The Partnership for Safe Medicines is pleased to announce the keynote speaker for Interchange 2014 on September 18, in Washington DC: Howard Sklamberg, Deputy Commissioner for the FDA’s Global Regulatory Operations and Policy.
Deputy Commissioner Sklamberg directs the Office of Regulatory Affairs and the Office of International Programs. He oversees the FDA’s efforts to supervise international product quality and safety, as well as the development of overseas field offices and international enforcement operations.
In recent testimony before the House subcommittee on Energy and Commerce, Mr. Sklamberg described the role his agency plays in protecting U.S. consumers from counterfeit drugs. “Our efforts to secure the supply chain both in the United States and abroad include minimizing risks that arise anywhere along the supply chain continuum, from the source of a product’s ingredients through the product’s manufacture, storage, transit, sale, and distribution. A breach at any point in this continuum could lead to dangerous and even deadly outcomes for consumers. Supply chain safety threats can also affect manufacturers’ bottom lines due to costs associated with both recalls and decreased public confidence.”
According to an FDA website devoted to globalization, FDA “has established a permanent in-country presence in China, India, Europe, Latin America, and Sub-Saharan Africa”
The global nature of the modern world economy means the FDA must work with sister organizations in other countries to share information on investigations and other cooperative efforts.
The coordination & collaboration on regulatory requirements between FDA and other governments & international organizations is one of the main goals of Sklamberg’s office. The idea behind effort, says the FDA is to pool resources between various international players to encourage uniform standards for public health protection and minimize cost and impediments to bring safe and effective medicines to patients all over the world.
During his recent Congressional testimony, Sklamberg explained why such international efforts are important: “Nearly 40 percent of the drugs Americans take are made elsewhere, and about 80 percent of manufacturing sites of active pharmaceutical ingredients (APIs) used in drugs manufactured in the United States are located outside our borders—in more than 150 countries, many with less- sophisticated manufacturing and regulatory systems than our own. In addition to the sheer volume of imports and foreign facilities, there has been an increase in the variety of sources, shippers, methods of transportation, and supply chain complexity of products. Combined, these factors create great challenges to FDA and industry in ensuring that all drugs and drug components are high quality and travel safely throughout their complex supply chains. These factors also provide opportunities for criminals to adulterate drugs for economic or other malevolent reasons.”
Get tickets for the Interchange to hear Deputy Director Sklamberg as well as counterfeit drug experts from medicine, policy, law enforcement, and patient advocacy at the 2014 Interchange on September 18th in Washington DC. Tickets go on sale March 15th.