3월 25일 세계 51개 시민사회단체는 길리어드 사에 항의서한을 보내, 렘데시비르에 대한 희귀의약품 신청을 철회하라고 요구했습니다. 앞서, 길리어드사는 미국 FDA에 코로나19의 유력 치료제인 렘데시비르에 대한 희귀의약품을 신청하였고, FDA는 이를 승인하였습니다. 희귀의약품 지정은 각종 세금 혜택과 신속승인, 7년간 무소불위의 시장독점권을 갖음을 의미합니다.
하지만 감염병 유행 상황에서 치료제가 희귀의약품 지정은 단지 제도의 허점(미국내 환자 수 20만명 미만)를 악용한 길리어드사의 탐욕이었습니다. 독점권을 연장하기 위해 제도를 악용하고, 코로나19 대유행을 악용했다는 시민사회의 비판 목소리에 결국 길리어드사는 FDA에 희귀의약품 지정 철회를 요청했습니다.
퍼블릭 시티즌(Public Citizen)이 작성한 항의서한에 건강사회를 위한 약사회도 연명하였습니다.
< 항의서한 원문 > 바로가기
Chairman and Chief Executive Officer
333 Lakeside Drive
Foster City, CA 94404
March 25, 2020
Dear Mr. O’Day,
We were shocked to learn that your company sought a lucrative orphan drug designation from the Food & Drug Administration for remdesivir, one of relatively few medicines being explored as a possible treatment for COVID-19 this year.
This is an unconscionable abuse of a program designed to incentivize research and development for treatments for rare diseases. COVID-19 is anything but a rare disease. Some estimates suggest that half or more of all Americans may ultimately contract the disease.
We are writing to demand you reverse course and renounce your claim to orphan drug designation privileges for remdesivir.
As you know, Gilead was able receive an orphan drug designation only by rushing to file its application while there were fewer than 200,000 COVID-19 U.S. cases.
The United States most likely will surpass 200,000 COVID-19 reported cases in a matter of days. The real number of people suffering with the new coronavirus likely already has passed this mark. Calling COVID-19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic.
The orphan drug designation would provide Gilead with seven years of marketing exclusivity, enabling you to exclude competitors and charge high monopoly prices while people struggle to gain access. It would also further subsidize any costs through additional tax credits and allow you to monopolize the supply of the drug during a public health crisis.
Making the claim to special orphan status even more outrageous is the fact that the public already has largely paid for remdesivir’s development through at least $60 million in grants and innumerable contributions from federal scientists. Public agencies around the world are sponsoring remdesivir’s clinical trials, including the National Institutes of Health and the World Health Organization.
America, and the world, has the right to expect better from Gilead.
We await your urgent response. Please contact Peter Maybarduk, Public Citizen Access to Medicines Program Director at firstname.lastname@example.org.
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