As a former attorney in the U.S. Department of Justice’s criminal division, Robert Litt knows plenty about what precautions companies need to take to stay on the right side of law. Now a partner at Arnold & Porter LLP (Washington, DC), his advice includes a list of six things that a company can do to help avoid problems related to compliance issues and what to do if problems occur.
1. Have a real compliance program. Show your commitment to the law, don’t tell it. It’s not enough to just have a compliance program in place. Companies need to have serious training and supervision to ensure that companies understand and follow the rules. Make sure there are consequences when employees aren’t compliant, too.
2. Make sure there is separation between science and sales. There’s a place for science, and there’s a place for marketing.
3. Be careful how hard you push the envelope. While some degree of risk-taking can be beneficial, companies also face the danger of coming too close to the line and then realize that the line isn’t where they thought it was. By then, it’s often too late and the government has taken enforcement action.
4. Investigate and remediate. Find out what the facts really are, and if you find that something is wrong, fix things before the prosecutor tells you to fix it.
5. To cooperate or not to cooperate? Litt advises, as a safe course of action, to always try to work with prosecutors but… (see #6)
6. Don’t say too much too soon. In addition, don’t take an aggressive posture. Hear what the prosecutor to say, and then educate him or her about the situation.
Litt spoke at the Medical Device Congress held at Harvard University last week.
– Maria Fontanazza
A study presented at this week’s American College of Cardiology meeting found that drug-eluting stents are safe for heart-attack patients and may help their chances of survival, Bloomberg News reports. The Harvard Clinical Research Institute studied a database of more than 7,000 patients in Massachusetts. Those who received a drug-eluting stent were less likely to die or need a repeat procedure than those who received a bare-metal stents. Heart attacks caused by clots, deemed a risk from drug-eluting stents in earlier studies, were about the same in both groups.
A second study, from Italy, found that major heart complications occurred half as frequently for patients with drug-eluting stents as compared to those with bare-metal stents.
The key, however, is that DES patients take their anti-clotting medication as prescribed.
These results mean that perhaps doctors have gone too far in cutting back their use of drug-eluting stents, based on previous findings.
Boston Scientific announced that it has sold off its aortic repair unit, reports the Boston Globe. The firm has been selling off its nonstrategic assets as part of an effort to pay down debt incurred from its purchase of Guidant. The buyer of Boston Scientific Santa Rosa Corp., formerly known as TriVascular Inc., is TV2 Holding Co. Boston Scientific will receive $30 million and a warrant allowing it to purchase a minority stake in TV2. Boston Scientific had purchased TriVascular in 2005.
As technology continues to rapidly evolve, patients are expecting a lot more from medical devices. They’re armed with a wealth of information from the Internet and are aware of more options, but they can’t necessarily distinguish good and bad science. Sometimes companies also need to be reminded that they must consider the most basic needs of patients, even when the solutions aren’t always simple.
Barbara Blakeney made sure that attendees of the Medical Device Congress, held at Harvard University in late March, heard this message, along with how patients perceive their treatment options. Blakeney, a registered nurse, is an innovations specialist at the Center for Innovations in Care Delivery at the Massachusetts General Hospital (Boston).
When patients begin to weigh their options in choosing a device, adaptability is an important factor to consider. Patients ask themselves several questions–does this device fit into my lifestyle? Will it need to be replaced due to obsolescence that is built into the technology design? This ties into user-driven innovation–how a user can adapt technology to meet his or her specific needs. Then there’s the issue of accessibility, at a reasonable cost. Will the device move in and out of a variety of environments as the patient moves? The device should, for the most part, remain unseen by people other than the user. Blakeney asked companies to expand who they currently have discussions with in terms of product design. (She implied that she wants manufacturers to go beyond talking to doctors.) She also wants them to think about what they can do with current technology to help prevent chronic diseases.
– Maria Fontanazza
Restore Medical, which makes a mouth implant that treats mild to moderate obstructive sleep apnea, has done a lot of things right in building its product, for which it was recognized as one of MD&DI’s Medical Manufacturers of the Year in 2005. But apparently it has not done as well in building a business. It disclosed yesterday that it may run out of cash by May because of investment in troubled auction-rate securities, reports the Star Tribune of Minneapolis. Companies holding these securities cannot cash out of them until an auction is successful, and the auctions have not attracted many buyers recently, because of the credit crunch and economic slowdown. This problem led the firm’s auditor to write a dreaded “going concern” letter to the Securities and Exchange Commission; that is, it determined that at the present time, the firm doesn’t have enough capital resources to fund future operations, which jeopardizes the existence of the company.
Restore CEO Robert Paulson said the company will seek additional funds through equity or debt financing or through licensing its technology. It would be a shame to see that technology no longer be available to patients because of the financial climate.
FDA’s work on regulations and guidances specific to combination products has advanced very slowly, and recent turnover at the Office of Combination Products hasn’t helped, reports a consultant who keeps close tabs on the OCP. Michael Gross, prinicpal consultant of Chimera Consulting and a member of the Combination Products Coalition, said OCP told him that a regulation regarding quality systems for combination products will come out this year. He spoke at the PharmaMedDevice conference in Philadelphia yesterday.
Such a regulation is important because it is not clear when firms should follow quality-system practices for devices and when they should follow the ones for drugs. However, Gross said, the OCP once said it would come out in 2007, so nothing about the timetable should be taken for granted. Similarly, he said, OCP has said it will publish a guidance on safety reporting this year, but when it will actually appear is anyone’s guess.
OCP had four directors last year: Mark Kramer, who left in April after more than five years in the post; Joanne Less, who left in October; Patricia Love, who served as acting director from October to December, and Thinh Nguyen, who took over in December. It also lost Jim Cohen, an attorney who was instrumental in drafting its regulations and guidances, and Suzanne O’Shea, its product jurisdiction officer. This turnover is exacerbating the slowness of progress, Gross said.
An FDA draft guidance posted yesterday calls for new and longer tests to determine the safety of drug-eluting stents. These could make it longer for them to achieve FDA approval and cost their sponsors much more money.
The recommendations include longer studies in humans, larger safety databases, and more postmarket studies, reports Bloomberg News. Also included in the document is guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. And it has draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device’s overall safety.
The guidance was put together by both CDRH and CDER. A public workshop to gather comments about the draft guidance will be announced shortly.
The idea is the brainchild of a former Georgetown University researcher who believes that, if successful, the innovative pacemakers could be made from lung or embryonic cells and would replace their mechanical counterparts. Martin Morad has received a $10 million public-private grant from South Carolina’s Centers for Economic Excellence program to conduct the research, which draws from experts in tissue regeneration, stem cells, and cell biology at surrounding universities. The Medical University of South Carolina is even building a facility to house Morad’s research. According to an article on devicelink.com, Morad hopes his work will “unlock the complex system to proteins and electrical signals that keep the heart pumping at the right speed.”
St. Cloud State University (St. Cloud, MN) has a unique regulatory affairs and services program that helps companies work with FDA. The university has selected Charles Swanson, formerly of Medtronic Inc. to head the recently developed program. In addition to being the head of the regulatory affairs department at Medtronic for almost thirty years, Swanson helped developed FDA guidelines and procedures related to medical devices. Those who complete the program are prepared to work in a regulatory affairs department at a medical device company, in roles from design to quality assurance to marketing. The Star Tribune features a Q&A with Swanson.
The Nasdaq stock market has informed Integra Lifesciences Holdings Corp., a broad-based device manufacturer, that it is out of compliance with the exchange’s rules and as a result may be delisted, the Associated Press reports. The compliance issue is that Integra has not filed its 2007 annual report with the Securities and Exchange Commission. The firm says it is still reviewing accounts and that there are “material weaknesses” in its financial reporting. These may have to do with accrued liabilities, income taxes, and other things.
The firm, which was named one of MD&DI’s Medical Manufacturers of the Year in 2007, has requested a hearing before Nasdaq’s Listing Qualifications Panel. That would at least delay a delisting until after the hearing.
It would be a shame if something that happened on the financial side affects what the company is doing on the clinical side.
