GAO renews critique of FDA medical device system
Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters.
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The Government Accountability Office will tell Congress Wednesday that the approvals remain a serious issue for the government — more than two years after the watchdog agency first cited the problem to the FDA, according to testimony obtained by The Associated Press.
The GAO previously faulted the FDA in a 2009 for not reclassifying more than 26 types of devices so they receive more stringent reviews. Since then, the agency has cleared 67 individual, high-risk devices through the so-called 510(k) system, which is used to clear the vast majority of devices.
Wednesday’s hearing comes as the FDA faces complaints from medical device manufacturers that the speed of U.S. device reviews lag behind other countries. At the same time, public safety advocates point to reports by GAO and others that suggest the agency is being too lenient in clearing critical devices that keep patients alive.
The Senate committee will hear testimony from representatives of both groups.
For its part, the FDA’s Dr. William Maisel is expected to tell lawmakers that the FDA will reclassify the 26 types of high-risk devices cited by GAO before the end of 2012.
“FDA evaluates thousands of medical devices annually and the vast majority of these devices perform well and improve patient health,” states Maisel’s prepared testimony. He is deputy director for science in FDA’s device center.
Medical devices include everything from tongue depressors to silicone breast implants and pacemakers. In 1976, Congress set up a three-tiered classification system for the devices.
Low-risk devices like crutches and hospital beds do not require FDA review. Moderate-risk devices such as mercury thermometers and power wheel chairs could be cleared by the speedy 510(k) method. If the FDA doesn’t object to a manufacturer’s 510(k) application within 90 days, the device is automatically approved for marketing.
High-risk devices such as pacemakers and heart valves have to go through tighter scrutiny, and their manufacturers are required to provide studies demonstrating their safety and effectiveness. Devices classified as high-risk tended to be ones that are implanted in the body or could spell the difference between life and death.
An exception was carved out for new versions of high-risk devices that were already on the market in 1976, such as certain types of defibrillators and orthopedic implants.
These devices could go through the faster 510(k) system if manufacturers could show they were “substantially equivalent” to their precursors. In 1990, Congress ordered the FDA to end the practice, but it has continued even as generations of technology have come and gone.
The report urged the FDA to promptly resolve the problem, either by carrying out full reviews or reclassifying the devices as lower risk, if appropriate.
According to GAO, the FDA has reclassified only one group of devices since 2009, leaving 26 remaining.
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FDA’s OK of Perrigo plant signals SOP fixes
The FDA’s all-clear sign for Perrigo’s Michigan manufacturing plant this week is in some ways an understatement of what must have happened there. Inspectors arrived on March 1 and Perrigo announced its “acceptable regulatory status” on Tuesday, six weeks later.
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The re-inspection follows a warning letter from nearly a year ago that cited the generics maker’s QC unit for not verifying label accuracy, a step spelled out in the company’s standard operating procedures. It also reminded the company that it’s been warned before on this count.
“FDA investigators documented your firm’s failure to follow standard operating procedures during the last three FDA inspections, as well as in other inspections since 1998,” according to the letter.
Two instances of tablet mix-ups related to poor inspection of packaging equipment were cited as well. One involved the discovery of a brown, round Ibuprofen tablet in a lot of brown, oval caplets. The other involved a mixing of orange and brown caplets.
To get the FDA’s OK on the plant, Perrigo likely had to revise SOPs and retrain operators, as well as executives unaccustomed to a culture of quality. The latter might have been the hardest part. As CEO Joseph Papa said in a statement, “We are convinced that this process has made us a better company.”
Read more: FDA’s OK of Perrigo plant signals SOP fixes – FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fdas-ok-perrigo-plant-signals-sop-fixes/2011-04-13#ixzz1JVIf40Ir
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Category : Press Releases
FDA opts for “effective remedy” with Triad
The FDA’s seizure of $6 million in products from Triad Group, “to stop Triad from continuing to distribute products which may pose a risk to public health” as the agency says in an announcement, marks the latest step in the entanglement of the two. And it’s not likely to be the last.
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U.S. Marshals took antiseptic products, cough and cold drugs, nasal sprays, suppositories and other products, in addition to in-process products and raw materials, from the Hartland, WI, facility. Last week’s action follows several microbial-contamination product recalls beginning with alcohol prep pads in early January.
An early March wipes recall generated news coverage by MSNBC that introduced a general audience to the FDA Form 483 inspection report. The news report described some of the 46 citations from a late 2010 inspection. Form 483 inspection reports and warning letters are common enough. Product seizures, however, are a different animal.
“Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMP requirements,” the FDA says in a statement. “Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.”
That’s appears to be the case with Caraco. Following the seizure of $33 million in products from its Detroit-area facilities in June 2009, the company came under consent decree with the FDA. As of January, it was still working on fixes.
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