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

EPA Announces Proposed Smog Standard

House Legislation Would Force Regulatory Review

House Bills Address Mining Health and Safety Shortfalls

Last week, the House Energy and Commerce Committee approved a bill to reform certain drug regulation practices at FDA and renew the Prescription Drug User Fee Act (PDUFA). The full Senate approved a similar bill in May. (For a detailed analysis of the Senate version, click here.

The Pharmalot blog has a good summary of some of the drug safety provisions in the House bill which go beyond what the Senate approved.

The user fee program, the other half of the bill, 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.

A provision in the House bill demonstrates this dichotomy. The bill would reduce the amount of fees paid by industry if federal appropriations increase. This is encouraging, because many public health and safety advocates believe the federal government, not the drug industry, should be responsible for ensuring FDA has enough resources to perform its regulatory duties.

However, there is a danger this may lead to lower funding for FDA in the long-run. If this appropriations process turns into a zero-sum game where both sides are jockeying to see who can pay less, it would ultimately force FDA to do its job for less money.

FDA is already under-funded. The House should take this provision but also force a steady rise in the drug safety budget. That would allow appropriators and the drug industry to haggle over their respective responsibility in a more productive way. It would be in industry's best interest to lobby for increased funding. Republicans would be in favor of giving industry a break, and Democrats (if they understood the problems with user fees, which they appear not to) could get behind no-strings-attached funding and a bigger role for government.

On June 21, EPA announced a proposal for a revised national standard for ozone exposure. The proposal, mandated by court order, proposes a range from which EPA will pick its final standard.

Any limit picked from within the proposed range will fall short of what is needed to protect the public health. EPA's proposed range is 0.070 to 0.075 parts per million, but in recent months scientific consensus has emerged in supporting a limit no greater than 0.070 ppm and ideally closer to 0.060 ppm.

EPA has already caught a lot of flack for skirting a real decision and proposing limits weaker than scientists have recommended. But the role of the White House should be scrutinized as well.

OMB Watch and Clean Air Watch have been carefully watching as the White House Office of Information and Regulatory Affairs (OIRA) reviews EPA's rule to revise the national standard for ozone, a.k.a. smog. OIRA already entertained industry reps on two occasions (read more on that here).

The press is starting to pay attention to this issue. Articles in Greenwire (subscription) and The Hill discuss the importance of a tighter standard and the scientific basis behind it. The articles also chronicle industry's efforts to block EPA from developing a more protective standard.

The ozone standard is the first big regulation OIRA is reviewing with its new administrator, Susan Dudley. President Bush recess appointed Dudley in April. Before that, OMB Watch adamantly opposed Dudley's nomination. One of our primary concerns was the undue access she would give to industry during the regulatory review process. It seems those concerns are now manifesting.

I have tried to contact both OIRA and EPA to talk about this issue. Despite my pleasant phone manners and polite emails, my queries have gone unrecognized. Perhaps the American Automobile Alliance is higher up in their inbox.

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

Democratic Disarray on Greenhouse Gases May Let Bush off the Hook

White House Meets with Industry on Smog Standard

Long-delayed EPA Risk Assessment of Endocrine Disruptors Exhibits Flaws

This week, the House Energy and Commerce Committee will begin tackling its version of the Prescription Drug User Fee Act (PDUFA) reauthorization/FDA reform bill the Senate passed in early May.

The House has already uncovered disturbing (but not surprising) information about the bill. FDA drafted and provided to Congress the basis for the Senate bill. However, FDA apparently had a lot of help from the pharmaceutical industry in composing the legislative language.

According to a report in today's Washington Post:

The Food and Drug Administration met 112 times with pharmaceutical industry representatives and five times with consumer and patient groups over 15 months to develop proposed legislation, according to two lawmakers who said the agency is "inappropriately close" to the companies it regulates.

Those two lawmakers — Reps. Bart Stupak (D-MI) and Maurice Hinchey (D-NY) — and the rest of the committee would be wise to examine PDUFA reauthorization with a cautious eye. The PDUFA program allows FDA to charge drug makers for drug approvals, but the money comes with strings attached. The subsequent financial ties blur the line between public regulators and the regulated community.

FDA has announced the creation of an advisory panel which will aid agency officials in communicating food and drug safety risks to the public. Last year, the Institute of Medicine recommended Congress pass legislation creating such a panel.

FDA should be applauded being proactive on the recommendation. During recent food and drug safety crises, FDA has seemed unwilling or unable to allay public fears with immediate communications and relevant information. Establishing this panel has the benefit of being both good politics and good policy.

But policy and politics don't always get along so well. Members of this panel will need to be unbiased and apolitical in their assessments of food and drug safety and the need for public outreach. Even so, because political officials will likely be doing most of the actual communicating, the potential for politically-motivated cover-ups remains.

The Institute of Medicine report states:

The expertise needed on the advisory committee may include consumer and patient perspectives…risk communication, health literacy, social marketing expertise, public relations expertise, social sciences expertise with an emphasis on qualitative research and survey science, journalism, and ethics.

Even if FDA improves its regulatory actions and post-market surveillance, drug and food safety problems are inevitable. America needs a trusted voice in these situations. One of the roles of government should be to provide that voice.

EPA is considering appointing Dennis C. Paustenbach to the asbestos panel of its Science Advisory Board. According to the Environmental Working Group (EWG), Paustenbach has made a career out of defending corporations in asbestos exposure suits.

Agency panels and committees, such as EPA's Science Advisory Board, are important tools for regulatory decision-makers. Panels are supposed to consist of impartial experts who can provide valuable scientific and technical advice.

EPA created the asbestos panel to aid the agency in maintaining risk assessments and exposure standards consistent with the most up-to-date scientific data and technological feasibility. Unfortunately, it appears Paustenbach's expertise is in downplaying the risks of asbestos exposure and advocating for less protective federal standards.

EWG has sent a letter to EPA further detailing their opinion as to why Paustenbach is a bad choice. To read the letter, click here.