Yesterday, Congress missed an opportunity to restore states' ability to impose standards stricter than federal standards on chemical plant security.

As OMB Watch reported in April, the Department of Homeland Security finalized interim regulations for instituting security performance standards at high-risk chemical facilities. The regulations fail to protect the public on a number of fronts.

Of particular concern is a controversial provision which allows DHS to preempt state rules. Although the DHS rules are temporary, and many states' rules are permanent, DHS could essentially terminate state programs. As OMB Watch and Public Citizen said in comments on the rules, "DHS's chemical security regulations should be viewed as a floor, not a ceiling."

Yesterday, the House and the Senate passed legislation to provide supplemental funding for the war in Iraq. The bill had included language which would have fixed the preemption problem. However, Congressional leaders stripped the language at the behest of the National Association of Manufacturers, according to The New York Times.

Ultimately, America needs comprehensive chemical security legislation that will force DHS to implement strong standards and prevent it from getting in the way of the states. When it comes time for Congress to act, let's hope lawmakers don't once again bow to the wishes of industry.

Yesterday, Michael Baroody withdrew himself as nominee to head the Consumer Product Safety Commission (CPSC). News of the withdrawal came less than 24 hours before today's scheduled nomination hearing.

It is unclear whether the withdrawal came at the behest of the White House or was of Baroody's own accord. Either way, it is not surprising. The Senate nomination panel was preparing to grill Baroody on his ties to industry and obvious conflicts of interest.

The withdrawal is a welcome decision. Sen. Barack Obama (D-IL) put it best in today's Washington Post:

His nomination highlights yet again the need to slow a revolving door that creates conflicts of interest between government officials and the industries they're supposed to be overseeing.

But back to the matter at hand. CPSC has been without a commissioner since July, and has been without a voting quorum since January, stripping it of its ability to conduct official business.

CPSC has not produced a final rule since mid-2006. Considering President Bush took eight months to nominate Baroody after the previous commissioner left, CPSC's problem is far from solved. Bush should immediately announce a more appropriate nominee, and the Senate should begin the confirmation process posthaste.

The Associated Press is reporting Michael Baroody has withdrawn his nomination to be commissioner of the Consumer Product Safety Commission. As Reg•Watch reported last week, Baroody's industry ties were increasingly making him an untenable nominee.

Consumer commission nominee withdraws [Associated Press]

Yesterday, OMB Watch submitted comments on FDA's proposed conflict of interest guidelines for agency scientific advisory panels. Avoiding conflicts of interest on these panels is important to ensuring scientific integrity, responsible use of agency resources, and strong final regulatory actions.

OMB Watch complements some provisions in the proposed guidance, but also encourages FDA to close certain loopholes which undermine its intent. As stated in the comments, "OMB Watch is concerned the draft guidance creates loopholes and does not reflect the spirit of impartiality in regard to the identification of the need for a unique individual to serve on an agency advisory committee."

Click here to read OMB Watch's comments.

Click here to read OMB Watch's detailed analysis of the proposed guidance.

On March 1, President Bush nominated Michael Baroody to be a commissioner on the Consumer Product Safety Commission (CPSC). Many have criticized the nomination because of Baroody's record of opposing safety regulation in his role as a lobbyist for the National Association of Manufacturers (NAM).

Yesterday, Sens. Dick Durbin (D-IL) and Bill Nelson (D-FL) sent a letter to President Bush asking him to withdraw the nomination. In the letter, the Senators really brought their A-game, citing statutory criteria for the qualifications of a CPSC commissioner:

Specifically, Section 4(a) of the [Consumer Product Safety Act] states: "In making such appointments, the President shall consider individuals who, by reason of their background and expertise in areas related to consumer products and protection of the public from risks to safety, are qualified to serve as members of the Commission."

There is no evidence in Mr. Baroody's professional background to indicate that he meets these criteria. To the contrary, Mr. Baroody has worked against the "protection of the public from risks to safety" in his work for [NAM].

In the letter, we also find out that Baroody received a $150,000 severance payment from NAM. Due to ethics rules, Baroody would likely have to recuse himself from CPSC decisions involving NAM or NAM member companies. According to the NAM website, the trade organization represents thousands of manufacturers. That would mean a whole lot of recusing for Baroody.

Currently, the Senate Commerce Committee has scheduled a nomination hearing for May 24. Check back with Reg•Watch later today for more on the Baroody nomination.

Reg•Watch Update: Beneath the Politicking, a Powerless CSPC

As Reg•Watch has reported, the Mine Safety and Health Administration (MSHA) has been absolutely abysmal in enforcing the MINER Act. Congress passed the MINER Act in the wake of the Sago and Darby mine tragedies and included some statutory deadlines. MSHA has failed to promulgate any meaningful standards related to the MINER Act.

Rep. George Miller (D-CA) has been displeased with MSHA and yesterday his committee, the House Education and Labor Committee, held an oversight hearing.

But the blame should not fall entirely to MSHA. J. Davitt McAteer, a former MSHA administrator and current VP of Wheeling Jesuit University (go Cardinals!), spoke of the muddied waters of our federal regulatory system:

In the best of circumstances, promulgating a new health or safety standard takes 2-3 years to complete. However, when the rule was substantial and/or controversial, it can take 4, 6, 8 or more years from start to finish. In the worst of cases, the procedural maneuvering completely obstructs the process…

The public policy considerations embodied in the Federal Administrative Procedure Act, Presidential Executive Order 12866, the Paperwork Reduction Act of 1995, the Information Quality Act of 2001, and their amendments and implementation documents as well as other requirements have suffocated the public health and precautionary values embodied in the statutes governing, among others, MSHA and OSHA. The harsh reality is that those interest groups, which have a stake in avoiding or postponing new workplace rules, have the financial resources and political clout to impede and/or bog down the current rulemaking system.

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

House Hearing Asks Interior: Entangled in Politics, or Enlightened by Science?

Cost-Benefit Provision Latches onto Fuel Economy Standard

Senate Passes FDA Reform Bill, Expands User Fees

Wednesday, the Senate voted 93-1 to pass S.1082, The Food and Drug Administration Revitalization Act. The two primary aims of the legislation are to renew the Prescription Drug User Fee Act and to generally strengthen the regulatory authority of the FDA.

Renewing PDUFA

The legislation would renew and expand (by about 33 percent) the FDA's user fee program whereby pharmaceutical companies pay for safety reviews of new drugs. The current PDUFA program is set to expire Sept. 30. If PDUFA renewal is not signed into law by July, FDA has said it will begin warning drug-review staff of potential layoffs.

The user fee program is a peculiar process. While the payments are an important source of funding for FDA, the program allows drug companies to negotiate with FDA the process for a drug's approval (particularly the speed of approval). The strings-attached approach gives drug companies far too much influence in safety reviews

Strengthening FDA's Regulatory Authority

If signed into law the bill would:

• Strengthen FDA's authority to require drug companies to perform post-market safety reviews
• Provide FDA the authority to force drug companies to change drug labeling
• Create a new database allowing FDA to collect information on adverse health effects related to drugs already on the market
• Provide FDA the authority to fine drug companies for false or misleading direct-to-consumer advertising
• Expand a program rewarding drug makers who study adverse effects of drugs on pediatric health
• Require FDA to establish labeling standards for pet food and a process by which pet food can be recalled

A number of amendments received close votes on the Senate floor. Stay tuned for a recap of that action later on.

Reg•Watch Update: Senate FDA Reform Bill: Amendment Frenzy

The Mine Safety and Health Administration has released a report citing lightning as the cause of the Sago mine disaster which killed 12 miners, according to The New York Times.

As OMB Watch reported in March, the United Mine Workers of America (UMWA) claims friction within the mine caused the explosion. UMWA President Cecil Roberts called the MSHA report "far-fetched."

UMWA has blamed MSHA and the mine's owner for conditions which made Sago susceptible to such a horrific explosion. Claiming an "act of God" such as lightning would certainly reduce the culpability of the owner and federal regulators. This controversy is still far from settled.

Moments ago, the Senate voted 93-1 to pass S. 1082, The Food and Drug Administration Revitalization Act. The two primary aims of the legislation are to renew the Prescription Drug User Fee Act and to generally strengthen the regulatory authority of the FDA.

The House will take up similar legislation in the coming weeks. President Bush has threatened to veto the legislation if it includes a provision allowing the importation of cheap drugs. As Reg•Watch reported yesterday, the Senate bill does include such a provision, but it was rendered useless by another amendment which requires an approval process too onerous for FDA to ever handle. Subsequently, the White House is now saying Bush is unlikely to veto the bill if it were to cross his desk in its current form, according to BNA news service (subscription). Stay tuned to Reg•Watch for more on the bill.

Early yesterday, the Senate voted favorably (63-28) to end debate on the drug importation provision of the PDUFA reauthorization legislation. The rest of the day was sucked into a sort of legislative vacuum, and no further progress was made. A final vote on the amendment will occur early next week. A vote on the entire bill may also occur next week.

"Senate Likely to Back Drug Reimportation" [Washington Post]

Both The New York Times' and The Washington Post's editorial boards have weighed in on the Senate's Prescription Drug User Fee Act (PDUFA) reauthorization.

The Times brings us back to the crux of the issue: FDA's power to require the drug industry to pay for drug approvals. While these so-called user fees are an significant source of revenue for FDA, The Times articulates the concerns of many who are following the issue:

This is a dangerous dependency for an agency that regulates such a critical part of the nation's health care system. It's as if the nuclear utilities paid for oversight by the Nuclear Regulatory Commission. The potential for abuse in such a chummy atmosphere is clearly there.

Nonetheless, the reauthorization contains other valuable provisions and has almost unstoppable momentum. That is, unless President Bush decides to veto it.

Which brings us to The Washington Post editorial. In today's paper, The Post puts on its protectionist cap, opposing a possible amendment to the lesgislation which would allow importation of cheap drugs from Canada and the EU (see Reg•Watch's coverage from yesterday).

The Post also defers to the White House on the issue:

Further, President Bush has threatened to veto the bill if it contains such language. For the sake of common sense, and to enhance the chances of urgently needed legislation, the Senate should reject the importation amendment before passing the bill.

In other words, "This is too important an issue to question Presidential authority." Isn't that the kind of logic The Post used in the run-up to the Iraq invasion?

The Senate is set to hold a cloture vote on the drug importation provision today. Stay tuned to Reg•Watch for more.

UPDATE:The Senate approved cloture 63-28, ending debate on the amendment.

Yesterday, Reg•Watch blogged about a conflict-of-interest controversy at the National Institutes of Health. A scientific consulting firm which prepares the Report on Carcinogens has a client list including, in addition to NIH, Merck and GlaxoSmithKline.

These kinds of stories are becoming more and more prevalent. OMB Watch has reported on the Honest Leadership and Accountability in Contracting Act, part of which aims to reduce conflicts of interest.

Legislation improving contracting practices is laudable, but America should also be discussing how much government contracting we are willing to tolerate, responsible or not. The Report on Carcinogens is a nationally renowned study which serves as a jumping off point for cancer research. Is it really appropriate for private enterprise to be handling this kind of research?

The contractor, the Constella Group, claims to have in place its own ethical safeguards, and those safeguards are probably fine and dandy. But when it comes to something as important as the Report on Carcinogens, the federal government has an obligation to ensure the utmost impartiality and integrity.

Scientists, doctors and researchers come from across the globe to America to engage on some of the world's most respected projects. Isn't there a danger we will jeopardize our reputation and integrity by shifting such work to private firms? Is it possible we are contracting out our national identity as a global leader in research and innovation? It will only be when we engage in this kind of a national dialogue that we will be able to set a proper course for our federal government to follow.

Click here for contractor data on the Constella Group [FedSpending.org]

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

OSHA's Lack of Standard Setting under Fire

White House Tightens Grip on Regulatory Power Grab

House Subcommittee Steps Up Oversight on Regulatory Changes

In March, Reg•Watch blogged about Julie MacDonald, one of the Bush administration's political minions who was manipulating environmental science to meet political ends. Yesterday, the Interior Department announced MacDonald's resignation.

Interior is right to hold MacDonald accountable for her transgressions, but, as The New York Times reports, the move comes as the House Natural Resources Committee prepares to hold an oversight hearing next week on scientific integrity.

Reg•Watch hopes MacDonald isn't just a sacrificial lamb. Union of Concerned Scientists Scientific Integrity Program Director Francesca Grifo welcomes the move, but also realizes MacDonald "represents a much larger problem of widespread political interference at federal agencies."

The Bush administration should not always be on the defensive in reacting to violations of scientific integrity. Senior officials should take a proactive approach to weeding out those pushing political agendas in lieu of faithfully serving the public.

The National Institutes of Health are once again under fire for relying on scientific consultants with industry ties. In March, OMB Watch reported on a contractor essentially running an office which researches reproductive health.

In this instance, the potential for irresponsible contracting is jeopardizing one of the federal government's most important scientific products — the Report on Carcinogens (RoC). NIH hires the Constella Group to prepare the RoC which is intended to be an authoritative study on the most significant cancer-causing substances to which humans are exposed.

However, the Constella Group has ties to Merck and GlaxoSmithKline. The Constella Group pushed to list HPV on the last RoC. Merck and GlaxoSmithKline produce vaccines for HPV. Therefore, those two pharmaceutical giants stand to benefit from the inclusion. Reg•Watch certainly sees that as a major conflict of interest.

Dr. David Michaels at The Pump Handle blog has a more detailed analysis of the story. He points out such controversy calls "the integrity of the product" into question.

Reg•Watch Update: Contracting out Our National Identity

Senate leaders on food and drug regulation continue to wrangle over provisions of the reauthorization of the Prescription Drug User Fee Act (PDUFA). A Senate Committee reported PDUFA to the Senate floor two weeks ago.

Because PDUFA expires in September, and because the funds it provides FDA are necessary for the agency to operate, the reauthorization legislation is considered a must pass. That makes it a golden opportunity for Senators to attach all sorts of additional provisions.

The most contentious thus far has been a proposal to give FDA the authority to approve generic drugs. The pharmaceutical industry opposes such a provision (surprise!), and, according to the National Journal (subscription) has the support of Senate Majority Leader Harry Reid. A provision for generic drugs would likely offer consumers more generic drug choices and lower prices. Sens. Ted Kennedy, Hillary Clinton, and Chuck Schumer are pushing for a generics provision. What is Harry Reid's deal?

Other additions include a moratorium on direct-to-consumer advertising for risky drugs, the creation of a single food safety monitoring agency (currently the duties are split among several bodies including FDA and USDA) and increased pet food safety monitoring, all according to the National Journal.