WASHINGTON — Federal regulators on Tuesday added stronger warnings to a group of best-selling drugs used to treat arthritis and other inflammatory diseases, saying they can increase the risk of cancer in children and adolescents.
After more than a year of review, Food and Drug Administration scientists said the drugs appear to increase the risk of cancer after they are used beyond 2 1/2 years. The agency studied several dozen reports of cancer in children taking the drugs, some of which were fatal. Half of the cases were lymphomas, a cancer that attacks the immune system.
Read More: The New York Times Article
The drugs which will carry a bolstered “black box” warning include: Humira, Remicade, Simponi, Enbrel, and Cimizia.
A few weeks back I wrote about the biologics exclusivity legislation that is currently moving through the U.S. Congress: The Battle Over Biologics.
Articles like the one shown above are yet one more reason to support Rep. Henry Waxman’s H.R. 1427: Promoting Innovation and Access to Life Saving Medicine Act. This legislation specifically calls for additional testing anytime a biologic response modifier drug is introduced for pediatric use.
The other version of this bill by Rep. Anna Eshoo, which benefits the biotech industry more than the consumer, continues to move forward. Just last week the House Energy and Commerce Committe voted 47-11 to grant the biotech industry the 12 year exclusivity period which they are seeking. Plus, Eshoo’s legislation actually allows for the following types of testing to be waived: analytical studies, animal studies, and clinical studies.