《TAIPEI TIMES》 FDA hikes penalty for fake diabetes injection devices - 焦點 - 自由時報電子報
FDA於12月25日宣布，因在美國查獲大量假冒的Ozempic糖尿病注射筆，將提高對假藥的處罰。今後若有人攜帶假Ozempic進入台灣，可能面臨最高10年徒刑及新台幣1億元罰鍰。此外，製造或進口假藥者也將受此處罰。FDA提醒民眾，應避免從未知來源或網路購買藥品，並強調只有經核准的藥品才應購買。
2023/12/26 03:00/ Staff Writer, with CNA
Anyone caught bringing fake Ozempic injection pens into Taiwan could face a prison sentence of up to 10 years with a possible fine of up to NT$100 million （US$3.21 million）, the Food and Drug Administration （FDA） said on Sunday after its US counterpart disclosed last week that it had seized thousands of the counterfeit diabetes injection pens.
On Thursday last week, the US Food and Drug Administration said the fake Ozempic pens it had seized were being tested by drugmaker Novo Nordisk and the national medicine regulator, but more might be circulating on the market.
The US’ seizure of the fake drug pens followed reports last month in the EU and the UK of counterfeit units of the drug being found.
An Ozempic pen is a device that is prefilled with the drug semaglutide, which can be used for easy self-injection to help with weight loss in specific patients, to lower blood sugar levels and reduce the risk of major cardiovascular events such as heart attack or stroke in patients with type 2 diabetes.
The FDA said it had stepped up inspections of imported packages, in collaboration with customs officers, and was monitoring illegal drug sales and online purchasing activities.
Anyone found manufacturing or importing counterfeit or prohibited drugs into Taiwan would be subject to a prison sentence of up to 10 years and a potential maximum fine of NT$100 million, it said, citing Article 82 of the Pharmaceutical Affairs Act （藥事法）.
The maximum penalty for knowingly selling counterfeit or prohibited drugs, or displaying them with an intent to sell, is seven years in prison and a possible fine of NT$50 million, it said.
It urged the public not to purchase online products from unknown sources, items with unclear labels, or products with exaggerated or misleading claims related to medical efficacy.
The agency said it had granted a license for the importation of Ozempic, and the label of the product should show the name in Chinese and the drug license number. The counterfeit drugs seized in the US would not have that type of labeling and would not be products approved in Taiwan, it said.
People in Taiwan should avoid buying those types of drugs online, from foreign countries or from other distributors, as their safety and efficacy cannot be confirmed under those circumstances, it said.
The agency has approved the use of four types of injection pens: Ozempic, Trulicity, Saxenda and Victoza — all prescription drugs.
来源：自由時報
