Yesterday, the House Science and Technology Committee subcommittee on Investigations and Oversight held a long-awaited second hearing on President Bush's recent changes to the regulatory process. Much of the hearing focused on the role of the Regulatory Policy Officer (RPO) — a position with newly enhanced responsibilities.

The changes state "no rulemaking shall commence" without the approval of the RPO. Steve Aitken, former acting administrator of the White House's Office of Information and Regulatory Affairs, told the panel that the Clinton administration had issued a dictate forbidding agencies to "issue" rulemakings without similar approval. Rep. Dana Rohrabacher (R-CA) latched on to this as reason to drop the whole case against the Bush administration.

Reg•Watch has checked its dictionary, and apparently "issue" and "commence" are two different verbs with two different meanings. Exactly when a rulemaking commences is unclear.

This kind of confusion begs the question: What transparency measures will be included in this process? Committee Chairman Brad Miller (D-NC) expressed legitimate concern that RPOs "can smother regulatory efforts in the crib before an agency can even begin considering a regulatory action."

In the hearing, OMB Watch Executive Director Gary Bass recommended several improvements in transparency. Though OMB Watch fully opposes the changes embodied in the new E.O. and Good Guidance Practices Bulletin, if they are to exist the American people should be allowed to see into the process. At the very most, Congress should act to nullify these changes. At the very least, it should shine more sunlight on the regulatory process.

Last night, the White House Office of Information and Regulatory Affairs (OIRA) issued a memo instructing agencies on how to implement President Bush's recent changes to the regulatory process. The memo was the first missive by newly minted OIRA administrator Susan Dudley.

On Jan. 18, the White House issued two documents changing aspects of the federal regulatory process and mandating agency guidance documents (memos, policy statements, etc) fall under OIRA review. If those documents were forms of guidance on guidance, yesterday's memo is guidance on the guidance on guidance.

Unfortunately, despite the plethora of guidance, many questions remain unanswered. For example, the E.O. states "no rulemaking shall commence" without the approval of agency Regulatory Policy Officers. OMB Watch has expressed concern this will allow RPOs to stifle regulations in their infancy because it is unclear when a rulemaking commences. Does a rulemaking commence when scientific testing on an issue begins, when a draft rule is published, or somewhere in between?

The memo fails to clarify this concern. It states: "As a general matter, a rulemaking commences when the agency has decided as an institutional matter that it will engage in a rulemaking."

Translation: A rulemaking commences when we say it commences.

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.

Today's New York Times features an in-depth expose of the Occupational Safety and Health Administration. The article highlights a variety of OSHA failings. The problem lies not in what OSHA does, but in what it does not do:

Since George W. Bush became president, OSHA has issued the fewest significant standards in its history, public health experts say. It has imposed only one major safety rule. The only significant health standard it issued was ordered by a federal court.

The part of OSHA charged with new regulations is the Safety and Health Standards program. President Bush's FY 2008 proposed budget requests $17 million (including salaries) for this program, a mere 3.5% of OSHA's total budget. The budget requests about twice that amount ($32 million) for safety and health statistics.

Nonetheless, $17 million is a pretty big chunk of change. Moreover, the Safety and Health Standards program employs 83 people but estimates it will promulgate only three standards in FY 2008. Your tax dollars at work.

Both chambers of Congress will examine workplace safety this week. The Bush administration's Occupational Health and Safety Administration has been woeful in promulgating new regulations, but Democrats are beginning to ramp up their oversight efforts. Read a preview of this week's hearings from The Pump Handle blog.

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.

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.

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