这是一种传统的活动：该机构一直在拍打假毒品产品。当Covid-19的大流行袭击现场时，饮食补充产品声称可以治愈或预防该病毒开始出售，而FDA和联邦贸易委员会立即开始定期习惯向向制造商发出严厉警告。产品。FDA已经向近70家不同的公司发布了此类警告信。例如，这些公司在产品标签或出售产品的网站上提出了未经证实的主张。他们声称这些产品可以预防或治愈COVID-19或其他疾病。这些机构声称，这些公司的虚假标签和广告声称使产品药物和未经批准的药物引导。目前，尚无证明可以预防或治愈COVID-19的药物。FDA还采取了“测试工具包和个人防护设备（PPE），并以未经证实的索赔为单位。”
在不了解每种产品的细节的情况下，一个人怀疑COVID-19治疗供应商，嗯，他们没有证明自己的主张。FDA执法行动一直存在两种目标。有些FDA目标公司的意图并不糟糕，并且正在努力遵守所有庞大的，有时甚至有时会出现的FDA要求，但不足。尽管有大量有关标签和广告违规的警告的接收者，但绝大多数公司都属于这一类别。然后有FDA目标公司aren’t试图遵守，但只是试图获利，似乎不在乎他们是否在此过程中误导了公众。抓住这些想法，我们将在片刻之后回到他们身边。
FDA与对可疑Covid-19产品的制造商的警告分开，FDA在面对紧急情况时一直使用其法律权力以各种方式调整其要求。For example, it’s been working with companies to help them quickly develop valid new drugs to treat, prevent, or cure COVID-19, and it’s been helping speed-to-market new diagnostic tests, masks, hand sanitizer, and other protective equipment and supplies, often by carving away some of the usual regulatory requirements that would otherwise have been required of the products or their makers.
FDA一直定期与其规范的行业进行沟通，并提供有关食品和其他制造商如何适应病毒提出的新安全挑战的建议，并且还在解释该机构在大流行期间如何调整其自己的运营。
这个大流行启发的主题是剃除监管要求非常符合政府的整体意识形态方法。You may remember that the administration had already imposed a requirement that called on agencies to withdraw two regulations for each new one it makes, and it’s common to hear the president tout his administration’s reduction of "‘regulations," which he talks about as if they are viruses that are always worthy of being eliminated.
What’s more, FDA commissioner Stephen Hahn said in early June, “To the extent that the innovations and adaptations we implemented during the pandemic crisis worked and would be appropriate to implement outside of a pandemic situation, we will incorporate them into standard FDA procedures.”
他特别提到了使用“分散”临床试验和现实世界证据（RWE）的使用，例如电子健康记录，保险索赔，患者注册和实验室结果的数据，以评估药物安全和有效性。
但是，哈恩重申了该机构对安全的承诺，即使它可以简化某些流程和要求。After all, each of the various requirements imposed on makers of drugs and devices—from registering the factories with FDA to putting specific statements on the products’ labeling to getting agency approval before hitting the market—is designed to help assure the products are safe and effective. Ideally, Congress and FDA should always be looking for ways to make life easier for those who are trying to comply, and harder for those who aren’t.
如果FDA消除其中一些要求，药物和设备是否会降低安全和有效？好吧，我们会看到的。But, as noted, it’s always been true and will continue to be true that the vast majority of regulated businesses try very hard to make products that are made correctly and are safe and effective, so maybe some of those regulatory requirements aren’t needed after all. Remember, FDA has all those powers now, but still the COVID-19 hucksters are trying to sell their questionable products.
长期以来，人们一直在倡导FDA从业务上强加许多要求的业务，这是因为它们是繁重的，并且不会增加安全性。After all, if you look at the history of drug regulation, there was a time when new drugs weren’t approved by FDA before marketing, then there was a time when they were approved by FDA only for their safety, and now the law requires that FDA approve new drugs for their safety and their effectiveness for their intended use.
That’s the law now, but that doesn’t mean it will be the law forever. Sometimes change is gradual, and sometimes a crisis introduces changes that stay.
INFORMATIONAL ONLY, NOT LEGAL ADVICE.
