FDA 重新考虑短缺问题，复合药房可以恢复生产 tirzepatide
https://www.nbcnews.com/health/health-news/compounding-pharmacies-can-resume-making-tirzepatide-fda-reconsiders-s-rcna174551
Berkeley Lovelace Jr. 2024 年 10 月 14 日
FDA 的举措是对复合贸易集团的诉讼的回应，该集团声称 tirzepatide（Zebpound 中的成分）仍然供不应求。
美国食品和药物管理局在周五晚些时候提交的一份法庭文件中表示，它将允许药剂师继续生产复合版 tirzepatide（礼来糖尿病和减肥药物 Mounjaro 和 Zepbound 中的活性成分），同时重新考虑将该药物从全国短缺名单中删除的决定。
这一意外举措对配药药剂师和患者而言是一次重大胜利，他们在 10 月 2 日 FDA 宣布替泽帕肽短缺问题已解决后对 FDA 感到愤怒。
该药物以及 Ozempic 和 Wegovy 中的活性成分索马鲁肽的短缺推动了配药药房生产自己版本的药物的空前需求，患者表示这些药物通常比品牌药物更便宜且更容易获得。
在 FDA 宣布短缺期间，配药药房生产“基本上是”短缺品牌药物的仿制品是合法的，尽管制药商强烈反对这种做法的合法性。
FDA 于 10 月 2 日宣布短缺结束，这意味着配药药剂师不得不停止配制替泽帕肽处方。 FDA 当时表示，生产大批量药物的药店将不再接受新的 tirzepatide 订单，并有 60 天的时间来填写现有订单。
10 月 7 日，复合贸易组织外包设施协会起诉 FDA，声称该药物仍然供应不足，因此应继续留在短缺名单上。
FDA 周五提交的文件是对该组织的诉讼的回应，称其举动“实际上是原告在其动议中寻求的救济”。该机构在文件中表示，目前，它不会对制造复合药物的原告及其成员“采取行动”，因为它正在重新评估其决定。
2023 年 6 月，南卡罗来纳州斯帕坦堡的 50 岁 Simone Williams 在她的 Mounjaro 储蓄卡过期后被开了复方 tirzepatide。Simone Williams
南卡罗来纳州斯帕坦堡的 50 岁 Simone Williams 表示，她对 FDA 将 tirzepatide 从短缺名单中剔除的决定深感不安。
去年，在她的 Mounjaro 储蓄卡过期后，Williams 开始服用复方 tirzepatide 减肥。她负担不起每月 1,060 美元的品牌药自付费用。
Williams 需要“玩转”并开具仍然短缺的复方 semaglutide 处方。
Williams 说，FDA 的更新是“好消息”，但她仍然很谨慎。
“在 FDA 做出明确决定之前，我仍然会对此感到紧张和愤怒，因为他们可能会回来说‘不，没有短缺’，我又回到了原点，”她说。
tirzepatide 真的短缺吗？
Tirzepatide 近两年来一直在 FDA 的药物短缺名单上。最初以 Mounjaro 的名称批准用于治疗 2 型糖尿病，许多患者被处方使用 tirzepatide 来减肥。去年，当它以 Zepbound 的名称正式获批用于减肥时，它的人气飙升，加剧了短缺。
礼来已采取措施提高 tirzepatide 的产量，包括投入数十亿美元建造一个专门生产更多药物的新制造工厂。
美国卫生系统药剂师协会 (American Society of Health-System Pharmacists) 药房实践和质量高级主管迈克尔·加尼奥 (Michael Ganio) 表示，该组织仍在听取患者和护理人员的报告，称提泽帕肽仍然难以获得。该协会是一个跟踪美国药品短缺情况的组织。
美国卫生系统药剂师协会仍将提泽帕肽列为短缺药品，不过加尼奥表示，随着药剂师了解到有库存，这种情况可能会改变。
“这种情况可能只需要几周时间就能实现供应平衡，”他说。“配送中心会得到补货，然后将其发送到药店。药店可能都有积压订单，他们的客户可能一直在从配药药房购买，现在正试图从零售药店和社区药店购买。”
一些患者现在转向流行减肥药的仿制品
03:30
在北卡罗来纳州卡里经营减肥诊所的胃肠病学家克里斯托弗·麦高文博士表示，他认为诉讼与药物是否真的短缺无关，而与复合 GLP-1 药物的利润丰厚性质有关。
“这是为了钱，”麦高文说。“复合行业将争辩
供应链还不够稳定，但实际上有数百万人处于危险之中。这就是问题所在。”
礼来表示，tirzepatide 并不短缺。
礼来发言人 Jared Shapiro 在周一的一份声明中表示，所有剂量的 Mounjaro 和 Zepbound 都是可用的，并警告说，重要的是患者“不要接触未经测试、未经批准的仿制品的风险”。
“没有什么能改变这样一个事实，即正如 FDA 所认识到的，Mounjaro 和 Zepbound 是可用的，短缺问题仍然‘得到解决’，”Shapiro 说。
FDA 没有回应对其逆转的更多评论请求。
FDA 发言人在周五晚上提交文件之前的一份声明中表示，该机构理解患者对其宣布结束短缺的决定感到沮丧，并表示，“我们理解高药价对患者有直接影响。”
“太多美国人买不起他们需要的药物，”发言人说。“然而，FDA 没有法律权力调查或控制制造商、分销商和零售商设定的价格。”
发言人说，FDA 的配药计划旨在为需要这些药物的患者保留获得“合法销售的配药”的机会，尽管该机构通常建议患者在可用时使用 FDA 批准的药物。
“安心”
与此同时，患者和配药药剂师正在庆祝 FDA 允许继续配制替泽帕肽的决定。
提起诉讼的外包设施协会发言人在一份声明中表示，“对我们的成员和他们服务的众多患者来说，这令人松了一口气。”
“我们认为，鉴于该机构在承认‘供应中断’的情况下草率决定将该药物从名单中剔除，这是一个公平的解决方案，”发言人说。 “最重要的是，如果 FDA 在短缺问题仍然存在的情况下重复其撤诉决定，我们将再次诉诸法庭。”
另一个行业组织药房配药联盟在一份声明中称，这是外包设施协会的“非凡胜利”。
本月初，APC 与记者进行了电话会议，称 FDA 的初步决定让配药药房“措手不及”，让患者“措手不及”。
礼来公司在 8 月首次表示，tirzepatide 短缺问题将很快得到解决，比 FDA 的正式决定早两个月。
APC 上周末在给客户的电子邮件中表示，它正在与律师合作，以弄清 FDA 的新申请是否意味着它不会对所有生产 tirzepatide 的配药药房采取执法行动，还是只对诉讼中的原告采取执法行动。
“我们的目标是以书面形式让 FDA 对所有目前配制替泽帕肽注射剂的药房采取执法自由裁量权，”APC 在电子邮件中写道。
对于北卡罗来纳州格雷厄姆市 59 岁的伊丽莎白·肯利来说，FDA 的决定让她“安心”。
肯利在 3 月份因 Wegovy 短缺而难以找到后，医生给她开了一种替泽帕肽的复合版本。
上周，肯利的配药药剂师通知她，由于替泽帕肽不再在短缺名单上，他们需要停止生产复合版本或寻找其他供应商。药剂师表示，他们将分发剩余的库存，并希望在年底前继续为患者提供处方。
由于 FDA 周五提交了申请，肯利不需要“匆忙制定 B 计划”。
自从她开始服用这种复方药物以来，她说她已经减掉了 30 磅，并希望再减掉 25 磅。
“复方药房是我继续接受这种对我非常成功的治疗的生命线，”肯利说。“我明白研发公司需要赚钱，但他们也需要与保险公司合作，确保公平公正地获得这些药物。”
伯克利·洛夫莱斯二世
伯克利·洛夫莱斯二世是 NBC 新闻的健康和医疗记者。他报道食品和药物管理局，特别关注新冠疫苗、处方药定价和医疗保健。他之前曾在 CNBC 报道过生物技术和制药行业。
Compounding pharmacies can resume making tirzepatide as FDA reconsiders shortage
https://www.nbcnews.com/health/health-news/compounding-pharmacies-can-resume-making-tirzepatide-fda-reconsiders-s-rcna174551
The surprise move is a major victory for compounding pharmacists and patients who were furious with the FDA after its announcement on Oct. 2 that the tirzepatide shortage was resolved.
During FDA-declared shortages, it’s legal for compounding pharmacies to make versions that are “essentially a copy” of the brand-name drugs in shortage, though drugmakers have vehemently pushed back against the legitimacy of this practice.
The FDA’s announcement on Oct. 2 declaring the shortage over meant that compounding pharmacists had to stop filling tirzepatide prescriptions. It said at the time that pharmacies that produce large batches of medications would no longer be able to accept new orders of tirzepatide and had 60 days to fill their existing orders.
On Oct. 7, the Outsourcing Facilities Association, a compounding trade group, sued the FDA, claiming that the drug is still in short supply and should therefore remain on the shortage list.
The FDA’s filing Friday was in response to the group’s suit, saying its move was “effectively the relief that Plaintiffs sought in their motion.” In the filing, the agency said that, for the time being, it wouldn’t “take action” against the plaintiffs and their members making compounded versions of the drugs as it re-evaluates its decision.
Simone Williams, 50, of Spartanburg, S.C., was prescribed compounded tirzepatide in June 2023 after her Mounjaro savings card expired.Simone Williams
Simone Williams, 50, of Spartanburg, South Carolina, said she had been deeply upset with the FDA’s decision to take tirzepatide off the shortage list.
Williams began taking compounded tirzepatide for weight loss last year after her Mounjaro savings card expired. She couldn’t afford the $1,060 a month out of pocket for the brand-name drug.
Williams would need to “play switcheroo” and get a prescription for compounded semaglutide, which remains in shortage, instead.
The FDA’s update is “good news,” Williams said, but she’s still cautious.
Is tirzepatide really in shortage?
Tirzepatide was on the FDA’s drug shortage list for nearly two years. Initially approved under the name Mounjaro to treat Type 2 diabetes, many patients were prescribed tirzepatide off-label for weight loss. When it was officially approved for weight loss last year — under the name Zepbound — it soared in popularity, exacerbating the shortages.Lilly has taken steps to ramp up production of tirzepatide, including committing billions to a new manufacturing facility dedicated to producing more of the drug.
Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, a group that tracks drug shortages in the U.S., said the group is still hearing reports from patients and caregivers suggesting tirzepatide continues to be hard to come by.
The ASHP still lists tirzepatide as in shortage, although Ganio said that could change as pharmacists learn that there is supply in stock.
“This can be the kind of thing that just takes a couple of weeks for supply to even out,” he said. “Distribution centers get replenished and then they send it out to pharmacies. The pharmacies probably all have back orders and they have customers that maybe have been getting it from the compounding pharmacy and are now trying to get it from a retail pharmacy and community pharmacy.”
Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina, said he believes the lawsuit is less about whether the drug is genuinely in shortage and more about the lucrative nature of compounded GLP-1 medications.
“It’s about money,” McGowan said. “The compounding industry will argue that the supply chain isn’t stable enough, yet, but really there are many millions at stake. That’s the issue.”
Lilly says that tirzepatide is not in shortage.
In a statement Monday, Jared Shapiro, a Lilly spokesperson, said all doses of Mounjaro and Zepbound are available, warning that it’s important that patients “not be exposed to the risks in taking untested, unapproved knockoffs.”
“Nothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available and the shortage remains ‘resolved,’” Shapiro said.
The FDA didn’t respond to a request for additional comment on its reversal.
An FDA spokesperson said in a statement prior to the Friday evening filing that the agency understands the patients’ frustration about its decision to declare an end to the shortage, saying, “we understand that high drug prices have a direct impact on patients.”
“Too many Americans are priced out of the medicines they need,” the spokesperson said. “However, the FDA has no legal authority to investigate or control the prices set by manufacturers, distributors and retailers.”
The FDA’s compounding program aims to preserve access to “lawfully marketed compounded drugs” for patients who need them, the spokesperson said, although the agency generally recommends patients use FDA-approved drugs when available.
‘Peace of mind’
Meanwhile, patients and compounding pharmacists are celebrating the FDA decision to allow tirzepatide compounding to continue.A spokesperson for the Outsourcing Facilities Association, which filed the lawsuit, said in a statement that it was “relieved, for our members and the many patients that they serve.”
“We believe that this is a fair resolution in light of the agency’s rash decision to take the drug off the list at a time when the agency has acknowledged ‘supply disruptions,’” the spokesperson said. “Most important, should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.”
In a statement, the Alliance for Pharmacy Compounding, another industry group, called it an “an extraordinary win” for the Outsourcing Facilities Association.
APC held a call with reporters earlier this month, saying that the FDA’s initial decision had caught compounding pharmacies “off guard” and left patients “flat-footed.”
Lilly had first indicated in August that the tirzepatide shortage would be resolved soon, two months before the official FDA decision.
The APC said in an email to clients over the weekend that it’s working with lawyers to get clarity on whether the FDA’s new filing means that it will not take enforcement against all compounding pharmacies who make tirzepatide or just the plaintiffs in the lawsuit.
“Our aim is to get in writing that FDA will take enforcement discretion related to all pharmacies compounding copies of tirzepatide injection at this time,” the APC wrote in the email.
For Elizabeth Kenly, 59, of Graham, North Carolina, the FDA’s decision gives her “peace of mind.”
Kenly was prescribed a compounded version of tirzepatide in March after she had trouble finding Wegovy because it was in shortage.
Last week, Kenly’s compounding pharmacists informed her that, because tirzepatide was no longer on the shortage list, they would need to stop making the compounded versions or seek out a different supplier. The pharmacists said that they would dispense the remaining stock and hoped to continue providing patients with prescriptions through the end of the year.
Because of the FDA’s filing Friday, Kenly doesn’t need to “scramble to figure out a plan B.”
Since she started the compounded drug, she says she has lost 30 pounds and wants to lose another 25.
“The compounding pharmacy is my lifeline to continue a therapy that has been so successful for me,” Kenly said. “I understand that research and development companies need to make money, but they also need to work together with insurance companies to ensure fair and equitable access to these medications.”
Berkeley Lovelace Jr.