Resource shortfalls at the Food and Drug Administration were the focus of a House panel hearing yesterday. The House Energy and Commmerce subcommittee on Investigations and Oversight heard from members of FDA's Science Advisory Board who recently completed a report titled, "FDA Science and Mission at Risk." Among other things, the report highlighted how funding and staffing have not kept pace with FDA's ever-growing responsibilities to ensure the safety of the nation's food and drug supply.

One member of the board, Gail Cassell, spoke of the glaring problems the board saw when preparing the report:

It became rapidly apparent that the FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities…Since every regulatory decision must be based upon the best available scientific evidence in order to protect the public's health, we concluded that American lives are at risk and that there is an urgent need to address the deficiencies.

But both members and witnesses recurrently brought the conversation back to resources. Another member of the board, Peter Barton Hutt, argued scientific problems at the agency cannot be fixed without an infusion of cash and an increase in staff:

The accumulating unfunded statutory responsibilities imposed on FDA, the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for premarket review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates — coupled with chronic underfunding by Congress — have conspired to place demands upon the scientific base of the agency that far exceed its capacity to respond. FDA has become a paradigmatic example of the "hollow government" syndrome — an agency with expanded responsibilities, stagnant resources, and the consequent inability to implement or enforce its statutory mandates.

Hutt called on Congress to double appropriations to FDA over the next two years and called on FDA to use that money to increase employment by 50 percent.

FDA Commissioner Andrew von Eschenbach also testified. Subcommittee chairman Bart Stupak (D-MI) pressed the commissioner on whether the president would be asking for an increase in funds for the agency when he releases his FY 2009 budget request next week. Von Eschenbach said he had asked for an increase in funding for his agency but could not comment on the president's budget before its release.

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 new article written for the American Constitution Society, Georgetown law professor David Vladeck examines a toubling yet underreported tactic the Bush administration has been using to undermine public health and safety protections: federal preemption of state tort claims.

Federal agencies are responsible for enforcing the positive law enacted by Congress. However, even when positive laws and regulations work, citizens must have an opportunity to seek legal redress if they are harmed by a product. Tort law provides that opportunity by allowing citizens to seek damages from the makers of those products.

The Bush administration is consistently conflating these two types of laws. In the article, "The Emerging Threat of Regulatory Preemption," Vladeck goes over several case examples in which federal agencies have written regulations that they claim "preempts" state tort law, thereby making it impossible for citizens to seek damages on products regulated by the federal government.

Preemption language has been included in all sorts of product safety regulations that cover everything from cars to mattresses. One FDA regulation preempts damage claims if a drug maker fails to warn consumers of a certain risk, so long as the drug has received FDA approval. In addition to robbing consumers of their right to sue, drug makers would have no motivation for monitoring the safety of their drugs after FDA approval.

Why would the Bush administration engage in such a broad attack on state law? One reason, Vladeck argues, is to help industry allies:

[T]here have been repeated charges that the regulators implementing this pro-preemption campaign have deep ties to the industries that will benefit. For example, the architect of the Food and Drug Administration's new preemption position is a partner at a major law firm where he specializes in representing drug companies regulated by the FDA — the very companies that benefit from the agency's new pro-preemption position.

As if the public health and safety ramifications of the campaign to render state law impotent was not enough, the administration is implementing these policies surreptitiously and undemocratically:

[A]gency decisions to extinguish common law remedies are not made in a transparent way. Agencies simply announce their conclusions in preambles, which are lengthy and jargon-filled explanations of agency regulatory action. Agencies do not go through notice and comment rulemaking to formulate their positions…Nor do agencies…provide states and local governments with notice and an opportunity to participate in any proceeding that may affect state and local law.

Read Vladeck's article here.

The Washington Post has obtained a copy of an FDA risk assessment that endorses the safety of food from cloned cattle, pigs, and goats. The assessment, long expected, comes on the heels of a European Union draft scientific opinion which came to similar conclusions. The Post has a summary of and excerpts from the risk assessment and background on the issue in an article published today.

Usually a risk assessment is an early stage of the regulatory process that informs officials responsible for making the ultimate decision. But in this case, the federal government does not need to regulate to allow food production from clones because there is currently a "voluntary moratorium," according to the Post. With FDA's endorsement, the agricultural industry may move more quickly with food production stemming from cloned animals.

According to the Post, FDA will be monitoring cloned animals should production increase:

Looking ahead, the report says FDA is collaborating with veterinary and scientific organizations, notably the International Embryo Transfer Society, to create a database on the health of new clones, which will help the agency track the field as the industry grows.

As the debate on cloned animals will surely continue, FDA should make this information publicly available.

Interestingly, neither the article nor the selected excerpts from the risk assessment mention USDA, the federal body in charge of monitoring and inspecting livestock and regulating meat products. Maybe it is more appropriate for FDA to conduct the risk assessment, but the continued safety of the nation's supply will depend on the work of inspectors in the field. Hopefully, FDA consulted USDA.

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.

Nancy Nord, head of the Consumer Product Safety Commission, will use the agency's newly-boosted budget to station product inspectors at the nation's busiest ports, according to an article in Congress Daily (via GovExec.com).

CPSC staff at ports will not be authorized to turn away dangerous cargo, but it can advise U.S. Customs and Border Protection officials who have the power to deny unsafe products entry into the country. CPSC employees are posted near ports and sometimes conduct inspections, but they also are assigned other duties. The permanent port staff will have access to information on recalls and high-risk products through a tracking system CPSC is developing, Nord said.

The omnibus spending bill for FY 2008, finalized in Congress in late December, included a $17 million (or about 27 percent) increase for CPSC, the regulatory body in charge of ensuring the safety of toys, clothes, and a host of other consumer products. Congress raised the agency's budget in light of mounting evidence that resource and staffing shortfalls were at least partially responsible for a spate of product recalls announced in 2007. President Bush's budget proposed less than $1 million in increases, a virtual budget cut when considering inflation.

Congress is also looking at long-term resource increases and other reforms which would improve CPSC's responsiveness and effectiveness. In December, the House passed the Consumer Product Safety Modernization Act. Senate progress has been slower. For more, read the Jan. 8 OMB Watch article, "Congress Limps Toward Product Safety Reform".

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. Four themes dominated regulatory policy in 2007: White House influence over agency rulemaking activity and discretion; the inability of the federal government to ensure the safety of imported goods; the influence of industry groups; and the Bush administration's refusal to regulate in the face of overwhelming scientific evidence.

Click on these links for a recap of 2007's highlights and lowlights:

• White House Interventions
• Import Safety
• Industry Influence
• Ignoring Science