An investigation by the House Oversight and Government Reform Committee shows that FDA is considering a new policy (which would take the form of a draft guidance document) that would allow drug companies to market unapproved use of pharmaceuticals by distributing journal articles. In a letter to FDA Commissioner Andrew von Eschenbach, Chairman Henry Waxman (D-CA) explains the problem:

A fundamental tenet of our drug and device laws is that a manufacturer cannot market a drug or device for a therapeutic use without FDA approval. The draft guidance would carve a large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved (off-label) uses of their products without first obtaining FDA approval by passing out journal articles about the off-label use to physicians. Published reports of company funded studies can be biased in favor of the company's product. Allowing drug and device companies to freely disseminate these articles can result in doctors using questionable study results to guide their prescribing habits. In addition, allowing marketing through journal articles can reduce the incentive for drug and device companies to conduct the rigorous studies needed to win full FDA review and approval, leaving physicians and patients without definitive data on the benefits and risks of medical products.

Currently, this type of activity would be considered "illegal marketing," according to Waxman. Waxman believes the new policy would contravene the intent of the federal laws that govern the drug approval process: "The draft guidelines appear to be an effort by FDA to displace Congress and establish by administrative fiat a new system for use of journal articles that lacks the safeguards set by Congress."

The Committee is investigating the issue further, and has requested documents from FDA related to the draft guidance. In the interim, Waxman has requested FDA not move forward with the policy.

The White House Office of Science and Technology Policy and Council on Environmental Quality have issued a memo to federal agencies titled, "Principles for Nanotechnology Environmental, Health, and Safety Oversight."

Nanotechnology involves manipulating matter the size of one-billionth of a meter or 100,000 times smaller than the width of a human hair. Nanotechnology has the potential to impact countless aspects of our lives, and many consider it the next great boon to society. However, early studies indicate it may also pose health, safety and environmental risks. Governments around the world have been grappling with how they should respond.

In a statement of the purpose of the memo, the White House lays out why government needs to be involved in the emerging field of nanotechnology:

Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology. The purpose of considering environmental, health and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.

That sounds great, proving the White House can talk the talk. But when it comes time to walk the walk, the White House stumbles. In a section called "regulatory path forward," the memo outlines how federal agencies should go about addressing nanotechnology policy. Among other things, the memo states:

• Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information;
• Where possible, regulatory approaches should enable rather than hinder innovation;
• Regulatory approaches should be performance based to the extent feasible and provide predictability and flexibility in the face of evolving science and technology;
• Benefits of regulation should justify their costs;

The memo sends the wrong message. "Aggressive efforts to close information gaps and increased research funding" should replace "reasonably obtainable" science, and "ensuring public health" should supplant mentions of cost-benefit analysis. Government should play a proactive role in a field with such significant uncertainty and potential impact.

A recent statement of principles — signed by more than 40 labor, environmental and public interest groups from around the world — called for a more sensible approach to nanotechnology regulation. In the statement, those groups urge a precautionary approach and "a committed focus on critical risk research and immediate action to mitigate potential exposures until safety is demonstrated."

From Saturday's Washington Post:

U.S. mine safety regulators failed to conduct inspections required by federal law at more than one in seven of the country's 731 underground coal mines last year, a year in which the number of worker deaths in mining accidents more than doubled to 47, a government report says.

The report is by the Department of Labor Inspector General, and it doesn't engender much confidence in the nation's premiere mine safety regulatory body. The IG report finds one major problem is a basic lack of documentation:

15 percent of the critical inspection activities we reviewed were not documented. This occurred because [MSHA's Office of Coal Mine Safety and Heath] did not require inspectors to document all critical inspection activities performed and Field Office supervisors to document their conclusions.

MSHA administrator Richard Stickler defends his agency by blaming paperwork, a favorite scapegoat of the anti-regulatory crowd. Stickler is quoted in the Post as stating, "Valuable and limited enforcement time by our inspectors should be placed primarily on identifying and abating hazards as a result of inspections rather than documentation and paperwork,"

That sounds nice, but what's the use of performing inspections if you don't write down the results? That's like trying to make a TV show with no cameras.

The IG report also discusses resource shortfalls at the agency. Much like we've seen with the Consumer Product Safety Commission, cuts in funding and staffing correspond with regulatory failures. Again, from the Post:

The number of MSHA coal mine inspectors fell 18 percent between 2002 and 2006, from 605 to 496, while mining activity increased 9 percent nationally. Funding for the coal safety and health agency increased 1 percent over that period, to $117 million, but that was not enough to offset cost-of-living salary increases for its personnel, which grew $6.1 million.

Today, the House Judiciary Committee subcommittee on Administrative Law held an oversight hearing on the Congressional Review Act (CRA). The CRA, passed in 1996, requires agencies submit final regulations to Congress at which point lawmakers have an opportunity to disapprove the regulation by joint resolution.

The CRA is theoretically a thoughtful check in government policy-making. Congress passes laws which agencies then enforce through regulations and is in the best position to determine its own intent. If Congress finds an agency has misinterpreted statute or overstepped its bounds, it can nullify the rule. If Congress takes no action, the regulation goes into effect as envisioned by the agency.

But witnesses at today's hearing find the CRA to be underutilized. House Parliamentarian John Sullivan uses statistics to illustrate:

However, of approximately 40,000 submissions to the Congress under the CRA to date, only one has been disapproved. Since the 105th Congress, only 43 joint resolutions of disapproval have been introduced in the House and Senate. None of the 25 House joint resolutions passed the House. Three of the 18 Senate joint resolutions passed the Senate. One of those Senate joint resolutions also passed the House. Thus, the disapproval mechanism established by the Act has invalidated one rule.

Other witnesses opined changes to the CRA may expand the law's viability as a congressional oversight mechanism. Sally Katzen, Clinton-era administrator of the White House Office of Information and Regulatory Affairs, suggested the process be leaner and meaner:

Limiting the scope of the CRA to the more important rules would somewhat reduce Congressional authority, but it would enable Congress to focus on the rules that are likely to have the greatest impact on the public.

Katzen recommended amending the CRA so that only "major" rules are covered. In regulatory policy, "major" has varying definitions. Beyond the definitional dilemma, Congressional Research Service scholar Mort Rosenberg recognized the subjectivity of the term major could lead to political shenanigans: "The difficulty would be designating a determiner that is politically acceptable and constitutionally appropriate."

Nonetheless, this could be a good way to make the CRA more effective and expand our elected representatives' involvement in agency rulemaking.

Sen. Barbara Boxer (D-CA) has requested from the White House documents related to the Office of Management and Budget's editing of testimony on climate change given by the head of the CDC. White House Counsel Fred Fielding responded with a letter on Tuesday. Here's an excerpt:

I note that the request by its very nature seeks communications involving pre-decisional deliberative materials relating to an inter-agency review process. … It is clear that the request implicates core Executive Branch interests and raises separation of powers concerns as well. For that reason … it will be necessary to discuss…the possibility of reaching an accommodation that balances Executive Branch prerogatives with the committee's legitimate oversight needs.

Translation: "Yeah right, we're never showing you any documents ever. Nice try."

Boxer wrote back yesterday saying she is "stunned" the White House would consider claiming executive privilege or separation of powers in this case. Boxer must be feeling hyperbolic this week, because one could not possibly be "stunned" the Bush White House is withholding information.

Seriously though, the controversy surrounding OMB's edits of the climate change testimony brings to light a serious point of opacity in the executive branch's policy of information disclosure. OMB officials should not be editing the congressional testimonies of public health officers simply to serve an intended political objective.

The best way to prevent future occurrences is to make the process transparent and ensure the public can see how its government is communicating.

Today, the House Energy and Commerce Committee held an oversight hearing on FDA's Foreign Drug Inspection Program. While unsafe imported pharmaceuticals have not garnered the same level of attention as unsafe imported foods and toys, the future does not look bright: FDA's drug inspection program is plagued by a lack of basic information.

The Government Accountability Office (GAO) released a new report in conjunction with the hearing. Among other things, GAO found:

FDA inspects relatively few foreign establishments. Data from FDA suggest that the agency may inspect about 7 percent of foreign establishments in a given year. At this rate, it would take FDA more than 13 years to inspect each foreign establishment once, assuming that no additional establishments require inspection. However, FDA cannot provide an exact number of foreign establishments that have never been inspected.

The hearing comes one day after The New York Times published the results of its investigation into Chinese chemical companies that produce pharmaceutical ingredients with little oversight or safety measures. As it relates to the FDA's role in monitoring the Chinese exporters, the investigation found, "China has an estimated 80,000 chemical companies, and the United States Food and Drug Administration does not know how many sell ingredients used in drugs consumed by Americans."