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008: High and Low Notes for FDA Enforcers, Budgeteers

Between litigation, moving staff abroad, and assuaging unhappy constituents, FDA had quite a busy year.

WASHINGTON WRAP-UP

The David-and-Goliath medical device report (MDR)–filing struggle between tiny TMJ Implants Inc. (TMJI) and FDA labors into its fourth year. Meanwhile, the agency ends 2008 with a mixed bag on its other medical device enforcement cases—as it does on resources for its device program generally.

FDA fared better than most other federal agencies in gaining $325 million (about 19% more) under an emergency “war” supplemental for the balance of FY 2008. The agency also gained more funding under a continuing resolution for next year—including $20.1 million more for CDRH field activities.

The nature of congressional continuing resolutions, as opposed to formal budgets, makes dollar breakdowns for specific FDA program areas difficult to discern. Before the election, the FY 2009 budget seemed hostage to both the makeup of Congress and the economic meltdown, while the continuing resolution provided temporary respite.

Litigation

On the enforcement “plus” side, FDA secured a consent decree against Medtronic's Physio-Control unit in April, and three months later settled a civil money penalties case against cochlear implants manufacturer Advanced Bionics for $1.1 million, half of what FDA originally sought. Both cases involved GMP and quality system regulation manufacturing violations. In addition, FDA said in May that GE Healthcare Surgery had satisfied criteria in a January 2007 consent decree and could resume shipping its OEC 9900 Elite C-arm fluoroscopy device.

On the “minus” side, FDA lost—as it usually does—two contested court cases. One was against Consumers for Dental Choice in May, in which the agency surrendered to demands that it move against dental amalgams that contain mercury. The outcome was officially termed a fault-free “settlement” for face-saving reasons, but the consumer group got much of what it wanted. The other, in April, saw orthopedic implant maker Endotec defeat FDA in four out of five “custom device” counts.

Andrew von Eschenbach (left) and other FDA officials have visited their Chinese counterparts before, but now the agency plans to establish full-time positions in China.

Somewhere in between, the agency's amicus role in the Riegel v. Medtronic Supreme Court FDA preemption case was decided in February in Medtronic's favor. The agency thought a federal determination of a premarket approval product's safety and effectiveness should trump any other such findings in state courts. That reflects Bush administration policy.

However, it is interesting to note that agency policy had previously been against preemption, and it may revert to that when a new administration takes over. In the meantime, the new Congress will be dealing with legislation to override the High Court's decision.

And the lingering $340,000 TMJI civil money penalties case remained unresolved in the 10th Circuit U.S. Court of Appeals as this column was written. The company argued that CDRH-written warning letters it had received about its failure to file 17 medical device reports (MDRs) did not represent FDA's final word on the matter because the agency's commissioner had not dealt with TMJI's appeal.

In addition to highlighting the disconnect between lower-level CDRH actions and top-level FDA final actions, the TMJI case raised other intriguing issues. One such issue is whether a medical device company is entitled to get clinical-level explanations from the center of its determinations that an MDR is required. The case also raises the issue of whether an appeal to the commissioner about a center-level decision demanding an MDR filing constitutes a “contract.”

The company contended that it was deliberately “ambushed” by FDA's mislaying of its appeal while the civil money penalties complaint against the firm was prepared.

The agency denied the allegation, although Commissioner Andrew von Eschenbach informally admitted a “process failure.” Government lawyers formally countered in the Denver federal appeals court that if companies were allowed to subjectively decide for themselves which adverse events to file, it would render the whole MDR program unworkable.

Imported Devices and Components

At the height of public concern over contaminated imports, mainly from China, FDA commissioner Andrew von Eschenbach announced plans in March to place resident FDA investigators in foreign countries.

He said that the agency had received State Department approval to establish eight full-time permanent FDA positions at U.S. diplomatic posts in China, pending authorization from the Chinese government. An agency release said it would hire and place the new FDA staff in China over the next 18 months and would also hire five local Chinese nationals to work with them at the U.S. embassy in Beijing and at the U.S. Consulates General in Shanghai and Guangzhou.

In September, von Eschenbach gave a status report on this program, dubbed the “Beyond Our Borders” initiative, at a Brookings Institution conference. In addition to three Chinese offices “coming online” then, the agency expected to have offices in India and Latin America by the end of the year, in Europe in 2009, and “hopefully, ultimately, the Middle East will follow,” he said.

In October, he laid out a plan to place 60 FDA regulators around the world throughout the following year. The plan is expected to cost about $30 million in its first year.

“We will work with our complementary regulatory agencies. And where they need to build capacity, we will partner with them to bring their regulatory processes up to a level that is considered consistent with a global standard,” von Eschenbach said. The process is also allowing FDA to work with agencies, he said, such as those in Canada, Japan, Australia, and Europe, “where we have much sophisticated regulatory capacity to create much greater harmonization and integration.”

In October, HHS released a statement providing a few more details. The department announced that staff will be posted in the Shanghai and Guangzhou regions of China next year, and that HHS secretary Mike Leavitt was scheduled to travel to China in November to meet with Chinese health officials to “review mutual efforts to ensure the safety of food and medical products consumed by the two nations, particularly imported goods.”

FDA plans to establish its second overseas office in India, first in the New Delhi area in 2008, and at least one additional office sometime in 2009. The agency expects to place 10 workers in India, and the “U.S. government is in the process of pursuing India's formal approval.”

Unique Device Identification

In March, the Advancing Patient Safety Coalition, representing 24 healthcare companies, reiterated to FDA its interest in the implementation of a mandatory medical device unique device identification (UDI) system.

A UDI system was mandated in the FDA Amendments Act of 2007, but the center has appeared too overwhelmed to do much about it. In a letter to Commissioner Andrew von Eschenbach, the coalition said an identifier “is a crucial factor in improving patient safety, reducing medical errors, facilitating device recalls, improving device adverse-event reporting, and improving postmarket surveillance efforts.”

The letter called on FDA to move as quickly as possible to promulgate regulations implementing the new law's UDI provision.



FDA continues to make changes to better carry out its mission. Keep up with FDA's changes at
transformingfda.com

Six months later, in a presentation to the Regulatory Affairs Professionals Society's annual meeting in Boston, CDRH director Daniel Schultz said developing a UDI system continued to be a priority for the center.

He said that CDRH was now “well into” developing a regulation. “This has to happen sooner rather than later,” Schultz said. “We are working on an advanced notice of proposed rule making coming out in the not-so-distant future. We are coming out with a very comprehensive document that will ask a lot of questions on how this should be done.

“We ask that all of you examine it and give us your feedback,” Schultz said. “Clearly, we understand that this is a very diverse industry and different from drugs and biologics, and we need to come up with a strategy that meets the needs of the industry in total.”

LASIK Patients Reveal Their Unhappiness

The LASIK (laser-assisted in situ keratomileusis) controversy could be listed on the “minus” side of CDRH's 2008 experience. The center saw a small revolt in April from LASIK vision-correction patients who complained of permanent injuries and suicidality after undergoing the procedure. The occasion was a daylong public meeting of FDA's Ophthalmic Devices Panel to hear about postsurgical quality-of-life issues.

FDA got more than it bargained for, prompting CDRH director Daniel Schultz to subsequently observe that “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.”

Numerous Web sites—some with emotionally volatile content—and malpractice lawsuits have erupted. Earlier, in a move seen by some injured patients as a conspiracy, FDA had partnered with the American Society of Cataract and Refractive Surgery (ASCRS), the National Eye Institute, and the American Academy of Ophthalmology to form a LASIK Task Force to study LASIK vision correction and its effect on the quality of patients' daily lives.

Common physical complaints by patient advocates and patients claiming to have suffered adverse effects from LASIK surgery included persistent pain and stinging (dry eye), impaired night vision with the appearance of glare, halos (also called starbursts), and loss of visual acuity.

But for some individuals, the chronic, unresolved nature of these and other conditions becomes so incapacitating as to lead to career and financial disaster, disruption of marriages and other personal relationships, and even suicide.

ASCRS estimates that between 1998 and 2006, FDA received about 140 comments relating to LASIK dissatisfaction, which represents less than one out of every 10,000 U.S. LASIK patients. But that number has provoked a scornful reaction from dissident patients, who alleged that FDA has been helping conceal injuries by not enforcing MDR requirements on ambulatory surgical facilities.

Schultz declined to answer my questions about whether FDA had ever inspected such facilities or planned to do so. FDA policy is not to comment on inspections.

Beyond Our Borders

FDA's Beyond Our Borders initiative is intended to expand FDA's capacity for regulating food, drugs, and medical devices that are imported to the United States.

“The globalization of the food supply and medical product manufacturing has demanded that we do things differently,” said FDA commissioner Andrew von Eschenbach in an HHS statement in October. “Through our Beyond Our Borders initiative, we won't have to send our experts to another country to work with foreign governments and regulated industry to improve our oversight—we'll have staff living there and working on the ground 365 days a year.”

The plan starts with staff in China and then India. In both countries, FDA staff will be tasked with working closely with local authorities to improve safety efforts. Strategies are expected to include providing technical advice, conducting additional inspections, and working with government agencies and private entities that are interested in developing certification programs.

Copyright ©2008 Medical Device & Diagnostic Industry
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