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According to an Associated Press report, some members of Congress are upset that FDA has increased spending on bonus payments to retain certain employees, especially reviewers.

Well, too bad.

There’s a reason why these bonuses are needed. Without them, the agency would be severely lacking in expertise. The private sector offers much better pay than the public sector, which means reviewers and other personnel are always at risk of crossing over to work for industry. It also means the top scientists and engineers coming out of school aren’t exactly chomping at the bit to work for the agency, either. If Congress thinks the agency hasn’t protected the public health as well as it would like to see, imagine how much worse it would be if the most experienced personnel all left.

The criticisms show a stunning ignorance of market forces, and a willfull disregard for budget issues. If Congress would appropriate the proper amount required for the agency to fulfill its mission, instead of shortchanging it year after year, this would be much less of an issue.

– From MD&DI’s blog.

FDA’s postmarket product safety network got jump-started during a two-day public meeting held in March to get feedback and suggestions from industry. Called the Sentinel Network, the integrated, nationwide electronic system would focus on data collection, risk identification and analysis, and risk communication.Although FDA continues to evaluate comments and what it learned from that public meeting, it has begun the process of developing a white paper that provides a road map of the network. Jeff Shuren, MD, JD, assistant commissioner at FDA’s Office of Policy, provided an update about the Sentinel Network at a risk management conference in May. He said that industry can expect the white paper in the “very near future.”

Establishing the postmarket surveillance network will be feasible if the agency is able to take advantage of current programs in both the public and private sectors.

Priorities of the network include rapidly identifying suspected risks as well as providing more information about known risks. Healthcare practitioners need up-to-date information about risk-benefit profiles. Part of the problem is that risk management strategies at the premarket phase are based on the best available information, which is often incomplete. “Current efforts tend to be crisis driven,” said Shuren.

Shuren noted a few areas on which the agency needs to focus when designing the network. Considering the volume and sensitivity of the information exchanged, the network will need to be able to protect patient privacy and data security while transferring data in real time. It’s possible that electronic health records would fit into this scheme.

He also suggested integrating a component involving safety biomarkers and pharmacogenomics. From a risk management position, this could help gather more information about patients before harm develops and help find better ways to identify which patients are prone to experiencing certain risks.

From a practical standpoint, the agency needs to look at what infrastructure it should use for the network, what kind of financing it will need for developing data-mining software, and how it can provide incentives to provoke industry participation.

Shuren strongly encouraged industry to give FDA feedback and suggestions about how to design the network. He also urged firms to support and advocate the network by getting involved in public collaboration.

– Maria Fontanazza

FDA and industry recently got together to negotiate renewal of medical device user-fee legislation. However, they left out any provision for postmarket surveillance.Such a provision had been included in the original Medical Device User Fee and Modernization Act of 2002 (MDUFMA), but the Republican-led Congress did not fund it.

Most mass media headlines faulting FDA’s performance on postmarket product safety have focused on drugs. However, agency deficiencies in the device industry have also been featured. Drug-eluting stents, defibrillators, breast prostheses, heart valve implants, infusion pumps, and contact lens solutions have all captured media attention.

Indeed, concerns have been intense enough to prompt CDRH to commission a study on bar coding for medical devices. And, last November, center director Daniel Schultz announced a Postmarket Transformation Leadership Team to enhance device safety in the marketplace.

So why was this entire issue left out of the second round of user-fee legislation?

Enter the new Democratic majority on Capitol Hill in the form of House Committee on Energy and Commerce Health Subcommittee chairman Frank Pallone (D–NJ). In a May 16 hearing on MDUFMA II, as the reauthorization is called, he described postmarket surveillance activities as “noticeably absent from this proposal.”

Asked to explain their absence, FDA assistant commissioner for policy Jeffrey Shuren explained the agency’s position. “If we can ensure adequate funding for the agency,” he said, “we will be in a fairly good place for postmarket safety.”

Although the user-fee reauthorization does not specifically address postmarket activities, the fees will still support necessary surveillance activities, he explained. For example, Shuren said, past funding has allowed the agency to hire experts. These experts provide “greater expertise in a variety of fields that is then integrated into our postmarket safety activities. In addition, we have a little more protection on appropriations that will go to the rest of the program, which will cover the remaining postmarket safety activities.”

Pallone asked whether the agency would support a congressional mandate that earmarked user fees for postmarket surveillance issues. Shuren said that FDA “would prefer [to] have the funding and then apply it as [it sees] fit.”

In explaining the reauthorization, Shuren said, “MDUFMA was about growth. It was about progressively increasing the size of the device review program through rapidly increasing funding linked to progressively more-aggressive performance goals. For MDUFMA II, we are recommending changes to fine-tune the program.” This includes getting funding to maintain a stable device review program and continuing to improve performance that is attainable through seasoned review staff and process efficiencies.

Shuren also highlighted three areas for refinement. “First, for premarket review performance, we are proposing to meet more-rigorous goals that build on the progress we made in the first medical device user-fee program,” he said. “The result would be a shortened decision time for several types of applications, including those for the most innovative devices. In addition, we are proposing several qualitative goals to continue to enhance the device review process and to make it more transparent.” For example, FDA has proposed additional steps to facilitate the informal interactions with manufacturers called interactive reviews. Such steps would make public more information about FDA’s performance.

“Second, to ensure financial stability for the review program, we are recommending a reasoned increase in user-fee revenues in the first year,” Shuren said, “followed by annual increases of 8.5% for the four years thereafter.” This system could help ensure that FDA has adequate resources to maintain a device review program, while providing the predictability and the fees for the duration of MDUFMA. Also, the establishment of two new fees will generate about 50% of the total fee revenue. (The additional fees are an annual establishment registration fee and an annual fee for filing periodic reports.) This revenue should stabilize FDA’s funding, enable it to lower the application fees, and provide a larger fee discount for small businesses.

“Third, we are recommending modest changes to the third-party inspection program,” Shuren explained. The changes are designed to encourage industry participation while maintaining safeguards against conflicts of interest. In addition, he said, a successful third-party inspection program will enable FDA to better focus its inspectional resources on high-risk devices.

Subcommittee member Henry Waxman (D–CA) urged that FDA be given more resources for device inspections. Since 2003, FDA has reduced medical device field investigators from 482 to 413, making it more difficult to perform mandated biennial GMP inspections. Shuren said that domestically, about 5500 facilities making Class II and Class III devices are eligible for biennial inspections. However, the agency is inspecting these firms only about once every four years.National Research Center for Women and Families president Diana Zuckerman urged lawmakers to add more device safety provisions in the legislation. She cited Bausch & Lomb’s recent problems with its 510(k)-cleared contact lens solution that caused eye infections and blindness. She said the agency should require clinical trials when potentially dangerous devices are modified. “MDUFMA II should make sure that the approval process protects consumers,” she said, complaining that performance goals would drastically speed up the 510(k) clearance process. (The goals would require 90% of 510(k)s to be reviewed within 90 days.) For premarket approval (PMA) application devices, review goals would also be faster. For those devices, 60% of PMAs and supplements would need to be completed within six months. Those time frames are considerably faster than what’s expected of drugs, she noted.

“MDUFMA II has performance goals for speed, but it needs performance goals for public health as well,” Zuckerman told the hearing. She noted that the user-fee reauthorization also lacks any fees for direct-to-consumer advertising reviews and adverse-event analyses. In addition, there are no fees for analyses to ensure that postmarketing commitment studies prove that products are safe. “Although FDA has flexibility to spend user-fee money however it wants, there’s just not enough money for all it needs to do.”

FDA Alliance executive director Steven Grossman echoed the concerns about resources. He said that since 2003, FDA has “lost about 20% of its buying power and has nearly 1000 fewer employees supported by appropriated dollars.” These deficits make it hard for FDA to recruit and retain the “best and brightest.”

Grossman said a $450 million increase in appropriated funding is needed to restore the agency to operational levels achieved in 2003. Of this, CDRH and related field activities should receive an increase of $72 million in FY 2008. “This would bring the center from its current $230 million to $302 million, not including user fees. Because devices employ cutting-edge science, CDRH needs these non-user-fee monies for additional staff to perform product reviews, assure pre- and postmarket safety, and facilitate innovative technology coming to market.”

– James G. Dickinson

The House on July 11 passed what it calls the FDA Amendments Act of 2007, which includes the new version of MDUFMA and a measure that provides grants and incentives for device manufacturers to develop pediatric products. Of course you’ll have to read way down in most mainstream media articles to find any references to the device industry, as what’s dominating the headlines is the measure’s giving FDA more power to regulate postmarket drug safety. But don’t be fooled, this is a significant development for the device industry, and one that appears to have support from both industry and consumers, both Democrats and Republicans. AdvaMed, for one, this morning issued a statement applauding its passage.

The bill must now be reconciled with the Senate version, which passed a few months ago. AdvaMed is pushing for a conference committee to be convened quickly so a consensus bill can be signed into law by the end of September, when the first version of MDUFMA expires. Time is of the essence here.

– From MD&DI’s blog.