In November, Reg•Watch blogged about an FDA proposal that would allow drug companies to market drugs for unapproved uses by passing out journal articles and other studies. In a letter to FDA Commissioner Andrew von Eschenbach, Rep. Henry Waxman — whose committee had discovered the proposal — complained that, by creating the loophole, drug companies could promote their drugs using studies they fund themselves, free from FDA oversight.

After some prodding by Waxman's committee, FDA turned over a memo from a meeting between FDA officials and drug industry representatives including Dan Troy, a former FDA chief counsel. In another letter to von Eschenbach, Waxman expresses concern:

According to this memorandum, Mr. Troy and the other drug company representatives urged you to issue FDA guidance allowing the distribution of journal articles promoting off-label uses to protect the drug companies from "Federal prosecutors pursuing distributors of this information for criminal conduct."

This document raises questions about the rationale for the draft guidance.

For now, that's the end of the story, because FDA has refused to turn over any more documents relating to the proposal. FDA claims those documents are "predecisional" and therefore privileged information.

Never deterred by the administration's obstructionism, Waxman is demanding more information:

In your December 2l letter, you state that you are not providing the Committee with other documents or answering the Committee's questions because this information is "predecisional." This is no basis for withholding from the Committee communications about the use of joumal articles that FDA received from private drug companies. This is also no basis for withholding internal FDA communications where — as in this case — there is evidence that FDA's actions may be unduly influenced by regulated companies.

For copies of letters and more information from Waxman's committee, click here.

In a MarketWatch article published today, reporter Ruth Mantell discusses how agencies are rarely held accountable when they miss statutory deadlines for writing regulations. In one particularly onerous example, EPA has missed a Congressional deadline — by more than 11 years — for a rule that would limit exposure to lead paint during home renovation.

The nonprofit group Public Employees for Environmental Responsibility (PEER) has sued EPA, a tactic that too often must be used to prod agency action, as Mantell points out:

Repercussions are typically light, if they are any at all, for a federal agency or other governmental body that's been late or slow in complying with a mandate, consumer advocates say. In response, a cottage industry in scheduling lawsuits, such as PEER's against EPA, has bloomed, looking to make sure that obligations are met.

Congress sometimes exerts its powers of oversight to push agencies along. However, oversight falls short when considering the scope of the federal bureaucracy (about 2.5 million civilian employees and half-a-trillion dollars in non-defense, discretionary spending) and the decades-worth of federal legislation agencies are responsible for enforcing.

As for the lead renovation rule, EPA plans to finalize the standard in March; but before EPA can do that, the rule has one more major hurdle to clear. The White House is currently reviewing the rule under Executive Order 12866. White House review — one of the many across-the-board government requirements agencies must abide by — certainly does not help agencies move more quickly.

This week, the White House Office of Information and Regulatory Affairs held a closed door meeting to discuss the rule with officials from EPA and representatives of the National Association of Home Builders — an outspoken opponent of the rule.

As Reg•Watch mentioned last week, in 2007, new regulatory policies and the inability of federal agencies to protect the public made headlines more so than at any time in recent memory. Newspapers continually ran stories on White House interference, unsafe imports, and new hazards being ignored by government despite scientific evidence imploring regulation.

In 2007, Americans became trenchantly aware of the positive role government can play and the consequences that can be wrought when regulatory protections break down. But 2007 may have only been the beginning of a new chapter in American domestic policy. Many problems have been identified, but few have been solved. Dangerous imports, workplace hazards and environmental degradation may dominate headlines to an even greater extent in 2008.

But will mounting evidence be enough to tip the scales in favor of regulation in the face of the Bush administration's obstructionist policies? Federal agencies like EPA and OSHA may continue to drag their feet on issues such as diacetyl exposure (which threatens workers and consumers exposed to the artificial butter flavoring in microwave popcorn) and greenhouse gas emissions, and the White House will likely continue to meddle with agency regulations and may find new ways to enact even more damaging systemic changes.

Will a Democratically controlled Congress be able to move with the force necessary to pass new laws that respond to public needs? Despite the increased attention given to resource shortfalls at agencies like the Consumer Product Safety Commission and FDA, Congress has been unable to approve appropriations bills that would make funding and staffing at those agencies commensurate with regulatory responsibility. Legislative measures, like those to improve import safety or reform our nation's energy policy, are constructive but have gained little traction in a Congress seemingly without a sense of national priorities — a Congress which prefers partisan bickering to positive governing.

Most importantly, will the public continue to look to government to play a positive role in society? If regulatory failures do indeed continue through 2008 and beyond, will the public succeed in imploring government intervention where circumstance has not? If our leaders continue to disregard science, govern on the cheap, and make politics a higher priority than policy, the public must hold those leaders accountable and demand change.

The National Toxicology Program (NTP) will conduct a thorough review of a controversial assessment of the health effects of bisphenol-A, a chemical commonly found in a host of consumer products including CDs and baby bottles. NTP will give the report "unprecedented scrutiny," according to The Milwaukee Journal-Sentinel.

NTP's reproductive health panel released the report, which was roundly criticized by scientists and environmental advocates, last August . The report came on the heels of a National Institutes of Health study which found health problems in newborn animals exposed to bisphenol-A.

Critics complained NTP had relied on industry-funded science which downplayed the negative effects of bisphenol-A. The panel called the chemical's risks "negligible" — a conclusion which could undermine the argument in favor of bisphenol-A regulation. In December, a Journal-Sentinel investigation confirmed those complaints.

The Journal-Sentinel found the panel "gave more weight to industry-funded studies and more leeway to industry-funded researchers." In one case, "The panel accepted a Korean study translated by the chemical industry's trade group that found bisphenol A to be safe."

The report's authors conveniently omitted other studies which concluded bisphenol-A does pose a health risk: "The newspaper found that the panel missed dozens of studies publicly available that the newspaper found online using a medical research Internet search engine."

The panel's report has been the object of controversy for some time. Last March, OMB Watch reported on Sciences International, a contractor with ties to the plastics industry which had been hired by NTP to prepare the report. After it was alleged Sciences International's conflict of interest had led to suspect scientific research, their contract was terminated.

Stay tuned to Reg•Watch for more.

Yesterday, 16 states sued the U.S. Environmental Protection Agency (EPA) over its refusal to allow California to implement a program for reducing greenhouse gas emissions from vehicles. Had EPA granted California permission, the other 15 states in the suit would have adopted the California program.

EPA administrator Stephen Johnson denied California's request on Dec. 19. Johnson claimed California's proposed program is unnecessary in light of a recent federal law which would tighten the national fuel economy standard and that a federal regulation is preferable to a "confusing patchwork of state rules."

Johnson's argument is bogus. Had EPA approved California's request, other states could have adopted California's program (not created their own willy-nilly). The presence of two policies is neither confusing nor a patchwork. Furthermore, the Clean Air Act (not to mention the Constitution) contains provisions affording states the opportunity to enact their own regulatory schemes even if they are stricter than federal standards.

EPA insiders have acknowledged Johnson's decision does not hold water and will likely be overturned in court. But, since federal lawsuits take months or years, the Bush administration will still achieve its goal: delaying any meaningful action on climate change for eight long years.

Some progress may occur in the short term if Congress moves swiftly with focused oversight hearings. Rep. Henry Waxman (D-CA), chairman of the House Oversight and Government Reform Committee, and Sen. Barbara Boxer (D-CA), chairwoman of the Senate Environment and Public Works Committee, have both requested EPA documents and communications related to Johnson's decision. EPA's general counsel has instructed agency personnel to provide said material, including any evidence of communications with the White House, according to the Associated Press.

Although congressional attention will alter policy, identifying who is responsible for the denial of the California's request will allow the public to hold the culprits accountable.