Young F E
Office of Public Affairs, Rockville, MD 20857.
Public Health Rep. 1988 May-Jun;103(3):242-5.
The Food and Drug Administration has instituted several pro-active measures to expedite the review of treatments, diagnostics, and vaccines for AIDS and related conditions. In particular, the agency has established a special designation--1-AA--for a potential AIDS product which gives top priority to its review. This special expedited review process for AIDS products has provided for greater cooperation between their sponsors and FDA's reviewers. AIDS products also receive prompt consideration for orphan product status--a status providing financial incentives to the developers of treatments for certain rare and complex diseases. FDA's special procedures for AIDS drugs have resulted in several major advances in available AIDS treatments. Foremost among these was the FDA's review and approval of zidovudine (commonly known as AZT) as the first effective palliative for AIDS within 107 days--an agency record. Similarly, the agency quickly evaluated and approved ELISA and Western blot diagnostic kits for detecting the presence of HIV antibody. These test kits have made an important contribution to safeguarding the nation's blood supply. The agency has also instituted new "treatment" investigational new drug regulations to allow earlier pre-approval distribution of promising experimental treatments to patients with immediately life-threatening conditions, including persons with AIDS. Under this system and its earlier prototype, eligible AIDS patients were able to receive pre-approval treatment with zidovudine and trimetrexate (an experimental drug for the treatment of AIDS patients with Pneumocystis carinii pneumonia who have experienced severe adverse reactions using standard approved therapies). The agency has made institutional reforms to effectively streamline the review of candidate AIDS treatments and vaccines. Two new centers within the agency have been established for the processing of drug and biologics. In addition,reviewing divisions have been created within these centers to give specialized attention to drugs and biologics designed to treat AIDS or related conditions.These efforts and the other aforementioned reforms, in part, have lead to the initiation of more than 100 ongoing clinical studies of potential drugs for AIDS and related conditions, as well as the clinical testing of two candidate vaccines against HIV. In other areas, FDA has increased inspections of the manufacturing and processing of condoms and begun a surveillance and sampling program to insure the quality of latex surgical gloves. The agency has worked with other authorities to move against quack AIDS products and to educate the public concerning this health fraud.FDA hopes that through all these efforts it can help researchers in government, academia, and industry advance the development, testing, and review of safe and effective therapies, preventatives,and diagnostics for AIDS and related conditions.
美国食品药品监督管理局已采取多项积极措施，以加快对艾滋病及相关病症的治疗方法、诊断手段和疫苗的审评。特别是，该机构为潜在的艾滋病产品设立了一种特殊指定——1-AA，给予其审评最高优先级。这种针对艾滋病产品的特殊快速审评程序促进了申办者与美国食品药品监督管理局审评人员之间的更大合作。艾滋病产品还会迅速获得孤儿药地位的考量——该地位为某些罕见和复杂疾病治疗方法的开发者提供经济激励。美国食品药品监督管理局针对艾滋病药物的特殊程序已在现有艾滋病治疗方面取得了多项重大进展。其中最主要的是，美国食品药品监督管理局在107天内审评并批准了齐多夫定（通常称为AZT）作为首个有效的艾滋病姑息治疗药物——这是该机构的一项纪录。同样，该机构迅速评估并批准了用于检测HIV抗体的酶联免疫吸附测定（ELISA）和蛋白质印迹诊断试剂盒。这些检测试剂盒为保障国家血液供应做出了重要贡献。该机构还制定了新的“治疗性”研究性新药法规，以便在更早阶段将有前景的实验性治疗方法预批准分发给患有危及生命疾病的患者，包括艾滋病患者。在这一体系及其早期原型体系下，符合条件的艾滋病患者能够接受齐多夫定和三甲曲沙（一种用于治疗患有卡氏肺孢子虫肺炎且使用标准批准疗法出现严重不良反应的艾滋病患者的实验性药物）的预批准治疗。该机构进行了机构改革，以有效简化对候选艾滋病治疗方法和疫苗的审评。该机构内部新设了两个中心来处理药品和生物制品。此外，在这些中心内设立了审评部门，专门关注旨在治疗艾滋病或相关病症的药品和生物制品。这些努力以及上述其他改革举措，在一定程度上促成了100多项正在进行的针对艾滋病及相关病症潜在药物的临床研究的启动，以及两种抗HIV候选疫苗的临床试验。在其他领域，美国食品药品监督管理局加强了对避孕套生产和加工的检查，并启动了一项监测和抽样计划，以确保乳胶手术手套的质量。该机构与其他当局合作打击庸医假药类艾滋病产品，并就这种健康欺诈行为对公众进行教育。美国食品药品监督管理局希望通过所有这些努力，能够帮助政府、学术界和业界的研究人员推进艾滋病及相关病症安全有效疗法、预防措施和诊断方法的研发、测试和审评工作。
