The June 2024 issue of Vanity Fair included the provocative headline: “Why Counterfeit Ozempic Is a Global-Growth Industry." Novo Nordisk’s patented drug Ozempic® (semaglutide injection) was first approved by the FDA in 2017...more
In April, Ambassador Katherine Tai, U.S. Trade Representative (USTR), issued the 2024 Special 301 Report. In a press release, the USTR stated that "[m]any of the issues highlighted in the Special 301 Report demand...more
On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of "suspect product" and "illegitimate product" as part of a continued effort to prepare trading partners for the...more
The U.S. Food and Drug Administration (FDA) has broad authority to evaluate and approve drugs for medical use or prescription drugs. It also has the authority to investigate fake or counterfeit medicines and substances in the...more
A growing problem in the U.S. is the widespread availability of counterfeit medications, or fake prescription pills. These drugs, made to look like authentic prescription medications, may contain no active ingredient or any...more
The Drug Enforcement Administration issued a public safety alert on September 27, 2021 to warn Americans of the alarming increase in the lethality and availability of fake prescription pills containing fentanyl and...more
The other shoe has dropped! At least it has in the world of counterfeit pharmaceuticals. Since early in the pandemic, the US has faced a significant and still ongoing wave of counterfeit PPE entering the country from abroad....more
The European Union Intellectual Property Office (“EUIPO”) and Organisation for Economic Co-Operation and Development (“OECD”) recently published a Report on counterfeit pharmaceuticals based on global customs seizure data...more
Almost as if on cue, as the United States ramps up testing and containment measures, US Customs and Border Protection (CBP) announced its first seizure of counterfeit COVID-19 test kits at the Los Angeles Airport...more
President Trump has signed Phase I of a much anticipated multi-part trade agreement between the United States and China with provisions that will aid the branded pharmaceutical industry. One of the main goals of the agreement...more
The trade relationship between China and the United States has been top of mind for businesses over the past year. In spring 2018, Chinese President Xi Jinping denied the U.S. Government's request to end subsidies for key...more
Fans of marijuana and its related products may want to take careful note of developments regarding their health and safety effects. Federal researchers are racing to trace thousands of cases of lung damage and dozens of...more
With more than 1,000 reported cases in 48 states, government agencies are scrambling to investigate and are advising consumers to avoid e-cigarettes and other vaping products. Even as a new regulatory landscape begins forming...more
On August 26, 2019, the China’s National People’s Congress passed the amended Drug Administration Law (the Amended DAL) which will take effect on December 1. The new law brings in some changes while codifying many existing...more
While the concept of “fake news” continues to trigger Twitter followers and grab headlines, the trade in counterfeit drugs is a worldwide problem of significant scale. This article discusses the problem and talks about some...more
Focus I: International black market trade - Among the industries that suffer most from black and grey market activities, the pharmaceutical sector sadly holds one of the top positions. The World Health Organization (WHO)...more
Last month, the Acting Associate Attorney General Stuart F. Delery, announced that the Department of Justice (DOJ) would continue to target illegitimate online pharmacies, which pose a threat to drug safety and undermine...more
Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more
Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise...more
In This Issue: - Six Things to Think About as Technology Advances - For More Information - Recent Health Care News You Should Know About - Check Out Our Previous Tips - Deep Thoughts for the New Year: Ethical...more