FDA核准新的仿製藥以補足藥品短缺問題

Valsartan用來治療高血壓

【CNN】美國FDA週二核准一項新的valsartan仿製藥(或稱學名藥)，幫助緩解藥物短缺問題，這是用來治療高血壓用藥的原料。

去年夏天以來，FDA在發現來自幾個藥廠製造的降血壓用藥之原料、valsartan、的幾個批號，含有亞硝胺雜質有致癌風險後，發動了幾波的回收。FDA只發現雜質出現在仿製藥原料，沒有在原廠藥發現。valsartan是血管收縮素II接受器拮抗劑的一型或稱ARB。

緊接著最初的回收之後，FDA又發現仿製藥ARB的其他型，不是含有氯沙坦(Losartan)，就是含有安普諾維的活性成分，也遭雜質汙染。

FDA委員Scott Gottlieb博士在禮拜二一項聲明中說：「我們知道現有的藥品回收，不讓遭雜質汙染的幾個批號的valsartan流通到用藥人手裡，因而造成藥品短缺。」所以FDA優先處理審核通過這款藥新的仿製藥版本，以解決短缺問題。

22個國家，包括加拿大德國與波蘭共同簽屬一份受汙染藥丸回收的文件。當天一家領先的印度公司，他所生產的valsartan 80mg錠劑在2016年報價是29分美元，漲價到每一錠是$1.67美元。由Alembic製藥公司訂定獲利率為496%，GoodRx的資料編輯Tori March表示，那是一家醫藥應用軟體與網站專供使用者查詢與比對處方籤價格。

製造商公布『定價』，March解釋說：『人們通常不會在藥局看到這些價格，但羊毛出在羊身上，它們扮演重要的角色。』 她還指出，賣給消費者的『最常見數量』是每月30錠。代表30錠價格約為50美元，跟前幾天價格在9美元以下比較起來。

匹茲堡醫藥學院的助理教授Inmaculada Hernandez表示，這種行為，當缺貨發生價格就提高，在處方藥的醫藥界並不罕見。

她最近發表一項研究，一般而言，『由FDA正式宣布會短缺的藥物』，她說。(該研究沒有特別針對目前這個回收事件。)『宣布短缺之後，藥品價格就如預期很快漲兩倍，更顯洛陽紙貴。』

她指出，當藥物短缺的藥只有少數幾家公司做的出來時，這種行為更加猖狂。『有鑑於纈沙坦的製造商有幾家，Alembic的漲價就很狠。』 她數一數有10家公司生產ARB的藥，沒有被美國FDA回收。

另一家總部在印度的公司，去年夏天回收後也漲價。從40mg纈沙坦錠劑10美分調到41分，漲了306%。

但這不是價格詐欺，埃爾南德斯說。在漲價之前，他們的價格『遠遠低於行情。一次漲很多，是要調回與市場其他產品一樣的水準。』

患者能做什麼？

消費者能做什麼？囤積藥物不是答案。『就是不可行，只因為無法預測哪些藥物會短缺』。赫爾南德斯說。

FDA官員表示，正在進行的檢驗降血壓藥物，可能發現更多污染的藥。

『沒有人會預測到Valsartan會受到短缺的影響。我們建議患者與醫生談過，看是否有替代性藥物。』患者也需要『清楚藥物的價格，並向政策制定者與立法人員提出關切』她說。

#製藥公司須向FDA回報，但有一半以上不講理由

總之，藥物短缺並不罕見。『2018年第一季，有200項需求量高的藥物發生短缺現象』Hernandez說。

雖然製藥公司必須向FDA解釋短缺的情形，但有一半以上的情況他們是不公布理由的。製藥公司通常只回報說是工廠生產問題她說。『某些工廠的品管問題，無法保證哪一批次的品質有問題。』

目前，美國分派的處方藥每10種就有9種是仿製藥。(台灣稱為學名藥，指原廠專利到期其他藥廠就可以生產。)

Hernandez希望能取得有關處方藥更多的價格資料，包括仿製藥的，才能幫助患者辨明哪些藥品公司趁機謀取暴利。

Valsartan的情況可能非常特別，但『藥物短缺近來非常普遍，』她說。『我們要打贏這場仗以防止價格進一步上揚的地方在國會。』

FDA approves new generic valsartan to make up for drug shortage

Valsartan is used to treat high blood pressure.

(CNN) — The US Food and Drug Administration approved a new generic of valsartan on Tuesday to help relieve the recent shortage of the medicine, which is used to treat high blood pressure.

Since last summer, the FDA has issued multiple recalls of generic valsartan medications from several manufacturers after discovering that certain lots contained nitrosamine impurities that pose a cancer risk to patients. The FDA discovered impurities in only the generic, not brand-name, valsartan, which is a form of angiotensin II receptor blockers, or ARBs.

(another article: )Common heart drug recalled in 22 countries for possible cancer link

Following the initial recall, the FDA found that other types of generic ARBs, those containing either losartan or irbesartan as the active ingredient, had also been tainted with impurities.

"We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines," FDA Commissioner Dr. Scott Gottlieb said in a statement Tuesday. The FDA prioritized review of the newly approved generic version of this medicine to address this shortage, he said.

On the day that 22 nations including Canada, Germany and Poland issued a recall of contaminated pills, a leading India-based company -- which had set a list price of 29 cents for its 80-milligram tablets of valsartan in 2016 -- raised the price to $1.67 per valsartan tablet. That's a 496% markup by Alembic Pharmaceuticals Ltd., noted Tori March, data editor at GoodRx, a medical app and website that lets users find and compare prescription prices.

A "list price" is published by the manufacturer, March explained: "People don't typically see these prices at the pharmacies, but they play a large part in what consumers inevitably pay." She also noted that the "most common quantity" sold to consumers is 30 tablets a month. That means the list price would be about $50 for 30 tablets, compared with just under $9 for the same amount days earlier.

Inmaculada Hernandez, an assistant professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy, said this behavior -- price increases when shortages occur -- is not unusual in the prescription drug industry.

She recently published a study that generally "looked at drugs that were officially on shortage as declared by the FDA," she said. (The study did not focus on the current recall.) "After a shortage is declared, drug prices increase twice as fast as they would have been expected to increase in the absence of shortage."

This behavior is more prevalent when there's a shortage in a drug made by fewer companies, she noted: "Given how many manufacturers of valsartan there are, Alembic did a pretty sharp price increase." She counts 10 companies making the same ARB drugs whose products have not been recalled by the US Food and Drug Administration.

Another India-based company also raised its price after last summer's recall. From a list price of 10 cents for 40-milligram tablets of valsartan, Macleods Pharma increased its price 306% to 41 cents in August.

But this is not price gouging, Hernandez said. Before the markup, their price was "much lower than other drugs. The sharp price increase leveled their price with everything else on the market."

What can patients do?

What's a consumer to do? Stockpiling drugs is not the answer. It's simply "not feasible, if only because it's impossible to predict which drugs will be subject to shortages," Hernandez said.

FDA official says ongoing blood pressure drug investigation will probably uncover more tainted pills

"No one would have predicted that valsartan would have been affected by a shortage. We recommend patients talk to their providers to see if there are somehow exchangeable medications." Patients also need "to be aware of the prices of drugs and raise concerns to policy and law makers and their representatives," she said.

After all, drug shortages are not uncommon. "In the first quarter of 2018, there were 200 active drug shortages," Hernandez said.

Although drug companies are required to explain to the FDA why there are shortages, in more than half of all instances, the reason is not announced. The companies that answer usually report manufacturing problems, she said. "Some problem in quality control in the manufacturing factory, and they cannot assure quality of the batches."

Most shortages do not make the news, yet some drug companies still raise their prices, she said. In her study, Hernandez had hoped to name names, but there are lots of associations and subsidiaries within the generic industry, so it is "complicated" to figure out which drug makers exploit a shortage and which do not.

Currently, nine out of every 10 prescription drugs dispensed in the United States are generics.

Hernandez hopes that wider availability of prescription drug pricing data, including for generic pills, will help patients become aware of those companies seeking to profit from shortages.

The case of valsartan may be "very unique," but "drug shortages are a very common phenomenon these days," she said. "The place where we have to win this battle to prevent further price increases is in Congress."

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