Susan Shiff of Pfizer (NYSE:PFE) focused on how the pharmaceutical company was developing an epidemiological database with Lagos University Teaching Hospital to help organize its pharmacies and improve patient health. The program has helped improve the management of its stocks and order transaction system between the hospital and its vendors, Shiff noted.

Ashifi Gogo discussed how his company, Sproxil, a Nigerian-U.S. company, was helping foreign governments crack down on counterfeit medications, particularly in Nigeria where counterfeiters have significantly undermined some pharmaceutical companies’ market share with hazardous medications. Fake drugs also kill 700,000 malaria and TB patients every year, Gogo said. Under Sproxil’s system customers can scratch off a code printed on the medication package and send the number in a text message to determine whether a particular medicine is counterfeit or authentic. The system has helped the Nigerian government crack down on the counterfeit trade, Gogo said.

Logistimo and SMS for Life are other examples of companies addressing supply chain issues in developing countries using mobile phone technology.

Sproxil’s system has also been utilized in the U.S. in Florida where the counterfeit drug problem is higher than the national average. Gogo added that it could also be utilized for online and mail-order sales in the U.S. for customers to verify whether or not medication coming to them is counterfeit.

That was the response of Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who participated in a panel Tuesday to discuss results of the survey that portrays the agency’s pre-market notification process as slow, unpredictable and damaging to U.S. innovation and global competitiveness. It also showed that smaller companies overwhelmingly choose Europe as the first venue to introduce their products and delay product introductions in the U.S.

Shuren pointed out that the survey undertaken by Northwestern University researchers only polled 356 individuals out of at least 5,000 device companies in the U.S., with multiple responses allowed from the same company. In other words, “less than 10 percent of industry responded to the survey and fewer still responded to specific questions,” Shuren noted.

He added that the survey found a significantly higher percentage of companies required to furnish clinical data with their 510(k) submissions, something that was much lower in the entire universe of 510(k) submissions to the FDA. However, he did not provide that lower percentage figure.

Shuren found fault with the subjective nature of the survey as well.

“For example, responses to whether or not FDA questions were considered scientifically justified is not only subjective, but small companies that have far less experience with FDA requirements tended to believe FDA questions were unjustified more often than large companies,” he said.

Despite taking issue with the methodology of the survey, Shuren described it as “informative.” He also acknowledged problems at the FDA — including high staff turnover and the need to be more predictable.

“It is critical to reduce the unacceptably high turnover rates at CDRH if we are to provide the kind of predictability that we and industry want to see in that program,” he said.

But Shuren rejected the notion that FDA reviewers were asking more questions unnecessarily, one cause contributing to unpredictability, according to companies.

“It’s not science for science’s sake,” he said. “While any unnecessary data request from FDA is a concern to us and some of them (identified in internal analyses) in fact were, the rate is significantly less than suggested by survey responses.”

At one point in the panel discussion after his prepared remarks, Shuren responded to that complaint of unnecessary data request by arguing that sometimes the agency has information that companies may not be privy to. But he did not expand on that.

Still, in his prepared response, he took some of the blame for the perception that the agency asks too many unnecessary questions. It’s the result of “inadequate guidance and inadequate communication by CDRH,” Shuren said. The agency is working to resolve those by preparing seven guidance documents that the FDA committed to completing this year.

Other panelists gathered at the Washington, D.C. event were Susan Alpert, former senior vice president and chief regulatory officer, Medtronic; Peter Barton Hutt, senior counsel at Covington & Burling; and Philip Phillips, president of Phillips Consulting Group.

Though the FDA believes the biggest risks of direct-to-consumer tests are false positive or false negative results, the watchdog agency said the “DTC model has created public health and social quandaries” because the general public can have tests for serious medical issues delivered to their doorstep without consulting a physician.

“While this may enable the consumer to learn more about themselves, it also raises important questions of whether there is sufficient information available to assure that associations are real and meaningful,” the FDA wrote in an executive summary (PDF) ahead of this week’s panel.

The watchdog agency cited numerous studies that raise questions on how DTC tests might “alter consumers perceptions and behaviors about their own health and medical care … whether the availability of these tests directly to a general public of varying health literacy, without the involvement of a healthcare provider, has appropriate informational content.”

The panel, which is meeting today and tomorrow, is considering whether consumers might take actions such a changing or discontinuing prescribed medications after taking DTC test, and whether doctors would rely on such test results to for without full knowledge of the test’s reliability.

The FDA considers such diagnostics tests medical devices and has approved home both “collection kits,” where the test subject mails a specimen to a lab, and “test kits,” such as pregnancy tests, but believes DTC genetic tests “effectively create a third type of home use tests,” the agency wrote.

According to FDA standards, a genetic tests involve “the analysis of human DNA, RNA, chromosomes, protein, or certain metabolites in order to detect alterations related to a heritable disorder,” and cover a wide range of medical issues as disparate as cancer and Parkinson’s risk to whether a patient will respond to Hepatitis C treatment.

Another federal judge has weighed in on the protracted battle over the constitutionality of the landmark healthcare reform act, moving the score to 3-2 in favor of President Barack Obama’s signature legislative achievement.

Judge Gladys Kessler of the U.S. District Court for the District of Columbia rejected a challenge to the Patient Protection & Affordable Care Act by the American Center for Law and Justice, a conservative legal group started by right-wing icon and former Republican presidential candidate Pat Robertson.

The plaintiffs argued that Obamacare “regulates inactivity” via the individual mandate by compelling Americans to buy health insurance or pay a penalty with their annual tax returns. Kessler scoffed at that argument, calling it “pure semantics.”

“This court finds the distinction, which plaintiffs rely on heavily, to be of little significance. It is pure semantics to argue that an individual who makes a choice to forgo health insurance is not ‘acting,’ especially given the serious economic and health-related consequences to every individual of that choice,” she wrote, according to court document. “Making a choice is an affirmative action, whether one decides to do something or not do something. They are two sides of the same coin. To pretend otherwise is to ignore reality.”

That aside, the judge added, people who opt not to but insurance are freeloaders who would unfairly deflect responsibility for their care onto the rest of society.

“To put it less analytically, and less charitably, those who choose — and plaintiffs have made such a deliberate choice — not to purchase health insurance will benefit greatly when they become ill, as they surely will, from the free health care which must be provided by emergency rooms and hospitals to the sick and dying who show up on their doorstep,” Kessler wrote. “In short, those who choose not to purchase health insurance will ultimately get a ‘free ride’ on the backs of those Americans who have made responsible choices to provide for the illness we all must face at some point in our lives.”

The five plaintiffs — Margaret Peggy Lee Mead, Charles Edward Lee, Susan Seven-Sky, Kenneth Ruffo and Gina Rodriguez — also argued that Obamacare would infringe their religious rights because “it requires them to perform an act that implies that they doubt God’s ability to provide for their health,” according to court documents. Kessler was not persuaded.

“First,” she wrote, “plaintiffs have failed to allege any facts demonstrating that this conflict is more than a de minimus burden on their Christian faith. Second, it is unclear how [the Patient Protection & Affordable Care Act] puts substantial pressure on plaintiffs to modify their behavior and to violate their beliefs, as it permits them to pay a shared responsibility payment in lieu of actually obtaining health insurance. In fact, plaintiffs specifically allege … that they view this shared responsibility payment as ‘the lesser of two evils’ and therefore intend to pay it rather than purchase health insurance.”

The ruling by Kessler, named to the bench by former President Bill Clinton, marks the fifth time a federal court has weighed in on the constitutionality of the healthcare reform law — and the fifth time a decision has come down along strictly partisan lines.

In October, a Michigan judge and Democrat appointee dismissed a legal challenge to the law. That was followed by another favorable ruling in the U.S. District Court for Western Virginia by another judge appointed by Clinton and a ruling by Judge Henry Hudson of the U.S. District Court for Eastern Virginia (a Republican appointee) that the individual mandate, which would require most Americans to buy health insurance, was unconstitutional because it exceeds the federal government’s power to oversee interstate commerce (known as the “Commerce Clause”).

Last month, Judge Roger Vinson of the U.S. District Court for Northern Florida (the other GOP appointee) ruled the entire law unconstitutional but stopped short of immediately halting its implementation.

Legal experts — including Kessler, according to her ruling — think the question will ultimately be decided by the U.S. Supreme Court.

The conclusions are based on a new study, paid for by the Advanced Medical Technology Assn., that compares four years of recall data from U.S. and EU regulatory bodies.

The study, “EU Medical Device Approval Safety Assessment,” conducted by the Boston Consulting Group, matched four years of medical device recall data for the United Kingdom, Germany, Switzerland and Ireland and compared it with similar U.S. data. The report’s authors conclude that there is no material difference between the regulatory regimes in the U.S. and Europe, from a safety perspective.

“Differences between the two systems do not ultimately affect performance,” according to authors Scott Davis, Erik Gilbertson and Simon Goodall. “In addition, given the expectation that the EU approves more devices than the U.S., it is likely that the EU recall rate may actually be slightly lower than the U.S. rate.”

AdvaMed, the industry council for the American medical device industry, touted the results as yet more evidence that the U.S. is losing its leadership position in medical technology, primarily because of the allegedly burdensome FDA regulatory process.

“It’s well-documented that it takes longer to bring medical technology to market in the U.S. than it does in Europe. Today’s report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety,” Advamed president and CEO Stephen J. Ubl said in prepared remarks.

Ubl compared the study to recent findings by PricewaterhouseCoopers and Stanford University that the U.S. is lagging in medical innovation due to over-regulation.

But there still may be some wriggle room in AdvaMed’s claims that EU regulators are just as good at spotting dangerous devices as their American counterparts.

The BGG study’s authors admit that an apples-to-apples comparison of device recall data wasn’t possible, due to the de-centralized nature of the EU’s regulatory system and differences in terminology. And accurate data from France — one of the EU’s largest medical device markets — was not counted due to incomplete data.

The report also relied heavily on two recent studies in comparing the recall rates in the U.S. and Europe, rather than the FDA’s Medical and Radiation Emitting Device Recall database, because the Boston Group authors could match only 28 percent of their records to the FDA’s internal database.

One of those studies, conducted by Ralph Hall of the University of Minnesota, estimated a rate of recall of 0.45 percent for 510(k)-approved devices over 10 years. The other study, conducted by the Battelle Memorial Institute, estimated a rate of recall of 0.16 percent, based on the total number of 510(k) approvals since 1998.

Hall, the author of the Minnesota study, recently told Minnesota Public Radio that the FDA needs to be more cautious in its overhaul of the 510(k) program and is carrying out reforms without proper data.

Related articles

• New FDA 510(k) medical device reviews will now be ‘smarter’ (medcitynews.com)
• 510(k) changes get approval (pending implementation) from AdvaMed (medcitynews.com)
• FDA 510(k) reaction: Center for Devices and Radiological Health (medcitynews.com)

A federal appeals court upheld a lower court’s dismissal of a lawsuit filed on behalf of all frozen human embryos in the U.S. that sought to halt federal funding of research using stem cells derived from the embryos.

The U.S. Court of Appeals for the Fourth Circuit ruled that the plaintiffs in the case, represented by “Mary Scott Doe, a human embryo ‘born’ in the United States (and subsequently frozen in which state of cryopreservation her life is presently suspended),” do not have standing to assert their constitutional and statutory rights. The court also ruled that the plaintiffs, which also included people who adopt children from embryos donated for adoption, could not prove that all frozen embryos in the U.S. would be harmed by the research.

“We cannot identify a particularized harm because the complaint does not identify any of the named plaintiff’s particularized characteristics. Instead, it leaves us only with questions such as whether the embryo will ever be used for research and whether that research will be funded by the [National Institutes of Health],’” according to the documents. “We have no idea under what terms the named plaintiff embryo was donated or stored or what its status even is. In the absence of answers, the chosen appellation of Mary Scott Doe could equally designate any member of an amorphous frozen embryo class.”

Citing federal rules stipulating that researchers who receive government funding use stem cells derived only from embryos earmarked for that purpose by their donors, the court also wrote that the plaintiffs can’t connect any harm to embryos to federally funded research.

“Where government policy not only allows the biological parents to choose what to do with their embryos, but also safeguards the independence of their decision with strict conditions, the connection between injury and policy is a ‘purely speculative’ one,” according to court documents.

But the court left a loophole for future plaintiffs, calling its ruling “a narrow one.”

“[W]e do not suggest that no party would ever have standing to assert similar claims. The bar of standing must not be set too high, lest many regulatory actions escape review contrary to the intent of Congress,” according to court documents. “A complaint that provided more concrete information about the identity of the named plaintiff embryo or the plaintiff parents’ plans for adoption would at least address more directly what the Supreme Court has identified as serious constitutional concerns.”

And the ruling in no way bears on a similar lawsuit unspooling in another federal appeals court, the court added.

Current medical news and unique business news for anyone who cares about the healthcare industry.

Drug development, sponsored by the feds. The Obama administration will increase the federal government’s R & D budget as the big drugmakers continue to scale back: a billion-dollar government drug development center to help create medicines.

The job of the new center, to be called the National Center for Advancing Translational Sciences, is akin to that of a home seller who spruces up properties to attract buyers in a down market. In this case the center will do as much research as it needs to do so that it can attract drug company investment.

That means that in some cases, the center will use one of the institutes’ four new robotic screeners to find chemicals that affect enzymes and might lead to the development of a drug or a cure. In other cases, the center may need to not only discover the right chemicals but also perform animal tests to ensure that they are safe and even start human trials to see if they work. All of that has traditionally been done by drug companies, not the government.

“None of this is intended to be competitive with the private sector,” Dr. Collins said. “The hope would be that any project that reaches the point of commercial appeal would be moved out of the academic support line and into the private sector.”

Latest healthcare reform strategy. Sen. Charles Schumer said Democrats plan to require Republicans in the Senate to “to vote on the individual protections in the bill that are very popular and that even some of the new Republican House members have said they support. So in the end, their repeal bill is going to be so full of holes it looks like Swiss cheese.”

FDA targets defibrillators. The U.S. Food and Drug Administration wants external heart defibrillators to be subject to premarket approval rules similar to those that stents receive.

Healthcare: The jobs brightspot. Healthcare added 36,000 jobs in December — more than one-third of the total gain and second to the leisure and hospitality sector.

Arizona seeks Medicaid exemption. Arizona will try to request a federal waiver to cut Medicaid from 280,000 citizens.

Meet The Super Angels. Via The Boston Globe: “An idea that first began in California’s Silicon Valley, super angels get involved in promising new companies when they are still too small and untried to attract venture capital. But super angels take a more aggressive and systematic approach than plain angels, investing more money, more often. Where a traditional angel might back one or two start-ups a year, super angels will get behind as many as 20, investing anywhere from $25,000 to $250,000 in each one.”

Staying in the know with pharma. Are you following any of these blogs? My favorites from the list include Eye on FDA, Health Care Renewal and In The Pipeline.

Paul Levy’s cushion. The former Beth Israel Deaconess Medical Center CEO received a $1.6 million severance.

British health lobby documentary. The Health Industry Lobbying Tour is a guided tour by the Alliance for Lobbying Transparency about companies lobbying Britain’s National Health Service. Money quote: “Among those companies waiting like vultures around a dying animal are those very same companies who spent $1 million a day in the States lobbying against Obama’s healthcare reforms.”

Dealflow and more. Prostate cancer treatment company Calypso Medical Technologies raises $6.4 million; personalized medicine business BlackBio raised $4.1 million

A survey by the Centers for Disease Control and Prevention’s National Center for Health Statistics found that the number of primary care physicians who have started using EHRs has increased from 19.8 in 2008 to 29.6 in 2010, a 49 percent jump.

The survey also showed that 41 percent of office-based physicians are planning to achieve the so-called “meaningful use” of EHRs, which would qualify them for government incentive payments. An American Hospital Association survey found that 81 percent of acute care non-federal hospitals hope to meet all meaningful use requirements to apply for the incentives, and 65 percent of hospitals plan to do so in the next two years.

The incentives were part of Health Information Technology for Economic and Clinical Health Act, which was part of 2009′s Stimulus bill. It stipulated that healthcare providers can receive up to $44,000 through Medicare or as much as $63,750 through Medicaid if they implement and prove meaningful use of an EHR system. Under both Medicare and Medicaid, hospitals are eligible for millions of dollars if they complete the EHR programs’ requirements.

In a letter to the American public, National Coordinator for Health Information Dr. David Blumenthal touted the results of both surveys.

“At [the Office of the National Coordinator for Health Information Technology] we are gratified that such sizable percentages of physicians and hospitals intend to take the plunge—and to take the plunge sooner rather than later,” he wrote.

A survey of about 3,000 physicians by Thomson Reuters and HCPlexus, which makes management products for physicians, indicated that most physicians do not feel negative about the impact of EHRs on patient care. While only 39 percent of the survey’s respondents saw a positive impact of the Health IT systems, a smaller 24 percent saw a negative impact.

The survey, which was conducted via fax machine, also found that doctors are pessimistic about the healthcare reform law, with 65 percent saying it will cause healthcare to “deteriorate” and 74 percent saying it will result in reimbursement becoming “less fair” over the next five years.

Related articles

• Electronic medical records payouts on the way Jan. 3 (medcitynews.com)
• Ohio doctors eligible for low-interest loans in federal EHR push (medcitynews.com)

The American Hospital Association says that overbearing regulation and an overly aggressive Dept. of Justice is hurting the hospital industry.

In a Jan. 14 letter written to Rep. Darrell Issa (R-Calif.), the new chairman of the Committee on Oversight and Government Reform, AHA president Rich Umbdenstock wrote that, “existing and proposed regulations that have negatively impacted the hospital field. Regulatory relief is of great importance to our members and one of our major legislative priorities this year.”

In particular, Umbdenstock wrote that anti-kickback provisions had “been stretched to cover any financial relationship between hospitals and doctors.”

“Congress, recognizing that the anti-kickback statute sometimes thwarts good medical practices, periodically has created ‘safe harbors’ to protect those practices. However, there is no safe harbor for clinical integration programs that reward physicians for improving quality. Congress should create a safe harbor to allow all types of hospitals to participate in clinical integration programs, establish core requirements to ensure the program’s protection from anti-kickback charges, and allow flexibility in meeting those requirements so that the programs can achieve their health care goals,” he wrote.

In addition, the AHA chief accused the DOJ and “certain Assistant United States Attorneys” of abusing the False Claims Act.

“These government officials have seized upon data analysis that flags billing errors and/or over-utilization and converted it into a presumption of FCA liability. FCA cases pose great risk to hospitals in terms of monetary and administrative sanctions. The threat of FCA liability leads hospitals to incur massive expenses related to retaining specialized counsel and outside forensic accountants and, in the event an overpayment is discovered, to negotiate a formal FCA settlement where a simple cost report adjustment is all that is really necessary,” he wrote.

The AHA represents approximately 5,000 members in the U.S.

Fresh off his vote to repeal healthcare reform, Minnesota Congressman Erik Paulsen is circulating a “Dear Colleague” letter hoping to gather sponsors and resurrect his bill to repeal the medical device tax (called the Defend Medical Innovation Act).

“If we are to strengthen our economy the government should be taking actions to encourage medical innovation, not killing it,” according to Paulsen’s letter. “As many of you know, device manufacturers will have to cut R & D or may be forced to lay off employees due to this disastrous tax.” (Emphasis his)

Paulsen originally introduced the medical device tax repeal legislation in April.

The bill foundered, though, and the re-introduction will likely get stuck in the guerrilla war that is healthcare reform repeal. The money raised from the medical device tax is being used to fund President Obama’s healthcare reform legislation. Unless healthcare reform disappears — and that may take two years — it’s unlikely that repealing the medical device tax will have enough votes.

Nonetheless, you have to admire Paulsen’s vigor in his letter.

Related articles

• Believe it or not, healthcare reform law actually benefits medical devices (medcitynews.com)

The Washington D.C. based industry council told reporters during a conference call that while it believes the 510(k) process is fundamentally sound, its slower pace, especially when compared to other country’s regulatory systems harm innovation and patient access to new technologies.Therefore the council said it will turn its attention to the pace at which the 25 announced changes are implemented.

The modifications are a step in the right direction and “generally adheres to our principal that changes should be targeted, have a corresponding health benefit and support timely access treatments and cures,” AdvaMed senior executive vice president David Nexon said during the call.

But Nexon warned that those steps are only the first part of what he called a “very complicated set of implementation steps”.

The FDA plans to roll out its new plan through a process of guidance documents and proposals for new rules, both of which will be open to public comment while in development.

There will be at least eight guidance documents that the agency needs to put out over the coming year, according to Nexon, and how those come out “will make a big difference in whether the FDA continues to move in the right direction,” he said.

Nexon said many of the proposals released yesterday have the potential to improve the timeliness and consistency of the review process such as enhancing reviewer training, involving external scientific experts, improving the consistency of reviews by developing device-specific guidance documents and streamlining the de novo process for medical devices without a predicate.

“I think that the FDA was pretty exhaustive in its proposals that it put forward for consideration and what they’re doing in terms of the implementation plan,” he said.

Click here (PDF) to download a schedule for the FDA’s changes to the 510(k) process.

U.S. Rep. Michael Burgess

A key congressional subcommittee on health, which could greatly affect the medical device industry has been named on Capitol Hill.

The 27-member health sub-committee of the House Energy and Commerce Committee of the 112th Congress has broad oversight over several regulatory bodies, including the Food & Drug Administration and the Centers for Medicare and Medicaid Services.

The GOP-controlled committee is chaired by Rep. Joseph Pitts (R-Pa.), and Rep. Michael Burgess (R-Texas) was named vice chair of the committee. The Texas republican is also a member of the Tea Party caucus in the House along with fellow Texan Rep. Joe Barton (R-Texas) and Phil Gingrey (R-Ga.), who were also named to the committee.

During the recent midterm elections republicans took control of the House on the backs of momentum drummed up by members of the Tea Party who championed smaller government, opposition to the healthcare reform law and less regulation on American businesses.

The committee, which will debate a whole host of healthcare-related issues, could also be instrumental in the upcoming re-authorization of the FDA’s Medical Device User Fee Act, which is slated for 2012.

The full list of congressional leaders named to committee are:

Chairman Joseph Pitts (R-Pa.)
Vice Chairman Michael Burgess (R-Texas)
Rep. Ed Whitfield (R-Ky.)
Rep. John Shimkus (R-Ill.)
Rep. Mike Rogers (R-Mich.)
Rep. Sue Myrick (R-N.C.)
Rep. Tim Murphy (R-Pa.)
Rep. Marsha Blackburn (R-Tenn.)
Rep. Phil Gingrey (R-Ga.)
Rep. Bob Latta (R-Ohio)
Rep. Cathy McMorris Rodgers (R-Wash.)
Rep. Leonard Lance (R-N.J.)
Rep. Bill Cassidy (R-La.)
Rep. Brett Guthrie (R-Ky.)
Rep. Joe Barton (R-Texas, ex officio)
Rep. Fred Upton (R-Mich., ex officio)
Rep. Frank Pallone (D-N.J., ranking member)
Rep. John Dingell (D-Mich.)
Rep. Edolphus Towns (D-N.Y.)
Rep. Eliot Engel (D-N.Y.)
Rep. Lois Capps (D-Calif.)
Rep. Jan Schakowsky (D-Ill.)
Rep. Charles Gonzalez (D-Texas)
Rep. Tammy Baldwin (D-Wis.)
Rep. Mike Ross (D-Ark.)
Rep. Anthony Weiner (D-N.Y.)
Rep. Henry Waxman (D-Calif., ex officio)

That industry’s made a long practice of advocating for more clarity in the 510(k) process while insisting that there’s nothing fundamentally wrong with the program — by which more than 3,000 medical devices are brought to the U.S. market every year.

With today’s announcement, FDA officials agreed, mostly. Yes, they say they made several changes that reflect a more transparent, reactive and ultimately smarter FDA. You’ll find few people in the medical device industry who would oppose those moves.

The agency’s also deferred the more controversial elements of its proposal — including a definition of its rescission authority (it already has the power and uses it) and the creation of a new device classification — that had earned nearly universal opposition from the industry.

CDRH chief Dr. Jeffrey Shuren said the agency would wait for a pending Institute of Medicine report on the 510(k) program before issuing its final judgment. Part of the reason to put the decision off was due to an onslaught of public comments, he added.

“Given the comments, we recognized that implementing some of those changes will be problematic,” he told reporters. “This gives us the time to move forward and to take measured steps.”

That delay could prove costly to the agency’s plans for the kind of structural makeover of the 510(k) system the FDA hinted at back in Sept. 2009. With Republicans at the fore on Capitol Hill, the respite gives the med-tech sector better odds.

The medical device industry has been successful in cobbling together bi-partisan support on the Hill for its fight against radical changes to the 510(k) program. Last year, 15 U.S. senators and 12 House members wrote to FDA chief Dr. Margaret Hamburg to ask that the agency act cautiously. Signees of the October 2010 letter included Rep. Joseph Pitts (R-Pa.), now chairman of the Health sub-committee of the House Energy and Commerce Committee, which has budget authority over the watchdog agency.

Medical device industry allies are also stationed in key positions in the House power structure, including Brett Loper, who left a job as AdvaMed’s lead lobbyist to join House Speaker John Boehner’s (R-Ohio) staff as policy director, giving the industry an ear in one of the highest offices in the land.

Washington is more preoccupied with machinations over Republican efforts to repeal the Patient Protection and Affordable Care Act. But once that’s resolved one way or the other, or maybe even before, industry will still have the better part of six months to pick away at the 510(k) issue and another, related pet peeve: The FDA’s Medical Device User Fee program’s re-authorization is on the Congressional docket this year.

Shuren and the rest of his reform-minded staff might wind up regretting the decision to punt instead of ramming it across the line.

Related articles

• New FDA 510(k) medical device reviews will now be ‘smarter’ (medcitynews.com)
• FDA 510(k) reaction: Center for Devices and Radiological Health (medcitynews.com)
• 510(k) reaction: The trade group (medcitynews.com)
• FDA 510(k) reaction: The med-tech giant (medcitynews.com)

Center for Devices and Radiological Health Director Dr. Jeffrey Shuren told reporters during a conference call that the changes the Food & Drug Administration plans to make this year to the 510(k) clearance program will help narrow a looming innovation gap between the continents while ensuring the safety of American patients.

“A key piece here is increasing predictability and reducing uncertainty. That is what we’ve heard time and time again,” Shuren said.

Asked about a PricewaterhouseCoopers report that the advantage the U.S. medtech industry holds is waning, Shuren said that the U.S. is still the top dog but that uncertainty about the regulatory climate among investors and stakeholders is undermining that status.

“What we’re proposing today is to address that uncertainty and to keep us a leader in medical innovation for many years to come, while at the same time — and this is critical — assuring that devices are safe and effective,” he said. “There are a number of differences between us and the European Union — they have a different standard than we do. Here in the U.S., the device has to be safe and effective. In Europe, a device has to be safe and it has to perform.

“For example, if I have a laser that’s supposed to treat an abnormal heart rhythm — you cut into the heart — in Europe, you have to show that when it cuts the heart, it cuts the heart well. In the U.S., you have to show when it cuts the heart it actually treats atrial fibrillation. It treats the abnormal heart rhythm — that patients get a benefit out of it.”

That said, Shuren noted, the U.S. does a better job of protecting patients from potentially harmful devices.

“We also have to remember, ‘Let’s not throw the baby out with the bathwater,’” Shuren said. “Here in the U.S., devices are safe and effective, but in many cases — and we have a number of examples — devices that came on the market in Europe, when they had to show data here for the U.S. we found they have safety concerns, where they didn’t work and they came off the market in Europe thereafter.

“I’ll leave this with a quote regarding one particular technology that was recently removed from the [EU] market. It was a breast implant that never made it here [in the U.S.]. This is from Nigel Mercer, a former president of the British Assn. of Aesthetic and Plastic Surgeons. He recently stated that, ‘Under the EU system, the public are being used as guinea pigs.’ We don’t use our people as guinea pigs in the U.S.”

Schmidt said this about today’s proposed changes to the U.S. Food and Drug Administration’s 510(k) program:

“While small companies will need time to understand all of the effects of the new FDA rule changes, all taxpayers and healthcare consumers need to understand that new regulations that add expense or cause delays in getting new cost-saving medical devices to market will increase healthcare costs while denying Americans better technology that is available in the rest of the world, making the U.S. less competitive.”

The goals of the (pdf) new guidelines are to support innovation, keep jobs in the U.S. and quickly bring safe and effective new innovative medical devices to patients, according to a statement from the FDA.

Changes to the 510(k) program require a delicate balancing act by the FDA. On one hand, industry has argued that the 510(k) process is “unpredictable, inconsistent and opaque,” according to the agency. To the contrary, consumers and health care professionals have argued that the agency’s review process for devices isn’t robust enough.

On some of the tough decisions, the FDA essentially punted, asking the Institutes of Medicine (IOM) to study the corresponding proposals further. The Wall Street Journal called the move to table some proposals a concession to the device industry.

Most lower-risk medical devices — such as imaging technology and catheters — that go on the market in the U.S. are cleared through the 510(k) program. Generally, a 510(k) application must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.

Among the key changes the FDA plans to make are:

• Streamlining the “de novo” review process for certain lower-risk medical devices
• Clarifying when clinical data should be submitted in a premarket submission
• Establishing a new council of senior FDA experts to assure timely and consistent science-based decision making
• Making device photographs available in a public database without disclosing proprietary information
• Implenting “notice-to-industry” letters that to inform the industry of when the FDA has changed regulatory expectations on the basis of new scientific evidence

The FDA plans to implement most of the proposals throughout 2011, but it has sent seven of the recommendations to the IOM for feedback, because those seven proposals raised “significant concerns” when subject to public comment last year, the FDA said. Those include:

• Defining the FDA’s authority to rescind devices that have previously received clearance
• Clarifying when a previously cleared device can no longer be used as a “predicate”
• Establishing a new class of devices, called “IIb,” that would require clinical data submissions

About 3,000 devices are cleared each year under the 510(k) program, according to the FDA. More than 90 percent of device approvals between 2003 and 2007 came through the 510(k) program, Bloomberg reported. The program was created in 1976.

“By increasing the predictability, reliability, and efficiency of our regulatory pathways, we can help provide better treatments and diagnostics to patients more quickly, stimulate investment in and development of promising new technologies to meet critical public health needs, and increase the global market position of U.S. medical devices,” wrote Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in (pdf) a letter explaining the changes to consumers.

The FDA unveiled a draft of the proposed changes last year, which prompted a medical device trade group to warn that some of the new rules could result in a “significant disruption” to the industry. However that group — the Advanced Medical Technology Association (AdvaMed) — greeted Wednesday’s announcement as “a step in the right direction.”

“The plan is clearly a good first step that will address some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the de novo process,” AdvaMed said in a statement.

“The critical next step is how FDA implements the plan through guidances and regulations,” AdvaMed continued.

The general consensus in the industry seems to be that the proposed changes aren’t nearly as heavy-handed as many device executives previously anticipated. “We continue to believe that the FDA’s work plan will be less onerous for the industry than many feared last year,” a Wells Fargo Securities medical technology analyst said, according to Bloomberg.

Consumer advocates, not surprisingly, were less pleased. Dr. Diana Zuckerman of the National Research Center for Women and Families said the FDA’s apparent concessions mean that “industry lobbyists won, and the public lost,” the Associated Press reported.

“Today’s FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments,” Zuckerman said.

The move to change the 510(k) program comes on the heels of a report from consulting firm PwC that warned that the U.S. is quickly losing ground to emerging markets in medical technology innovation.

In an opinion piece for The Wall Street Journal, on how to make U.S.’s regulatory systems more efficient, Obama included one sentence regarding the the process for which 2,654 new medical devices were cleared for market last year.

“Tomorrow the FDA will lay out a new effort to improve the process for approving medical devices, to keep patients safer while getting innovative and life-saving products to market faster,”Mr. Obama wrote.

The Advanced Medical Technology Assn., which provided detailed comments on the recommendations the CDRH released for an overhaul of the 510(k) system last August, is hopeful that the FDA will be responsive to industry concerns. AdvaMed was supportive of many of the recommendations put forth in August, but a lot depends on how the guidance is implemented.

“We’re hopeful. We have the sense that the FDA has been sensitized and is responsive to industry concerns and issues over competition,” AdvaMed senior executive vice president David Nexon told MassDevice. “The FDA’s own report showed a real deterioration in their performance, so we’re cautiously optimistic, but we’re concerned over sweeping recommendations that could have a negative effect on the industry,” he said.

The reception of the 510(k) recommendations has been mixed. Outgoing Medtronic CEO Bill Hawkins last week predicted the forthcoming changes “will be neutral to slightly negativee” for companies looking to get innovative new devices to market. Former 510(k) chief Heather Rosecrans said in November she is skeptical of the CDRH’s proposal to create a new Class IIb designation, which would require clinical data submissions. Meanwhile, Minnesota Sens. Amy Klobuchar (D) and Al Franken (D) along with Rep. Erik Paulsen (R), have championed the medical device industry with speeches and letters to the FDA about upcoming changes to the 510(k) program over the past few months.

FDA chief Dr. Margaret Hamburg has sought to quell concerns over the overhaul.

“We are really undertaking a serious, thoughtful process of review of all the comments as we shape the process,” Hamburg said in an October speech at the annual AdvaMed MedTech conference in Washington, D.C. “As we go forward, there will be still be opportunities for comment, feedback, discussion and shaping.”

The FDA plans to release its proposal on the 510(k) changes tomorrow afternoon at 1:00 p.m.

Related articles

• Medtronic’s Hawkins: 510(k) changes to be ‘neutral to slightly negative’ (medcitynews.com)
• Medical device protocol changes get cool reception (medcitynews.com)
• Minnesota senators recruit buddies to pressure FDA over 510(k) (medcitynews.com)

Dr. Deborah Rhodes

A Mayo Clinic internist’s talk at the high-profile TEDWomen conference in Washington, D.C., outlined the stunning limitations of mammography for 30 to 60 percent of women (depending on age) and added fuel to her 10-year quest to offer a new, alternative screening technology.

Dr. Deborah Rhodes spoke in early December at TEDWomen, one of a series of events that highlights innovative thinkers and “ideas worth spreading.” Other cutting-edge leaders included Facebook Chief Operating Officer Sheryl Sandberg and Ugandan farmer Annet Namayanja, who’s created a new kind of protein-rich bean.

Since the speech was posted online late last week, it has become one of TEDWomen’s “most emailed” and has caused a deluge of interview requests, said a Mayo spokesperson.

In her talk, Rhodes zeroed in on the center of recent controversy and confusion over mammogram guidelines: breast density.

• Breast tissue density is a higher risk for breast cancer than having a mother or sister with the disease, but 95 percent of women don’t know this, or how dense their breast tissue is.
• Mammography has only a 40 percent chance of detecting early stage tumors, like dense tissue, are white on a mammogram image.
• Molecular Breast Imaging (MBI) technology, currently licensed to California’s Gamma Medica, catches three times as many tumors in breasts with dense tissue, using significantly lower levels of radiation than currently offered by other gamma screening cameras. It also costs about $500, compared to more than $1,100 for an MRI.

“It is time for us to accept both the extraordinary successes of mammography and the limitations,” Rhodes said, issuing a challenge to the interests that would protect the status quo. “We need to individualize screening based on density.”

An Unanswerable Question

Ten years ago breast density was little understood, but Rhodes learned enough to realize she could not offer an at-risk patient a definitive early diagnosis with a mammogram. She then teamed up with Michael O’Connor, a professor of radiologic physics at Mayo Clinic. His team designed a type of scanner using a gamma camera, which produces images from a gamma radiation-emitting radioisotope that is injected. Gamma camera technology had just been made small enough to fit onto a mammography plate, which was what the team used for its first prototype.

When injected, the radioisotope concentrates in active clusters of cells, or tumors, which show up as black dots on the image. Mayo quickly got great results testing the technology, catching more and much smaller tumors than mammograms. In 2004, the Susan G. Komen Foundation funded a study of 1,000 women with dense breasts comparing a screening mammogram to MBI. Of the tumors found, MBI caught 83 percent, while mammogram caught only 25 percent.

The Competition

In 2004, while the Mayo team was conducting its study, Dilon Diagnostics, based in Newport News, Virginia, began selling its own gamma screening units. The clarity of gamma scans makes it easier to plan surgery or see if chemotherapy administered before surgery is shrinking a tumor. The technology has its own name — breast-specific gamma imaging, or BSGI. Nancy Morter, director of marketing and communications, said Dilon has installations in about 150 clinics in the U.S. as well as several other countries.

The Downside

Radiation levels are the key concern for MBI, BSGI, and related therapies. Because the radioisotope is injected, all organs are exposed instead of just the breasts. Radiation levels in scans are the subject of ongoing controversy, because nobody really knows for sure the true risk they pose. “If you don’t have dense breasts or other risk factors, then you don’t want the radiation exposure — you don’t need this,” Morter said.

Getting that dose as low as possible is the goal for Rhodes and her team, and MBI is currently one-fifth the level of other gamma technologies, or “comparable to a mammogram,” states the Gamma Medica site. The Mayo team will be publishing studies that attempt to weigh MBI’s potential against its risks as a regular annual screening tool for women with dense breast tissue.

The Market

A 2009 Elsevier Business Intelligence report valued the U.S. market for breast cancer detection and diagnostic technologies at approximately $2.18 billion in 2008, estimated to climb to $2.84 billion by 2013. But all gamma imaging technologies, at the time of the report, were considered too new and experimental to be included. Gamma Medica did not return a call for comment, but Morter of Dilon Diagnostics said there are about 9,000 U.S. Mammography Quality Standard Act-certified centers, plus independent imaging centers, and about 10,000 abroad as well. “Asian markets really like this (BSGI) device, as well as other countries with socialized medicine,” Morter said. “It is very affordable and easily accessed.” BSGI systems cost about $300,000 each for just the capital equipment.

The Future

Gamma Medica has been selling its Lumagem molecular breast imaging system with Mayo technology since 2009, but no sales figures are known; in her talk Rhodes said it was “still not widely available.” (Rhodes does not profit financially from the technology.) Given that replication of its studies will take years, and that the medical industry as a whole is slow to change, it’s anybody’s guess whether MBI or some other “disruptive” technology — or technologies — will improve early breast cancer screening.

Until MBI or other alternatives such as a new test that will better quantify density are more widely employed, both Rhodes and Morter say, it’s up to women to ask about their breast density classification when they get screened.

In a clarification on his blog offered in response to “questions,” CBO chief Douglas Elmendorf said repeal would reduce revenue by $770 billion over the next ten years and reduce outlays by $540 billion. This got me thinking. Would repeal actually reduce revenue by $770 billion? I don’t recall a massive tax increase in the original bill.

Then I remembered: The reform legislation contained about $500 million of “revenue” from eliminating extra payments for Medicare Advantage, increasing the efficiency of the fee-for-service Medicare program, and instituting a mechanism — the Independent Payments Advisory Board — that would lower outlays if overall spending ran out of  control. In other words, they were spending cuts. Shouldn’t repeal of these measures be properly categorized as increased outlays, not decreased revenues?

So, here’s a better way to understand the fiscal implications of H.R. 2, the Repeal of the Job-Destroying Health Care Act, better  known as the Affordable Care Act or simply health care reform to its proponents. By voting for repeal, Republicans (I’m assuming it will be a party-line or close to party-line vote) will be voting for a ten-year reduction in taxes of approximately $270 billion; a ten-year reduction in outlays of approximately $40 billion; and a ten-year increase in Medicare spending of approximately $500 billion.

The Republicans dubbed their new House rules “cut-go,” to distinguish them from the Democratic rules they replaced, which were called “pay-go” because you had to pay for every new program you passed. Seems to me a better name for H.R. 2 is “cut-grow.” It cuts benefits for the uninsured while growing the inefficient parts of Medicare.

Taylor, counselor to the commissioner will take on the new role Jan. 10, an FDA spokeswoman told MassDevice. Sharfstein’s last day on the job is Jan. 7.

Sharfstein, formerly Baltimore’s top public health official, is slated to be named secretary of health and mental hygiene for Maryland by Gov. Martin O’Malley.

“John Taylor will be acting in the role for 60 days beginning Monday,” spokeswoman Meghan Scott wrote in an email.

Starting with his brief tenure as acting commissioner in 2009, Sharfstein shook up the agency in a series of moved aimed at addressing safety issues. Most prominently, he helmed a probe into the watchdog’s controversial 2008 clearance of ReGen Biologics Inc.’s (OTC:RGBO) Menaflex knee implant. That probe led to the agency’s decision to put the device through its paces again, which in turn prompted the rescission of the clearance and a feisty response from ReGen.

The Menaflex 510(k) clearance in December 2008 came despite the fact that the device often failed and required second operations — and over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.

In March, the agency’s Orthopaedic and Rehabilitation Devices Panel at the Center for Devices and Radiological Health decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying Regen failed to produce adequate evidence that device was safe before it was cleared to hit the market.

Sharfstein, formerly Baltimore’s top public health official, is slated to be named secretary of health and mental hygiene for Maryland by Gov. Martin O’Malley, according to “government officials familiar with the issue” cited by the newspaper.

Sharfstein declined to comment, the newspaper reported; a spokesman for O’Malley wouldn’t confirm Sharfstein’s appointment, but noted that O’Malley intends to make an announcement about the post tomorrow.

Starting with his brief tenure as acting commissioner in 2009, Sharfstein shook up the agency in a series of moved aimed at addressing safety issues. Most prominently, he helmed a probe into the watchdog’s controversial 2008 clearance of ReGen Biologics Inc.’s (OTC:RGBO) Menaflex knee implant. That probe led to the agency’s decision to put the device through its paces again, which in turn prompted the rescission of the clearance and a feisty response from ReGen.

The Menaflex 510(k) clearance in December 2008 came despite the fact that the device often failed and required second operations — and over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.

In March, the agency’s Orthopaedic and Rehabilitation Devices Panel at the Center for Devices and Radiological Health decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying Regen failed to produce adequate evidence that device was safe before it was cleared to hit the market.