Today, President Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007. The law reauthorizes the Prescription Drug User Fee Act, an important source of funding for FDA, just in time to avoid agency layoffs. The law should also improve the ability of the agency to assure the safety of prescription drugs after they have been approved for the market.

For a description of the bill and a recap of the debate in Congress, see OMB Watch's analysis, "Congress Expands FDA User Fee Program, Reforms Drug Safety Process."

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Regulatory policy articles this time:

Congress Hears Pleas for Expanded Authority and Resources at CPSC

New White House Guidelines Fit into Broad Attack on Federal Protections

Senate Reviews Agencies' Attempts to Preempt Congress and the States

Congress Expands FDA User Fee Program, Reforms Drug Safety Process

The House and Senate have both passed the final version of the PDUFA reauthorization/FDA reform bill. The bill now goes to the White House where the president is sure to sign it. The Pump Handle blog has all the details on the final version: "Congress's FDA Bill Includes Reforms"

The Center for Science in the Public Interest (CSPI) has launched a new database providing information on food-borne illness outbreaks that occurred in the U.S. from 1990-2004. (CSPI defines outbreaks as "events where two or more people become ill from eating the same food.")

The database, "Outbreak Alert!," breaks down over 5,000 outbreaks by food type, pathogen and location. It also lists the number of cases resulting from each outbreak.

Check it out here.

The Sunday New York Times featured an article on the efforts of U.S. industry groups to push for federal regulation. As the article points out, this represents a marked shift in the traditional conception of industry's views on regulation. Historically, industry representatives often see regulation as costly and vexing.

A graphic in the article briefly summarizes 14 examples of new federal regulations supported by manufacturers or industry lobbyists.

In some cases, such as the toy industry, representatives appear to have good intentions. A recent hearing proves that industry representatives recognize the benefits associated with a strong federal regulatory regime.

Unfortunately, as with lead paint in toys and diacetyl in popcorn, even the combination of strong public and industry support (not to mention overwhelming health-based evidence) is not enough to prompt the Bush administration into action. As the article shows, agencies often don't act to regulate substances like lead and diacetyl despite support for doing so from industry lobbyists. Is this a sign senior administration officials' anti-government ideology trumps their industry loyalties?

In other cases, representatives may be employing a calculated strategy. Industry lobbyists may rather have product regulations written by the Bush administration (and edited by Bush's OMB) than by a future administration that may be less friendly. With the clock running down on Bush's second term, this may be the last opportunity for a middle-of-the-road regulatory approach.

The Sunday Times also featured two editorials (here and here) titled, "The Need for Regulation."

In today's Washington Post, columnist Dana Milbank reports on yesterday's Senate hearing on toy safety and the Consumer Product Safety Commission's role in assuring it. The hearing, held by an appropriations subcommittee responsible for approving CPSC's budget, featured testimony from Nancy Nord, acting chairman of the commission.

CPSC has been under increasing scrutiny for failing to protect American children from the dangers of lead paint in toys — by no means a newly discovered threat. While most of the tainted products have come from China, the string of recalls has left many Americans wondering why our strong regulatory system is being circumvented by shoddy foreign manufacturing.

Milbank characterizes Nord as evasive and smug and the panel's senators as confounded by the idea our federal regulatory protectors could operate with such complete and utter ineffectiveness.

Of course, as Durbin recognized in the hearing, the agency is not wholly to blame for its troubles. Congress and the White House have slowly let the agency fall into a state of disrepair. Milbank includes a summary of some startling statistics:

Among the nuggets served up at yesterday's hearing: The CPSC's staff, once 978, is down to 401; its budget is half of what it was three decades ago, in inflation-adjusted terms; its toy-testing department consists of one man, Bob, who drops toys on the floor in his office; and its toy-testing lab is an overloaded workbench in its outmoded headquarters.

Another panel of witnesses included Mattel chairman Robert Eckert. Some of Eckert's recent comments in the wake of massive recalls of Mattel products indicate he does not believe federal consumer product laws apply to his company. (See the Sept. 5 post, "Is Barbie above the Law?")

Refreshingly, Eckert was contrite for the dangers posed by Mattel's now-recalled products and expressed full-throated support for a strong and well-resourced CPSC. Unfortunately, none of the Senators pressed Eckert on his comments. It is still unclear if Mattel violated federal law by failing to report potential product defects in a timely manner.

Sens. Ted Kennedy (D-MA) and Patty Murray (D-WA) have written to the FDA and the Centers for Disease Control and Prevention (CDC) expressing their concern over diacetyl exposure and asking the agencies to take action. (More from the Pump Handle blog here.)

The federal government, the popcorn industry and public and occupational health advocates have known for some time that exposure to diacetyl — a chemical used to give microwave popcorn its buttery flavor — can cause severe lung problems for workers in the popcorn manufacturing industry.

Recent evidence shows the presence of diacetyl in microwave popcorn may also pose a danger to consumers. The news has thrust the issue back into the national spotlight. No word yet on how FDA and CDC might respond to the Senators' letters.

Congress might also consider prodding the Environmental Protection Agency on its response to the potential danger to consumers. As OMB Watch has reported, in 2003, EPA began studying the risks and completed a report last year. EPA has released the report to the popcorn industry but has refused to give access to the public.

The popcorn industry has begun to take voluntary steps to eliminate the use of diacetyl and should be commended. However, that is no reason for EPA to withhold crucial public health information from concerned Americans. Federal officials should be in the business of fostering knowledge, not hiding the facts.

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Regulatory policy articles this time:

Federal Agencies Knew of Diacetyl Dangers and Kept Silent

Bush's Anti-Regulatory Ideology under Increasing Scrutiny

It's Industry vs. Consumers and Health Specialists in National Ozone Hearings

New Small Business Program Will Influence Agency Regulatory Reviews

Yesterday, The Chicago Tribune published a story about a new medical study that has found a dramatic increase in adverse effects associated with prescription drugs. According to the article, "The annual number of 'serious adverse event' reports jumped to 89,842 in 2005 from 34,966 in 1998. Meanwhile, the number of 'fatal adverse drug events' increased nearly threefold to 15,107 in 2005 from 5,519 in 1998."

The article also mentions the Congressional reauthorization of the Prescription Drug User Fee Act (PDUFA) and the FDA reform measures lumped in with it. The legislation renews PDUFA (a program which allows FDA to collect money from drug makers in order to conduct drug safety reviews) and expands FDA's authority to conduct post-market safety reviews and pull drugs from the market if necessary.

The Senate passed its version in May, and the House approved its version in June. Because of disparities in the FDA reform provisions, a House/Senate conference committee will need to reconcile the bills before sending a final version to the president. The bill is considered must-pass legislation, because the PDUFA program expires at the end of September.

While the bill must pass, findings in the medical study underscore the fundamental problems with the legislation. The PDUFA program is a double-edged sword. While it is an important source of funding for the agency, it comes with strings attached and allows drug companies to call the shots during the approval process.

Moreover, by focusing only to expand FDA's powers in regard to post-market drug safety, Congress is only trying to close the gate after the horse has left the corral. When it comes to drug approval, both parts of the bill presume speed to be more important than safety.

In the Chicago Tribune article, FDA spokeswoman Julie Zawisza tries to put a positive spin on the news by saying, "More reporting to us gives us more information on which to evaluate a drug's safety once it is on the market. Now that we get more reporting, people are saying that there is something wrong. We know that under-reporting is a problem so one would think that when we get more reports it could suggest that the system is actually working better but we don't for sure."

Tortured logic aside, Zawisza's quote and Congress's pending legislation beg the question: Do our government leaders ever consider assuring a drug's safety before it hits the market?

Reg•Watch Update: "For Congress, an Opportunity to Limit Conflicts of Interest at FDA"

Mattel is recalling another batch of toys because of lead paint contamination. This time, it's 675,000 Barbie toys.

As it has with past recalls, Mattel is working in cooperation with the Consumer Product Safety Commission, the federal agency responsible for regulating toys and other products. Reg•Watch has blogged about the problems with this industry-lead voluntary recall system and the ineffectiveness of CPSC.

The problems are underscored by a recent Wall Street Journal article in which Mattel's chairman revealed the toy maker often conducts investigations of hazardous products on its own (and outside of the public view) before notifying CPSC.

With rare exception, manufacturers are to notify CPSC within 24 hours if they believe a product to even be potentially hazardous. According to the Journal, Mattel has a different take:

Mattel Chairman and Chief Executive Robert Eckert said in an interview that the company discloses problems on its own timetable because it believes both the law and the commission's enforcement practices are unreasonable. Mattel said it should be able to evaluate hazards internally before alerting any outsiders, regardless of what the law says.

Reg•Watch once tried that "the-law-is-unreasonable-argument" to get out of a parking ticket. It didn't work.