The World in BriefThis e-newsletter is provided courtesy of Reed CNY Business Law, P.C.
Bio-Pharma: Call for US to Have Independent Inspections of Drugs from FDA-approved Foreign Manufacturing Sites
The COVID-19 pandemic has exposed significant flaws in the FDA's ability to adequately inspect drugs produced by foreign manufacturers and might cause quality concerns in the U.S. supply for years to come, Valisure CEO David Light testified to the Senate Finance Committee, calling on senators to consider instituting independent laboratory testing of all foreign-imported drugs as a prerequisite for distribution in the U.S. After NMDA contamination in multiple foreign-produced drugs, Light said problems with the FDA's testing policies, including allowing manufacturers to supply their own lots for lab analysis, is potentially putting dangerous drugs on U.S. shelves. Reed Business Law can assist non-U.S. drug manufacturers in coming to the U.S., thus avoiding the increased regulatory burdens foreign sites are likely to experience.
전례없는 코비드 19 팬데믹로 인하여 미 FDA 는 능력의 한계를 노출하고 있습니다. 특히 미국외 다른 국가에서 생산된 제약의 검사가 제대로 이루어지지 않는다는 우려가 증식되고 있습니다. Valisure의CEO, David Light은상원청문회에서 다른국가에서 생산된 약품들에 대한 철저한 검사를 위한 연구시설을 설립하는 것을 요첨하였습니다. David Light는 FDA의 현재 방침으로는 잠재적인 위험물질을 포함한 약품들이 미국내에 유통될 수있다고 경고했습니다. 저희 로펌은 미국외 국가의 제약회사들이 미국바이오시장에 진출할시겪게 되는 제도적 어려움들을 컨설팅해드리고 있습니다.
Bio-Pharma: U.S. seeks to 'onshore' drug production in response to COVID-19.
U.S. Congress is considering multiple bills that would seek to bring drug manufacturing back to the U.S., at the expense of major producers abroad, particularly China and India. They argue that reliance on drugs made or sourced outside the U.S. is a national security issue. “Onshoring,” bringing manufacturing back to the U.S., diminishes reliance on bad actors abroad. Meanwhile, the White House is working on a "Buy American" executive order requiring government agencies to purchase American-made medical products. The FDA said only 28% of Active Pharmaceutical Ingredients (“API”) sold in U.S. in 2014 were produced in the U.S., while 24% were produced in China and India. Today the percentage is lower for theU.S. and higher for China and India. Proposals before Congress include (a) "Protecting our Pharmaceutical Supply Chain from China Act," requiring government payers to phase out reimbursement for drugs made or sourced in China by 2022, and (b) "Manufacturing API, Drugs and Excipients (MADE) Act," using tax credits to incentivize onshoring of drug manufacturing. But, Amneal Pharmaceuticals, the largest U.S.-based player with API capacity, isn’t waiting; it purchased a 61.5% majority stake in AvKARE, a U.S. generic supplier selling almost exclusively to the Departments of Defense and Veterans Affairs. And some companies could use the incentive money to upgrade existing or newly acquired facilities, such as Mylan (Morgantown, West Virginia); Teva (Irvine, California); and Pfizer’s Hospira (North Carolina). Reed Business Law assists companies around the world establish a U.S. presence (legal entity, offices and manufacturing facilities) in order to take advantage of customs, duties and tax provisions favoring U.S. operations. Let us know if you need to learn more.미국 하원은 미국외 다른국가, 특히 중국과 인도의 제약회사들이 미국내 제약공장을 필수적으로 설립하는 것에 대한 여러가지법안의 발의를 준비하고 있습니다. 하원의원들은 타국에서 생산되는 약품들의 공급이 많아지는 것은 국가안보와도 관련이 있는 사안이라고 주장하고있습니다. “온쇼어링”이라고 명칭될수 있는 형태의 과정으로 의원들은 1)중국제약회사로부터의 바이오유통산업보호에 관한 법안과 2)원료의약품 및 약품제조를 위한 법안(MADE Act) 를 함께 준비하고 있습니다. 원료의약품제조에 관해 미국내 가장큰 제약회사인 Amneal Pharmaceutical 은 법안발의전에 이미 미국 제네릭 회사인 AvKare 의 지분 61.5%를 매수해 미국소비자들의 신임을 얻으려 하고있습니다. 저희 로펌은 미국내 제약생산공장의 부지선정및 관련 법안들에 대해 자세한 컨설팅을 해드리고 있습니다.
FDA: U.S. Food and Drug Administration Explains Impact of COVID-19 On May 26 the FDA issued immediately effective guidance explaining how coronavirus and the COVID-19 health emergency is impacting formal meetings and its review of certain user fee-funded applications. The guidance features 11 questions and answers on how the agency intends to handle disruptions under its user fee programs established by the Prescription Drug User FeeAct (PDUFA), Biosimilar User Fee Act (BSUFA) and the Generic Drug User Fee Amendments (GDUFA).
미 FDA 는 코로나바이러스사태로 인해 지연되고 있는 FDA 승인절차에 대해 가이드라인을 최근 업데이트했습니다.Drug and biologics: “With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level,” FDA writes. It says it will focus on applications and submissions related to COVID-19. FDA notes that it aims aim to conduct initial investigational new drug application (IND) 30-day safety reviews and respond to “other important safety issues that may emerge during IND development.”
일반약품에 관한 검사: 기존의 30 일간의 신약검사기간(NDA)이 지연될수있습니다.
Formal meetings: FDA says all meetings with industry will be held virtually, most likely at the same dates and times as originally scheduled. It is still accepting meeting requests, but may provide a written response only in some circumstances. For advisory committee meetings, FDA says it is trying to figure out whether meetings can be held virtually on a case-by-case basis.
FDA 와 신청제약회사간의 모든미팅은 간접적으로 진행됩니다. FDA 자문위원회 미팅은 사안에 따라 직접 미팅이 가능할수 있습니다.
Generic drugs: For the time being, FDA says it is continuing its generic drug program application assessment activities but says it “may need to shift resources,” in response to shortages. Generic drug applicants should contact the appropriate project manager for their application if they “experience a missed goal date.” Mid-review cycle meetings and post-complete response letter meetings are typically done via teleconference; upcoming face-to-face pre-abbreviated new drug application (ANDA) meetings are being converted to teleconference. FDA is prioritizing ANDA reviews according to its recently revised manual of policies and procedures – emphasizing drugs in shortage or used to address the public health emergency. It will consider “whether the ANDA is for a drug being investigated to treat or prevent COVID-19, but is not labeled for this use.”
제네릭약품: FDA 는 제네릭약품승인에 대해 최대한 기존검사기간에 맞추려하겠지만, 제네릭사들은 담당직원관의 직접적인 연락을 통해 제품신청을 진행해야한다고 했습니다. 제네릭신약검사인 ANDA 는 해당제품이 코로나바이러스의 치료를 목적으로 신청되었다면, 우선순위로 검사가능합니다.
Reed Business Law is monitoring FDA’s ever-changing priorities in order to help its clients know how – and when – the FDA may act on their applications. If you often wonder what is going in the U.S. healthcare market, and what it may mean for your product, please give us a call.
리드 로펌은 FDA 의 변화된 방침들을 항상 숙지하며, 고객들에게 최선의 서비스를 제공하고 있습니다.