Third Of Approved Drugs Need Safety Follow-Up, Study Finds – Law360

By Dani Kass Law360, New York (May 9, 2017, 3:00 PM EDT) — About a third of drugs approved by the U.S. Food and Drug Administration end up having additional safety concerns, Yale University researchers found in a study published Tuesday by the Journal of the American Medical Association. Thirty-two percent of new drugs approved between 2001 and 2010 had some kind of safety issue detected by 2017, the university said in a news release. For the most part, those concerns were not severe enough to require the drugs to be pulled from the market, instead requiring a black-box warning or a safety communication from the agency. The researchers called for the FDA to diligently monitor drugs after they’ve been approved, but also noted that the study results are proof the agency is already doing so. The FDA’s follow-up includes studying case reports, epidemiological and clinical studies and safety reports from the drugmaker, the agency said. “The fact that the FDA is issuing safety communications means it is doing a good job of following newly approved drugs and evaluating their safety up in the post-market period,” Joseph Ross, an associate professor of medicine and public health who led the study’s team, said in the statement. The FDA approves drugs based on premarket tests and studies, which often involve less than 1,000 patients over about six months, which is why it’s hard for drug companies to know the long-term effects of their drugs, the university said. This is especially true for drugs approved using accelerated pathways and for biologics, according to the statement. “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,” Ross said, adding that the study will contribute to the debate about how to evaluate drugs before they’re on the market. The study was conducted by Ross, Nicholas Downing, Nilay Shah, Jenerius Aminawung, Alison Pease, Jean-David Zeitoun and Harlan Krumholz and included no outside funding, Yale said. “In general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health,” the agency said in a statement Tuesday. “The FDA is reviewing the findings of the paper.” –Editing by Kelly Duncan.


About John Fagan

John is a Jacksonville native who grew up on the First Coast. He graduated from Bishop Kenny High School in 1975 and went to college at Florida State University where he completed a 4-year program in 3 years. John graduated from the Florida State University College of Business in 1978 and went straight into Florida State University College of Law. While in law school, John earned a position on the prestigious Law Review Board serving as its Business Editor. As a law student, John studied in the Oxford program. He also interned with the Florida Legislature working in the Florida House of Representatives Criminal Justice Committee. John was admitted to the Florida Bar in 1981. John began his legal career as a law school intern in the State Attorney's Office in Jacksonville in 1981. After his internship, legendary State Attorney Ed Austin hired John as a full-time Assistant State Attorney for the Fourth Judicial Circuit (Clay, Duval, and Nassau Counties). As a prosecutor, John tried jury and non-jury trial on charges ranging from DUI to Murder. In 1983, John moved from the State Attorney's Office to begin his career in private practice. He has practiced law for 30 years on the First Coast. For the last 20 years, John and his family have made Clay County their home. John limits his practice to personal injury and disability cases. While there are many fine attorneys in Clay County, John is one of only a few Clay County attorneys who limit their practice to personal injury and disability cases. John takes pride in helping clients resolve injury claims in ways that avoid the stress, uncertainty, and the expense of unnecessary litigation. Professional Activities John is the past President of the Clay County Bar Association and has served on the Board of the Clay County Bar Association from 2009-2013. He is an active member of the Florida Bar, and the Federal Bar of the Middle and Southern Districts of Florida. He is also a member of the American Association of Justice, the Florida Association of Justice, the National Organization of Social Security Claimants' Representatives, and the National Organization of Veterans' Advocates. Service to the Community John is involved in the Clay County Community serving as a member and Director of the Rotary Club of Orange Park, of the Clay County Bar Association, and the Putnam County Bar Association.
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