New marching orders come on an hourly basis, almost as often as the new hires, and everyone knows that tectonic changes are occurring behind closed doors.
Welcome to the new reality at the Food & Drug Administration, according to officials and experts at an industry breakfast Dec. 2.
In a nutshell, they described an agency not unlike the proverbial sleeping giant, prodded awake. The FDA is engaged, growing, and soon will be focused squarely on aspects of the medical device industry.
How else do you explain the opening of new offices in Calais, Maine, a town so far north that if you slept sideways you’d wake up in Canada?
The speakers were part of the Massachusetts Medical Device Industry Council‘s annual FDA Update, where officials from the agency address the medtech community directly.
Here are some of the new realities at the federal watchdog, according to the speakers:
- The FDA’s streamlined warning letter policy has teeth.
On Sept. 15, 2009, the agency began enforcing a hard cap of 15 business days for companies to respond to violations found and noted on FDA 483 forms by its inspectors. Also called a “Notice of Inspectional Observations,” the form details the opinions of the investigators about potential violations found during the inspection of any facility involved in the making of a food, drug or medical device. If not addressed, those violations can be rolled into an official warning letter from the agency.
- The FDA has allowed its regional office more authority in issuing warning letters. The hard cap and new local enforcement powers are having an immediate effect, according to Mutahar Shamsi, director of compliance for the agency’s New England branch office. Shamsi said that office, which covers the six New England states and New York, has already issued 8 warning letters to some of the nearly 3,000 medical device firms it polices. That’s more than half of last year’s total of 15, logged in only in two months. The New England office activity is of particular interest to medical device makers because the industry makes up more than a third of the FDA’s total jurisdiction here.
“The FDA wants quick and immediate action on what is deemed public health concerns,” Shamsi said, echoing the call of commissioner Margaret Hamburg early in her tenure.
Besides its new office almost north of the border, Shamsi also noted that the New England bureau has grown significantly over the past year, beefing up its staff to 151 employees from 128 by hiring new inspectors, supervisors and compliance officers. The tight economy has increased the agency’s ability to bring more talent on board, he added.
- Dramatic changes lie ahead for the 510(k) review process at the Centers for Devices and Radiological Health. The FDA’s two-pronged audit of the CDRH’s 510(k) approval process has staff members operating “under the microscope,” according to Seth Mailhot, a lead attorney for Nixon Peabody’s FDA regulatory practice in Washington, D.C.
“Nobody wants to be the next reviewer to approve a Menaflex,” Mailhot said, referring to the debacle surrounding the approval of ReGen Biologics’ meniscus repair implant.
Everyone in the agency is awaiting the results of the Institutes of Medicine’s $1.3 million, independent review of the 510(k) approval process, due in March, 2011, anticipating that big changes are likely to be coming down the pike, he said. But in the meantime, reviewers seem to be doubly conscious of avoiding mistakes and erring on the side of caution, which has slowed down the process, Mailhot added.
- Tighter regulation on suppliers. Kimberly Trautman, the CDRH’s medical device quality systems expert, said lessons from the disastrous 2008 Heparin contamination case has regulators looking much more closely at suppliers to the medical device industry, particularly those from China.
In 2008, Baxter Healthcare (NYSE:BAX) initiated a massive recall of products containing Heparin after it was found that a contaminant from a Chinese supplier had tainted the active pharmaceutical ingredient used to produce the drug. The case resulted in a call for independent audits of all pharma company suppliers. If similar calls are heard for the medical device industry, it could have a dramatic effect on the sector.