As Reg•Watch blogged yesterday, the House Science and Technology Committee subcommittee on Investigations and Oversight will hold a hearing on President Bush's changes to the regulatory process. OMB Watch Executive Director Gary Bass will be testifying. Watch the hearing live starting at 10:00 a.m.

The EPA's Clean Air Scientific Advisory Committee (CASAC) is supposed to be a group of scientists who independently analyze standards for the implementation of the Clean Air Act. Those standards are integral in ensuring progressive air pollution limitations that embody the latest scientific and technological breakthroughs.

As Reg•Watch has reported, CASAC recently recommended tighter standards for smog, much to the chagrin of industry and EPA brass.

As though determined not to let that happen again, EPA has appointed to CASAC two members with industry ties. The new members will serve on the panel for nitrogen and sulfur oxides (NOx and SOx). The Center for Science in the Public Interest sums it up:

Ignoring protests from consumer watchdog groups, the EPA has appointed two conflicted scientists to the Clean Air Scientific Advisory Committee primary advisory panel that will evaluate NOx and SOx pollution. In January, CSPI wrote to the EPA opposing the nomination of Richard B. Schlesinger, who has received financial support from the American Petroleum Institute, and Christian Seigneur, who works for Air Quality Division at Atmospheric & Environmental Research (AER) Inc., which is funded by three organizations (API, the Electric Power Research Institute and the Health Effects Institute) that receive money from industries that have a direct financial interest in the committee's decisions. The final roster did exclude Roger McClellan, the New Mexico-based industry consultant whom clean air advocates also protested.

Advisors with ties to the power industry are grossly inappropriate for a panel charged with scientific recommendations on two greenhouse gases. It is not EPA's duty to include the views of industry in enforcing the Clean Air Act.

The Clean Air Act is one of our country's greatest environmental achievements in part because it was designed to stay one step ahead of pollutants and polluters. Standards are to be improved every five years and, according to the U.S. Supreme Court in Whitman v. American Trucking Association, cost and achievability are not to be considered. CASAC should be a place for unpolluted scientific thought.

Yesterday, the Senate Health, Education, Labor and Pensions Committee voted favorably to reauthorize the Prescription Drug User Fee Act (PDUFA). PDUFA allows FDA to collect money from the drug industry in order to pay for safety tests of new drugs. While this may sound like a good way for the government to raise funds, the money comes with strings attached. The drug industry, to some extent, dictates the timetable for drug approval.

PDUFA reauthorization is one part of the Food and Drug Administration Revitalization Act (S. 1082). Four Republicans and one independent joined all committee Democrats in voting to report the bill to the full Senate. If enacted in its current form, the legislation would:

• Reauthorize PDUFA for another five years. FDA will be able to collect more user fees from the drug industry, per the agency's recommendation.
• Allow FDA to review TV ads for new drugs (you know, the commercials that list a variety of unpleasant side effects). Some Republicans have raised First Amendment concerns in regard to this provision.
• Strengthen FDA's ability to monitor drug safety after the drugs reach the market.
• Reauthorize MDUFMA, a law similar to PDUFA but for medical devices instead of drugs.
• Create special provisions for the study of pediatric drugs and medical devices.
• Place medical marijuana under the regulatory purview of FDA. Sen. Tom Coburn (R-OK) added this provision as an amendment.

The bill will now move to the Senate floor. Bill cosponsor Ted Kennedy has also vowed the final bill will include language to allow FDA to approve generic drugs, a provision the drug industry adamantly opposes. The House is still developing its PDUFA reauthorization bill.

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

Recess Appointment Makes Dudley Head of White House Regulatory Policy Office

Courts Rebuke Bush Administration's Forest Actions

EPA Issues another Delay in Contaminant Regulation

An editorial in today's Washington Post revisits the issue of truck driver safety. Last month's deadly crash on the Capital Beltway showed us how easy it is for delinquent drivers to slip through the system. The editorial chides the Federal Motor Carrier Safety Administration for lax enforcement:

States get away with filing tardy, incomplete and faulty data, there are still opportunities for fraud in obtaining commercial driver's licenses, and testing and training standards need stiffening.

Of course, most truck drivers do their jobs safely and efficiently and federal regulations should do more to protect them. Truck driving is a profession more dangerous than it should be. Unfortunately, the industry continues to push its employees too far while the Bush administration continues to pull back safety standards and enforcement measures. The Post editorial concludes by calling for reform:

That there has been so little progress in reducing the number of people killed or hurt in big truck crashes each year argues for trying to fix a system that is still easy to game.

Today, a House panel held a hearing examining the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA forces the drug industry to pay for safety studies of new drugs, but also allows the industry to dictate timelines for approval.

Some members of the House Energy and Commerce Committee subcommittee on Health expressed concern about the influence industry can exert through user fees. However, the general tenor of the hearing was that of assuming Congress would reauthorize PDUFA, and user fees would actually increase.

It would have been nice to see an intense debate over the validity of user fees in the first place. Why is the FDA relying on industry money to do its job, and why can't Congress appropriate adequate funds so the agency doesn't have to?

These are the kinds of questions the George Washington University's project on Scientific Knowledge and Public Policy (SKAPP) is asking. Medical professionals from SKAPP and elsewhere are opposing reauthorization of PDUFA. Read more here.

On the other side of Capitol Hill, the Senate Health, Education, Labor and Pensions Committee will hold a hearing tomorrow to markup PDUFA reauthorization. A bill strengthening FDA's drug review process is likely to be lumped in with PDUFA. Stay tuned to Reg•Watch for more.

Last week, the National Institutes of Health officially ended its relationship with Sciences International, a private consulting firm. As OMB Watch has reported, SI had essentially been managing an NIH group studying reproductive health. The consultant's research and summaries of a particular chemical, bisphenol A, exhibited industry bias. Subsequently, SI became the focal point of a controversy over scientific contractors and conflicts of interest.

Now, NIH will review all the work SI performed related to bisphenol A (The Washington Post reports ). This is a welcome step by NIH. Without such oversight, SI would have been able to affect scientific decisions through previously prepared documents despite having been fired.

Yesterday, the Senate Appropriation Committee held a hearing to examine the budget of the White House Office of Management and Budget (not the federal budget, but the budget of OMB itself). During the hearing, Subcommittee Chairman and Senate Majority Whip Dick Durbin (D-IL) questioned OMB Director Rob Portman on a number of issues. These included the recess appointment of Susan Dudley to be the administrator of the Office of Information and Regulatory Affairs (OIRA) at OMB, and the installation of Regulatory Policy Officers (RPOs) in federal agencies as required by recent White House changes to the regulatory process.

Durbin addressed OIRA at large, calling its work "Freakonomics to the 10th power." He then pointed out some of Dudley's anti-regulatory positions and asked Portman to identify the need for presidentially appointed regulatory foot-soldiers — the RPOs — to invade each agency. Durbin said the White House appeared to be "attempting to take away the regulatory authority of agencies."

Unfortunately (but not surprisingly), Portman evaded questioning. He gave a roundabout answer on Dudley, and did not appear to be familiar with her record. By the time Portman was done avoiding the Dudley issue, everyone had forgotten about the RPO question, and it was never answered. Almost three months after the amendments to the regulatory process, no senior administration official has answered any questions or said anything meaningful about the changes.

Ellen Smith, editor of Mine Safety and Health News, has an opinion piece in today's North County Gazette (NY). The issue is private OMB meetings that too often include special interests and shut out the American public. Smith argues these meetings result in biased decision-making placing Americans (in her example miners) at risk. More important is the loss of transparency in the decision-making process — a fundamental democratic right.

Read the column here.

FDA's ability to monitor and ensure the safety of drugs and medical devices after they appear on the market has been the subject of great scrutiny lately. As OMB Watch has reported, Congress and others have been critical of the agency for failing to conduct post-market safety studies.

There are plenty of ideas for how the agency can improve their practices. Legislation is floating on Capitol Hill to beef up FDA funding and authority.

Today, with the realization that those solutions are months off, FDA took a good step to improve the process in the near term. FDA has launched a webpage where the public can monitor the progress of post-market studies on medical devices. This is certain to hold the FDA more accountable to the American people. It also improves the transparency of the agency's actions which are often criticized for being too subject to industry influence. Reg•Watch hopes FDA expands this transparency to post-market studies on drugs as well.

Susan Dudley's recess appointment is the subject of editorials in this morning's Washington Post, New York Times and Wall Street Journal. Let's compare and contrast.

Read the rest of this entry

Posted by Matt Madia, 10:54:30 AM

Thursday, April 05, 2007

Wednesday, April 04, 2007

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

OMB Manipulated Climate Science, Report Says

Miners Detail MSHA's Failings in Emotional Testimony

FDA Issues New Conflict of Interest Guidelines

Tuesday, April 03, 2007