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Oversight and Government Reform Committee shows that FDA is considering a new policy (which would take the form of a draft guidance document) that would allow drug companies to market unapproved use of pharmaceuticals by distributing journal articles.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 The draft guidance would carve a large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved (off-label) uses of their products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The Committee is investigating the issue further, and has requested documents from FDA related to the draft guidance.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."

EPA has finally released its study of the chemical exposures that occur for consumers of microwave popcorn. EPA had previously refused to release the study to the public.

The study includes information on consumer exposure to diacetyl, the butter flavoring chemical known to cause lung disease. Much of the furor over diacetyl has related to those exposed during the manufacturing process, but consumers are also at risk.

The Pump Handle blog has an analysis of the study: "EPA Microwave Popcorn Emissions Study Finally Published"

EPA Deputy Administrator has put up an interesting post on his blog "Flow of the River." EPA is in the middle of a rulemaking which would tighten the air quality standard for ozone, a.k.a. smog. The Clean Air Act requires EPA to set the standard based on public health considerations. Peacock writes,

I have something to say today for the sake of those many states, cities, counties and other local entities that have been commenting on EPA's proposal to tighten the National Ambient Air Quality Standard (NAAQS) for ozone:

THE LAW DOES NOT ALLOW THE ADMINISTRATOR TO CONSIDER COSTS WHEN HE REVIEWS A NAAQS.

And the emphasis is his!

Opponents of a tighter ozone standard (including industry lobbyists and the White House) consistently complain the regulation may have an adverse economic impact. But EPA is legally prohibited from considering economic costs, or benefits for that matter, in setting the standard. As Peacock writes, "when commenting on a NAAQS proposal if you feel the urge to raise the cost of compliance, save your breath."

Kudos to Peacock for using his public forum to set the record straight.