A Secretive Agency Makes a Secretive Safety Appointment

The appointee, William Maisel, “is no figurehead,” an anxious-on-industry’s-behalf Med City News writer, Thomas Lee, reported in August.

“He will oversee auditing of CDRH procedures to ensure consistency and accuracy across the center. More importantly, however, Dr. Maisel will chair the new Center Science Council (CSC), a new body responsible for setting scientific standards for approving devices and issuing recalls.”

Opining on the face value of Shuren’s various public remarks that industry “will see much more transparency and certainty” from CDRH as it reforms its 510(k) program, Lee went on to fan the flames of anxiety that he knows are mounting out there.

Maisel’s new charge, CSC, “is still a little vague,” Lee reported, citing an FDA report that said part of its work should be to meet regularly and “be available, as needed, to discuss and vet potential changes in the center’s regulatory expectations on which staff at lower organizational levels wish to seek additional advice from a wider range of experts, or whose impact could be cross-cutting enough to warrant broad or center-level attention. Another role for the CSC relates to increasing the consistency of 510(k) decision making.”

What was missing from the FDA report was CSC’s potential role in resolving disputes between medical device companies and staff examiners. Maisel’s appointment will bring no comfort to medical device makers. As director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Massachusetts, Maisel has been “an outspoken safety expert,” Lee said, citing a trade newsletter.

This is disturbing to industry, Lee suggested. For example, Maisel criticized Medtronic Inc. for its handling of the massive recall of its Sprint Fidelis leads. “Manufacturers have repeatedly and knowingly sold potentially defective devices without public disclosure,” Maisel wrote in a 2008 article published in the New England Journal of Medicine. “For example, after identifying and correcting a design flaw that could cause premature depletion of ICD batteries, Medtronic continued to sell its inventory of potentially defective ICDs without public disclosure. Similarly, the two other major ICD manufacturers, Guidant (now part of Boston Scientific) and St. Jude Medical, have knowingly marketed potentially defective arrhythmia devices unbeknownst to the public.”

Lee ominously reminded readers that in the same article, Maisel concluded: “The welfare of medical device recipients must become a higher priority for FDA and manufacturers, and it is increasingly apparent that such a change will require congressional action. Essential consumer protections are currently lacking.”

Maisel is hardly the kind of man manufacturers would like to see being secretly added to a key position in FDA’s embattled—and formerly most industry-courting—program center. Under Shuren and his furtive appointee Maisel, CDRH is clearly slipping out of the industry bed it has been in for so long, and raising the focus on safety for a constituency that holds no financial stake in device approvals—the largely voiceless American public.

The cloistered nature of FDA’s personnel system has deepened under the Obama administration. Previously, personnel appointments were routinely announced and shared with interested media through open e-mail messages from the appointing manager, describing the individual’s background and closing with, “Please join me in welcoming…”

That openness faded away in the closing months of the Bush administration, and when I asked commissioner Margaret Hamburg and deputy commissioner Joshua Sharfstein during a private meeting for its restoration, they seemed disinterested but said they’d “look into it.” The curtain has not been lifted since.

Of course, there are theoretical detriments from a management point of view to outsiders knowing who at FDA is or might be looking at their stuff—inappropriate contacts might result, interfering with management’s control of a matter.
Under both Bush and Obama, no information may reach inquiring reporters about CDRH appointments except through designated CDRH press officer Dick Thompson. Asked to respond to Lee’s article, and to provide Maisel’s bio and date of appointment, Thompson did not respond.

More FDA Secrecy on LASIK Outcomes Study

FDA is maintaining stoic silence on persistent questions about the protocol and the principal researchers for a long-term LASIK eye surgery patient-experience study it asked the Department of Defense (DoD) and the National Eye Institute to conduct in October 2009.

The study, which is due to report in 2012, has been called “conflicted” by LASIK critics because the DoD component, the U.S. Navy Refractive Surgery Program in San Diego, has publicly testified in favor of the surgery and performs it for all DoD service arms. The challenged study involves military service personnel who have undergone the procedure.

At a CDRH advisory committee public hearing on LASIK in April 2008, U.S. Navy Refractive Surgery Program director David Tanzer presented data indicating that more than 98% of naval aviators who had undergone LASIK surgery said they were either “extremely satisfied” (90.9%) or “moderately satisfied” (7.2%) with their results.

Based on these data, plus a 95.4% satisfaction rate reported to FDA in preapproval IDE clinical data, DoD has been encouraging vision-impaired service personnel to undergo the procedure at government expense, eliminating their need for glasses and contact lenses and thereby improving their performance on the battlefield. However, the data source for this high satisfaction rate remains secret, and this rate is considerably higher than publicly available data.
In the LASIK procedure, a U-shaped flap is cut in the surface of the cornea and a laser is used to reshape the cornea to enhance vision. The flap is then put back in place, but according to critics, it never heals and remains susceptible to accidental dislodgement and infection. In some cases, these conditions may lead to deferred, later-life permanent vision impairment, blindness, depression, loss of employment, and suicide.

An estimated 4 million LASIK surgeries—quadruple the rate nine years ago—are performed in the United States each year at vividly advertised prices as low as $299 per eye. According to a premarket clinical data analysis by former CDRH ophthalmic surgery devices branch chief Morris Waxler, who led the 1998 review and approval of lasers used in these surgeries, there had been an overall long-term success rate for LASIK of less than 50%. Long-term postmarketing data, he says, confirm the premarket incidence (15% or higher) of adverse events leading to permanent vision problems including (but not limited to) dry eye, haze, night driving problems, blindness and suicidality caused by these FDA-approved devices in the commercially exploited civilian population.

FDA has agreed to study this issue, but details of the study have been kept secret. Innumerable requests since March for the names and affiliations of its principal researchers and for a copy of its protocol have gone unanswered by FDA’s press office, now the sole portal for news media access to internal agency information. The office’s former head, George A. Strait, once said he saw its function as “telling the good news about FDA,” and the office consequently is not known for releasing negative news about the agency’s activities—which agency complicity in an allegedly biased LASIK safety study would seem to be.

It could be argued that maintaining military confidence in the LASIK procedure is a national security issue, justifying FDA’s suppression of the 15%-plus long-term real-world failure rate through agency adherence to the preferred 4.6% rate submitted in premarket data that supported LASIK device approvals 12 years ago.

FDA’s acceptance of the smaller number has recently been publicly recanted by Waxler, who is now retired and working with injured LASIK patients campaigning for beefed-up FDA warnings and marketplace enforcement. Earlier tis year on ABC’s Good Morning America, Waxler criticized the data on which he says his team erroneously approved the LASIK lasers in 1998. Since that television appearance, FDA has asserted that the data were not flawed, but have not provided substantiation for that claim.

In retrospect, it may seem important for FDA to conceal the shortcomings of that approval and the newer data showing a much higher failure rate for LASIK than was seen in the data supporting the device approvals. After all, if military service personnel elected not to undergo the procedure because of a reputed threefold higher risk of postservice and long-term vision impairment, battlefield consequences could feasibly endanger military objectives and even national security.

Asked to comment, FDA’s press office and senior agency management did not respond.

AdvaMed Calls Infusion Pump Guidance “Premature”

AdvaMed says FDA’s announced intention to convert its draft infusion pump guidance into a special control is premature at this time. In recent comments on the guidance, AdvaMed says deferment would allow FDA and manufacturers some flexibility to meet FDA’s objectives.

“Although FDA has given thought to the draft guidance and to the new requirements it will impose on infusion pumps in order to improve the safety profile of infusion pumps,” the comment letter says, “manufacturers may develop more effective mechanisms to meet FDA’s objectives and requirements than can be predicted now at this early stage.

Additionally, as manufacturers strive to meet FDA’s new objectives and as infusion pumps change over time, there will inevitably be new issues and questions that arise. Guidance enables FDA and manufacturers to pivot more quickly to address those questions and issues than does a special control regulation.”

If FDA proceeds to convert the guidance to a special control, AdvaMed says it recommends that the agency allow sufficient time for implementation of the new, final guidance to ensure that there are no unforeseen issues that are then transferred to the special control regulation.

The letter also raises concerns and makes comments on assurance case reports, clinical evaluations, preclearance inspections, different technological characteristics, different pump types, legacy devices, and changes to marketed pumps.

Meanwhile, in submitted comments, the Medical Device Manufacturers Association (MDMA) challenged many aspects of the draft guidance, saying that while some of its elements are warranted, others are overly broad and opaque. “Failure to address the points raised [...] will create more uncertainty for companies developing these important products and as a result, patients suffering from severe pain, cancer, and other ailments may not have access to the most effective therapies,” it said.

MDMA also raises serious concerns about FDA’s process in developing and implementing the guidance. It says the agency’s announcement that it is treating the draft guidance as being immediately effective before stakeholders have an opportunity to comment and for those comments to be incorporated is inconsistent with Good Guidance Practices regulations and with agency efforts to enhance transparency and communication with various stakeholders.

The group encourages FDA “to wait until the public comment period is concluded, review, and incorporate the comments provided by stakeholders, and issue a final guidance based upon this feedback,” the comments say. MDMA wants the final guidance to “recognize the unique characteristics of various infusion pumps, provide data in support of new recommendations, and afford medical device manufacturers a reasonable timeline in which to comply with the new policy so that patient access to these important products is not impacted.”

In its comments on the document, the Combination Products Coalition praised FDA on its stakeholder outreach and discussions and said it agrees with the guidance’s general principles concerning information and data that should be submitted in a premarket notification submission for an infusion pump.

But the coalition called on FDA to clarify that the guidance document relates only to noncombination products. It said that some of the guidance’s concepts could be misinterpreted as applying to drug-device or biological-device combination products. The long-standing regulatory position of FDA and industry is that infusion pumps and the drugs or biological products they dispense are not considered combination products.

FDA and FCC Coordinate on Wireless Medical Devices

FDA and the Federal Communications Commission recently spent a day and a half listening to industry and others on how to keep up with and not hinder the wireless medical devices revolution. FDA commissioner Margaret Hamburg, who was at FCC for the first time, told the session that “To harness the full power of the devices’ benefits, we must improve the efficiency of the regulatory processes where the two agencies’ jurisdictions’ overlap and jointly understand the challenges.”

She said the range of wireless devices could “reduce costs, bolster quality, and benefit both patients and providers by making health data and information immediately accessible for patient care,” possibly changing the face of medicine forever. Noting that the first national broadband plan, released by FCC in March, “commits the agencies to clarifying and streamlining the regulation of converged communications and healthcare devices,” she asked attendees to speak freely about concerns over regulatory requirements and potential barriers.

In the coming months, FDA will issue a draft guidance, informed by the meeting, on “how to approach mobile apps that are truly medical devices,” and facilitate innovation, Hamburg said.

She and FCC chairman Julius Genachowski signed a memorandum of understanding at the meeting committing their agencies to coordination on medical devices. Genachowski said the “enormous benefit” of FCC and FDA working together became clear during his agency’s outreach for the healthcare chapter in the broadband plan.

Hamburg also noted that as she walked around the displays of medical devices at the meeting, she also realized they “would make an enormous difference to families [and] caregivers in homes and communities.”

Among the current or expected devices described during the meeting were a “smart Band-Aid” that continuously reads an individual’s vital signs and sends them to a monitor; remote diagnostic devices; technology to allow patients to get care from a specialist thousands of miles away; and devices that track patients’ glucose level or cardiovascular data.
A number of speakers indicated that the innovations are outpacing best practices standards as well as regulation.

MedApps CEO Kent Dicks said that when his company got its first FDA clearance a few years ago for a smart phone application, the agency had not previously dealt with that kind of innovation. He said both the company and the agency had learning to do. MedApps had to train a new reviewer in a different FDA department each time as it added capabilities, such as in vitro testing and cardiology. He did say he thought that situation is improving.

Tom Watlington, head of Sotera Wireless, asked the agencies not to be perfectionists. For instance, he said there are times when wireless connections with devices will be lost, but those issues can be ameliorated through patient education and through devices that can tell the patient they are outside the network’s range and can thus store data to forward it later. That’s where FDA will play a major role “with its expertise in risk management and human factors
 design,” he said.

Dexcom chief technology officer Jorge Valdes urged the agencies to stay flexible in what they allow, noting for instance that consumers already expect the excellent color and graphics available on smart phones. He asked the agencies to clarify where the regulatory authority sits between them. Valdes also asserted that “plenty of technology” already exists in financial and consumer applications to deal with devices’ reliability and security, so the agencies should not reinvent the wheel in that arena.