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The FDA has not asked firms producing these substandard products to suspend manufacturing nor have the products been withdrawn from the market.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.