The White House Office of Information and Regulatory Affairs (OIRA) is reviewing under Executive Order 12866 a revised air pollutant rule. The rule is the National Ambient Air Quality Standard for ozone, a.k.a. smog.

Over the past several months, Reg•Watch has been tracking the growing support for tightening this critical air pollution standard. Scientists and medical professionals have been lining up to voice their support, but EPA has been cautious in expressing its opinion on more protective smog regulation.

Considering the environmental track record of the current administration, experts are skeptical. Frank O'Donnell at Clean Air Watch is framing the revision of the standard as a science vs. politics showdown. Read his breakdown here.

OIRA should complete its review within 90 days. Reg•Watch hopes science prevails and the proposed rule calls for tighter standards. If not, who will be to blame: EPA, the White House or both?

David Michaels at The Pump Handle blog pointed out this incredible piece of news from the Associated Press.

A Chinese court has sentenced to death the former head of the State Food and Drug Administration Zheng Xiaoyu. Zheng, roughly the equivalent of the U.S.'s FDA commissioner, was convicted of taking bribes which ultimately led to the approval of pharmaceuticals with deadly side effects.

Capital punishment is a grave overreaction. Nonetheless, China's food and drug safety record has been atrocious and is beginning to leech into the United States. The AP article rattles off a number of recent food contamination scares originating in China (pet food, toothpaste, monkfish and catfish).

China's top drug regulator gets death sentence [AP via MSNBC]

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 As stated in the comments, "OMB Watch is concerned the draft guidance creates loopholes and does not reflect the spirit of impartiality in regard to the identification of the need for a unique individual to serve on an agency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.

Reg•Watch apologizes for jumping to conclusions this morning regarding the renomination of Susan Dudley. Apparently, the renomination is a paperwork requirement. The good people at Public Citizen have this to say:

The White House was forced to resubmit the nomination within 40 days of the Senate's return from the spring recess, however, in order to ensure that Dudley can be paid a salary as OIRA administrator under section 5503(a) of title 5 of the U.S. Code.

Resubmitting the nomination means that Dudley will once again be up for a confirmation hearing in the Senate and, barring any holds, a final vote on her suitability for this powerful office.

So despite Reg•Watch's earlier comments, the renomination is not a strategic power-play. It merely ensures Dudley's continuing paychecks. A thousand pardons.

Last night, President Bush nominated Susan Dudley to the position of administrator of OMB's Office of Information and Regulatory Affairs (OIRA).

No, you have not traveled back in time. The White House has nominated Dudley to the position in which she currently serves. Bush recess appointed Dudley in April.

What gives? The White House is likely trying to push Dudley through the standard confirmation process in order to legitimize her. It's not a bad strategy. If the Senate confirms Dudley, critics like OMB Watch will no longer be able to chastise the White House for circumventing the Constitution.

Meanwhile, a confirmation process could drag on for months. Because the renomination continues the process, the White House will be able to present Dudley as legit.

As a bonus, the White House has nothing to lose. If the full Senate rejects Dudley, she can continue to serve in her position (though likely without pay). Just like the founding fathers intended!

Reg•Watch Update: Dudley Nomination Just a Paperwork Requirement

This week, a number of business journals across the country are running an article titled, "New Regulatory Czar Will Have Plenty to Review," by Kent Hoover. (Here it is in the Philadelphia Business Journal.) The article spotlights Susan Dudley in her new position as administrator of OMB's Office of Information and Regulatory Affairs (OIRA).

The article's title is apropos, as a number of factors are converging to make the last two years of the Bush administration an interesting time in regulatory policy. First, President Bush's recent changes to the regulatory process will force thousands of agency guidance documents to undergo OIRA review for the first time.

Second, OIRA has been without a full-time administrator since John Graham left in February 2006. There is likely a backlog of decisions for Dudley to make.

Third, the waning years of a presidency are notorious for resulting in a surge of regulatory activity. As a president's relevance declines, there is a natural tendency to take the path of least resistance in order to leave a policy legacy. The article quotes Tom Sullivan from the SBA as equating this time to "the end of the NBA playoffs," in terms of intensity and increasing public attention.

But these two years are more likely to resemble a rugby scrum than a fast-paced NBA match-up. OIRA will maintain its resource and staff levels for the remainder of Bush's term. Meanwhile, an unprecedented amount of paperwork will descend on a hapless, under-staffed OIRA. The results won't be pretty.

"This is life — too few resources, too many things to do," Dudley says in the article. It's unfortunate how correct Dudley may be.

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

Monday, the Senate Commerce Committee sent a vehicle fuel economy reform bill to the floor. The bill would do some good by providing more information on fuel efficiency to car buyers and increasing funding for our national fuel economy program — the Corporate Average Fuel Economy (CAFE) standard run by the National Highway Traffic Safety Administration (NHTSA).

However, the bill would also mark a shift in the legislative view of vehicle fuel economy — from protecting the environment and strengthening national security to making economic factors a paramount consideration.

The legislation (S. 357) originally set a standard based on national need. However, amendments in committee (from Sens. Daniel Inouye (D-HI) and Ted Stevens (R-AK)) inserted a cost-effectiveness provision which could allow NHTSA to undermine the entire program.

NHTSA may promulgate a weaker standard if the statutorily mandate standard "is shown not to be cost effective." Yes, stricter fuel economy standards will impose costs on automakers which will then be passed on to consumers. But what about all the intangible benefits? Although the legislation would instruct NHTSA to consider benefits like "national security" and "human health," NHTSA will not be able to monetize them. The cost-effectiveness provision does no good, and only serves to provide the current and future administrations with an opportunity to give breaks to industry.

America's enormous appetite for fuel makes us beholden to foreign exporters, and increasing emissions accelerate global warming and jeopardize public health. Americans do not have a choice in dealing with these dangers — neither should NHTSA.

For more on the bill, visit Public Citizen.

Today, BNA news service (subscription) published the recap of a lengthy interview with new White House regulatory czar Susan Dudley, conducted by reporter Ralph Lindeman. Dudley claimed she does not anticipate any delay in the issuance of agency guidance documents during her tenure.

In January, President Bush amended the regulatory review process. Among the changes, the White House will begin reviewing agency guidance documents (interpretive memos, policy statements, etc.) for the first time. In April, Bush recess appointed Susan Dudley to head the Office of Information and Regulatory Affairs (OIRA) which gives her the responsibility of carrying out guidance review when the changes take effect in July.

Much of the rhetoric spewing out of the White House has been vague, but a few things are clear: OIRA will be reviewing agency guidance documents (possibly hundreds per year) for the first time; OIRA will not be adding additional staff; and, subsequently, the administrative mud that is the regulatory review process is about to become thicker and deeper.

As Reg•Watch blogged recently, OIRA review of guidance (currently voluntary) is already resulting in delay. But in the interview, Dudley refused to acknowledge the potential for delay, claiming OIRA will treat guidance document differently than it does regulations. This is at odds with the new White House directives, which outline a process for review of guidance quite similar to that of regulations. Moreover, if Dudley believes guidance will move through OIRA quickly and result in no noticeable change in the speed of their issuance, why did the White House make these changes at all?

Ultimately, Dudley acknowledged timetables for review of guidance "haven't been resolved." This is despite a recent memo which OIRA issued with the intention of defining how these changes will affect agency practices. The memo, written by Dudley, states "OIRA will complete its consultative process within 30 days or, at that time, advise the agency when consultation will be complete." Based on Dudley's own words, it seems like there will be ample opportunity for delay.

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.

Yesterday, the Senate attached by a voice vote a drug importation amendment to the PDUFA reauthorization/FDA reform bill moving through the chamber. However, the amendment passed with its own amendment (called a second-degree amendment) which requires the Department of Health and Human Services to certify the safety and cost-effectiveness of all imported drugs.

The FDA does not have the resources to assure the safety of all domestic drugs, let alone imported ones. Therefore, the second-degree amendment renders the drug importation amendment impotent. Nonetheless, the second-degree amendment passed 49-40, with 33 misguided Republicans, 15 wayward Democrats, and Sen. Joe Lieberman voting in the affirmative. (Here's the roll call.)

Proponents of second-degree amendment raised safety concerns about drugs coming into the U.S. from Canada or the E.U. But this argument is specious. The drugs being imported are manufactured by American companies and are subject to strict safety tests in the exporting country.

It is unclear what this amendment will mean for the fate of the overall bill. President Bush has vowed to veto a bill containing a drug importation provision. However, since this provision is mere rhetoric, the bill may now be more palatable to the White House. A final vote on the Senate bill is expected this week.

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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]

OMB Watch recently reported on OSHA's utter failure to promulgate meaningful standards in the Bush administration. Critics frequently point to a court-ordered metal coatings standard as the only significant action the administration has taken in its six-plus years.

But even when non-significant (these are subjective terms) standards are considered, OSHA's performance is dismal. Some fine investigative work by the good people at The Pump Handle blog acquired documentation from OSHA's communication office indicating the agency has promulgated 22 standards. Still less than four per year, but perhaps a passable performance.

However, on further inspection, The Pump Handle determined at least half of these 22 standards to be fairly bogus. Check out their analysis here.

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

Yesterday, Reg•Watch blogged about the various amendments to the Senate PDUFA reauthorization bill. An additional provision has become the subject of political wrangling.

Sens. Byron Dorgan (D-ND), Olympia Snowe (R-ME) and Chuck Grassley (R-IA) support a provision which would allow importation of drugs from Canada and the European Union. Yesterday, OMB released a statement indicating the president would likely veto PDUFA reauthorization if it included such a provision.

The White House argues importation poses a safety concern: imported drugs are not subject to FDA approval. Even if we excuse the recent litany of FDA screw-ups (too many to list on this blog), the White House's concerns are misplaced. Americans deserve access to basic drugs from countries with excellent safety records. Importation would save consumers money and stoke competition in the American pharmaceutical market.

What's really startling is Bush's veto threat. PDUFA reauthorization is considered must-pass legislation. PDUFA expires in September and the funds it provides FDA are necessary for the agency to operate. Moreover, the bill currently carries other provisions which would strengthen FDA's ability to regulate. With its usual bravado and contempt for bipartisanship and good governance, the White House would be willing to derail the bill thereby hindering FDA's operations severely.

For now, it seems as though Senate Democrats are willing to get on board with the White House. Dorgan has indicated he will consider withholding the amendment if he is promised an opportunity to introduce it at a later time. Unfortunately, if the drug importation provision is not attached to the must-pass PDUFA reauthorization, it will face a much more difficult track in Congress.

Reg•Watch Update:

• Cloture vote on drug importation amendment
• Opinions on PDUFA Reauthorization

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