New board to improve internal oversight, consumer communication of drug safety issues
The new independent Drug Safety Oversight Board (DSB) within CDER will employ a two-pronged approach to create "a new culture of openness, improved oversight, and enhanced independence," according to FDA officials.
The new independent Drug Safety Oversight Board (DSB) within CDER will employ a two-pronged approach to create "a new culture of openness, improved oversight, and enhanced independence," according to FDA officials.
Specifically, the board will: 1) oversee the internal management of drug safety issues and 2) provide better communication channels regarding medication safety. The DSB will include representatives from FDA, HHS agencies, the DVA, and patient and consumer groups.
As part of its oversight component, DSB will address internal FDA disagreements over approaches to drug safety issues and oversee implementation of CDER drug safety policies.
Components of the proposed website include consumer-friendly literature for health-care professionals and patients. A 1-page sheet for health-care professionals will provide the latest notices on safe and effective product use, such as potential adverse events, new prescribing information, and approved indications. Patient hand-outs will include updated safety and drug use information.
FDA acting commissioner nominee Lester M. Crawford, DVM, PhD, said of the newly created DSB: "FDA understands that the public expects better and more prompt information about the medicines they take every day. Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to US consumers." Dr Crawford added: "There has been considerable publicity regarding high-profile products about which safety questions have been raised. It is important that these concerns do not distort the fact that drugs are safer today than they have ever been before."
The announcement about the creation of the new board came just before a joint FDA advisory committee meeting in February on the risk-benefit profiles of specific NSAIDs, especially the COX-2 inhibitors.
SOURCES HHS website. Reforms will help improve oversight and openness at FDA [press release]. Available at: http://www.hhs.gov/news/press/2005pres/20050215.html. Accessed April 25, 2005.
FDA website. FDA improvements in drug safety monitoring [press release]. Available at: http://www.fda.gov/oc/factsheets/drugsafety.html. Accessed April 25, 2005.
FDA website. Speech before FDA all-hands briefing with new HHS secretary Mike Leavitt [press release]. Available at: http://www.fda.gov/oc/speeches/2005/safedrugs0215.html. Accessed April 25, 2005.
Acronyms
CDER=Center for Drug Evaluation and Research; HHS=US Department of Health & Human Services; DVA=Department of Veterans Affairs
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
