U.S. Drug Supply is ‘Best Ever:’ CDER
The quality of the U.S. drug supply is the best it has ever been, says CDER Office of Pharmaceutical Quality director Michael Kopcha. This FDA assurance comes on the heels of a 5/10 CBS News report about allegations of widespread fraud associated with generic drugs made overseas and imported to the U.S. “There is no difference in the quality of drugs based only on where they are made,” Kopcha says in an online post. “We use the same tools to assure quality whether a drug is manufactured in the United States or abroad. We apply the same quality standards and conduct the same inspections of manufacturing facilities regardless of where they are located – and we inspect all over the globe.”
The CBS report features investigative journalist Katherine Eban, who said that there are many generic companies falsifying their data. A former FDA investigator also told CBS News that when he and others looked closely at inspection records at some foreign generic companies, they found serious problems, including fraud.
“Some regions of the globe,” Kopcha says, “do have somewhat higher levels of violations found during inspections, but this is because facilities without a history of regular FDA inspections are likely to be less familiar with our requirements. It is very important to keep in mind that our requirements for these facilities are designed to prevent problems. If an inspection uncovers an issue at a facility, it does not mean there is a defect with the marketed product. Rather, the inspection is meant to assure that there will not be a problem with the quality of a marketed product.”
To shore up his statement, Kopcha says FDA recently conducted a major test on marketed products. “We bought 323 different drugs sold in the United States but made around the world – including more than 100 generic drugs from India,” he says. “All samples we tested met the market quality standards regardless of where they were made.”
Joined in the online post is CDER Office of Compliance Donald Ashley, who says 80-90% of foreign drug makers that are inspected are substantially compliant with FDA requirements. “When we do identify manufacturing issues, we see similar issues in the United States and around the world,” he says. “Some manufacturers are still working on improving their processes. We have been inspecting manufacturing facilities for many decades, but not all types of facilities have been inspected with the same frequency, particularly those making lower risk over-the-counter (OTC) medicines. In the past several years, we have been working to inspect all facilities that had not been previously inspected. This is one of the reasons we have recently seen an uptick in problems identified in facilities making lower-risk OTC medicines.”
While the CBS report took issue with FDA’s practice of announcing an inspection weeks in advance for planning purposes, Kopcha says the agency does conduct unannounced inspections when necessary. “For example,” he says, “if we receive information from a credible informant or a complaint involving allegations of data destruction or manipulation, or our own reviewers identify concerns, we will conduct an unannounced inspection of the facility to investigate the allegations. If we find problems, regardless of whether the facility is domestic or foreign, we immediately take action to address potentially harmful medicine, such as recommending the company recall its medicine if it is already on the U.S. market. If it is a foreign manufacturer, we may put companies on import alert to block potentially unsafe medicines from entering the U.S. market. Import alerts are one of our most effective tools for preventing substandard medicines from reaching U.S. patients.”