Medical Device Daily

WASHINGTON — A bill to prohibit employers and insurance companies from discriminating because of an individual's genetic makeup is continuing to move through the House of Representatives, with an Energy and Commerce subcommittee approving it last week.

This is the latest hurdle for the legislation, which has always stalled in the past. Still, the measure must clear three panels before it reaches a floor vote in the House.

The Education and Labor Committee already has approved it, and the recent subcommittee endorsement would seem to signal pending success before the Energy and Commerce Committee.

Action before the Ways and Means Committee has yet to begin.

The bill, the "Genetic Information Nondiscrimination Act," or H.R. 493, was introduced by Rep. Louise Slaughter (D-New York). It establishes protections against using someone's genetic information in making decisions about health coverage or jobs.

Advocates such as Francis Collins, director of the National Human Genome Research Institute, have testified that without such protections the full potential of genomic research and personalized medicine may never be realized.

A companion bill sponsored by Sen. Olympia Snowe (R-Maine), S. 358, cleared the Senate's Health, Education, Labor and Pension Committee in January. Sharon Terry, president/CEO of the Genetic Alliance (Washington), said the Senate is soon expected to bring it to the floor for a vote.

Twice before, in 2003 and 2005, the Senate has unanimously passed it, but the House has never voted on the matter.

This year's progress in the House represents a reversal of previous years, when opposition from large employer groups held up any advances. Of note, President Bush has voiced his support for such legislation.

Grassley: Eschenbach censoring FDA staff?

Chuck Grassley (R-Iowa), ranking member of the Senate Finance Committee, reportedly has sent a letter to FDA Commissioner Andrew von Eschenbach to clarify statements suggesting that agency employees cannot testify before Congress.

Grassley warned von Eschenbach that "interfering with a congressional inquiry is against the law" and punishable by fines or as many as five years in prison and that he could lose his salary.

Grassley's letter addresses quotes attributed to von Eschenbach last month in the Newark Star-Ledger. According to the Star-Ledger, von Eschenbach on Feb. 21 in reference to FDA whistleblowers said, "To go outside the process is destructive, not constructive… . I expect people to adhere to that because that's the way to do business. Otherwise, it's chaos."

Grassley cited previous reports that von Eschenbach has told FDA staff that they risk their jobs if they express disagreements with FDA officials publicly. According to Grassley, "individuals, both inside and outside of FDA," have raised concerns that von Eschenbach's statements "are being interpreted to prohibit FDA employees from talking to Congress and threaten FDA employees who choose not to abide by your decree."

Grassley wrote, "The danger is that FDA employees interpret this to mean they can't talk with Congress if they want to about problems inside the agency, and, as a result, those problems are less likely to see the light of day and be fixed."

Bill would boost trauma center funding

The House Energy and Commerce Subcommittee on Health last week unanimously approved a bill that would authorize an additional $46 million between FY08 and FY12 in spending for rural medical centers that treat patients during times of national crisis.

The spending would be used to give the centers the capacity to treat large influxes of patients, improve patient data systems, and increase research and development by public and private groups.

In addition, the grant money would be used by states and not-for-profit organizations to create model curriculum for training programs for emergency first responders, medical technicians, nurses, doctors and paramedics.

Rep. Joe Barton (R-Texas), ranking member of the Energy and Commerce Committee, said that the additional spending "will provide much needed coordination for trauma care in our nation's rural areas."

Subcommittee Chair Frank Pallone (D-New Jersey) said that $30 million has been spent on trauma center improvements since 1990.

New bill aimed at SOX reform

New legislation has been introduced to reform certain provisions of Section 404 of the Sarbanes-Oxley Act to make compliance more efficient, reducing some of the financial burdens on small- to mid-cap businesses in attesting to the soundness of their internal control functions.

Called the "Compete Act of 2007," or H.R. 1508, its primary sponsor is Rep. Gregory Meeks (D-New York). This seems to follow proposed changes from the SEC, which late last year suggested that auditing standards should be eased for such companies, which have for some time called for scaled reforms to Section 404.

Companion legislation, S. 869, has been introduced by Sen. Jim DeMint (R-South Carolina).