A Senate committee last month took a step forward in addressing the rising costs associated with the Medical Device User Fee and Modernization Act (MDUFMA), which have been a concern to device companies especially of the early-stage variety and industry organizations. The Health, Education, Labor and Pensions Committee, which oversees the FDA, held a markup session on proposed legislation called the Medical Device User Fee Stabilization Act of 2005 (S.1420), voting unanimously to send the legislation to a full Senate vote.
The proposed fix is a big win for device companies, especially small- to mid-sized firms. Fees have increased rapidly since the program's inception in 2002. A series of compensating adjustors in the original law allowed Congress and industry to defer budgeted fees from one year to the next. This has sent fees for new-product submissions skyrocketing and average annual cost growth for the program to more than 20% per year, according to FDA figures. The proposed stabilization would hold annual growth over the next year to roughly 6%.
Under the current law, $32 million would have been required to make up the shortfall in fees and government appropriation from 2003 and 2004. The new legislation would wipe the slate clean, requiring no added appropriations, but full congressional funding would be mandated for 2006 and 2007. The workload and inflation-compensating adjustments in the current law also would be removed in the new version.
User fee increases for standard premarket applications (PMAs) for FY06 and FY07 would be capped at 8.5%. Right now, the increases, if left unchecked would be 21% and 20%, respectively. This would make a PMA for 2006 $259,000, rather than $287,000, and $281,000 for 2007 vs. $344,501 without the change.
In what appears as a lobbying win for the Medical Device Manufacturers Association (MDMA; Washington), which has fought for changes to MDUFMA, the bill would increase the small-business threshold from companies with $30 million in gross revenue to $100 million. It also would eliminate the FDA's ability to modify the small-business threshold. To receive a first-time PMA fee exemption, however, a company will still have to be below the $30 million threshold.
The new legislation also will attempt to clarify Section 301 of MDUFMA, which deals with labeling and branding of single-use devices (SUDs). The proposed language would limit the branding provision only to reprocessors of SUDs.
"We worked as hard as we could to ensure that the fee increases were as small as possible and the small-business threshold was a large as possible," Mark Leahey, MDMA's executive director, told Cardiovascular Device Update following the meeting. "We have members who have been holding PMAs because they can't afford the fees. This is not just a political victory. Patients, ultimately, are the ones who benefit from allowing this new technology to get to market faster."
Committee member Sen. Barbara Mikulski (D-Maryland), who briefly was hospitalized earlier this summer when she was diagnosed with atrial fibrillation, told Senate colleagues that she didn't have to look far to see the benefit of the device industry, especially now that she is wearing a heart monitor. "Medical device development in this country is really phenomenal, and I am not just talking about the really high-tech stuff," she said. "My heart monitor was invented in the United States of America and ap-proved by the FDA. We ask where the jobs are going to come from in the future in this country. They will come from dynamic sectors like this."
Industry groups hope the House and Senate will act before this month's congressional recess so the target sunset date of the MDUFMA program is not reached. In 2007, MDUFMA will be re-evaluated and subject to a more comprehensive overhaul.
Ubl new president of AdvaMed
Rudderless for nearly 3-1/2 months, the Advan-ced Medical Technology Association (AdvaMed; Washington) tapped Steven Ubl to steer the association as its new president and CEO. Ubl is no stranger to the medical device industry or AdvaMed. He served as the organization's executive vice president for government relations from 1998 until last year, when he opened his own healthcare consulting firm. With his experience both in industry and the association, Ubl will "undoubtedly hit the ground running," Art Collins, CEO of Medtronic (Minneapolis) and board chairman of AdvaMed. "What's important is his passion, his enthusiasm and his energy about medical technology," Collins said.
Ubl was one of the lead architects of AdvaMed's work to hammer out the Medical Device User Fee and Modernization Act of 2003. That experience may come in handy as the October deadline approaches for a "fix" of the legislation to help curb sharply rising user fees. "His knowledge of the industry and his accomplishments within a broad range of legislative decisions that have been made was clearly part of the decision-making process, but it wasn't exclusive," Collins said. "It was a number of factors. He possesses a rare combination of policy depth and political acumen that has earned bipartisan respect on Capitol Hill and among policymakers."
Identified with the help of a professional search firm, along with recommendations from member companies and lawmakers, more than 50 candidates were reviewed by an internal search committee, Collins told CDU. The list then was honed to a handful of possibilities. "I must add also that [the search committee] received and I have personally gotten a number of calls from very influential people involved in legislation and the administration, that were universally favorable of Steve Ubl, assuming that he would be one of the final candidates," Collins said.
He said that with a new president finally named, AdvaMed may shake up the status quo a bit. "We made it very clear to Steve as we went through his process that we were not looking for an administrator to come in and conduct business as usual," he said. "AdvaMed has been extremely effective up until this point, but are we not going to do things exactly as we've done in the past. Steve will come in with fresh eyes, and we want to continually raise the bar in terms of what we expect in performance."
Ubl began his Washington tenure on Capitol Hill, serving as special assistant to Sen. Charles Grassley (R-Iowa). He later worked as vice president of legislation at the Federation of American Hospitals (Washington). The Hill newspaper and Legal Times cited Ubl as one of Washington's top lobbyists for securing passage of FDA and Medicare reforms, AdvaMed said.
Ubl replaces Pamela Bailey, who left the position in late March to head the Cosmetic, Toiletry and Fragrance Association (CTFA; Washington), a group representing a sector that is marked by significantly fewer regulatory burdens than those facing med-tech. Bailey, had headed AdvaMed since 1999.
Crawford confirmed as chief of FDA
After months of political wrangling, the Senate voted in mid-July to confirm Lester Crawford as FDA commissioner. The confirmation passed handily with a vote of 78-16. The 67-year-old Crawford, who has served as acting commissioner since Mark McClellan left the FDA more than a year ago to head the Centers for Medicare & Medicaid Services (Baltimore), was nominated by President George Bush in February. Since then, a series of roadblocks and a little scandal conspired to delay Crawford's move from "acting" to official head of the agency.
There were allegations that Crawford improperly promoted an employee with whom he had an affair, an investigation later clearing the nominee of those charges. Some lawmakers also pointed to Crawford as a symbol of a system that needs to be revamped, citing questions about FDA post-approval surveillance of drugs and devices, drug safety monitoring, alleged mismanagement of flu vaccine supplies and the status of an application to make the Plan B morning-after contraception available over the counter. Democratic Sens. Patty Murray (Washington) and Hillary Clinton (New York) had vowed to block the full Senate vote until the FDA ruled on whether the morning-after pill could be sold without a prescription. Murray and Clinton agreed to lift their hold last week following assurances from the FDA that it would issue a decision on Plan B by the beginning of September.
Many senators including Edward Kennedy (D-Massachusetts), ranking Democrat on the Senate's health committee and one of Capitol Hill's most widely recognized healthcare hawks said they believed the need for permanent leadership the agency made it important for the process to move forward. And they want Crawford to tackle the change necessary at FDA, unencumbered by his "acting" status. "With a commissioner in place, we can work more effectively on the key issues facing the agency, from how FDA monitors drug safety, to ways to address flu vaccine shortages, to how it handles conflicts of interest on its advisory committees, and how it has acted on Plan B," Kennedy said on the Senate floor.
"While I respected the right of my colleagues to disagree with a president's choice, in the end, I believe we have made the right decision to promote Dr. Crawford," Sen. Mike Enzi (R-Wyoming), chairman of the health committee, said in a statement. "He has a long and distinguished history of leadership and public service, and I look forward to his continued work in promoting and protecting the public health." Enzi added that the Senate's vote provided Crawford with "a mandate to act."
Ubl, on his first day as president of AdvaMed, said Crawford understands the "unique characteristics" of the device industry. "We have collaborated with him on a broad range of issues over the years designed to ensure timely reviews of innovative medical technologies and effective postmarket surveillance."
Praise, brickbats for GPO code
In what appears to be an agreement worked out between large players in the group purchasing organization (GPO) sector and a small but influential group of senators, GPO conduct is getting praise from some quarters, brickbats from another. The Healthcare Group Purchasing Industry Initiative, which proposes a short list of basic principles for business conduct ethics, has been signed onto by nine GPOs that describe the initiative as a clearer code of business conduct with hospitals and offering an "extraordinary" degree of transparency and disclosure. But that transparency seems to have been worked out in a non-transparent way in order to dodge legislation that the GPOs would find restrictive.
The Medical Device Manufacturers Association, a long-time and frequent critic of GPOs, says the code lacks both specifics and the teeth for ensuring compliance. The initiative "talks about generic principles," MDMA's Leahey told CDU, and fails to present details. Further, it provides no penalties for off-code behavior. It "doesn't address key concerns," Leahey said.
An even more skeptical view would suggest that the initiative is an attempt to avoid federal legislation that would target alleged anti-competitive practices that MDMA has said give GOPs a dominant position in hospital purchasing to the tune of up to $80 million annually. The potential for more restrictive legislation has been looming over the GPO sector in the past three years or so, driven by a series of Senate Judiciary Committee hearings and ongoing criticism of GPO dominance in the market. The hearings have probed the business practices of the GPOs as well as their oft-stated claims that they provide large cost savings for hospitals.
As push-back to the proposed toughening of laws, the GPO "code-of-conduct" initiative in July received well-orchestrated praise from the Senate and the hospital industry. Three members of the Judiciary Committee's Antitrust Subcommittee, which has looked into GPO practices Sens. Jon Kyl (R-Arizona), Sam Brownback (R-Kansas) and Charles Schumer (D-New York) stepped forward to back the initiative. In a statement, Schumer praised the proposed code as "strong," though adding a comment pointing to the potential for stronger action by congress. "I am hopeful," he said, "that, with the steps the industry has taken, the Senate will not have to intervene." Other senators voicing the same hope were Judiciary Committee members Edward Kennedy and John Cornyn (R-Texas). Kennedy called the initiative "an important step in the right direction."
A statement from a group of hospital associations among them the American Hospital Association, the Catholic Health Association of the United States and the Federation of American Hospitals said the code offered "enormous promise" in providing greater fairness within the market while improving patient access to the best medical products.
Still more praise came from Kirk Hanson, executive director of the Markkula Center or Applied Ethics and professor at Santa Clara University (Santa Clara, California), though not exactly an independent voice since he serves as interim coordinator for the initiative. He called the GPO Initiative the "most extensive, voluntary disclosure of ethical and business practices undertaken by any industry in the country."
MDMA's Leahey, however, said that the one-page description of general principles fails to establish a uniform set of contracting practices. "In fact, the proposed initiative actually allows the GPOs to utilize the same codes that the Government Accountability Office (GAO) criticized as insufficient." Backing that view, he cited testimony from the GAO in 2003 hitting the lack of uniformity in these codes and that, even when present, some of these codes "include exceptions and qualified language that can limit the potential of the codes of conduct to effect change."
Noting that the initiative's oversight coordinator has been employed by the nation's second-largest GPO since 2002, Leahey said: "It will be virtually impossible for a GPO-sponsored coordinator to independently evaluate GPO practices to determine whether they are preventing access to patients or harming innovation." He said that MDMA has taken the position that the only real way to change GPO behavior is to inflict financial penalties and to revoke the "safe harbor" status by which GPOs are protected from Medicare anti-kickback regulations.
Challenging the GPO initiative as a way of skirting further congressional action, Leahey said that congress should continue to pursue action "to reform the industry in a meaningful way." He also challenged the GPOs' claim that they save healthcare dollars, saying that without legislative reform, "certain GPOs will continue to push business to a limited number of vendors who are willing to pay hundreds of millions of dollars in fees at the expense of patients and providers."
Study: gastric bypass lowers heart disease risk
A Stanford University School of Medicine (Palo Alto, California) study using new measures of heart disease risk shows that gastric bypass surgery reduces the risk of heart disease even more than previously believed. The researchers say the finding underscores the value of the surgery for extremely overweight people, whose obesity puts them in danger of heart attack, stroke and other cardiovascular illness.
The researchers measured biochemical cardiovascular risk factors in 371 patients before surgery and again 12 months after gastric bypass surgery, adding three new tests to the standard panel of cholesterol and triglyceride assays. They saw improvements in all cardiac risk factors, with the most significant improvements for triglycerides and one of the new tests: C-reactive protein.
"Medication with statins the most effective non-surgical treatment available lowers C-reactive protein by about 16%. But we found that gastric bypass lowered it by 50%. That's a pretty significant improvement over what's been considered state-of-the-art therapy," said senior author John Morton, MD, assistant professor of surgery at the Stanford School of Medicine and director of bariatric surgery at Stanford University Medical Center.
Lead author Brandon Williams, MD, a general surgery resident, presented the study's findings during the annual meeting of the American Society for Bariatric Surgery in Orlando, Florida.
Gastric bypass surgery, the most common form of weight-loss surgery, reduces the stomach's size to limit the amount of food intake and bypasses more than 35 inches of the about 20-foot-long small intestine, which cuts down on nutrient absorption. The number of gastric bypass surgeries has shot up in recent years, increasing from 29,000 procedures in 1999 to about 141,000 in 2004, according to the society. The procedure poses about a 2% risk of mortality and requires lifelong changes in eating habits, but it's a life-saving operation for most morbidly obese individuals, Morton said.
Fish oil not a help with arrythmia
People who have diets high in fish oil have been shown to be at lower risk of dying from heart attacks. But a new study has found that fish oil supplements may pose a risk to some patients who use implanted defibrillators to control irregular heart rhythms.
The researchers said the results did not mean that the omega-3 fatty acids found in fish do not help fight heart disease. But the study, which appeared in the June 15 issue of the Journal of the American Medical Association, does suggest that fish oil does not help in the way that many researchers had thought.
The theory had been that the fatty acids helped stop the irregular heartbeats known as arrhythmia, which can lead to cardiac arrest. So for this study, the researchers took a group of 200 patients with defibrillators, gave half of them fish oil supplements and monitored them over a period of up to two years.
"We thought that it would be a great population to prove that fish oil is preventing arrhythmia," said the lead author of the study, Dr. Merritt Raitt of the Portland Veterans Affairs Medical Center and Oregon Health and Science University (both Portland, Oregon). Instead, the researchers found that patients who took the supplements did no better than those who did not. And those with one kind of arrhythmia had more problems with irregular heartbeats.
As a result, Raitt said, doctors should consider advising patients with defibrillators to avoid the supplements. Researchers began looking into omega-3 fatty acids after Greenland Eskimos, who eat a diet heavy in fish, were found to have a low risk of cardiac death. Later studies found that heart attack patients fared better with diets high in fish oil or supplements. One explanation for the findings in the new study, Raitt said, is that the fatty acids may work different- ly in people who have had heart attacks.