As if it were proud, the U.S. Food and Drug Administration (FDA) issued a press release Thursday, November 3, announcing that 35 new drug medications were approved in this federal fiscal year. This comes as the agency takes criticism from the biotech and medical device industries that it is too slow in approving new drugs and devices for the market.
The agency said this is the second highest number of drug approvals and that the majority of the drugs, 24 total, were approved in the U.S. before other countries, where gaining approval is usually easier. Included in the approvals was a new drug for Hodgkin’s lymphoma and one for late stage melanoma that may prolong survival.
FDA Commissioner Margaret Hamburg called it a “very strong performance.”
The biotech and medical device industries want to weaken the approval process so devices and drugs can make it to the marketplace faster and are pushing back on a proposal to ask for more information before approval.
All of this is very upsetting news to consumers and patients who have been injured by drugs and devices introduced into the market with little scrutiny and which were later found to be dangerous.
Case in point: synthetic medical mesh, which is coming under fire as hundreds of lawsuits are filed from patients suffering devastating and permanent injuries from the plastic material that erodes and hardens in the body of men who used the mesh for hernias, and women who were treated for pelvic organ prolapsed and incontinence with mesh.
Mesh was approved for the market under the 510(k) procedure, meaning it had to apply to be marketed with no requirements for safety. Metal-on-metal hip implants are another medical device that got the pass from the FDA before being put on the market. With a high failure rate, the implants must be removed and replaced, adding an additional risk of injury to the patient.
The Florida product liability lawyers of Farah & Farah feel that to ensure the public’s safety, the FDA needs to review devices and drugs more closely, not less. Congress is currently considering a medical device fee that is negotiated every five years, according to a story in the New York Times, and helps finance the agency. Without fees, the FDA will have to lay off many staff members who are needed to review the safety and efficacy of drugs and devices.
Source: http://www.fairwarning.org/2011/11/under-pressure-fda-points-to-increased-drug-approvals/; http://www.nytimes.com/2011/11/04/health/policy/drug-approvals-rise-for-fda.html?scp=2&sq=hamburg&st=cse
