Is Abbott the next GE? Or, perhaps we should ask, is the new Abbott the next old Abbott?
FDA in a warning letter told the company it is not satisfied with its progress on correcting quality-control problems at a diagnostics-equipment plant in Irving, TX, reports the Chicago Tribune. Oddly, the plant is one of several about to be transferred to GE, which has agreed to buy Abbott’s diagnostics business, and GE recently had two plants shut down by FDA because of quality issues. The letter states that Abbott violated Good Manufacturing Practices, was slow in its Medical Device Reporting process, and failed to follow adequate purchasing procedures.
Some of the problems identified on the latest inspection four months ago were the same ones identified in 2003 and 2004. This is the kind of thing that tries FDA’s patience. Given Abbott’s history with FDA — it signed a consent decree, paid a $100 million fine, and pulled numerous products off the market in 1999 because of quality problems — don’t be surprised if the agency’s patience runs out.
“The medical device industry is no longer under the radar screen,” assessed AdvaMed’s president and CEO, Stephen Ubl during a conference at Harvard University (Cambridge, MA). Many experts agree with this statement, as it was a clear theme during much of the Medical Device Regulatory, Reimbursement, and Compliance Congress this week. Device companies should take notice of the government’s enforcement actions against drug companies, because the device industry is most likely next. It’s anticipated that increased enforcement will be seen in areas from off-label promotion of devices to improper payments given to doctors.
Companies also need to be aware of the new tactics that the government is using to find evidence. “The government has stepped it up a notch in terms of investigative techniques,” said John Bentivoglio, partner at King & Spaulding (Washington, DC). If your company is looking at past settlements –which generally involve conduct that happened a long time ago — as a model for assessing risk areas, then you’re essentially looking in the rearview mirror, said Bentivoglio. As more government offices and prosecutors become involved in investigations, more tactics are being used than in the past. Some examples include taping promotional events, creating a paper trail within a company when dealing with human resource issues, and doctors serving as cooperating witnesses. The government has also been focusing on internal financial documents of a company of interest, because these records (which also detail audits, incentives, etc) can serve as powerful evidence of a company’s intent.
How confusing is Japan’s premarket approval system? CDRH official Larry Kessler, chair of the Global Harmonization Task Force, used that word to describe it at last week’s AAMI/FDA annual conference. And if there’s anyone from outside Japan who you’d think would understand its premarket approval system, it’d be the GHTF chair.
That notion has been reinforced in a report by the U.S. International Trade Commission. It found that approval times in Japan were longer than those in other principal global markets. As the leader in developing and exporting innovative medical technologies, the United States may be disproportionately affected by this.
Even though reform was enacted in 2005, significant challenges remain, especially for small and mid-sized businesses, the report states. And if the GHTF chair can’t succinctly explain how Japan’s approval system works, don’t expect them to be overcome any time soon.
Two studies published today call for women with breast cancer or at high risk of it to undergo a magnetic imaging scan once a year after age 30, reports the New York Times and others. MRI was found to pick up tumors that mammography doesn’t. This could boost the use of MRI, and the number of MRI units sold, as right now, the U.S. healthcare system doesn’t have the capacity to perform all the MRIs that would be required if the advice were heeded. GE, Siemens, et al must be salivating.
A pending article in the New England Journal of Medicine, whose results were released yesterday at the American College of Cardiology meeting, concludes what some have suspected: Most patients who undergo angioplasty don’t need it. The study found that angioplasty did not save lives or prevent heart attacks in non-emergency heart patients, reports the Associated Press. This has never been claimed, but it has often been assumed by doctors and patients. More stunning is that angioplasty gave only slight and temporary relief from chest pain, which is the main reason the procedure is performed. Drugs are just as effective, and 2/3 of the patients who tried drug therapy first did not need angioplasty or bypass surgery later, the study found. The findings could drastically reduce the number of angioplasties performed — many of which also result in stents being implanted. The debate may shift from what kind of stent to use to whether stents should be used at all.
As expected, many interventional cardiologists and the device companies who supply them with stents, balloons, and catheters are not happy with the study. A Boston Scientific adviser decried it as “rigged to fail.” This could be a huge blow for the cardiovascular device industry.
In recent years, researchers have found that arterial plaque works differently than assumed. Blockages that are complete or nearly complete are not the ones most likely to cause a heart attack. Instead, it is blockages that contain “vulnerable plaque” that can move unexpectedly. Angioplasty and stenting solve the problem of blockages, but not of vulnerable plaque. Thus, the finding that they did not prevent heart attacks and death was not surprising. The finding that they did not do much to alleviate chest pain was more of a shocker.
Michael Drues, PhD, president of Vascular Sciences (Grafton, MA), says that “unfortunately, this is not new. I (and a very small number of others) have been talking about these issues for years. We are using lots of devices today, but we are using them very unintelligently. In the future, we will be using more devices, not fewer, than we use today. The question is, will we be using them more intelligently?”
Abbott’s Xience drug-eluting stent outperformed Boston Scientific’s Taxus for keeping blood vessels open, according to a study presented at the American College of Cardiology meeting over the weekend, reports Bloomberg News. Xience also showed that it could significantly reduce major cardiovascular complications, a trait not seen in previous DES trials. Abbott also reported that the first human trial of its bioabsorbable stent has gone well. For Boston Scientific’s part, it reported that Taxus outperformed brachytherapy in treatment of in-stent restenosis.
Xience is likely to get FDA approval in early 2008 and is expected to garner 30% of the market or more. The only reason Abbott has the technology, originally developed by Guidant, is that Boston Scientific had to sell off Guidant’s stent business to satisfy antitrust concerns when buying Guidant. Wouldn’t it be ironic if the stent technology it sold overtakes the stent technology it kept?
In the fall, FDA and Health Canada launched a pilot program allowing authorized third-party inspectors to cover US and Canadian requirements in a single inspection. It was viewed as a step toward eventually having a single authority inspect for worldwide requirements, which industry has said it wants.
So how many U.S. firms have expressed interest in taking advantage of the program so far? One. This was reported by Larry Kessler, director of CDRH’s Office of Science and Engineering Laboratories and chair of the Global Harmonization Task Force, at this week’s AAMI/FDA International Conference on Medical Device Standards and Regulation.
Kessler said that CRDH obtained a list from Health Canada of all U.S. plants it plans to inspect in 2007, and sent a note offering the joint inspection to all firms whose plants are also on the list for an FDA inspection this year, a total of about 150. Almost all Canadian inspections are done by third parties, so these firms would have to hire an outside inspector anyway.
He offered two possible explanations for the lack of interest. One, firms may already be under contract for 2007 with a Canadian third-party inspector who is not authorized to do simultaneous U.S. inspections, and don’t want to break their contracts and go through the process of finding someone else. Two, and more foreboding, there may be a perception that “if you do badly [on a multi-nation inspection], you won’t be able to market your product anywhere in the world. That’s not the way it should work. Yet, it’s a legitimate fear.”
There is a disconnect between what industry says it wants and what it seems willing to do. Industry needs to drop the pretense of wanting a single inspection covering multiple authorities if firms aren’t willing to participate in pilot programs.
Experts who advise FDA on the approval of a medical device or drug could soon be facing much tougher rules. In efforts to further limit conflicts of interest, FDA’s new draft guidance proposes stringent guidelines for advisory committee members and those who want to participate in meetings regarding the approval of a device or drug. Potential participants will no longer be able to advise on a product if they have related financial interests exceeding $50,000. These include interests in the company whose product is being discussed or one of its competitors. A person who has interests $50,000 or less can apply for an exemption, but he or she won’t be allowed to vote. Comments on the draft will be accepted for the next 60 days.
FDA has approved what St. Jude Medical (St. Paul, MN) calls the first U.S. heart failure device to suppress atrial fibrillation (AF). The device, called the Atlas II + HF cardiac resynchronization therapy defibrillator, has a special algorithm that helps control the heart’s atrial rhythm. It does this by pacing slightly faster than the patient’s natural heart rate, according to the company. Nearly 5 million Americans experience heart failure and about 40% of patients who have heart failure also have AF, cites St. Jude in a news release.
British authorities have issued a safety alert about a potential malfunction in implantable cardioverter-defibrillators made by Guidant, now owned by Boston Scientific, reports the Star Tribune of Minneapolis. The U.K.’s Medicines and Healthcare Products Regulatory Agency issued two advisories, one concerning potential delays in shocks and one concerning an erroneous signal that the battery is nearing the end of its life. No deaths have been reported but 31 devices have been prematurely removed from patients. FDA has not issued a similar warning in this country. While the news may not necessarily indicate that manufacturing problems are still pervasive for the Guidant devices, some doctors could take it that way.
At home, FDA announced a Class I recall by HoMedics, Inc. (Commerce Twp., MI) of five heating-pad models that may short-circuit, causing burns or fires.
