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Oversight and Government Reform Committee shows that FDA is considering a new policy (which would take the form of a draft guidance document) that would allow drug companies to market unapproved use of pharmaceuticals by distributing journal articles.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 The draft guidance would carve a large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved (off-label) uses of their products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The Committee is investigating the issue further, and has requested documents from FDA related to the draft guidance.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

At a House Energy and Commerce Committee hearing yesterday, members, meat industry representatives and federal regulators debated the safety of using carbon monoxide to make packaged meat appear red for longer periods of time. Critics believe using the gas to preserve the redness of the meat, even after it has potentially spoiled, is misleading to consumers.

Tests into the safety of the practice revealed dubious results. According to The Washington Post:

The tests, conducted by Cargill and Hormel Foods, both of Minnesota, were part of a joint effort to persuade federal regulators to allow use of the gas without going through a public approval process. Inexplicably, however, the tests found that microbial counts on meat that had been left under-refrigerated went down over time instead of up, as expected, even as other indicators of spoilage increased, suggesting the possibility of some kind of error….

Yet Agriculture Department scientists did not question the data when they reviewed them a few weeks later, and then relied upon them to reverse the agency's earlier decision to oppose the technology.

Despite this revelation, officials from USDA and FDA would neither acknowledge the mystery nor commit to investigating the matter themselves. According to Reuters, "Officials at the Food and Drug Administration and U.S. Agriculture Department said they stand by the safety of the carbon monoxide practice and would revisit the process if new data becomes available."

Why would officials wait for new data when the existing data make no sense?