The sudden recall of a popular diabetes drug because of NDMA contamination (cancer-causing agent) creates a cloud over the Food and Drug Administration\u2019s entire review process.<\/p>\n
Time-Cap Labs Inc.\u2019s generic drug is used to treat Type 2 diabetes. Its lower cost makes it a popular alternative to brand-name drugs.<\/p>\n
When the most recent test results showed additional NDMA contamination<\/a>, the FDA expanded a June 2020 recall to include two additional lots, as apparently, the company failed to take effective steps to stop the contamination.<\/p>\n Most of the recalled lots have expiration dates in 2021 or 2022.<\/p>\n The FDA, which is charged with ensuring drug safety, gets 75 percent<\/a> of its funding from the drug and other companies it regulates. That\u2019s like football teams paying the game referees.<\/p>\n The so-called \u201cdrug lag\u201d routinely made headlines in the waning years of the twentieth century.<\/p>\n Most European countries approved new drugs at least a year faster than the FDA. So, this matter was partly a health and safety issue and partly a national pride issue.<\/p>\n Politicians were determined to close the gap. They were equally determined not to raise taxes so the FDA could hire more inspectors.<\/p>\n User fees seemed like a good idea at the time. Almost immediately, the FDA worked through its backlog. It approved a record number of drugs in 1996.<\/p>\n User fee requirements steadily increased from $208,000 per new drug application in 1995 to $2.5 million per NDA in 2018.<\/p>\n In exchange for these payments, the FDA agreed to decrease review times to as little as six months. Such a brief review time leaves regulators no time to fully investigate the drug.<\/p>\n NDMA contamination usually happens when medicine is stored at room temperature for too long. And, most drugs spend lots of time at room temperature.<\/p>\n NDMA, which is also common in cured meats, drinking water, and rocket fuel, is a probable carcinogen. There are no human trials linking N-Nitrosodimethylamine to cancer, but hundreds of laboratory studies confirm the connection.<\/p>\n That\u2019s certainly enough to establish a link by a preponderance of the evidence (more likely than not), which is the burden of proof in civil court.<\/p>\nRecall Conflict of Interest?<\/h2>\n
N-Nitrosodimethylamine Contamination<\/h2>\n
Your Claim for Damages<\/h2>\n