Medical Device Link The Online Information Source for the Medical Device Industry.

When it comes to enforcing quality system and GMP regulations, FDA can be vicious. This is especially true when its quarry is a small device firm, as some recent cases (TMJ Implants, Utah Medical, Shelhigh, etc.) seem to indicate.

But when push comes to shove with a big, well-heeled company, maybe state attorneys general can get bigger and quicker results. Case in point: a brief and barely noticed August 30 news release from Boston Scientific.

The news release announced that three of the company’s subsidiaries, each acquired last year, will pay $16.75 million and admit no liability to end an investigation by the attorneys general of 35 states and the District of Columbia. Up to $1 million of that total will supplement Guidant’s warranty program, in order to compensate consumers.

The subsidiaries, now known as Boston Scientific Cardiac Rhythm Management (formerly Guidant Corp.), Cardiac Pacemakers Inc., and Guidant Sales Corp., were accused of knowingly selling implantable cardioverter-defibrillators (ICDs) that were defective.

In addition to the financial payment, the subsidiaries agreed to extend their supplemental warranty program by six months for three ICD models. The models are the Guidant Ventak Prizm 2DR Model 1681, Contak Renewal Model H135, and Contak Renewal 2 Model H155. The divisions also reaffirmed a commitment to implement changes recommended by an independent panel commissioned by Guidant in 2005. Changes include having a patient safety officer and a patient safety advisory board as well as a commitment to communicating product performance issues more effectively.

Contrast this with FDA’s approach. Goaded by Senator Chuck Grassley (R–IA) and a May 2005 New York Times investigative report, CDRH opened an official investigation into Guidant defibrillator problems it had known about since early in 2002. The agency then issued public health advisories, ordered a recall, scheduled meetings and inspections, and issued a warning letter in its efforts to address the ICD devices’ electrical problems.

An FDA analysis, kept under wraps until discovered as part of private product liability litigation, found the devices were 10 times more likely to fail than Guidant had projected. In April 2007, 12 months after it acquired the three Guidant divisions, Boston Scientific announced that it had settled all FDA issues with Guidant that had been enumerated in a December 2005 warning letter. The letter, in turn, was the result of an inspection the previous August after 73,000 defibrillators had been recalled.

Of course, the state attorneys general and FDA had different goals. The states wanted Guidant to extend its supplemental warranties on the problematic defibrillators, while FDA wanted the GMP issues addressed.

But whatever the cause of action, the devices in question were mostly the same in both cases, and the problems in both cases were manufacturing defects that injured people.

In one case, FDA proceeded slowly while concealing its own discoveries about the devices’ weaknesses, and after about six years, quietly closed its books on the matter. In the other, the state attorneys general coalesced and swiftly emerged victorious—with headlines to prove it—after a 28-month effort.

There’s a political reality to all of this that should not be overlooked: State attorneys general are expected to go after big companies that hurt people, and get a lot of credit if they succeed. CDRH, beholden to user fees and those who send them in, gets nothing but angst if it tries the same thing. This might explain why it seems easier to target small companies that have no political clout even if their devices haven’t hurt anyone.

Perhaps FDA could outsource its device enforcement to the states?

– James G. Dickinson

Seven of the 13 Office of Regulatory Affairs (ORA) field labs that FDA planned on consolidating will remain open for the time being. Much to the dismay of many lawmakers, FDA had planned to merge several facilities across the country into five multi­purpose labs to make better use of space and allow for modern research equipment.Although most of the attention to the lab closings has been in light of the various problems related to food safety and import issues, ORA field labs also inspect and analyze medical devices.

In August, FDA’s Margaret Glavin, associate commissioner for regulatory affairs, told agency staff in a letter that the lab closings would need to be reconsidered, given the import challenges that FDA is facing.

The House of Representatives took its own measures to prevent the closing of the field labs. An amendment to the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act of 2008 (H.R. 3161) prohibits funds in the act from being used to close or consolidate any of the 13 field labs or 20 district offices. The House adopted the amendment in August.

There have been conflicting reports over whether the announcement to keep the labs open is a permanent decision. According to FDA spokeswoman Julie Zawisza, the plan to keep the labs open is temporary. However, this doesn’t mean that all of the labs will definitely be closing at some point.

“The plans to restructure our field operations, including the lab closures and consolidation, are temporarily suspended so we [FDA] can rethink the best way to proceed,” says Zawisza. “The plan is to proceed with something but [we] don’t know how that looks yet. We know we need to modernize the field operations but need to incorporate and reflect whatever comes out of the president’s import working group as well as our own reevaluation.” In July, President Bush issued an executive order to establish an inter­agency working group on import safety.
– Maria Fontanazza

FDA and the Department of Defense (DoD) are partnering to share data related to how medical devices, biologics, and drugs are reviewed and used. The agreement is part of FDA’s Sentinel Network, an integrated, electronic postmarket safety network that aims to provide product safety information directly to clinicians.Part of the purpose of the memorandum of understanding (MOU) is to build the infrastructure and processes that meet requirements for assessing the safety, efficacy, and use of devices and drugs. It also seeks to promote better use of tools for risk identification, validation, and analysis of products. Sharing product information could help FDA identify potential concerns and other trends.

Although patient data such as prescriptions and lab results will be shared between the agencies, FDA and DoD have agreed not to share information under the MOU until proper safeguards are put into place. Each agency will appoint liaisons, including one from CDRH, to handle activities under the partnership.

The MOU was signed in July by FDA commissioner Andrew von Eschenbach and W. Ward Casscells, MD, assistant secretary of defense for health affairs at the DoD. The agencies are planning to meet later in the year to discuss details of the agreement.

– Maria Fontanazza

A summer storm erupted in Washington political circles over the Washington Post’s disclosure that senior FDA managers had received large bonuses in 2006—when the agency was supposed to be tightening its belt and spending every cent on import surveillance.

Three CDRH managers received notable bonuses: Deputy CDRH Director Linda Kahan ($34,000), Compliance Director Tim Ulatowski ($21,000), and Senior Associate Center Director Lillian Gill ($20,000). But those paled in comparison to higher-ups in the Center for Drug Evaluation and Research and the Commissioner’s Office, whose bonuses were as high as $47,000 for a grand total of $13 million.

In a rare move, FDA commissioner Andrew von Eschenbach spoke publicly about the matter. In a letter to the Washington Post, he wrote that contrary to its report, more than 90% of the $13 million retention bonus pool went directly to the agency’s physicians and scientists. “Members of the Senior Executive Service and other managers received 9% of that bonus pool,” he wrote.

Von Eschenbach chided the Post for having “mischaracterized the many contributions of two senior executives who received bonuses. [Associate Commissioner for Regulatory Affairs] Margaret Glavin effectively oversees FDA’s nationwide field operation of 3200 employees as our first line of public health defense. She established FDA’s Office of Counterterrorism Policy and Planning and has received two Presidential Rank awards.

“[Office of Criminal Investigations Director] Terry Vermillion, also a recipient of the Presidential Rank Award, founded FDA’s Office of Criminal Investigations and has led more than 4600 national and international criminal investigations, resulting in 4338 arrests, more than 3100 convictions, more than $2.15 billion in fines and $750 million in assets forfeited to the Justice Department.

“Responsible use of pay flexibilities helps FDA find and keep expert, dedicated employees—and [this practice] has proven essential to our ability to fulfill our public health mission.”

His avowals of bonus award purity of purpose didn’t sway some skeptics. One commented on my Web site: “You get extra money for doing the job you were hired to do? I guess this is like the tip jar you see at Starbucks. Now I understand.”

Meanwhile, the Government Accountability Office is investigating the use of such bonuses by executive-branch agencies.

– James G. Dickinson

On September 20, Congress approved a bill that renewed FDA funding that would have otherwise run out at the end of September. This bill forestalls FDA’s plans to lay off as many as 2000 employees had funding not been approved.

The bill renews for five years programs that enable the agency to continue to collect user fees from drug and device companies. Without the user fees in place by October 1, the agency would not have the funds to keep much of the staff it has hired as a result of the fees. The bill calls for device makers to pay $48 million in fees next year and more than $52 million in 2009.

The 424-page bill focuses primarily on new rules governing the pharmaceutical industry, but a few provisions are aimed at you, and others could be a sign of what is to come. In addition to the MDUFMA-related provisions, the bill contains changes in the approval process for pediatric devices. It also limits the number of conflict-of-interest waivers the agency can grant for members of its advisory committees. In addition, the bill provides for the implementation of a unique identification system and a study of nosocomial infections relating to medical devices.

Compared with the number of pharmaceutical-related items, “overall the legislation has little direct impact on devices,” notes Jonathan Kahan, an attorney with Hogan & Hartson. He notes, though that “there are a couple of provisions that could have an indirect effect on devices, such as the panel conflict waiver provisions.”

However, Larry Pilot says there are a few key items in this bill that might “trip up the device industry.” Pilot is an attorney with McKenna, Long & Aldridge. Among those that are troublesome, he says, is a section that requires a General Accounting Office study on the appropriate use of the process under section 510(k).

“This need for a report by the GAO to determine whether a new device is as safe and effective as a classified device puts a completely different spin on the classification notification process,” he says. “What is the impact of that report going to be in the context of a possible future change in the legislation? This suggests to me an opportunity to tamper with what was a good concept out of the 1976 amendments.”

Pilot also notes that new medical device reporting requirements are worth watching. “The expansion of the MDR authority is quite troublesome because that program simply isn’t working. Success has to be measured in the context of early warning and prevention,” he says. In the 20 years FDA has had its MDR system, the program hasn’t been evaluated, and this new provision “makes it even more complicated and more onerous,” he says. “It is particularly troubling because it expands greatly upon the language in the statute with regard to reports for a system that is I believe of very little value.”

Pilot suggests that the clinical trials provision may also pose some problems. “The language isn’t very clear because it says if you’re doing a trial for a 510(k), that information has to be listed somewhere. There’s a possible complication here, and this requirement could be onerous to those who undertake a study under the IDE regulation,” says Pilot.

You should certainly take a look at the provisions that address devices, but you should also look at those addressing the pharmaceutical industry, because those may signal what is to come for devices.

“Our clients are worried that the burdensome drug-safety provisions are a template for future changes in the device area,” says Kahan. “We’ll have to wait and see. Hopefully, Advamed is attuned to the footsteps that may be coming toward the device industry.”

– Sherrie Conroy