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FDA and the Veterans Health Administration announced a formal agreement to share information and expertise related to the review and use of medical devices and other FDA-regulated products. The goal of the Memorandum of Understanding is to enhance postmarket safety data collection. By working together, the agencies hope to identify, validate, and analyze product risks more effectively. Within 30 days, there will be a meeting to establish procedures and safeguards. The VHA has been at the cutting edge both of adopting medical technology and of implementing patient safety measures. FDA could learn a lot from its experiences.

From MD&DI’s blog

The Washington Post has a Bloomberg News column that assesses the impact of a Jan. 18 executive order issued by President Bush that may curb the powers of federal agencies to regulate industry through guidance. This is hugely significant for the device industry as FDA relies heavily on guidance documents to regulate manufacturing and quality issues. The concern, not only expressed by FDA-regulated industries but by many industries regulated by the federal government, is that issuance of guidance had come to serve as back-door rule writing, without being subject to the same scrutiny that proposed new rules are. Under the order, federal agencies must submit to the Office of Management and Budget for review any guidance with an impact of $100 million or more, and must make such guidances available for public comment. An agency must also state the “specific market failure” that the guidance would help cure. If implemented properly, the order could make FDA more accountable, which is sometimes necessary.

– From MD&DI’s blog

FDA Commissioner Andrew von Eschenbach has named two people, one of whom should be very familiar to FDA observers, to top positions in the agency. Janet Woodcock, MD will assume a newly created position, Chief Medical Officer, which will oversee scientific and planning operations. Woodcock has previously been Deputy Commissioner for Operations and director of the agency’s drugs and biologics centers. John Dyer, MPH, has been named Deputy Commissioner for Operations and Chief Operating Officer. He will focus on issues concerning management, business processes, and information technology. He was previously COO at CMS, where he helped implement the vast reforms at that agency. In other words, Woodcock’s charge will be to ensure the agency fulfills its scientific mission. Dyer’s will be to ensure it fulfills it with as few bumps in the road as possible. Success in both is badly needed in this era of tribulation for the agency.

– From MD&DI’s blog

After a nomination that had been on hold for months, Andrew von Eschenbach, MD, was sworn in as FDA commissioner on December 13. While the presence of a permanent commissioner is significant, it might not have a direct effect on the daily operations at CDRH.

Von Eschenbach’s nomination was delayed as a result of controversies, mainly in the drug arena. Senators Hillary Rodham Clinton (D–NY) and Patty Murray (D–WA) worked to hold his nomination over the emergency contraceptive, Plan B. Von Eschenbach took heat from Senator David Vitter (R–LA), because Vitter wanted to legalize the importation of prescription drugs. Republican Senator Jim DeMint (SC) also put a hold on von Eschenbach’s nomination in efforts to push FDA to stop the sale of an abortion drug.

Majority Leader Bill Frist (R–TN) put an end to the dispute by calling for a procedural vote, which resulted in an 80–11 approval for von Eschenbach’s confirmation.

The permanent FDA commissioner will now have to deal with concerns about postmarket surveillance of both drugs and devices, which have afflicted the agency in recent years. Jonathan Kahan, partner at Hogan & Hartson (Washington, DC), notes that von Eschenbach can’t avoid involvement with postmarket safety issues on the drug side, but he’ll probably leave more of the responsibilities related to devices, including postmarket surveillance, up to CDRH Director Dan Schultz.

Larry Pilot, partner at McKenna, Long & Aldridge LLP (Washington, DC), adds that von Eschenbach must restore the agency’s reputation with the help of others at FDA. He began serving as acting commissioner after Lester Crawford’s sudden resignation in September 2005. Crawford pleaded guilty last October to conflict-of-interest charges related to stock holdings. And in light of highly publicized controversies involving drug safety and device recalls, FDA’s reputation has taken a hit.

With the resignation of Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, and Patrick Ronin, FDA chief of staff, von Eschenbach will also be challenged to select the right people for management positions. “He has to do it through competent supervisors and subordinate supervisors. The test for him is going to be how well he’s able to take advantage of the position that he’s in and restore what the agency appears to have lost in the context of reputation and image,” says Pilot. (In late December, von Eschenbach named Randall Lutter to replace Gottlieb on an acting basis.)

While having a permanent commissioner is beneficial to the industry, there’s also speculation that von Eschenbach won’t remain at the FDA post for long.

“I believe he’s a 24-month commissioner. I think everybody in the world believes that,” says Kahan. “He’s a friend of the Bush family. Even if a new Republican candidate came in, von Eschenbach would resign.”

Kahan adds that the absence of a long-term FDA commissioner who’s willing to defend initiatives makes it difficult for the agency to take a tough stance on issues. “I think it has an effect on morale at the agency and the ability of senior management at FDA to take a strong new direction on anything.”

—Maria Fontanazza

When Daniel Schultz took over CDRH in 2004, he made beefing up postmarket surveillance a priority. The following year, problems with Guidant Corp.’s implantable cardioverter-defibrillators intensified the pressure on CDRH to hold industry to stricter standards on postmarket issues. Now, the center has come out with a plan for reform.

Most of the proposals, unveiled in November, focus on tightening up CDRH’s own practices. For example, a top priority is setting up “cross-cutting product groups” to enhance communication between people from different offices who deal with the same products. But some will require extra efforts from industry. Electronic reporting of adverse events may be mandated. Putting unique identifiers on most or all devices for better tracking is likely to happen. And annual reports for PMA products might have to be better organized.

The recommendations should not come as a surprise to industry, says Bradley Thompson, a partner at Epstein, Becker & Green (Washington, DC).

“A lot of the proposed requirements and expectations have been around for a while,” he says. “The agency is doing its best to educate industry as to what its expectations are and what, in my mind, it should have been doing all along. It has given everyone an early warning that it is not pleased with the current level of postmarket surveillance. But the totally new stuff will require rulemaking, which means the implementation is quite a while off in the future.”

Therefore, he says, device companies are not likely to make significant changes to their practices until they see how exactly the proposed changes will be implemented.

“The firms that have made changes to how they handle postmarket issues have done so because of issues that turned up in audits, not because of what the agency has been talking about,” he says.

The effect on industry will depend on the extent of the reforms, says Jonathan Kahan, partner at Hogan & Hartson, a Washington, DC law firm. Radical change could bring costly new regulations, “but what I got from reading it is that the actual cost will be minimal in terms of cost and burden.”

The proposals to strengthen the Medical Device Reporting program should not be too costly to industry, he says. As for plans to reform the monitoring of postmarket clinical trials, “some in Congress are in the process of pushing an entirely new paradigm [for the drug industry], but I don’t see that coming over to CDRH,” he says. “We should get a much more moderate, step-by-step approach.”

Nothing can be taken for granted, though, Kahan cautions. The Democrats now control Congress, and they are even more displeased with FDA’s performance on postmarket issues than the Republicans were. “Everyone is in watchful, waiting mode, but my gut tells me it will be OK, that it will not blow up on the device industry like it did the drug industry.”

—Erik Swain

The world of Washington is a busy one, with a seemingly never-ending rush to get things done. In that climate, the big picture often gets lost in the shuffle, and planning for FDA and other federal agencies becomes haphazard at best.

But the coming months present a rare moment for Congress, FDA, and industry to take stock of things and to make some thought-out, long-term decisions about how the agency will be run in the future. This is a chance that had best not be blown.

The opportunity has presented itself in three ways: the Democrats taking over Congress; Andrew von Eschenbach finally being approved as permanent FDA commissioner; and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which must be ratified by October 1, 2007, awaiting reauthorization. This means there is new blood being given the chance to shape legislation that will affect how CDRH is run over the next few years.

“There [will be] a confluence of legislation in the coming year,” Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs, told The Scientist. “There are some big, must-pass bills, and that will create an environment where a lot of people will be proposing a lot of different ideas.”

Perhaps the most important question that needs to be considered is CDRH’s funding. One of the problems with the original MDUFMA is that Congress, then under Republican control, failed to come up with all of the increased funding for the CDRH budget that it had promised. Although Democrats are not considered to be as industry-friendly as their Republican counterparts, here is one case in which they might be in a better position to help industry. Traditionally, Democrats have been more willing to spend for domestic programs than have Republicans. Perhaps, then, the new Democrat-controlled Congress may be willing to fund the CDRH budget at a higher level than its Republican-controlled predecessor was.

That could also mean that Congress is willing to rethink the user-fee program and third-party program. (Many Democrats vigorously opposed the third-party inspection program.) The user-fee structure needs radical reworking; a solution that gives CDRH the funds it needs without overburdening industry is seriously overdue. Another option to be considered when MDUFMA is reauthorized is a structure that provides incentive for both quick reviews of applications and prioritizing presubmission activities that streamline the development process and produce better applications.

Also to be rethought is CDRH’s approach to postmarket surveillance. The Postmarket Transformation Leadership Team issued a comprehensive report with proposed reforms. Will this be enough to satisfy Congress, or will the Democrats want more? Since postmarket surveillance has been politicians’ favorite topic on which to bash FDA recently, let’s hope the debate is a forum for substantive discussion, not grandstanding.

Indeed, Congress has already started weighing in. Senators Charles Grassley (R–IA) and Christopher Dodd (D–CT) have proposed a bill that, among other things, would give FDA more teeth to require postmarket studies and penalize firms that fail to complete them.

Congress and the new commissioner will spend this year taking a fresh look at CDRH.
Erik Swain for the Editors

This coming year could bring sweeping changes to how CDRH regulates the device industry. There is a new Congress, a new FDA commissioner, a new approach to postmarket issues, and at least one piece of major new legislation (the MDUFMA reauthorization). Since so many stakeholders will be taking a fresh look at CDRH, so will we at MD&DI. The changes under consideration may be so sweeping as to impact all of you, our readers, not just those who deal with regulatory affairs. We want to make sure you don’t miss any of this vital coverage. So we will be identifying all articles concerning these major issues with the “Transforming FDA” logo, shown here. When you see an article with this logo, you will know it is calling your attention to an issue that could affect CDRH, the device industry, and you. More such items will appear on our blog at www.devicelink.com/mddi/blog. And to help you get the big picture, we are putting all print and online “Transforming FDA” articles in one place, here at www.transformingfda.com. We welcome reader suggestions about topics and angles to explore. Please send them to mddi@cancom.com.