"Oh what a tangled web we weave when first we practice to deceive!” Scottish poet Sir Walter Scott famously wrote in 1808. Exactly 200 years later, CDRH seems to be unintentionally weaving a very tangled web over its surveillance of LASIK (laser-assisted in situ keratomileusis) device effects.
To a historically unprecedented degree, FDA now controls what the public knows about its decision making. Except for disclosures coerced by other parts of the government, chiefly federal courts or congressional investigations, FDA is the sole determinant of what is known and when it is known.
A rare peek into this process may be had by examining CDRH's role in regulating the use of LASIK devices.
Reliable statistics are hard to come by, but there have been published estimates that about 7.6 million vision-corrective LASIK procedures have been performed in the United States, for a 95% patient satisfaction rate, out of some 8000 ambulatory surgical facilities (a 2007 USA Today estimate). For all this traffic, there are 15 FDA-approved LASIK devices.
A 95% patient satisfaction rate implies a 5% patient dissatisfaction rate, which translates to 380,000 dissatisfied recipients of LASIK surgery, based on the figures above.
For this estimated volume, CDRH's MAUDE database in September showed only 194 product problem reports since 2000 for ophthalmic lasers. The database, of course, does not record patient dissatisfaction.
However, there has been so much dissatisfaction that, in April 2008, CDRH held a meeting of its Ophthalmic Devices Panel specifically to address patient experiences with LASIK surgery.
This meeting is where the center's web begins to get really tangled. The meeting elicited 252 written comments from LASIK patients for the record, which FDA has posted on its Web site at www.fda.gov/ohrms/dockets/ac/08/written%20comments/2008-4353-written%20comments-00-index.html.
A quick scan of these comments in August showed that all but two had been redacted to delete all information identifying patients, devices, surgical facilities, surgeons, and manufacturers. The redaction was so complete that not even geographical locations of events survived, rendering the posted comments all but useless for any purpose.
One representative remnant of a comment was left to read:
I have recommende[REDACTED] edure several times, and I will keep doing so. I know two people who had LASIK with[REDACTED]and, like me, do not regret it. I understand that every case is different and I strong[REDACTED]that the doctor's role, dedication and honesty are essential to the success of the procedure.
Why the censorship? 21 CFR 20.103 says all public comments received by FDA are to be available for unredacted disclosure. My inquiries initially produced some bureaucratic evasion. One FDA employee even suggested that the Health Insurance Portability and Accountability Act, which since 1996 has guaranteed patient privacy, might be to blame. But that law applies to the provider community and exempts federal agencies such as FDA.
Outsiders' inquiries must go through channels, which in my case meant through the press office. Days passed, and to cut a long story short, eventually two contradictory explanations were offered:
- Because most of the commenters “were not informed that written comments could be posted on a public Web site...CDRH opted to ensure the protection of personal privacy information and redacted personal, patient, and doctor information from the written comments received.” Moreover, other redactions were made because “device and manufacturer names are often associated with a particular LASIK center...[and] were removed uniformly to prevent association of either negative or positive comments with a particular LASIK provider.”
- Rather than CDRH “opting” to redact certain information, FDA established a “policy” of not posting individual consumer comments at all “due to the high number of individual consumer requests to remove their names and comments from the FDA Web site. In addition, if there is any personal information contained in the comment, it is not posted. Therefore, any comment which contains ‘individual consumer' in the ‘Submitter Category' or personal information in the comment, does not get posted to the FDA Web site.”
This despite the fact that 252 such comments remained posted, albeit in redacted form.
Patients claiming injuries from their LASIK procedures took to the blog-osphere to allege that FDA was in a conspiracy with the American Society of Cataract and Refractive Surgery to suppress bad news about the wildly popular and profitable procedure.
Meanwhile, FDA on Sept. 12 opened a formal public docket to receive public comments on LASIK experiences, which it said in a Federal Register notice “may be posted to the FDA's Web site for public viewing.” The notice did not say that personal or other identifying information would be redacted from such comments.
As to the agency's claim that it now has a “policy” of not posting such comments to its Web site, Washington attorney Larry Pilot, of McKenna Long & Aldridge LLP, promptly challenged the agency in an e-mail in which he said the policy was new to him. He asked for a copy of the policy “along with related supporting documents. In addition,” he said, “please identify the statutory reference that supports such policy and explain how this policy is reconciled with specific language appearing in FDA's [Freedom of Information Act] regulations appearing in 21 CFR Part 20.” That's the regulation stating that public comments to FDA are just that: public.
Further tangling the LASIK web is the fact that CDRH does indeed have a partnership, as its LASIK-dissatisfied critics complain, with the American Society of Cataract and Refractive Surgery. The agency has said nothing publicly about the policy, possibly fueling the suspicion and conspiracy theories being advanced in cyberspace. But according to the society's Web site, the partnership also involves the National Eye Institute and the American Academy of Ophthalmology. The society created a joint LASIK Task Force to study LASIK vision correction and its effect on the quality of patients' daily lives.
Schultz seeks to dispel the idea that no action has been taken since the public meeting on LASIK devices and procedures.
Acknowledging the frustration—if not its cause—that dissatisfied LASIK patients have been expressing, CDRH director Daniel Schultz said in September that his center is “putting together a total strategy for LASIK, and we are trying to get some of the stuff that we are doing out [to the public].” Speaking after an appearance at the Regulatory Affairs Professionals Society's annual meeting in Boston, Schultz acknowledged that “there is this sort of vacuum of information that looks like we had the public meeting and [that] nothing has happened. That is not right.”
According to my online research the same day, CDRH's Web site for LASIK had not been updated since March, a month before the aforesaid Ophthalmic Devices Panel meeting that heard scads of patient testimony about injuries.
Without referring to the lack of update on the Web site, Schultz said, “We need to figure out how to get the information out. There are a lot of angry people, no question, and I think we need to be careful when we put information out, recognizing that there are [also] a lot of happy people out there.”
Pilot and others believe that information should have been made public long ago, however.
Asked whether inspections would be part of the center's plan or whether there was a resource issue involved, Schultz answered: “No, I don't think it is so much a resource issue. I think it should be part of an overall coordinated plan.”
GE Healthcare Warned on Centricity QS, MDR
An FDA inspection begun last April at a GE Healthcare facility found quality system (QS) and medical device reporting (MDR) violations, according to an Aug. 12 warning letter from FDA's Chicago district office. The action concerns the firm's Integrated IT Solutions manufacturing facility for Centricity Imaging and other picture archiving and communication system products, located in Barrington, IL.
Violations noted on the FDA-483 included poor procedures for handling quality data, poor complaint-handling procedures, failure to submit and document a number of MDRs, failure to report corrections and removals, and failure to investigate the cause of adverse events.
The warning letter said some of the company's June 2 responses appeared to be adequate, while others were inadequate because results of promised retrospective reviews had not been submitted.
The company was told to respond within 15 days on specific steps taken to correct the violations, including an explanation of the plan to prevent the violations from recurring, documentation of corrective actions taken, an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not occur again. The company must also submit a timetable for implementing corrective actions.
FDA and ICE Serve Search Warrant on Spectranetics
FDA and U.S. Immigration and Customs Enforcement (ICE) served a search warrant on Spectranetics Corp. (Colorado Springs, CO) on Sept. 5. The warrant asked for information and correspondence related to the
• Promotion, use, testing, marketing, and sales of company products for treating in-stent restenosis, and payments made to medical personnel and an institution for that application.
• Promotion, use, testing, experimentation, delivery, marketing, and sales of catheter guidewires and balloon catheters manufactured by third parties outside the United States.
• Two postmarket studies completed during 2002–2005 and payments to medical personnel in connection with the studies.
• Compensation packages for some company staff.
Spectranetics said it is cooperating fully with the authorities.
CDRH Enforcement Actions Decline
Enforcement by the Numbers
CDRH enforcement actions declined significantly in fiscal year 2008, which ended Sept. 30. On Sept. 15, center director Daniel Schultz told the Regulatory Affairs Professionals Society's (RAPS) annual meeting in Boston that there had been no device-related seizures, injunctions, or civil money penalties for FY 2008, with data collected for 11 of the 12 months. This compares with four seizures, four injunctions, and one civil money penalty case in the previous year. And in FY 2006, CDRH was involved in four seizures and one civil money penalty, but no injunctions.
Device-related warning letters also were on a downward trend in FY 2008, with 134 being issued through Aug. 30, according to Schultz. In 2007, 155 warning letters were issued, and in 2006, there were 154. And recalls are on pace to be down about 11%, with 537 so far reported through Aug. 30, compared with 661 in 2007.
“Basically, we take the actions that need to be taken,” Schultz told RAPS. “We are not looking to take more actions, and we are not looking to take fewer actions. We are looking to take the right actions to be able to achieve compliance. We much prefer to do it through a well-placed warning letter or a well-placed FDA-483 and have those things fixed so we don't have to go on to the next steps. ”
Schultz said the top priority in FY 2009 is to develop and begin implementing a CDRH import safety strategy.
Schultz said developing a unique device identification (UDI) system also remains a priority for the center, and this is receiving increased attention after being added to FDAAA. He said that CDRH is now well into developing a regulation, which will require medical devices to bear a UDI to
assist in identifying and, if necessary, recalling problematic devices, as mandated by the law. “This has to happen sooner rather than later,” he said.
CDRH's Other Priorities
Although developing an import safety strategy is CDRH's top priority, the center's other priorities include the following:
- Implementation of the center's postmarket transformation, including successful integration of the matrix network into CDRH's daily activities.
- Improved product access through continued implementation of the FDA Amendments Act of 2007 (FDAAA).
- Successful transition of all CDRH operations to the White Oak, MD, consolidated campus.
- Developing and implementing a knowledge-management strategy that maximizes the potential of every CDRH employee and advances every aspect of CDRH's mission.
Clinilabs Chief Medical Officer Heads New FDA Unit
FDA has selected Jonathan Sackner-Bernstein, MD, chief medical officer of contract research organization Clinilabs, as CDRH's new associate director for postmarket operations.
Since Sept. 2, he has been overseeing the center's recently created matrix structure, which comprises 13 networks each responsible for a specific product category or activity.
“Each network brings together experts from various functional areas within the center, spanning premarket review to compliance and postmarket surveillance, forming cohesive groups focusing a wide variety of expertise on identifying, analyzing, and acting on specific postmarket issues,” an agency statement said.
“Dr. Sackner-Bernstein will supervise the work of the networks by providing clear direction and priorities, fostering the development of a common vision, and clarifying roles and responsibilities. As a member of the center's senior leadership team, he will also act as a liaison between the networks and senior center management.”
Sackner-Bernstein previously served on CDER's Cardiovascular and Renal Drugs Advisory Panel and CDRH's Dispute Resolution Panel.