FDA commissioner Dr. Andrew von Eschenbach is opposed to bipartisan legislation that would allow FDA to regulate tobacco products. Sensible bills in both the House and the Senate would dramatically improve public health as it relates to tobacco products. The bill would do so by placing the tobacco industry — which currently goes unregulated — under the purview of FDA.

In a Mar. 6 interview with the Associated Press, von Eschenbach manipulates the facts in his opposition to the bill. His specious arguments are a poorly veiled attempt to side with the tobacco industry. He also claimed tobacco products are too complex for the FDA to handle. How can an FDA commissioner hold such little regard for his own agency?

One of the bills sponsors, Rep. Henry Waxman (D-CA), wrote a letter to von Eschenbach asking him to correct his various misstatements.

Your statements suggest a serious misunderstanding of the bill and appear to ignore overwhelming evidence that such regulation is necessary to address the continuing epidemic of tobacco-related death and disease.

The Environmental Forum, a bimonthly publication of the Environmental Law Institute, has published six opinions pieces on President Bush's changes to the regulatory process. The magazine features three opinions in favor of the changes and three opposed, including a piece by OMB Watch Executive Director Gary Bass.

Of particular concern is the opinion of John G. Knepper, Deputy General Counsel of OMB. One new amendment requires agency Regulatory Policy Officers (RPO) be presidential appointees. Knepper argues this will make those officials more accountable to Congress and the public. But the Executive Order does not require the Senate to approve the RPO. Knepper, presumably involved in the drafting of the changes, should be more forthright in his argument.

In opposition, Rep. Henry Waxman (D-CA) reinforced the common conclusion that the White House — in the face of an opposition Congress — is attempting in its last two years to leave an anti-regulatory legacy. Waxman articulates the underhanded Bush tactic with a great simile:

"Like a retreating army that mines the road behind it, the Bush administration is erecting new barriers to prevent commonsense safeguards from advancing in the next administration."

As Reg•Watch has blogged before (here and here), President Bush is attempting to further undermine EPA's ability to promulgate regulations to protect the environment by slashing the agency's budget. Administrator Stephen Johnson has inexplicably defended the cuts, towing the administration line instead of sticking up for his own agency.

In a Senate hearing yesterday, Sen. Barbara Boxer (D-CA) expressed this same concern: "To have the EPA administrator talk about how he's not really fought the cuts is very disturbing to me." (Reported in E&E Daily)

Today, the House committee on Energy and Commerce is grilling Johnson on the cuts. You can watch the hearing here. Kudos to Congress for putting up a fight where EPA hasn't.



Posted by Matt Madia, 10:58:31 AM

Wednesday, March 07, 2007

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Regulatory policy articles this time:

Bush Continues Anti-Regulatory Efforts with Industry Nominee to CPSC

Scientific Consultant Sparks Controversy over Conflicts of Interest

In Congress, No Shortage of Fuel Economy Proposals

Tuesday, March 06, 2007

Yesterday, the EPA's Clean Air Scientific Advisory Committee (CASAC) unanimously voted on recommendations to EPA concerning ground-level ozone (or smog), according to BNA news service (subscription). CASAC voted to lower the allowable standard to between 0.060 ppm and 0.070 ppm from its current level of 0.08 ppm. CASAC purposefully used an extra digit so regulators could not manipulate the standard by rounding. And you thought you would never use significant figures after high school.

CASAC's recommendation is similar to that of an EPA staff paper released in January. The EPA should now adopt the recommendation when it revises the standard which the Clean Air Act requires EPA to do every five years.

Though based on sound science and developed by bright minds, the CASAC recommendation took some guts too. Industry has been vocal in opposing a tighter standard on smog. Also, EPA has been meddling with CASAC's ability to act independently, as a recent Senate oversight hearing uncovered.

EPA has until Mar. 2008 to make its final decision, but with this administration it's never too early to start urging administrators to prioritize science and the public interest ahead of politics and special interests.



Posted by Matt Madia, 11:21:01 AM

Monday, March 05, 2007

FDA Ignoring Medical Advice on Antibiotic Resistance

The Washington Post on Sunday ran a front page story about the FDA's pending approval of a bovine antibiotic, despite grave concerns over antibiotic resistance. Public health organizations including the American Medical Association — as well as the agency's own advisory board — warned against approval of the drug which is an important "medicine of last resort" in treating otherwise "nearly invincible infections." If the antibiotic is used on cows, resistant bacterial strains will likely develop with the ability to infect the human population. The effectiveness of this appropriately powerful drug will be severely weakened.

In the Post article, epidemiologist Edward Belongia chides the drug industry for exerting its influence:

The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use.' But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open.

As the case for reform at FDA grows, this example is merely another brick in the wall. FDA is once again showing its disregard for medical consensus and scientific integrity, and jeopardizing public health in the process.



Posted by Matt Madia, 11:17:42 AM

Thursday, March 01, 2007

Johnson Defends EPA Budget Cuts, Improves BTO Grammar

Yesterday, U.S. Environmental Protection Agency (EPA) administrator Stephen Johnson testified before a House Appropriations subcommittee on the agency's proposed FY 2008 budget. Johnson was prodded on an EPA water quality program (budget to be cut), a local enforcement initiative (budget to be cut), and the agency at large (budget to be cut), according to BNA.

Naturally, budget cuts make it more difficult for agencies to create and enforce the rules that keep our nation clean, safe, and democratic. However Johnson is optimistic: "This budget will fulfill EPA's responsibilities as guardian of our nation's environment and the taxpayers' money." Commenting on EPA air quality programs, Johnson channeled famed rock group Bachman Turner Overdrive saying, "If you think our air is clean now, you haven't seen anything yet."

In another ill-advised comment, Johnson responded to Rep. James Moran (D-VA) who questioned the administrator on endocrine disruptor (ED) research (budget to be cut). EDs are potent chemicals which can alter hormonal behavior. In 1996, Congress asked EPA to identify and test EDs, but no tests have been performed thus far. Defending the agency, Johnson said, "We have been doing the research, but there's this pesky thing called science."



Posted by Matt Madia, 02:56:47 PM



Latest Developments on Bush Changes to the Regulatory Process

OMB Watch has created a new web center to be the one-stop source for news and developments on President Bush's recent amendments to Executive Order 12866. The web center will be frequently updated with fresh insights, news from Capitol Hill, and links to media coverage.