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Oversight and Government Reform Committee shows that FDA is considering a new policy (which would take the form of a draft guidance document) that would allow drug companies to market unapproved use of pharmaceuticals by distributing journal articles.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 The draft guidance would carve a large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved (off-label) uses of their products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The Committee is investigating the issue further, and has requested documents from FDA related to the draft guidance.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

Every two weeks, in OMB Watch's e-newsletter The Watcher, we analyze a few recent issues in regulatory policy. Here are the articles from the November 20 issue:

More of the Same: Import Safety Panel Leaves Business in Charge
The Bush administration's cabinet-level Interagency Working Group on Import Safety released its final report Nov. 6 on ways to improve the safety of food and consumer products imported into the U.S. The report calls for limited increases in some federal agencies' responsibilities but does little to change the current voluntary regulatory scheme for imports. Read more...

Bush Fuel Economy Measure Rejected by Court
A U.S. court of appeals has overturned a recent National Highway Traffic and Safety Administration (NHTSA) rule that revised a national standard for fuel economy. Environmentalists hailed the ruling as a victory and framed it as condemnation of the Bush administration's record on fuel economy and global warming. Read more...

OSHA Issues Personal Protective Equipment Rule
Eight years after proposing it, the Occupational Safety and Health Administration (OSHA) has finalized a worker safety rule. The final rule mandates employers pay for worker personal protective equipment (PPE). Read more...

White House Rejects Krill Protection Rule
The White House has rejected an effort by the National Oceanic and Atmospheric Administration (NOAA) to protect krill, an important marine species abundant in the Pacific Ocean. NOAA's proposed rule is a precautionary measure aimed at protecting krill in the future but was rejected by White House officials for failing to identify a need for the regulation. Read more...

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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?

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"

Every two weeks, in OMB Watch's e-newsletter The Watcher, we analyze a few recent issues in regulatory policy. Here are the articles from the November 6 issue:

Vice President Reemerging in Regulatory Review Meetings
Representatives from the office of Vice President Richard Cheney have been involved in three current administration rulemakings. Their presence is indicative of a recent trend in which Cheney has involved his office in high-profile regulations. OIRA has held more than 540 regulatory review meetings since February 2002. A representative from OVP has been present at only 11, about two percent. However, eight of those 11 meetings have occurred since February. Read more...

Congress Told of FDA's Lax Inspection of Foreign Drug Makers — Again
The Government Accountability Office (GAO) recently told Congress that the U.S. Food and Drug Administration (FDA) inspects an estimated seven percent of foreign drug manufacturing facilities. Read more...

CPSC Reform Efforts Progress as Agency Woes Continue
On Oct. 30, the Senate Commerce Committee approved by voice vote the CPSC Reform Act of 2007 (S. 2045). Recent high-profile regulatory failures have highlighted the need for expansion of CPSC's authority and resources. Read more...

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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."