Making a case for the nation’s current drug approval system, federal officials have announced that a relatively high 35 new medicines were cleared by regulators in the recently completed federal fiscal year.
The Food and Drug Administration said in a news release that only one other year in the past decade has yielded more drug approvals. The release noted that 24 of the drugs were approved in the U.S. before they were cleared in any other country. The newly approved products included the first new drug for Hodgkin’s lymphoma in 30 years and the first new drug for lupus in 50 years.
The agency’s commissioner, Dr. Margaret Hamburg, called it “a very strong performance, both by industry and by the FDA.”
The New York Times said part of the reason for the agency’s message is that it wants to try to defuse growing calls in Congress — supported by biotechnology and medical device industry groups — to weaken its approval processes.
Some conservative economists argue that Europe is now more supportive of innovation than the U.S., noting that devices sometimes are approved earlier there. Industry officials are particularly incensed that the FDA is considering asking for more information about medical devices before approving them.
The proposed changes result from a series of safety scandals involving devices, including metal-on-metal hip implants that underwent very little testing before being approved for sale. The battle between the industries and the agency is expected to intensify in the coming months as Congress considers legislation governing industry fees paid to the drug agency.
Separately, data released Thursday shows that a Medtronic bone growth drug that the FDA has rejected, Amplify, might increase the risk of cancer. That finding, the Times reported in another news story, raises concerns about an approved, already controversial lower-strength version of the drug, Infuse, which is used in spinal fusion procedures.
As Reuters reports, Infuse was once hailed as a major advance in spine surgery but it’s now the subject of investigations by the U.S. Senate and the Department of Justice over omissions of safety problems from its clinical trial data.
Infuse also drew intense public scrutiny after an influential publication, The Spine Journal, reported in June that surgeons who were paid tens of millions of dollars by Medtronic failed to report serious and widespread side effects from the drug. The unreported complications included cancer, sterility in men, infections, bone dissolution and worsened back and leg pain.
The editor of The Spine Journal, Dr. Eugene Carragee of Stanford University, is the scientist who provided the analysis Thursday on the cancer risks associated with, rhBMP-2, the active ingredient in Amplify and Infuse.
STUART SILVERSTEIN
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