FDA Drug Approvals
Written by Faith Anderson on November 4, 2011
FDA Drug Approvals Among the Most in a Year Since 2001
The FDA said in a statement that its 35 drug approvals over its past fiscal year were among the most in a year throughout the past decade, surpassed only by the 37 drugs approved in 2009. And in response to those who say drug regulators in other countries are more supportive than the FDA of new drugs, the agency boasted that 24 of the 35 drugs were approved before oversees regulators gave them the green light. According to the agency, in Fiscal Year 2011, the new FDA-approved medications offered important advancements in treatment for conditions like lupus, hepatitis C, late-stage prostate cancer, pneumonia, drug-resistant skin infections, and other serious and life-threatening diseases.
FDA Approves New Drugs Under Expedited Approval Process
According to the FDA, the agency is “approving innovative drugs earlier and faster than any other country in the world, while at the same time making sure that Americans’ medicines are safe and effective.” The report issued by the FDA provides details about how the FDA accelerated the review and approval of these new drugs by “utilizing ‘expedited approval’ pathways and by streamlining clinical trial requirements to permit smaller, shorter, or fewer studies wherever possible.” FDA commissioner Dr. Margaret Hamburg defended criticisms against the agency, saying, “I want to underscore that we approved a set of drugs that are truly medically important, and in fact did so in a way that made these drugs available to Americans before other places around the world.”
New Drugs May Not Undergo Adequate Testing
In a move to facilitate drug approvals, the FDA has provided makers of cancer drugs an accelerated review process, if their medications offer breakthrough treatments for patients, a trend which contributed significantly to the increase in approvals over the past year. For example, the FDA approved Seattle Genetics’ cancer drug Adcetris in August based on promising data from a pair of studies, noting that the drug was the first approved treatment for Hodgkin’s lymphoma in more than thirty years. The expedited approval of these new medications raises serious concerns however, about the adequate testing of these drugs to ensure their safety and effectiveness. If new medications aren’t subjected to sufficient clinical trials and research, the potential side effects of these drugs may not be revealed until they adversely affect consumers.