My 18 year old son has epilepsy and so I bring you the following news with gratitude and excitement and courtesy of the FDA website. The full story can be found at www.fda.gov.
The Food and Drug Administration announced today that a drug to treat seizures, has become the 100th medicine to have new information for children and teenagers included in its labeling. Under eight years of legislation to enhance pediatric drug information, 100 pediatric drugs now include additional labeling information on safety, efficacy, dosing and unique risks for children.
The Federal Food, Drug, and Cosmetic Act (as amended by the Food and Drug Administration Modernization Act of 1997 — FDAMA) and the 2002 Best Pharmaceuticals for Children Act (BPCA), provides incentives to companies who perform research to determine the safety, efficacy, dosing and unique risks associated with medications for children, based on the same level of scientific evidence required for adults.
Under the law, FDA works with the larger pediatric community to determine which products should be studied in the pediatric population based on the public health needs of children. FDA has issued more than 300 requests for studies of medications, based on either the frequent use or the potential use of those medicines in the treatment of children, or on the need for pediatric information so the drugs may be used to treat disorders for which children have few or no other options. Since FDAMA was enacted in 1997, manufacturers have conducted more than 250 pediatric studies for 125 products. By comparison, in the 7-year period before FDAMA was enacted only 11 such studies were conducted. The studies from 114 products responded to the requests by FDA and these products have been granted six months of additional marketing without generic competition.
“The studies were conducted for a wide range of childhood conditions, such as asthma, HIV, seizures, juvenile rheumatoid arthritis, pain management, diabetes, high blood pressure, attention deficit hyperactivity disorder, brain tumors and leukemia,” said Steven Galson, MD, Director of FDA’s Center for Drug Evaluation and Research. “They have resulted in important new pediatric information in 100 new drug labels and additional drugs are presently being studied to further protect our children from any serious side effects.”
I hope that those who are quick on the draw to criticize the FDA are penning notes of congratulations in advance of the holiday break.
