Robert F. Kennedy Jr. 希望允許調劑藥局生產某些合成肽，儘管 FDA 專家聲稱缺乏足夠的人體試驗臨床數據來證明其安全性。

The current administration is proposing a change in how several peptides—chains of amino acids used for various health purposes—are regulated. Secretary Kennedy has moved twelve of these substances into 'Category 1,' which is necessary for compounding pharmacies to produce them. He argues that moving these products from an unregulated 'gray market' to licensed pharmacies will reduce risks such as contamination and incorrect labeling. Furthermore, the Secretary has stated that the safety warnings issued by the previous administration were incorrect.

現任政府正提議更改數種肽（用於各種健康目的的氨基酸鏈）的監管方式。Kennedy 部長將其中 12 種物質移至「第一類」，這是調劑藥局能夠生產的前提。他主張將這些產品從不受監管的「灰色市場」轉移到持牌藥局，將能降低污染和標記錯誤等風險。此外，部長表示前任政府發布的安全警告是不正確的。

On the other hand, FDA scientists insist that there is not enough evidence to prove these substances are safe or effective. Internal documents show that for several peptides, such as TB-500, KPV, and MOTS-c, there are no published human clinical trials at all. Regarding BPC-157, the agency noted that the available data was too limited to make a formal recommendation. Additionally, the FDA emphasized that there are already approved medical treatments for the conditions these peptides aim to treat, including insomnia and eczema.

另一方面，FDA 科學家堅持認為沒有足夠證據證明這些物質的安全或有效性。內部文件顯示，對於數種肽（如 TB-500、KPV 和 MOTS-c），完全沒有發表過人體臨床試驗。關於 BPC-157，該機構指出可用數據過於有限，無法做出正式建議。此外，FDA 強調，針對這些肽旨在治療的病症（包括失眠和濕疹），已有獲批准的醫療方案。

There is also visible tension regarding the Pharmacy Compounding Advisory Committee. The FDA recently appointed nine new members, many of whom have financial or professional links to wellness clinics that promote peptide therapy. This change in the committee happens just before the July 23-24 meetings, where seven specific peptides will be reviewed. While the FDA usually follows the advice of its panels, the agency has clarified that a final decision will only be made after all reviews are complete.

關於藥局調劑諮詢委員會也存在明顯的緊張局勢。FDA 最近任命了 9 名新成員，其中許多人與推廣肽療法的健康診所具有財務或專業聯繫。委員會的此次變動恰在 7 月 23 至 24 日會議之前，屆時將審查 7 種特定肽。雖然 FDA 通常遵循其專家小組的建議，但該機構已澄清，最終決定將在所有審查完成後才做出。

The FDA's advisory committee will meet in late July to decide the status of seven peptides, balancing the Health Secretary's goal of deregulation against the agency's scientific findings.

FDA 的諮詢委員會將於 7 月底開會，決定 7 種肽的地位，在衛生部長的去監管化目標與該機構的科學研究結果之間取得平衡。

Health Secretary Robert F. Kennedy Jr. is seeking to permit compounding pharmacies to produce specific synthetic peptides, despite internal FDA assessments citing a lack of human clinical data.

衛生部長 Robert F. Kennedy Jr. 正尋求允許配藥藥局生產特定的合成胜肽，儘管 FDA 內部評估指出缺乏人體臨床數據。

The current administrative trajectory involves a proposed shift in the regulatory status of several peptides—amino acid chains utilized for various health claims. Secretary Kennedy has reclassified twelve such substances as Category 1, a prerequisite for their production by compounding pharmacies. This initiative is predicated on the hypothesis that transitioning these substances from an unregulated 'gray market' to licensed pharmacies would mitigate risks associated with contamination and mislabeling. The Secretary has further characterized previous safety designations by the prior administration as erroneous.

目前的行政方向涉及擬改變數種胜肽的監管狀態——這些是用於各種健康聲稱的氨基酸鏈。Kennedy 部長將其中 12 種物質重新分類為第一類，這是配藥藥局生產這些物質的前提。此舉是基於一個假設，即將這些物質從不受監管的「灰色市場」轉移到領有執照的藥局，將能降低與污染和標記錯誤相關的風險。部長進一步將前任政府之前的安全定級描述為錯誤的。

Conversely, FDA career scientists maintain that the evidentiary basis for the safety and efficacy of these substances is insufficient. Briefing documents indicate that for several peptides, including TB-500, KPV, and MOTS-c, there is a total absence of published human clinical trials. Regarding BPC-157, the agency noted that available data on ulcerative colitis was limited to meeting abstracts, lacking necessary detail for a formal recommendation. Furthermore, the FDA highlighted the existence of established, approved therapies for the conditions these peptides aim to treat, such as insomnia and eczema.

相反地，FDA 的職業科學家認為，這些物質安全性與療效的證據基礎不足。簡報文件指出，對於包括 TB-500、KPV 和 MOTS-c 在內的數種胜肽，完全缺乏已發表的人體臨床試驗。關於 BPC-157，該機構指出可用於潰瘍性結腸炎的數據僅限於會議摘要，缺乏正式建議所需的必要細節。此外，FDA 強調，針對這些胜肽旨在治療的症狀（如失眠和濕疹），已有成熟且獲批准的療法。

Institutional tension is further evidenced by the composition of the Pharmacy Compounding Advisory Committee. The FDA recently appointed nine new members, many of whom maintain financial or professional affiliations with wellness clinics that promote peptide therapy. This shift in committee demographics occurs ahead of the July 23-24 sessions, where seven specific peptides—BPC-157, emideltide, epitalon, KPV, MOTS-c, semax, and TB-500—will be evaluated. While the FDA typically adheres to the recommendations of its advisory panels, the agency has stated that a final determination will only be reached after all reviews are finalized.

藥局配藥諮詢委員會的組成進一步證明了機構內部的緊張關係。FDA 最近任命了 9 名新成員，其中許多人與推廣胜肽療法的健康診所保持著財務或專業聯繫。委員會人口結構的轉變發生在 7 月 23 日至 24 日的會議之前，屆時將評估 7 種特定胜肽——BPC-157、emideltide、epitalon、KPV、MOTS-c、semax 和 TB-500。雖然 FDA 通常遵循其諮詢小組的建議，但該機構表示，只有在所有審查最終完成後，才會達成最終決定。

The FDA's advisory committee will meet in late July to determine the status of seven peptides, weighing the Health Secretary's deregulation goals against the agency's scientific findings of insufficient evidence.

FDA 的諮詢委員會將於 7 月下旬開會以決定 7 種胜肽的狀態，在衛生部長的放寬監管目標與該機構關於證據不足的科學發現之間權衡。