In today's New York Times, there appears a story by reporter Gardiner Harris about FDA's new guidance intending to reduce conflicts of interest on agency advisory boards. (Note: The story refers to the proposal as "rules" but it is actually "draft guidance" which, unlike rules/regulations, does not carry the force of law.)

The guidance is a response to an increasing problem at FDA: Scientists determining the public safety of drugs and medical devices often have financial ties to the products or industry on which they are commenting. There are pros and cons to the draft guidance.

The good:

• Most advisors having obvious financial conflicts of interest of more than $50,000 will not be able to serve on committees.
• Most advisors with less significant conflicts of interest will be able to serve but not vote.
• The guidance addresses not just current financial conflicts of interest, but those that have occurred in the past year.

The bad:

• The guidance is loaded with loopholes, including reserving the right of the FDA commissioner to grant waivers.
• The guidance only addresses financial conflicts of interest, not personal or professional. (This is politics! Relationships and egos are important.)
• This is guidance, not a regulation. Therefore, it "does not operate to bind FDA or the public."

The ugly:

• An advisor with a significant financial conflict of interest may still be able to serve (but not vote) if "the need for the individual's services outweigh the potential for a conflict of interest." Doesn't a big pile of cash undermine the objectivity of an "expert?" Shouldn't pharmaceutical expertise funded by a pharmaceutical company be considered ill-gotten gains?

Stay tuned to Reg•Watch for more on this.

Posted by Matt Madia, 12:56:57 PM

Wednesday, March 21, 2007

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

Mine Safety Concerns Remain after Sago

Leaders of Finance Committee Respond to IRS Outsourcing Program

Tuesday, March 20, 2007

As Reg•Watch blogged yesterday, a House committee held a hearing to investigate the Bush administration's manipulation of government climate science. The hearing was the second by the Oversight and Government Reform Committee to examine political interference in climate science.

Chairman Henry Waxman (D-CA) called the first hearing after the White House Council on Environmental Quality's refused to turn over documents the committee had requested. In his opening remarks, Waxman said CEQ has turned over eight boxes but has not yet fulfilled the months old request. Still, the evidence the committee has seen "suggests there may have been a concerted effort directed by the White House to mislead the public about the dangers of global climate change."

The testimony of Philip Cooney was nothing to write home about. Cooney was CEQ chief of staff (in between stints at the American Petroleum Institute and Exxon-Mobil) until 2005. He resigned after it was discovered he had altered climate science documents to plant seeds of doubt.

Not surprisingly, Cooney claimed his actions were completely justified and cited a National Academies of Science report as his basis. The committee quickly shot holes through his defense. Waxman pressed Cooney on a verbatim quote from the NAS report he had completely removed. The sentence indicated the breadth and severity of climate change.

Read more from The New York Times



Posted by Matt Madia, 09:55:17 AM

Thursday, March 15, 2007

OMB Watch Releases Report on Bush Changes to Regulatory Process

Today, OMB Watch released a full report titled A Failure to Govern: Bush's Attack on the Regulatory Process (download it here). This report outlines President Bush's recent amendments to Executive Order 12866 — Regulatory Planning and Review. The report details the potential impacts the amendments will have on federal agencies and the American public, as well as what the changes mean to democracy at large.

A Failure to Govern: Bush's Attack on the Regulatory Process

Friday, March 09, 2007

Outsourcing Regulations

Today, The New York Times published a story documenting a recent and disturbing trend in government: allowing the regulated to write regulations. The story begins by detailing an IRS program in which tax lawyers and accountants are encouraged to draft rules on behalf of IRS. These tax professionals — who make money by finding new ways to reduce their clients' tax burden — will now formulate the regulations they will later be subject to. I challenge you to find a better example of a conflict of interest.

The IRS program is merely the tip of the iceberg. The article goes on to broadly discuss the outsourcing of regulations:

It is common for special interests of all types to be closely involved in drafting legislation and shaping rule making. But in recent years there has been a quickening pace of moves to outsource the actual work of regulation, hiring contractors to write the rules.

Considering, as the article states, "Rule making is the heart of what Washington does," one would think federal regulators would take the process seriously. Instead, the federal government is passing the buck, then allowing industry to pocket it.



Posted by Matt Madia, 02:14:24 PM

Wednesday, March 07, 2007

Latest Watcher

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

One Step Closer to Less Smog

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

Friday, March 02, 2007

Bush Nominates Manufacturing Ally to CPSC

Thursday, President Bush nominated Michael Baroody to be a commissioner on the Consumer Product Safety Commission (CPSC). Baroody is the current executive vice president of the National Association of Manufacturers, a trade group whose mission includes "shaping a legislative and regulatory environment" on behalf of manufacturers.

Baroody's ability to shape America's regulatory environment will take on new meaning if he becomes a CPSC commissioner. The CPSC is the independent agency charged with protecting the public from dangerous products. The commissioners (of which there are only three) must be able to work with manufacturers to assess product safety, but also exert authority when industry cooperation does not go far enough in protecting the public.

If you think a commissioner with such obvious strong ties to the industry he must regulate is a bad idea, you are not alone. Public interest groups are already sounding the alarms, and Sen. Barbara Boxer (D-CA) says she will give the nomination "thorough scrutiny," according to the LA Times.

As Reg•Watch has blogged in the past, the CPSC has been short a commissioner since July, and its voting quorum recently expired. I find it depressing to have to contemplate which is worse: a commissioner like Michael Baroody, or no commissioner at all.



Posted by Matt Madia, 10:39:47 AM

Thursday, March 01, 2007

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.