FDA to 2013: Good Riddance

Posted in Regulatory and Compliance by Chris Wiltz on December 4, 2013

 For medical devices, the year in Washington, DC, turned out to be a bummer.


The best way to sum up 2013’s balance sheet in Washington, DC, with respect to the advancement of medical device law and regulation may be “good riddance!” 

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This was the year when nothing seemed to work. No amount of lobbying bent, moved, or even dented the new medical device excise tax provision of the Affordable Care Act. Meritorious legislation to protect and advance technological innovation withered on the vine. FDA promised much in the way of guidance and expedited processes but delivered little. The federal government shutdown in October worsened everything in ways still being assessed.
The year gave scant comfort to those in the less-government-is-better camp; the less we got during the shutdown, the quieter they became on the regulatory fringes, marooned with their wider-world compatriots in the collective hope that by election day most people will have forgotten the misery of stymied (also known as less) government.
No Support for Healthcare Innovation Bill 
We started the year with an optimistic report here about a new congressional bill from Representative Mike Honda (D-CA). Titled the Healthcare Innovation and Marketplace Technologies Act (H.R. 2363), the bill was aimed squarely at helping medical device startups.
Because Honda, a former science teacher, has practically no technology experience or visible following in the device-heavy Silicon Valley–San Jose district he represents, one is left to assume that this bill was written with a lot of good input from parties like Akin Gump, a legal and lobbying firm that has plenty of both and is a Honda campaign contributor.
If you want to know how useful your support of your local congressperson is, consider this bill’s fate: Six months after its introduction, the Web site showed it as having been referred to committee but rated its chance of getting reported out at a big, fat zero. For one thing, the bill did not have a single cosponsor and had attracted no comments. The Web site PopVox shows the bill as having no organizations endorsing it and no constituent input.
Honda, a seven-term Democrat, is now under severe challenge in California’s June 2014 primary election from fellow Democrat Ro Khanna, a lawyer and former Commerce Department official who has reportedly raised four times as much campaign money as Honda—none of it from the medical device industry.
Honda’s going-nowhere bill would do the following:
  • Establish an FDA Office of Wireless Health to coordinate with other government agencies and private industry to provide recommendations to FDA on how to develop and maintain a consistent, reasonable, and predictable regulatory framework on wireless health issues.
  • Establish an mHealth developer support program in HHS to help mobile application developers build their devices in line with current privacy regulations.
  • Create a prize program and small innovator challenge grants that incentivize risk-taking and attract outside investment to stimulate new approaches.
  • Create a low-interest small business loan program to help clinics and doctors’ offices purchase new health information technologies and services.
  • Establish two-year grants to assist medical care providers in retraining their employees into new positions that use health information technology.
All are laudable and seemingly well-informed provisions, but the bill’s miserable performance is a dark monument to Washington dysfunction. [Back to Top]
MDIC is Slow on the Gas Pedal 
In February we reported on another initiative failed to rattle Washington’s rafters: FDA’s excited announcement of the Medical Device Innovation Consortium (MDIC), an independent, nonprofit corporation created in collaboration with the trade association LifeScience Alley.
Although the MDIC was touted by the agency as an engine to “prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations,” it has conducted only one joint activity with FDA, and even that did not align with the announcement’s stated goals. The event was a public workshop in September on incorporating patient preferences into FDA device regulatory processes, and it drew only nine comments on, none of which had been posted at press time because of the government shutdown.
That shutdown, combined with the government-wide budgetary sequester, is probably more to blame than any other factor for MDIC’s less-than-stellar start. With 33 members, in August it announced that it had appointed a full-time president and CEO—William V. Murray, formerly of Envoy Medical and Medtronic—and set up its first three projects: computational modeling and simulation, patient-centered benefit/risk assessment, and clinical trial Innovation and reform. [Back to Top]
FDA’s Mysterious Misclassification of Devices
In March, we reported a big jump in FDA enforcement against medical device companies—not the sort of thing that warms the cockles of industry hearts.
It came in the form a $99 report from the Greenleaf Health consultancy, which is staffed with numerous ex-FDA heavyweights, that analyzed FDA compliance and enforcement data plotting an Obama-era surge in four areas of CDRH enforcement: inspections, FDA-483 observations, warning letters, and that perpetual bane of device industry performance, product recalls. The report found an almost 40% increase in CDRH inspections since 2008, almost 30% more warning letters to medical device companies, and more than a 250% increase in device recalls since 2007.
Others weighed in. Compliance firm Stericycle reported a 30% increase in recalls during the first quarter of the year, and quality assurance and regulatory affairs consultancy Emergo Group noted a 47% increase in inspections over three years. None of these numbers could be confirmed by FDA, even though the data in question are all FDA-generated.
The people who track and report such things at FDA were backlogged in their sequester-stifled work. And, increasingly, there are two prisms for looking at the agency’s performance: One is what FDA is actually doing, and the other is what FDA tells us it is doing. Who’s to say they are the same?
FDA’s Web site, for example, shows device recalls and inspections by manufacturer name, fiscal year, and month—each lagging far behind real time. This and the overlaps (or underlaps) between the government’s fiscal years and the calendar years used by the world beyond the Beltway combine to allow confusion and perhaps mischief.
In both April and May—in a rare example of an FDA story advancing across two consecutive months—we reported how ex-CDRH engineer LeRoy Hamilton had discovered a willfully ignored CDRH definitional error that, he contended, allowed FDA to classify dozens, or possibly hundreds, of devices into Class III that didn’t need to be there.
As a bureaucracy probably like most others across the government, FDA has a bad habit of ignoring squeaky wheels that keep pointing out a deep-down, obscure error in its work, and all the more so when the squeaker is a tad on the eccentric side, as Hamilton admits he is.
Hamilton says he found flawed logic in a prior version of FDA Form 3429, which is intended to guide staffers and industry, step-by-step, to determine the class a particular device should go in. Hamilton said a “no” answer to two questions meant that the device in question could go to market without going through the PMA process, but for decades, he says, CDRH had been ruling the opposite.
MD&M West will be holding conference sessions, "FDA & Global Regulations in Practice" Feb. 10-13, 2014 
Almost everyone Hamilton talked to about this, inside and outside the agency, disagreed with him except for Larry R. Pilot, a former FDA device compliance director who helped write the 1976 Medical Device Amendments and who is well-known for faulting many of CDRH’s interpretations of that law and its latter-day implementation.
Hamilton’s persistence won him a 20-minute telephone conference call with CDRH director Jeffrey Shuren and deputy for policy Nancy Stade, during which they conceded he had been correct all along but that the matter was now moot because the form had been corrected already. 
In a letter she’d already sent to Hamilton, Stade asserted that FDA “is aware of no devices that have been misclassified into Class III as the result of Form FDA 3429.” His petition contained insufficient information to support his claim that certain devices had been misclassified, she wrote.
Answering me on this point through the FDA press office, Stade said that the defective Form FDA 3429 had not been used to classify any of the 17 allegedly misclassified Class III devices Hamilton said he had discovered.
When I shared this startling information with Hamilton, he was at first incredulous. In his many attempts over more than eight months to get precisely this information from various people in CDRH, none had come forward with it. Indeed, they shunned his questions.
Stade’s disclosure to me raised the question in both our minds: How did the 17 devices get into Class III if not by the questionnaire? Indeed, what use is the questionnaire at all if it plays no part in classifying devices?
On first impression, none of the 17 devices (and Hamilton emphasizes there may be more he did not detect) seem to meet the statutory definitions of a Class III device in that they are not life-supporting or life-sustaining, they are not for a use which is of substantial importance in preventing impairment of human health, and they do not present a potential unreasonable risk of illness or injury.
Viewed in retrospect, this episode seems yet another example of the oft-repeated lesson that FDA never admits a mistake. [Back to Top]
The Need for Cybersecurity
In August, we reported something from FDA that bears repeating frequently: A “safety communication” to the industry on the risk of cyber attacks and how to strengthen medical devices against them.
Part of a government-wide appeal to all vulnerable industries, FDA urged device manufacturers and healthcare facilities to take steps to ensure that appropriate safeguards are in place to reduce the risk of failure due to cyber attack that could come through introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks. 
The alert identifies such risks as the following:
  • Network-connected/configured medical devices infected or disabled by malware.
  • The presence of malware on hospital computers, smartphones, and tablets targeting mobile devices using wireless technology to access patient data, monitoring systems, and implanted patient devices.
  • Uncontrolled distribution of passwords, disabled passwords, and hard-coded passwords for software intended for privileged device access (e.g., to administrative, technical, and maintenance personnel).
  • Failure to provide timely security software updates and patches to medical devices and networks and to address related vulnerabilities in older medical device models (legacy devices). 
  • Security vulnerabilities in off-the-shelf software designed to prevent unauthorized device or network access, such as plain-text or no authentication, hard-coded passwords, documented service accounts in service manuals, and poor coding/SQL injection.
Among explicit recommendations in the alert is advice to manufacturers that they “take steps to limit unauthorized device access to trusted users only, particularly for those devices that are life-sustaining or could be directly connected to hospital networks.” [Back to Top]
CDRH Under Financial Threat
In September, we reported an alert from a subcommittee of FDA’s Science Board on “financial and strategic threats” confronting CDRH’s regulatory science and engineering programs.
Its 37-page report warned that politically imposed loss of federal investment in CDRH regulatory science “will interfere with the regulatory approval of emerging technologies and, in doing so, cost lives. With the medical device industry setting a record pace in advancing life-saving technology, there is no more pressing need at FDA than to fund fully a robust and successful CDRH regulatory science program.”
On the basis of two site visits to CDRH, the subcommittee found that, among other things (including much scientific excellence among existing staff), there are focus deficits in that “the existing spectrum of projects is not sustainable in the current environment. We advocate for continued vigilance about the need for a focus of CDRH on research that directly impacts regulatory science and serious consideration of reorganization in structure and leadership in the research arm of CDRH and in particular OSEL to achieve this goal.”
The report found, as other have before it, that there’s a disconnect between what center management clearly sees as the scope and intent of the mission and what is understood by “some members” of the center’s research team at lower levels. [Back to Top]
Hamburg Preaches Optimism
Finally, as this discouraging year comes to a close, consider the optimism in sequester- and shutdown-beleaguered commissioner Margaret Hamburg’s words to the annual AdvaMed conference in Washington, DC, in September: an official promise of increased cooperation and collaboration between the agency and medical device industry.
Delivering a plenary address at the conference, Hamburg said FDA wants to “work closely with you to promote the development of quality, innovative medical devices through predictable and smart regulations. One of our primary goals is to bring additional regulatory predictability, consistency, and transparency to the process. To achieve this, we will continue to be ready to work with the medical device industry and to listen and respond to your needs . . . and we seek to be thoughtful, flexible regulators as we consider adapting or implementing new regulations policies and procedures.”
FDA inspections and other types of enforcement mechanisms should not be the only ways to ensure the consistent quality of devices, Hamburg said. “It is our hope to complement our traditional regulatory activities with a more collaborative regulatory model and include the development of stronger partnerships and increased coordination from the agency, industry, and other stakeholders.” 
To accomplish this, she said the agency is supporting an ongoing initiative called the case for quality. “It seems only logical that greater collaboration and coordination will produce higher quality products, lower costs, and enhance public health,” she said. “Certainly, from the standpoint of limited resources and growing global production, I think we will all benefit by rethinking our approach. We are looking forward to working with you to strengthen the drivers of quality . . . and there will be many areas where we will seek your input and collaboration.”
But, as is often said, “it takes two to tango.” First, FDA must assertively reach out with believable sincerity, and second, industry, if it isn’t too jaded by Washington’s serial inability to deliver, must respond in kind.
This year doesn’t provide much of a record to build on. The impact of the government shutdown and its loss of 12 working days alone will take a long time to recover from. The Alliance for a Stronger FDA says this is because of the accumulative effect of new work that is coming in at an even faster clip because of delays caused by the shutdown.
As the alliance’s deputy executive director, Steven Grossma,n writes in an online commentary:
When you consider food, medication, devices, dietary supplements, pet food, and drugs . . . most people are touched by the FDA every day, often a dozen times or more. The agency is not an optional part of government, but rather is critical to the fabric of life and commerce. 
As reporters and citizens understand this, they can appreciate that it takes manpower (and therefore money) to have the benefits of innovation and the assurance of safety. [Back to Top]
Jim Dickinson is a contributing editor to MD+DI.


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