Sen. Tom Coburn (R-Okla.) on Wednesday outlined his concerns with food-safety legislation that's pending in the Senate.

In a detailed entry on his Web site, Coburn in particular raised concerns with duplication and overlap of responsibilities between the Food and Drug Administration and the U.S. Department of Agriculture. Coburn also objected to the bill's $1.4 billion price tag over five years, not including $230 million directly offset by new fees. 

In the absence of guaranteed future appropriations, Coburn writes, "at best we are just passing it for a press release, and at worse, we shackle the FDA with unfunded mandates."

Coburn's objection might derail what could otherwise be smooth passage of legislation that has bipartisan support in the Senate. The House passed food-safety legislation in July 2009.

The bills in the House and Senate would give FDA the power to recall tainted food, quarantine geographical areas and access food producers’ records.

The chairman and ranking member of the House Ways and Means health subcommittee introduced legislation Wednesday that would allow the Department of Health and Human Services to ban corporate executives from doing business with Medicare if their companies were convicted of fraud, even if the conviction takes place after their departure.

The bill, introduced by Reps. Pete Stark (D-Calif.) and Wally Herger (R-Calif.), would also give the HHS Office of the Inspector General the ability to exclude parent companies that may be committing fraud through shell companies.  

The OIG's chief counsel asked for the two changes during a hearing on Medicare fraud in June, according to the bill's sponsors.

"This legislation gives the Office of Inspector General the authority to go after crooked executives and corporations that continue to bilk Medicare," Stark said in a statement. "Stopping these swindlers will save taxpayer money and protect Medicare beneficiaries. I appreciate the OIG making this request for more authority, and thank my Democratic and Republican colleagues, especially Mr. Herger, for working together to address this issue."

The industry group representing medical devices released a new report on Wednesday that touts the safety of a federal approval process the Obama administration wants to overhaul.

Researchers with Battelle examined more than 47,000 devices approved since 1998 through the Food and Drug Administration's 510(k) premarket review process for low- and moderate-risk devices. Battelle scoured FDA recall notices and press releases and found only 77 Class I recalls, which involve  products that could cause serious injury or death, between Jan. 1, 2005, and May 1, 2010 — a .16 percent recall rate.

"What this study shows is that the 510(k) process has an extraordinary safety record," said David Nexon, senior executive vice-president for the Advanced Medical Technology Association (AdvaMed), which funded the study. "If you look at the data, you'll see a situation where it's hard to imagine any other regulatory process that will have as good a record at weeding out unsafe products before they reach patients."

The FDA is currently debating more than 70 changes to the 510(k) process amid concerns that approval rules are too lax, and will be gathering public input through Oct. 4. AdvaMed supports some changes to the program, such as increased reviewer training, development of additional guidance, and greater communication of reviewer decision rationale to prevent delays and inconsistencies in the program. But the industry argues that the basic expedited review process is sound and should be preserved to help American products get to market quickly and efficiently.

"Our view," Nexon said on a conference call, "is that this study reinforces a message we've putting out for some time: Reform of the 510(k) program is appropriate, but you need a scalpel, not a meat axe."

Rep. Stephen Lynch (D-Mass.) prevailed against a primary challenger Tuesday who sought to punish him for his vote against the healthcare reform bill.

Lynch had 64 percent of the vote to 36 percent for union activist Mac D'Alessandro. The Associated Press called it with 88 of 225 precincts reporting.

Lynch hadn't faced a difficult primary in his five terms in office but his vote against healthcare reform legislation angered unions, some of which campaigned against him. 

D'Alessandro, a first-time candidate for office, served as the New England political director for the Service Employees International Union, which spent almost $300,000 on direct mail and other activities in support of him.

He called Lynch's healthcare vote the "final straw" that prompted him to run.

"It goes all the way back to his vote to authorize the war in Iraq and its continued funding time and time again, even as our economy here at home fell apart,” he told The Hill Monday, also citing Lynch’s anti-abortion position.

Still, healthcare was a big part of D'Alessandro’s campaign.

"I think that his 'no' vote on healthcare was a vote against the interests of middle-income families, middle-class families, working families, not to mention small businesses," he said. "Those are reforms that benefit a lot of working families in this district."

The SEIU said the challenger put up an "impressive result" against the incumbent. 

"Mac D'Alessando may have come up short in his campaign but his impressive result proves that when you stand up for your beliefs you will never stand alone,” SEIU Massachusetts State Council President Mike Grunko said in a statement. "Mac ran for Congress on a set of values and principles that will never waver and a support for working families that make us proud to call him part of our SEIU family."

Lynch wasn't without union support. He was endorsed by the AFL-CIO during the primary, but the union didn't make any independent expenditures on his behalf.

—This story was crossposted from Ballot Box

Sens. Jon Tester (D-Mont.) and George Voinovich (R-Ohio) introduced legislation this week aimed at aligning federal efforts regarding prostate-cancer research, awareness and healthcare delivery.

The bill establishes a federal interagency task force, convened by the Department of Veterans Affairs with representation from the Department of Health and Human Services and the Department of Defense.

Rep. Edolphus Towns (D-N.Y.) is expected to introduce companion legislation to the Prostate Research, Outreach, Screening, Testing, Access and Treatment Effectiveness (PROSTATE) Act of 2010 in the House.

The bill comes as prostate-cancer activists are marking National Prostate Cancer Awareness Month with several requests from lawmakers:

• Increase the National Cancer Institute’s $5 billion annual budget to accelerate basic and treatment sciences research for human prostate cancer from $294 million to a transparent $400 million;

• Increase the appropriation for the Congressionally Directed Medical Research Program for Prostate Cancer at the Department of Defense to $120 million from $80 million;

• Establish an Office on Men’s Health (OMH) in the Department of Health and Human Services equivalent to The Office on Women’s Health (OWH) established in 1991;

• Create a Prostate Cancer Scientific Advisory Board for the Office of the Chief Scientist at the U.S. Food and Drug Administration to accelerate real-time sharing of the latest research data and accelerate movement of new medicines to patients;

• Create human capital by launching more careers of the best and brightest scientists in the U.S. to solve the prostate cancer problem.

The Senate Health, Education, Labor and Pensions Committee has postponed Wednesday's hearing on Utah Republican Sen. Orrin Hatch's Stem Cell Therapeutic and Research Reauthorization Act of 2010. The panel was also supposed to take action on the nomination of Subra Suresh to be director of the National Science Foundation.

A committee staffer says the hearings won't occur this week but may be rescheduled for next week.

The Department of Health and Human Services (HHS) on Wednesday released $14 million to bolster programs designed to identify which healthcare treatments work best on ethnic minorities.

The move is part of a broader transition to adopt so-called "patient-centered" care strategies, which aim to inform healthcare providers which drugs, devices, tests and other interventions are most effective on different populations. 

"A healthier nation must include our underserved and minority communities," Howard Koh, HHS assistant health secretary, said in a statement. "We now have the opportunity to determine which interventions truly help diverse populations achieve optimal levels of health."

The funding arrives as part of the Democrats' new healthcare reform law, which allocates more than $1 billion toward patient-centered care research, $400 million of which is to be used at the discretion of HHS leaders.

The $14 million was awarded in the form of grants to researchers at schools in Florida, Hawaii, Illinois, New Mexico and New York. In addition, Maryland-based Westat, Inc. also received a portion of the funds.

Administration officials said the grants will go a long way toward eliminating the health disparities that plague many minority groups.

"Patient-centered outcomes research must become a critical part of our strategy as a nation to understand and eliminate health disparities," said John Ruffin, director of the National Institute on Minority Health and Health Disparities. "This joint initiative complements the work that we are currently doing."

Congress tackles a full slate of hearings: There are only a few short weeks left for legislative accomplishments in the 111th Congress, but members are eager to hold forth on their favorite topics. Today they start by tackling a slew of issues, from stem cell research to Medicare reimbursements.

The Senate HELP Committee kicks things off in the morning with a hearing on  the Stem Cell Therapeutic Reauthorization Act of 2010, introduced by Sen. Orrin Hatch (R-Utah) early last month. The bill would reauthorize $53 million in funding for bone marrow and cord blood transplants and has bipartisan support. http://bit.ly/bwn9A8 

Medicare pricing under review: Lawmakers on the Energy and Commerce health panel delve into the touchy issue of adequate reimbursements for the durable medical equipment - wheelchairs, oxygen tanks, diabetic testing supplies - vital for seniors with disabilities and other conditions to continue living independently. Auditors have uncovered many problems with overpayments and fraud over the years, in part because reimbursement policy is based on 1987 prices; in 2006, for example, the Health and Human Services of the Inspector General found that Medicare would allow $7,215 in payments over three years for oxygen supplies that cost on average 12 times less - $587 - to purchase.

The hearing will examine the conception and implementation of the Medicare competitive bidding program and its potential effects on patients, providers and suppliers. The new healthcare reform law vastly expands competitive bidding, from nine metropolitan statistical areas currently to 100 in the second round of bidding to be conducted in 2011. By 2016, the new law requires that CMS apply rates observed in the competitively bid areas to other parts of the country. 

Sen. Mike Johanns' amendment to repeal the health reform law's 1099 business reporting requirement would have had a direct effect on several provisions of the law.

While most of the attention was focused on the 1099 provision itself, the Nebraska Republican also wanted to cut funding for prevention and public health by $11 billion and weaken the requirement that most Americans buy health insurance starting in 2014. The amendment failed a cloture vote by a 46-52 vote on Tuesday.

The American Public Health Association immediately praised the vote, saying the Johanns bill would have "effectively eliminated" the health reform law's Prevention and Public Health Fund.

"Today, the Senate signaled that it will not tolerate any efforts to undermine health reform and embraced public health and prevention as hallmarks of reform," executive director Georges Benjamin said in a statement. "The public health community applauds the Senate for  protecting the fund and appreciating the promise that disease prevention holds for all Americans."

The Johanns amendment would also have exempted many more people from the law's individual mandate requirement. The liberal Center for Budget and Policy Priorities estimated that the provision would result "increasing the number of uninsured people by 2 million (relative to what would occur under the health reform law), driving up premiums by as much as 4 percent for people with coverage through the new health insurance exchanges (because the pool of people in the exchanges would be less healthy, on average)."