Earlier, Reg•Watch blogged about the concerted lobbying efforts of senior administration officials intent on killing an effort by the state of California to enact its own greenhouse gas reduction program. There are so many issues at stake here it's mind-boggling:

• Environmental Simply put, Waxman's investigation shows how the Department of Transportation, EPA, and White House Council on Environmental Quality (CEQ) tried to kill a program which would effect a major reduction in greenhouse gas emissions from vehicles. That's probably not in their respective mission statements.
• Industry influence As Reg•Watch mentioned earlier, the Department of Transportation was aided and abetted by the Auto Alliance in targeting certain congressmen. The Auto Alliance — comprised of Ford, GM, Toyota and others — has a big interest in making sure California and other states can't require tougher vehicle emissions standards.
• Federalism California's appeal for a waiver has always been a federalism issue. The Clean Air Act reserves the federal government's rights to regulate vehicle emissions, but also permits EPA to grant waivers for state programs. By delaying California's plan and rendering state regulators impotent, the administration is unfairly and unilaterally shifting power away from the states and to the federal government. The Bush administration ought to be more faithful to the principles of federalism upon which our nation was founded.
• Legal The Anti-Lobbying Act prohibits government personnel from lobbying Congress on proposed legislation. While administration officials may not have said "vote no" so explicitly, they did convey their opposition to the California waiver, and Congress is considering legislation that would force EPA to make a decision on the waiver. Moreover, Congress has the ultimate authority in initiating and overseeing agency regulatory activity through statute, so any opinion on a regulatory decision could be construed as lobbying. The Department of Justice does not apply the Anti-Lobbying Act to direct communications between agency personnel and legislators (only to "grassroots" lobbying) so don't hold your breath on legal action unless someone takes this to the courts.
• Resources and priorities Regardless of the legal question, this controversy raises significant concern over agency priorities and the use of resources. Couldn't Secretary Peters' and Chairman Connaughton's time be of better use elsewhere? More importantly, as Rep. Waxman says in his letter, "It is not an appropriate use of taxpayer dollars to organize a lobbying campaign to politicize this vital regulatory decision."

The Sunday New York Times featured an article on the efforts of U.S. industry groups to push for federal regulation. As the article points out, this represents a marked shift in the traditional conception of industry's views on regulation. Historically, industry representatives often see regulation as costly and vexing.

A graphic in the article briefly summarizes 14 examples of new federal regulations supported by manufacturers or industry lobbyists.

In some cases, such as the toy industry, representatives appear to have good intentions. A recent hearing proves that industry representatives recognize the benefits associated with a strong federal regulatory regime.

Unfortunately, as with lead paint in toys and diacetyl in popcorn, even the combination of strong public and industry support (not to mention overwhelming health-based evidence) is not enough to prompt the Bush administration into action. As the article shows, agencies often don't act to regulate substances like lead and diacetyl despite support for doing so from industry lobbyists. Is this a sign senior administration officials' anti-government ideology trumps their industry loyalties?

In other cases, representatives may be employing a calculated strategy. Industry lobbyists may rather have product regulations written by the Bush administration (and edited by Bush's OMB) than by a future administration that may be less friendly. With the clock running down on Bush's second term, this may be the last opportunity for a middle-of-the-road regulatory approach.

The Sunday Times also featured two editorials (here and here) titled, "The Need for Regulation."

Yesterday, Reg•Watch blogged about Congress's FDA reform bill which has passed the House and the Senate but is now stuck in a conference committee charged with reconciling the two versions.

One important provision contained in the House bill, but not in the Senate version, would reduce conflicts of interest on FDA advisory panels. Those panels make important recommendations about the safety of prescription drugs, among other things. However, FDA is often criticized for letting individuals with ties to the pharmaceutical industry serve on the panels. The provision in the House bill would allow only one conflicted member serve on each panel.

Sen. Dick Durbin (D-IL) offered a similar provision as an amendment to the Senate version. Unfortunately, it was not added to the bill because the vote on the amendment was a 47-47 tie.

Two of the senators who voted against Durbin's amendment, Ted Kennedy (D-MA) and Chris Dodd (D-CT), are now serving on the conference committee and will soon work with House members to decide whether the bill Congress sends to the president will contain the conflict-of-interest provision or not.

Now, the heat is on Kennedy and Dodd to make the right call and support the provision. According to the Center for Science and the Public Interest (CSPI):

nine prominent physicians, including two former editors of the New England Journal of Medicine, are calling on Senators Edward M. Kennedy and Christopher J. Dodd to limit the number of industry-connected scientists who may serve on Food and Drug Administration advisory panels.

The letter is available on CSPI's website. Stay tuned to Reg•Watch for updates on this provision and the overall FDA reform bill.

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

Federal Agencies Knew of Diacetyl Dangers and Kept Silent

Bush's Anti-Regulatory Ideology under Increasing Scrutiny

It's Industry vs. Consumers and Health Specialists in National Ozone Hearings

New Small Business Program Will Influence Agency Regulatory Reviews

Yesterday, The Chicago Tribune published a story about a new medical study that has found a dramatic increase in adverse effects associated with prescription drugs. According to the article, "The annual number of 'serious adverse event' reports jumped to 89,842 in 2005 from 34,966 in 1998. Meanwhile, the number of 'fatal adverse drug events' increased nearly threefold to 15,107 in 2005 from 5,519 in 1998."

The article also mentions the Congressional reauthorization of the Prescription Drug User Fee Act (PDUFA) and the FDA reform measures lumped in with it. The legislation renews PDUFA (a program which allows FDA to collect money from drug makers in order to conduct drug safety reviews) and expands FDA's authority to conduct post-market safety reviews and pull drugs from the market if necessary.

The Senate passed its version in May, and the House approved its version in June. Because of disparities in the FDA reform provisions, a House/Senate conference committee will need to reconcile the bills before sending a final version to the president. The bill is considered must-pass legislation, because the PDUFA program expires at the end of September.

While the bill must pass, findings in the medical study underscore the fundamental problems with the legislation. The PDUFA program is a double-edged sword. While it is an important source of funding for the agency, it comes with strings attached and allows drug companies to call the shots during the approval process.

Moreover, by focusing only to expand FDA's powers in regard to post-market drug safety, Congress is only trying to close the gate after the horse has left the corral. When it comes to drug approval, both parts of the bill presume speed to be more important than safety.

In the Chicago Tribune article, FDA spokeswoman Julie Zawisza tries to put a positive spin on the news by saying, "More reporting to us gives us more information on which to evaluate a drug's safety once it is on the market. Now that we get more reporting, people are saying that there is something wrong. We know that under-reporting is a problem so one would think that when we get more reports it could suggest that the system is actually working better but we don't for sure."

Tortured logic aside, Zawisza's quote and Congress's pending legislation beg the question: Do our government leaders ever consider assuring a drug's safety before it hits the market?

Reg•Watch Update: "For Congress, an Opportunity to Limit Conflicts of Interest at FDA"

Mattel is recalling another batch of toys because of lead paint contamination. This time, it's 675,000 Barbie toys.

As it has with past recalls, Mattel is working in cooperation with the Consumer Product Safety Commission, the federal agency responsible for regulating toys and other products. Reg•Watch has blogged about the problems with this industry-lead voluntary recall system and the ineffectiveness of CPSC.

The problems are underscored by a recent Wall Street Journal article in which Mattel's chairman revealed the toy maker often conducts investigations of hazardous products on its own (and outside of the public view) before notifying CPSC.

With rare exception, manufacturers are to notify CPSC within 24 hours if they believe a product to even be potentially hazardous. According to the Journal, Mattel has a different take:

Mattel Chairman and Chief Executive Robert Eckert said in an interview that the company discloses problems on its own timetable because it believes both the law and the commission's enforcement practices are unreasonable. Mattel said it should be able to evaluate hazards internally before alerting any outsiders, regardless of what the law says.

Reg•Watch once tried that "the-law-is-unreasonable-argument" to get out of a parking ticket. It didn't work.