Diagnostics & Imaging Week Washington Editor

FDA warning letters occasionally nudge a firm out of the business of making devices or diagnostics, and such seems to have been the case in connection with the Jan. 23 warning letter to Mainline Technology (Ann Arbor, Michigan), which FDA inspected between July and August 2008.

The firm's president, Martha Mazurek, discussed a few aspects of the situation off the record, but for the record would only tell Diagnostics & Imaging Week that the firm "has discontinued manufacturing and is not doing anything related" to the diagnostics cited in the warning letter. Mainline had been in the business for roughly two decades, she said.

The company made several tests for pregnancy which FDA states in the letter that Mainline had not cleared prior to commercial distribution. It is not clear from the letter whether the agency is referring to changes to existing diagnostics or to entirely new products for the company, but the agency acknowledged receiving an Aug. 15, 2008, letter from the company which stated "that you intend to discontinue manufacturing" and would instead "purchase these products exclusively from" suppliers with cleared versions of the diagnostics. FDA apparently issued the warning because the Aug. 15 letter "provided no evidence indicating that you have in fact done so, and your promises to comply with cGMP (current good manufacturing practices) requirements suggests that, to the contrary, you intend to continue manufacturing these products."

Many of the violations refer to lack of documentation of compliance with regulations, such as a citation that the company could offer "no evidence that you have established quality audit procedures or that quality audits have been performed." A similar citation regarding management reviews preceded it. On the other hand, FDA asserted that Mainline's employees "have not been trained" in manufacturing, testing, shipping and complaint handling for in vitro reagents, although the citation states that the company was able to document such training for one employee.

FDA also cited the company for lack of procedures governing quality requirements for contract manufacturers and lack of procedures for acceptance activities. Procedures for device history and device master records were said to be absent, which was also said to be the case for corrective and preventive action. However, the warning letter does not cite any problems with medical device reports.

BD snared in FDA swine flu roundup

FDA also posted a number of warning letters addressed to firms attempting to market products that purportedly diagnose or treat swine flu, and a surprising addition to the list is Becton-Dickinson (Franklin Lakes, New Jersey), which the agency wrote up due to promotion of an unapproved diagnostic. The text of the warning suggested that someone with the firm's marketing department forgot that FDA and the Centers for Disease Control and Prevention are distinct agencies at the Department of Health and Human Services.

According to FDA, the diagnostics section of Becton's web describing the company's Directigen EZ flu test as one which "we are confident . . . can detect this newer Type A, H1N1 flu virus," and that given that the test "detects the conserved portions of the influenza nucleoprotein, we understand from the CDC that in its view, there is no reason that our assay should not work to detect this flu virus."

FDA also cited the sponsor of the web site located at www.spilldepot.com for violative promotions of surgical masks purported to filter out the swine flu virus, H1N1, the same claim as was made at the web sites www.sunsetsurvival.com and www.novatechgadgets.com.

CMS reopens PET/FDG for bone cancer

The Centers for Medicare & Medicaid Services has decided to reopen consideration of the use of positron emission tomography (PET) using fluorodeoxyglucose (FDG) to identify bone metastasis of cancer, and according to at least one observer, the move is prompted by the continuing short supply of technetium-99, a radioisotope that is produced in only a handful of processing sites around the world.

Atomic Energy of Canada (Mississauga, Ontario) reported last month that it would suspend production of technetium-99, and has since posted a June 2 announcement that it has commenced with removal of the rods of radioactive precursor from the reactor, a process expected to take three to four weeks. AEC did not offer an estimate of how long repairs would take, given that it has not yet had a first-hand look at the inside of the reactor vessel, which is said to have sprung a persistent leak.

In a June 8 statement, the Society for Nuclear Medicine (SNM; Reston, Virginia) offered a diagnosis of the new coverage analysis. The statement remarks that the long-term prospects for supplies of technetium-99 are almost as shaky as short-term prospects and that "because of the severity of the radioisotope supply crisis and the long-term duration of the anticipated outage, CMS has opened" the current reimbursement memo for another look.

SNM's president, Robert Atcher, PhD, is quoted as saying that the medical community "is in crisis right now" and that patients are either unable to get tested or have to deal with "more radiation dose, less accuracy, more cost or more invasive techniques."

According to CMS, the request for re-examination of the coverage status came from within the agency, and CMS said it will take comments until July 4, an interesting date to cut off a comment period. The agency expects to complete the analysis by Dec. 4, 2009 and publish a final decision memo on March 4, 2010.