Obama ‘Change’ Agenda at FDA Yields Nought

That omission was probably due in part to the activist group’s preoccupation with macroscale issues such as national security. But part of it may also owe to the fact that “small” domestic agencies such as FDA haven’t accomplished anything new with regard to governmental openness.

As public opinion polls reflect deepening disappointment over the Obama “change” agenda, the failure to open agencies such as FDA is all the more confounding when one considers how easy and inexpensive it would be, i.e., requiring no congressional horsetrading or public persuasion. All it would take is an executive order saying that government employees are henceforth free to talk to the public, Congress, and the news media within existing legal restraints.

I especially hoped this would happen at FDA, which has been a sealed fortress since the Bush administration. The agency has let out only information that it wants to let out, often parsed in terms that reflect credit on itself and carefully obscuring and concealing that which does not.

At this political midpoint, I am left to conclude that however easy to eliminate, needless secrecy in government is more comfortable for those doing the governing than openness would be. The new broom we voted into office has been seduced by the same irresistible forces as prior administrations—the surprising decency and dedication of the government managers they came to tame.

The onboard indoctrination of the new by the old is subtle and swift. The newbies’ zeal for change is blunted to the point where small, barely consequential changes become big and worth boasting about, while real change becomes unthinkable.

In the medical device arena, this FDA instinct to protect the internal status quo showed itself in August. Advised that its typical refusal to address employees’ public complaints about continuing clearances of 510(k)s for allegedly unsafe devices implies some truth in such complaints, FDA nevertheless declined to comment on a New York Times exposé on that topic. No change here.

Written by Washington staff reporter Gardiner Harris, the report quoted from internal CDRH documents showing that look-alike medical plastic tubing could cause dangerous mix-ups when interchangeably used to “deliver or extract medicine, nutrition, fluids, gases or blood to veins, arteries, stomachs, skin, lungs or bladders.”

Under the headline “U.S. Inaction Lets Look-Alike Tubes Kill Patients,” Harris wrote that the problem has been known in CDRH for many years, but legal interpretations of the 510(k) statute conflict with medical staff interpretations of new information about safety issues, including hospital staff mistakes in mixing up tubes.

“The result of these rules is that FDA sometimes approves devices even when officials suspect that they might harm or kill patients,” Harris’s report said. “Indeed, FDA has on occasion approved a new device, mandated that it be recalled, and then approved another just like it because the rules are set up to require such approvals.”

Among several examples, Harris cited the 2005 forced recall of Gambro’s Prisma dialysis machine. Patients died or were injured after they or caregivers ignored warnings from the machine and, as a result, received too much or too little fluid.

Two years later, Harris reported, Edwards Lifesciences sought 510(k) clearance for the Aquarius system, a dialysis machine that an agency reviewer noted had the same problem.

“The agency had never rescinded its original approval of the Gambro device; such approvals are rarely rescinded, even after a recall, partly because there is some debate about whether it would be legal to do so. So the agency (cleared) the Edwards one as well, documents show. In February, the Edwards device was recalled because of ‘reports of clinically significant fluid imbalance,’ according to the recall alert.”

Harris quoted from an internal February 18 e-mail by CDRH reviewer Joshua Nipper that was obtained by the Times. It said: “I raised this issue during the review, but the division director at the time advised that the device should be cleared. We knew that the device could result in serious injury or death, and we allowed it to be marketed anyway. Not surprisingly, the device causes serious injury/death and now must be recalled.”

Harris’s report also quoted industry sources complaining about the length of time that CDRH reviewers’ unexpected safety questions add to the 510(k) clearance process. One year, a tubing 510(k) application needed 193 pages of explanation plus a four-month review; a similar one a year later for another company required almost 455 pages and nine months.

And Harris reported Edwards Lifesciences vice president John McGrath as saying that there had been no patient injuries or deaths in the United States caused by the Aquarius system, notwithstanding the recall.

Christy Foreman, acting director of CDRH’s Office of Device Evaluation (ODE), told Harris that the agency was considering the creation of a list of old products that manufacturers should avoid using as predicates for new ones. Another problem, Foreman said, is that FDA is trying to make tubing standards changes consistent in a global environment.

Like beleaguered egg producers who meanwhile were lavishing praise on FDA for the “wonderful” job it had done inspecting them before the current nationwide recall, AdvaMed spokesman Mark E. Brager was quoted as saying FDA’s current device approval process “has an excellent safety record, facilitates medical innovation, and has served patients well for more than 30 years.” The current 510(k) revamp, he said, “could, if implemented the wrong way, result in delaying patient access to improved medical technology.”

Harris’s report quotes CDRH reviewer and 510(k) whistleblower Robert Smith, who left the agency July 31, as saying that the device approval process illegal and dangerous, and the decades-long tubing problem is another example of how the agency failed to protect the public. “FDA could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die,” Smith said.

FDA leadership did not reply to my request for comment on the Harris article. Although media requests have no legal force, the same logic may apply in the court of public opinion as it does in a court of law—that an allegation not denied may be taken as fact.

FDA’s silence may be seen as further evidence that the Obama administration’s transparency initiative has yet to bear fruit at the agency.

Looking at Recall Records: 510(k) vs. PMA Devices

A new Battelle Memorial Institute study commissioned by AdvaMed has found that there has been a lower percentage of 510(k)-cleared devices recalled than devices with premarket approval since 1998. The study is presumably intended to show a favorable safety track record for 510(k) devices in hopes of limiting a major revamp to the program that FDA is currently considering.

Seventy-seven 510(k) Class I recalls were initiated during the study period, which represents less than 0.16% of the 46,690 devices that were cleared, according to the study. In comparison, 0.85% of PMA devices were recalled, it says.

In looking at recall reasons, the study found that about 50% of the recall causes of 510(k)-cleared devices in the review period were attributed to design deficiencies (representing less than 0.1% of all 510(k) clearances since 1998), 29% to manufacturing deficiencies, and 6% to labeling deficiencies. The remaining 15% of 510(k)-cleared device recall causes were classified as design or manufacturing—data were not available to make a determination with a reasonable degree of confidence.

CDRH Gets More Submissions, Reviews Faster

ODE’s 2009 performance report shows that the number of major submissions received in FY 2009 increased while some review times have decreased. ODE received 9655 major submissions, up from 9601 in FY 2008. The report says the increase is primarily due to an increase in the total number of 510(k)s received.

The report does not include FY 2009 review performance data because a significant number of PMA submissions received in that fiscal year are still under review and a final decision has not been issued.

A chart for review of PMAs filed in FY 2004 to FY 2008 shows that the average total FDA review time for original PMAs and panel track supplements has decreased from FY 2006 to FY 2008. The decrease in total FDA time has been accompanied by a decrease in total elapsed time.

The report also contains other performance indicators and says that overall ODE has made “excellent progress in implementing MDUFMA and is achieving nearly all of the performance goals.”

Chinese Lenses Blocked for Failing Impact Tests

FDA has issued import alerts against prescription and nonprescription impact-resistant eyeglasses and sunglasses imported from four Chinese manufacturers and one Taiwanese manufacturer. The agency said that its tests demonstrated that a high proportion of the lenses failed to meet impact resistance tests specified in their required certificates. Between 38% and nearly 100% broke under standard ball-drop testing.

The five manufacturers named in the alerts are Coomex Source Ltd. (Quingdao, China); Danyao San-Sino Optical Co. Ltd. (Jiangs, China); Wenzhou Outlook Optical Co. Ltd. (Wenzhouwenzhou, China); and Zhenjiang Wanxin Optical Co. Ltd. (Jiangsu, China); and Hang Chow Industrial Co. Ltd. (Taipei City, Taiwan).

“This is a new area for FDA to show such intense scrutiny and enforcement,” observes former FDA attorney Benjamin England, who now operates FDAImports.com. “Impact-resistant lenses are a rising commodity in the United States and importers and foreign manufacturers should expect FDA to take aggressive enforcement action against any ‘certified product’ that does not meet mandatory quality standards,” he says.

Former Spectranetics Execs Indicted for Illegal Imports

Three former executives of medical laser manufacturer Spectranetics have been indicted on federal charges of illegally importing unapproved medical devices. The three are former CEO John Schulte, 62, of Wellesley; former business development vice president Obinna “Larry” Adhigije, 50, of Encintas, CA; and former business development manager Trung Pham, 37, of Colorado Springs, CO.

Also named in the 12-count criminal indictment was a representative of a Florida company contracted by Spectranetics to identify potential sources for the company’s products, Hernan Recaurte, 41, of Ladera Ranch, CA.

Counts against the four include conspiracy, making false statements, receiving illegal imports, selling adulterated and misbranded medical devices, and other offenses. Not every defendant was charged with every count. The indictment also says the former executives concealed their alleged misdeeds from internal investigators and federal agencies.

Last year, the company settled a Department of Justice case for $5 million that charged it with illegally importing unapproved medical devices. The company was not named in the latest indictment against the former executives.

Stryker Biotech Settles Suit

Less than 24 hours after the Massachusetts attorney general filed suit against Stryker Biotech alleging false marketing and fraud, the firm agreed to pay $1.35 million to resolve it.

State attorney general Martha Coakley charged that the company had illegally promoted combined use of its bone growth products and had falsified institutional review board (IRB) documents. Under the settlement, Stryker will pay $325,000 in civil penalties, $875,000 into an anti–false marketing and consumer protection fund, and $150,000 in legal and investigative costs.

The case involved Stryker’s OP-1 implant and OP-1 putty, each of which had been given an FDA humanitarian device exemption restricting its use. “Stryker Biotech subverted review procedures designed to safeguard patients and promoted uses of its products that were not shown to be safe and effective,” Coakley said.

A federal grand jury indicted the company and its former president in October 2009 on charges that they misled FDA about use of the products. The former president and three sales managers have all pleaded not guilty, according to court records.

New Guidance Highlights BPH Devices

A new CDRH guidance identifies key features of nonclinical and clinical investigational plans used to support investigational device exemptions, PMAs, and 510(k)s for devices used in treating benign prostatic hyperplasia (BPH).
The document, titled Guidance for the Nonclinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH), addresses general concepts that the center recommends sponsors consider when designing an investigational plan (nonclinical and clinical) for a medical device indicated for treating BPH.

The guidance says that the “ultimate goal...is to design a study using objective, unbiased outcomes to measure the safety and effectiveness of treatment.”

Major challenges faced when designing a clinical study to assess the safety and effectiveness of a BPH device include the placebo effect and spontaneous remissions that commonly occur with BPH, the inherent variability and subjectivity of the typical outcome measures commonly used to assess the effectiveness of treatment, and the availability of effective treatments for BPH.