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CDER’s Work to Ensure Drug Safety is An Ongoing Top Priority

By: Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research

Janet Woodcock, M.D.; Director, Center for Drug Evaluation and Research; FDA
CDER Director, Janet Woodcock, M.D.

Yesterday, I reflected on the FDA’s Center for Drug Evaluation and Research’s (CDER’s) wide array of new drug therapy approvals in 2018. Today, I’d like to discuss the work we do to make sure the drugs we approve are not only effective, but safe. Safety is a priority both before and after approval and maintaining the safety of drugs that Americans rely on is a complex undertaking because new safety issues can arise at any time—regardless of how long a drug has been in use or its past record of safety.

In 2018, we faced one of those challenges. In July, we learned of an unexpected impurity in a manufacturer’s version of the generic drug valsartan, an angiotensin II receptor blocker (ARB) commonly used to treat high blood pressure and heart failure. The impurity was N-Nitrosodimethylamine (NDMA) a probable human carcinogen (cancer-causing). Initially, we had no idea how many patients would be affected, how the impurity got there, whether NDMA was in other products, or the degree of risk from this impurity. But we did have a safety infrastructure in place—and we put it to use. We quickly informed the public, issued a list of recalled valsartan products, and established a web page for updates. Our inspectors implemented plans to determine the extent of the products affected, and our scientists set out to help determine risk to patients using an affected product.

We soon determined that the immediate risk of taking an affected product is low, and that patients should not stop taking their medicine without an adequate replacement. Keeping our stakeholders informed—patients, physicians, pharmacists, and the manufacturing community—remained a top priority as we regularly updated our website. Since the initial impurity was identified, another impurity, N-Nitrosodiethylamine (NDEA), was found in some other valsartan products, as well as in other ARBs, including some lots of generic versions of irbesartan and one lot of losartan. Our Q&A on the topic provides a summary of this complex and continually-evolving situation, with many questions answered in detail and a number of weblinks to further information.

CDER’s response to the discovery of impurities in ARB products illustrates several aspects of our approach to managing drug safety problems, including the transparency and rapid public communications described above. But there is also behind-the-scenes work integral to our ability to understand and respond when drug safety concerns arise, including that of our laboratory scientists who investigate the precise chemical nature of drug safety questions. In the case of ARB-related impurities, CDER’s analytical chemists, working around the clock, were able to identify the impurities involved and devise testing methods that provide options for other drug regulatory agencies and industry to detect NDMA and NDEA impurities. It is this kind of scientific capacity that allows CDER to offer not only a deeper understanding of the chemistry behind a drug safety concern, but also help our partners and stakeholders to apply the techniques we develop in their own efforts to contain a drug safety problem.

Our annual report, Drug Safety Priorities 2018, illustrates how CDER applies our approach to drug safety in many ways. It provides updates on our ongoing initiatives, discusses new work, and highlights last year’s safety-related milestones and achievements.

Our report highlights key programs CDER has in place to drive those actions, including the Safe Use Initiative to reduce preventable harm from medications; the FDA Adverse Event Reporting System (FAERS), which collects vast amounts of data about side effects and medication errors from medical products reported by patients, health care professionals, and manufacturers; and the Sentinel System, our state-of-the-art electronic drug safety surveillance system. We’ll be sharing more soon about our plans for leveraging the possibilities for the Sentinel System to capture real-world data to help in our safety surveillance framework.

Our efforts encompass all drugs, but there are two categories that warrant special mention. Generic drugs are critical cost savers, but they must still meet our strict safety standards. The report explains how we monitor generic drug use in the marketplace to flag early safety concerns. Additionally, we have taken many steps to strengthen safety measures for compounded drugs, especially in light of the 2012 outbreak of fungal meningitis associated with contaminated compounded drugs.

We are addressing the nation’s efforts to combat the opioid crisis with a wide variety of opioid-related safety activities, focusing our efforts on decreasing exposure and preventing new addiction; safely treating those with opioid addiction; developing safe and effective novel alternative therapies to opioids; and, improving enforcement of safety measures and assessing benefit-risk ratios.

The report also details how we keep pace with evolving technology. For instance, we are evaluating the use of technologies like machine learning methods and other advanced computation techniques, to help our analytics systems contribute to more predictive safety and risk data. We are also exploring ways to leverage mobile apps, social media, and electronic prescribing data while ensuring patient privacy.

I cannot emphasize enough the importance of communication in every one of our safety efforts. We view transparent communication with the public as a critical part of our public health mission. For instance, to date, our Division of Drug Information has fielded almost 7,500 calls specifically about ARBs affected by NDMA or NDEA. In Fiscal Year 2018, this same dedicated staff collectively responded to 63,615 inquiries from the public (44,334 by phone, 1,297 by social media, 17,330 by e-mail, and 654 via letters), each an opportunity to help a patient safely use his or her medication. Our Drug Safety Podcasts reached an estimated 350,000 listeners each week. These and many other communication efforts, such as our Drug Safety Communications, alert consumers and health care professionals about new or potential safety issues and serve to keep the public informed of important drug safety concerns as they arise and that may impact them.

We know that drug safety issues will always exist. Our job is to detect them when we are able, prevent them from affecting consumers when possible, and to do all we can to mitigate and manage them as they arise.


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