WASHINGTON WRAP-UP

By “mutual agreement” with the commissioner, Daniel G. Schultz resigned as CDRH director in August amid a quagmire of controversies that had become a barrier to the new FDA leadership's agenda for change at the agency.
The newest controversy concerned a rule making from which commissioner Margaret Hamburg had to recuse herself due to a perception of possible conflict of interest—ironic, considering that she is the chief change agent. It was the reclassification of mercury-based dental amalgams into the Class II device category on August 4. Before coming to FDA, Hamburg sat on the board of the country's biggest amalgams shipper, Henry Schein Inc.
The final rule was immediately denounced as not stringent enough by the same group of injured and activist amalgam patients that had forced the rule making a year earlier in federal court. This was a situation in which the presiding judge called FDA's 32-year reluctance to act a symptom of “government at its worst.”
In his five years as CDRH director, Schultz superintended more than a few processes in the center that might be similarly described by the people they affected. For examples, see FDA's federal court loss to Utah Medical Products and its aftermath, the yet-unresolved civil money penalties case against TMJI Implants, bitter relationships with hundreds of injured LASIK patients, etc. And even from within, there were complaints by dissident CDRH scientists and physicians about alleged pro-industry biases in the reviews of medical devices.
In none of these situations was Schultz seen as being able to take a CEO-like problem-solving role. Instead, he finally got politically bogged down in them. This is how Schultz and his predecessors helped CDRH build a reputation for being FDA's most dysfunctional center. This situation led Public Citizen Health Research Group director Sidney Wolfe—who admittedly has a jaundiced view of FDA's leadership—to describe Schultz in February as “the worst of a lot of terrible people who have headed CDRH.”

With the Obama administration still rolling up its sleeves at FDA, Schultz may have recognized the beginning of the end for himself in early June when, with the whiff of 510(k) scandal still in the air, he addressed the annual meeting of the Medical Device Manufacturers Association. Both FDA and the industry, he said, had not done a good job of communicating to the public that the 510(k) process is not the “mindless rubber stamp that some people are making it out to be.”

Almost in the same breath, however, he acknowledged there had been “situations where we started with one device a long time ago and ended up some place very, very different. And it is really hard to explain that entire complicated path that got us from where we were in 1976 to where we are in 2009.”
That's a barely coherent description of the problem from someone who may have been a few too many rungs up the ladder above the daily nitty-gritty to see and feel what's been going on in the product-review trenches. It is an all-too-common syndrome in government that invites the rubber-stamping of decisions.
The case of the 510(k) was well described in a New York Times article last January by physician Peter B. Bach: “So on the one hand, the manufacturer wheels in their new Ferrari to FDA and says, ‘Look, it's a car just like the Model T.' Then they go out in the marketplace and say to doctors, ‘Why would you drive anything but a Ferrari?'”
This outcome could—or should—have been predicted by the drafters of the 1976 Medical Device Amendments when they created the 510(k) process for “substantially equivalent” devices. But because they didn't, unequivalent devices have slipped through the process so easily that today 510(k) is the main route to market for new high-tech devices, right under the noses of eager-to-please CDRH directors.
Schultz may have been more eager to please than others. His dog-and-pony shows at industry meetings were better than most, both well illustrated and interactive with audiences. However, he didn't go as far as the man who appointed him in 2004, former commissioner Lester Crawford. Crawford once boasted to device makers at a Phoenix meeting that he was the only commissioner to have his home phone number in the phonebook, inviting attendees to give him a call any time.
Industry appreciated Schultz's efforts. After his resignation, AdvaMed noted: “Dan supervised FDA's device center at time of unprecedented scientific advancement and helped continue U.S. leadership in the development of safe and effective medical treatments.”
In a farewell message to his CDRH coworkers, Schultz called his resignation “one of the hardest” among many “difficult” decisions he had made in his 35-year career. He said he made this one based on “discussions” with Hamburg “and a mutual agreement that my stepping down at this time would be in the best interest” of CDRH and FDA.
Making no mention of the problems that had brought him to this point, Schultz instead presented a sunny view of his 5 years as center director, and 10 years before that in lesser FDA positions. Schultz told his coworkers that his record is something that he will “cherish and carry” with him for the rest of his life. “Working side-by-side with dedicated professionals from diverse academic and career backgrounds for a common goal of protecting and promoting the public health of this nation is the greatest privilege that anyone could ask.” He also said that
Anyone who has followed the course of medical care over the last two decades as an analyst, care provider, or patient will recognize the impact that device technology has had in improving health care delivery through advanced diagnostics, minimally invasive interventions, smart drug delivery systems, etc. What often goes unrecognized is the impact that CDRH staff have had on the design, manufacturing, refinement, and labeling of those products, which have made them safer, more effective, and more user-friendly.
In addition, Schultz praised the user fee program because “its influx of resources and people has led to a more efficient and consistent premarket review process.” More of Schultz's comments on his resignation can be found at transformingfda.com.
In an all-hands memo announcing Schultz's resignation but giving no reasons for it, Hamburg said associate commissioner for policy and planning Jeff Shuren, a neurologist and lawyer in his tenth year at FDA, would serve as acting CDRH director. A national search will be conducted for a permanent director.
The Project on Government Oversight (POGO) issued a statement saying that Schultz's departure “offers a long-awaited opportunity for openness and reform.” However, the group cautioned that there is still much work to be done, including “dealing quickly and openly to correct the harm caused by retaliation against the extraordinary number of CDRH whistle-blowers who have reached out to Congress, the media, and public interest groups including POGO.” The group also cited the need to investigate the allegations made by these insiders—most notably the claims of improper outside influence over FDA approval decisions. “Until it is clear that the culture of fear at CDRH is over,” POGO said, “it will be impossible to restore integrity to the important work of the CDRH.”
Senate Warned of ‘Regulatory Chaos' in Preemption Bill
Senate passage of a bill that would allow state product liability suits to proceed against medical devices approved via premarket approval (PMA) would result in “regulatory chaos,” according to Peter Barton Hutt. Hutt, who is senior counsel for Covington & Burling and former FDA chief counsel, made this statement at a Health, Education, Labor, and Pensions Committee hearing in August.

The hearing, led by Senator Tom Harkin (D–IA) in Edward Kennedy's (D–MA) absence, was in support of moving S. 540 (also called the Medical Device Safety Act of 2009) forward. This bill would reverse a recent U.S. Supreme Court decision (Riegel v. Medtronic) on preemption barring state product liability cases involving PMA devices.

“National uniformity” involving the regulation of Class III PMA devices is “essential to preserve the jurisdiction and integrity of the FDA PMA process,” Hutt told the hearing. “If judges and juries can summarily disregard FDA decisions on Class III PMA devices, why should physicians, hospitals, or anyone else pay attention to them?” Hutt charged that S. 540 undermines FDA's credibility and authority.
Allowing product liability actions to proceed against FDA-approved devices, he warned, could lead to manufacturers tacking on additional or unsubstantiated warnings to their products. Such a move could result not only in underusage of valuable treatments, Hutt said, but also in confusion among both physicians and their patients. “‘Defensive labeling' by manufacturers helps no one.”
In supporting the bill, University of Texas School of Law professor Tom McGarity argued that tort law provides a valuable backstop to the regulatory system by sending a message to potential defendants to collect data on the harm-producing potential of their products and activities and to take action to prevent future harm. He said litigation may be more effective in removing risky products from the market than regulatory controls.
McGarity told listeners at the hearing that there are two reasons why the deterrence function of state tort law is relevant for medical devices. He said that first, medical OEMs that conduct clinical trials and continually receive reports on their products will generally have more information than FDA, doctors, or patients on the risks their products pose. Also, McGarity said that OEMs “are in a far better position than doctors, patients, or FDA to improve the safety of their products both before and after they enter the marketplace.”
As a result, McGarity says, “manufacturers' incentive not to violate its common law duty to market nondefective medical devices therefore reinforces the protective policies underlying the Medical Device Amendments.”
Weighing in on the matter after the hearing was Public Citizen's Allison M. Zieve, who argued on behalf of the Riegels before the U.S. Supreme Court. “When medical devices are defectively designed or marketed without adequate labeling, they can cause grave injury and death to patients,” she said. Zieve also said that patients have a severely limited ability to seek compensation from medical device manufacturers without legislation to allow it.

Earlier, Zieve told the hearing that FDA's premarket scrutiny cannot ensure that products will perform as intended. “No matter the strength of FDA's review, some devices will be defective; some labels will be confusing or inadequate; and some injuries are unavoidable. And when injuries occur, lawsuits are a patient's sole means of obtaining compensation for lost wages, medical bills, and pain and suffering.”

FDA Labels Medtronic Infusion Sets Recall Class 1
FDA classified a recall of Medtronic's Lot 8 Quick-set infusion sets in July as Class I (most serious). The sets are used with the firm's MiniMed Paradigm insulin pumps. A company recall notice says that 2% of Lot 8 Quick-set infusion sets may not work properly. FDA's recall notice notes that affected infusion sets may not allow the insulin pump to vent air pressure properly, which could result in the device delivering too much or too little insulin and thus causing serious injury or death.
Medtronic says the manufacturing process has been changed and is no longer a problem. It is also providing replacement sets to customers. A
June 1 FDA warning letter had identified quality system violations in the manufacture of Synchromed II pumps and MiniMed Paradigm insulin pumps at the company's Ceiba Norte Industrial Park facility in Juncos, Puerto Rico.
Synthes Execs Plead Guilty in Clinical Trials Case
Four senior Synthes executives have pleaded guilty to criminal misdemeanor charges in connection with illegal clinical trials of the company's Norian SRS and Norian XR bone cement.

The four executives are Michael Huggins, COO of Synthes's spine division from 1994 to 2008; senior vice president for global strategy Thomas E. Higgins; vice president for operations Richard E. Bohner; and John Walsh, spine division director of regulatory and clinical affairs. They entered their pleas before a Philadelphia federal court and face one year in prison and $100,000 in fines when they are scheduled to be sentenced on October 22.

The government says that Synthes didn't tell some 200 patients that they were participating in what amounted to human experimentation. Three of the patients died. The two Norian bone cement products had been approved by FDA to fill bone defects in some parts of the body, but not the spine. And the Norian XR label explicitly warned that the product was “not intended to treat vertebral compression fractures.”
According to a plea agreement memo, Synthes once promised FDA that it would not promote Norian XR for spinal use. However, it then ordered that product be “test marketed” by training 50 spine surgeons to use it to treat fractures in the vertebrae.
Huggins's plea memo says that he was aware of and involved in the process of approving test marketing of the two products, while Walsh's agreement says that he approved the continued promotion of Norian XR for spinal surgery even after three elderly patients died during surgery.
FDA Classifies Abbott Recall as Class I
FDA has classified a recent recall by Abbott Vascular-Cardiac Therapies on its Powersail coronary dilatation catheters as a Class I recall.
FDA issued a recall notice in August that says the catheter's distal shaft may show damage or tears, which could cause a leak of contrast material during use. “This could lead to catheter functional failures and medical consequences, including a blocking of a blood vessel caused by air entering the bloodstream (air embolism) and heart attack (myocardial infarction), which has the potential to lead to death,” it says.
Healthcare professionals were advised to stop using the devices and return them to the company.
Ohio Medical Warned by FDA on Quality Systems
An FDA inspection conducted in May at Ohio Medical's manufacturing facility in Gurnee, IL, found quality system violations in the company's production of portable suction units, oxygen flow meters, and vacuum regulators. This information was detailed in a July 22 warning letter from FDA's Chicago district office. Violations noted on the FDA-483 included the following:
•Failure to establish and maintain procedures for implementing corrective and preventive action, including identifying actions needed to correct and prevent reoccurrence of nonconforming product and other quality problems.•Failure to maintain complaint files, including establishing and maintaining procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and ensuring that all complaints are processed in a timely manner.•Failure to document acceptance activities.
The warning letter said that most of the company's responses to the FDA-483 were inadequate. The company was told to take prompt action to correct the violations and to submit a listing of specific steps taken, including documentation and a timetable.
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