The Food and Drug Administration (FDA) is concealing pharmaceutical companies’ violations of the law that have made members of the public “guinea pigs,” a health insurance watchdog group said yesterday.
Good Manufacturing Practice (GMP) inspections conducted by the FDA earlier this year of pharmaceutical manufacturers found that many drugs had been manufactured in a way that failed to comply with what had been described in their marketing authorizations, Democratic Progressive Party Legislator Chen Chieh-ju (陳節如) said.
The inconsistencies are in violation of the Pharmaceutical Affairs Act (藥事法), the Pharmaceutical Good Manufacturing Practice Regulations (藥物優良製造準則) and the Regulations for Registration of Medicinal Products (藥品查驗登記審查準則), and the firms and the FDA have placed patients at risk due to inadequate safety and quality of the drugs produced, Chen said in a joint statement issued with the National Health Insurance Civilian Surveillance Alliance.
The alleged changes, without seeking the approval of the regulator, have been made to package inserts, packaging and the excipient used, the group said.
However, the most dangerous of the violations has been the failure to provide bioequivalence (BE) test reports, or reports on clinical trials and whether, by monitoring the differences in blood levels, a potential to-be-marketed generic drug product is bioequivalent to a reference brand-name pharmaceutical, it added.
“As of this March, the FDA found at least 3,841 items that failed to comply with the regulations. We have no idea how many of these drugs did not have BE reports, since a request to the FDA for the relevant information has been denied by the authority, which cited the Personal Information Protection Act,” Huang Sue-ying (黃淑英), convener of the alliance, told a press conference at the legislature in Taipei.
The FDA has not asked firms producing these substandard products to suspend manufacturing nor have the products been withdrawn from the market. The list of products and the relevant information has not been made public, which means patients and healthcare providers cannot avoid using these drugs, she added.
What has enraged the group is how the drug companies’ actions were exposed. The FDA made an announcement on March 28 saying that for drugs without a BE report, but which have been on the market for at least five years and thereby have a long-term clinical experience, “their clinical experience can substitute for the required BE test if no serious adverse effects or therapeutic inequivalence have been reported.”
“This is no different to exploiting patients, allowing them to become the manufacturers’ guinea pigs at the NHI’s expense,” alliance spokeswoman Eva Teng (滕西華) said.
What is more, drugs that were manufactured and marketed after Jan. 1, 2009, and which therefore do not meet the five-year requirement, have been granted a two-year probationary period to complete BE tests without a suspension of sales of the drug during the testing period, Huang said.
“The BE test reports done by the these manufacturers are only subject to random spot-checks by the FDA,” Huang said.
In response, FDA official Tzou Meir-chyun (鄒玫君), who was also present at the press conference, said all pharmaceutical products currently on the market have been approved by the FDA, with BE tests conducteds before being approved.
“They are all post-approval changes. As post-approval changes can be, according to international standards, categorized into major and minor changes, it is only when major changes take place that a further risk assessment is needed,” Tzou said.
The FDA released a statement later in the day saying that a risk assessment meeting evaluating the drugs that underwent major changes — about 5 percent of the drugs where post-approval changes have been made — would be held within the next month.
There are 77 incidents of Taiwanese travelers going missing in China between January last year and last month, the Straits Exchange Foundation (SEF) said. More than 40 remain unreachable, SEF Secretary-General Luo Wen-jia (羅文嘉) said on Friday. Most of the reachable people in the more than 30 other incidents were allegedly involved in fraud, while some had disappeared for personal reasons, Luo said. One of these people is Kuo Yu-hsuan (郭宇軒), a 22-year-old Taiwanese man from Kaohsiung who went missing while visiting China in August. China’s Taiwan Affairs Office last month said in a news statement that he was under investigation
‘JOINT SWORD’: Whatever President Lai says in his Double Ten speech, China would use it as a pretext to launch ‘punishment’ drills for his ‘separatist’ views, an official said China is likely to launch military drills this week near Taiwan, using President William Lai’s (賴清德) upcoming national day speech as a pretext to pressure the nation to accept its sovereignty claims, Taiwanese officials said. China in May launched “punishment” drills around Taiwan shortly after Lai’s inauguration, in what Beijing said was a response to “separatist acts,” sending heavily armed warplanes and staging mock attacks as state media denounced newly inaugurated Lai. The May drills were dubbed “Joint Sword — 2024A” and drew concerns from capitals, including Washington. Lai is to deliver a key speech on Thursday in front of the Presidential Office
An aviation jacket patch showing a Formosan black bear punching Winnie the Pooh has become popular overseas, including at an aviation festival held by the Japan Air Self-Defense Force at the Ashiya Airbase yesterday. The patch was designed last year by Taiwanese designer Hsu Fu-yu (徐福佑), who said that it was inspired by Taiwan’s countermeasures against frequent Chinese military aircraft incursions. The badge shows a Formosan black bear holding a Republic of China flag as it punches Winnie the Pooh — a reference to Chinese President Xi Jinping (習近平) — who is dressed in red and is holding a honey pot with
Taiwan was listed in 14th place among the world's wealthiest country in terms of GDP per capita, in the latest rankings released on Monday by Forbes magazine. Taiwan's GDP per capita was US$76,860, which put it at No. 14 on the list of the World's 100 Richest Countries this year, one spot above Hong Kong with US$75,130. The magazine's list of the richest countries in the world is compiled based on GDP per capita data, as estimated by the IMF. However, for a more precise measure of a nation's wealth, the magazine also considers purchasing power parity, which is a metric used to
RSS