The Elephant Lumbers On

Washington Wrap-Up

Former FDA commissioner Donald Kennedy once said, “FDA is like a slow-moving elephant that bleeds profusely when hit.” Today that phrase seems more apt than ever, especially in light of the agency's federal court defeat in the Utah Medical Products case. In December, the U.S. Justice Department notified Utah Medical's legal counsel that it would not appeal the decision.

Just 10 days before, FDA's Eric Blumberg said that the defeat did not mean FDA would stop pursuing firms with quality control problems even if there were no safety-related issues. Blumberg, associate chief counsel for litigation, spoke at a Food and Drug Law Institute conference. He insisted that a product is considered adulterated if it is not made according to GMPs And FDA does not need to prove safety problems to bring an action.

This is doubtless true as a matter of law. However, it raises the question: What went wrong in the development of FDA's case against Utah Medical? Blumberg and others at FDA will likely never address the question publicly, because its honest answer might reflect very poorly on the agency.

Cumbersome bureaucracies rarely admit fault or candidly explore their failings in public. But you can be sure that behind its closed doors, FDA is pondering the lessons to be learned from this defeat. However, it will not have the benefit of any qualified external input, other than the presiding judge's 15-page decision.

What happened here is pretty clear to anyone and should have been clear to Blumberg and his team in the Office of Chief Counsel. There were not sufficient quality system regulation (QSR) deviations to allow the case to develop into litigation. Blumberg's team did not recognize that fact, though, when it took in good faith the evidence reported by the investigators and supporting FDA experts. This is the area on which FDA should concentrate if it wishes to avoid a repeat of this outcome.

The agency has now lost all four of the QSR/GMP cases lacking real safety issues that it has brought against device firms. Interestingly, those cases were all against small companies that FDA presumably thought would not resist.

Big firms have a way of leveraging their way out of such troubles, usually by allowing the agency to have its way. For small companies, there is often too much at stake to follow that example. Entering into a typical FDA consent decree, for example, would mean leaving the market while remedial steps are being taken. Temporarily losing a few sales from one or several product lines would not hurt a large, diversified firm much, but it could kill a small one.

So, to follow Kennedy's analogy further, we may expect the slow-moving FDA elephant, even though bleeding profusely, to lumber on. At least, it will so long as Blumberg remains in charge of its case development, which was so flawed in the Utah Medical case.

More Guidant Device Deaths Reported

Guidant Corp. has submitted reports to FDA of three more deaths since June, according to the New York Times. All three deaths were linked to electrical short circuits in its heart devices. The Times said the cases occurred after Guidant had recalled the devices. The recall took place when the company came under scrutiny for not promptly warning doctors and patients about the short-circuit risk. The latest reports bring the number of known deaths connected with the short-circuit problem to seven.

The Times noted that the amount of media attention being paid to the defects might have some bearing on the latest reports. It speculated that doctors and family members are having units checked for problems after a heart patient's death more often because of that attention. It also suggested the new data may pose further legal problems for the firm. Even though the electrical failures involve different models, they all relate to the company's use of polyimide, an insulation material. The polyimide was used in a way that apparently made it prone to deterioration.

The Guidant devices at issue are the Prizm 2 DR defibrillator and the Contak Renewal and Renewal 2 combination pacemaker and defibrillator.
The company reiterated it “regularly communicates information about product performance to various stakeholders including physicians and regulatory bodies.”

AdvaMed on Condition of Approval Studies

AdvaMed says three broad principles should guide FDA in setting up criteria for ordering and designing condition of approval (CoA) studies. First, a CoA study should be designed to answer only clearly defined questions related to ensuring a device's continuing safety and effectiveness. Second, FDA should only require extra data when existing data collection methods do not ensure a device's continued safety and effectiveness. Finally, a CoA study should be designed to provide the needed data in the most reasonable fashion, considering study center logistics, time frame, and patient recruitment.

In comments on a draft guidance, AdvaMed agreed that FDA needs to seek advisory panel advice when considering initiation or progress of postapproval studies. But, it said, the draft appeared to suggest that sponsors will update such a panel only on study status, while FDA will present analysis and evaluation of the study to date.

In light of that observation, AdvaMed suggested that section be rewritten. It should “clearly state that sponsors will be invited to present their analysis and evaluation of study data to date before the advisory panel,” AdvaMed said. The group encouraged FDA to work with sponsors to develop a clear and balanced presentation.

AdvaMed's comments also addressed other issues. Among those were least-burdensome requirements, study termination, protocol action, clarification of terms, and public disclosure of study status.

More Boston Scientific Recalls

Boston Scientific in December announced a new recall involving all 40,000 Flextome Cutting Balloon Device Monorail delivery systems and Peripheral Cutting Balloon Microsurgical Dilatation Device Small Monorail delivery systems. The firm said complaints led it to test the devices. It found that the distal shaft of each system's catheter could separate during device withdrawal.

Eight patient complaints had been received, Boston Scientific says. Of those, three needed surgery to correct the problem. The cutting balloon portion of each system consists of an angioplasty balloon with microsurgical blades, called atherotomes, mounted to the balloon surface. As the balloon expands, the atherotomes score the lesions with incisions. The incisions allow the balloon to dilate the blood vessel with less pressure.

Boston Scientific has lately been plagued with device recalls. At the end of November, it recalled all stainless-steel Greenfield Vena Cava filters with 12-Fr femoral introducer systems manufactured before March 10, 2004. The recall was prompted by adverse-event reports it received on unexpected device detachments. In September, the firm recalled all of its Hemashield Vantage vascular grafts. On the grafts, the device fabric may fray and tear at the suture line between the graft and the patient's artery. And last year, it recalled 96,000 of its leading Taxus Express2 Paclitaxel-eluting coronary stent systems. That recall was due to a malfunction that could impede balloon deflation during a coronary angioplasty procedure.

Democrat Seeks More Industry Oversight

Congresswoman Rosa L. DeLauro (D–CT) has renewed her call for more oversight of medical device safety. Her latest statement follows a series of articles in the Washington Post on the alleged dangers from reprocessed single-use devices.

“News of potential health risks with medical devices has increased significantly in recent months,” DeLauro said. She believes that news should prompt concern by doctors and patients who use such devices, as well as FDA. She noted that FDA is in charge of overseeing public health matters such as device safety.
“FDA has made strides to increase regulation of medical devices, yet significant gaps remain,” she continued. “It is clear from the Post's investigation that the agency must improve its premarket approval process and its postmarket surveillance of medical devices.”

DeLauro is the ranking Democrat on the House Committee on Appropriations subcommittee that oversees the annual budget for FDA. She sent acting commissioner Andrew von Eschenbach a letter in November asking him to reform crucial public health areas, including device oversight.

DeLauro pointed out that the system relies on a voluntary system for doctors and hospitals to report faulty devices. That means that there is not a set number of inspectors assigned to investigate reprocessing plants. This “has led to a number of small facilities operating outside of FDA's oversight system,” she said. “Reusing medical devices deemed for one-time use has serious implications for doctors and patients. As the Post series demonstrated, what medical providers save in costs with reprocessing medical devices, they lose in patient safety. Rigorous oversight of reprocessing is needed.”

Meanwhile, the Association of Medical Device Reprocessors (AMDR) said that the Post series found no proof that using reprocessed devices increases patient risk. However, the group said, such articles could scare patients with “outdated, irrelevant examples.”

AMDR represents SterilMed, Vanguard Medical Concepts, and Alliance Medical. It said the Post stories used anecdotal reports, mostly from years before strict FDA regulations were in place, or reports from overseas. “The articles also failed to inform readers that FDA has in place a stringent set of reprocessing-related regulations that protect the patient,” the association said in a statement. “Instead, readers are exposed to graphic, tragic cases of patients who were treated before these regulations existed. Furthermore, the article presents a mishmash of different types of problems, with no clear demonstration whether the problem was caused by original manufacturing or reprocessing.”

According to AMDR, the Post ignored the fact that no medical procedure is without risk. Moreover, it said, adverse-event reports to FDA about original equipment are increasing. AMDR also noted FDA and the Government Accountability Office have said there is no increased safety risk from properly reprocessed devices.

In fact, AMDR said, “it may be that reprocessing makes medical procedures safer. If an original device fails when it is first used, it is not reprocessed. And because every reprocessed device is inspected or tested prior to use, the strong likelihood is that the device will again work properly. The same cannot be said for new devices, which are subject only to sample testing.”

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