July 19, 2012
In 1959, a Nobel Prize-winning physicist challenged his colleagues to use submicroscopic particles to manufacture a wide range of products—an idea that captivated the imagination of scientists and inspired the science fiction movies “Fantastic Voyage” and “Innerspace.”
Fifty years later, “nano” (small) technology has moved from the science fiction realm to scientific fact, and federal regulators are laying the groundwork for monitoring a new generation of medical devices, drugs, cosmetics, and other products.
The Food and Drug Administration is continuing a dialogue on nanotechnology begun in 2011 by publishing proposed guidelines on the evaluation and use of nanomaterials in FDA-regulated products.
The first draft guideline, “Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”, was published in the Federal Register in June, 2011. The FDA is still reviewing and receiving comments on this document from the public.
In April 2012 the FDA is issuing two new draft guidelines for manufacturers of food substances and cosmetics, which are also open for public comment.
FDA Commissioner Margaret A. Hamburg, M.D., says the guidelines provide a starting point for the nanotechnology discussion. “Our goal is to regulate these products using the best possible science,” Hamburg says. “Understanding nanotechnology remains a top priority within the agency’s regulatory science initiative and, in doing so, we will be prepared to usher science, public health, and FDA into a new, more innovative era.”
FDA is working with the White House, the National Nanotechnology Initiative, other U.S. government agencies, and international regulators to focus on generating data and coordinating policy approaches to ensure the safety and effectiveness of products using nanomaterials.
July 5, 2012
Young children have died or become seriously ill from accidental exposure to a skin patch containing a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a safety alert to warn patients, caregivers and health care professionals about the dangers of accidental exposure to and improper storage and disposal of the fentanyl patch.
“These types of events are tragic; you never want this to happen. We are looking for ways that we can help prevent this from happening in the future,” says Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “This reinforces the need to talk to patients and their families to make sure that these patches are stored, used and disposed of carefully.”
The fentanyl transdermal system—the patch marketed under the brand name Duragesic and available as a generic product—contains fentanyl, a potent opioid pain reliever, and treats patients in constant pain by releasing the medicine over the course of three days. (Opioids are synthetic versions of opium that are used to treat moderate and severe pain.) An overdose of fentanyl—caused when the child either swallows the patch or applies it to his or her own skin—can cause death by slowing breathing and increasing the levels of carbon dioxide in the blood.
According to Zachary A. Oleszczuk, PharmD, in FDA’s Division of Medication Error Prevention and Analysis, there have been 26 cases of accidental exposure to fentanyl since 1997, most of them involving children younger than 2 years old. There have been 10 deaths and an additional 12 cases requiring hospitalization.