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"

In June, OMB Watch reported on EPA's new risk assessment program for endocrine disruptors. An endocrine disruptor is any substance which alters the function of the endocrine system. The endocrine system regulates certain mood, growth and development functions including hormonal and thyroid functions.

Scientists are still uncertain as to the types of substances which may be endocrine disruptors and the levels of exposure that may jeopardize public health. Scientists suspect endocrine disruptors to be commonly found in a number of consumer products including pesticides, cosmetics and finished plastics.

In 1996, Congress passed the Food Quality Protection Act (FQPA), which requires EPA to screen the effects of pesticides on the human endocrine system. Since then, EPA has done…well…nothing.

Congress is pressing EPA on the issue. Today, seven representatives wrote to EPA Administrator Stephen Johnson expressing their displeasure with the inexplicable delay:

Over the past ten years, EPA has not completed a single step of this multi-stage process. This summer, the agency finally published its first draft list of chemicals to be screened by pesticide manufacturers for endocrine disrupting properties. This initial list of 73 chemicals is only a small fraction of the universe of 1,700 chemicals that the agency has identified for screening under the FQPA mandate, and a minute percentage of the 75,000 chemicals currently listed on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory. EPA apparently has no internal deadline for identifying subsequent sets of chemicals for testing, and no plan whatsoever for ensuring that all chemicals of potential concern will be tested.

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.

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"

An article in yesterday's New York Times describes how President Bush has started a flurry of 11th hour regulatory activity. Every president since John Adams has used the waning days of his presidency to issue executive edicts and final regulations in order to ensure his policy beliefs outlast his days in the White House.

The article mentions the environmentally damaging mountaintop mining rule the administration proposed last month (click here for details) as a precursor of things to come.

Reg•Watch is concerned Bush may be more effective at this than many of his predecessors. While presidents have spent the end of their terms pursuing individual policy goals, Bush appears to place just as high a priority on altering the policymaking system.

In January, Bush amended Executive Order 12866, Regulatory Planning and Review. The changes will further politicize the rulemaking process by giving senior officials unlimited reach into agency scientific and technical decisionmaking (as if they needed it). The changes also force agency guidance documents — i.e. policy statements and interpretive memos — through a White House review process.

The next year may bring more meddling in the cross-cutting policy by which agencies develop rules. Susan Dudley, the White House's regulatory czar, has indicated she will pursue finalization of OMB's Risk Assessment Bulletin. The Bulletin would create uniform and inflexible requirements for the preparation of agency risk assessments — the process by which agencies determine the severity of an environmental risk. Dudley would pursue the Bulletin despite the pleadings of Congress and the National Academies of Science.

And that's just what we know they're planning. The next 16 months could prove to be tumultuous.

Reg•Watch has frequently blogged about the butter-flavoring chemical diacetyl and the lung problems it causes in workers exposed to it (particularly in the microwave popcorn industry). The evidence of danger is overwhelming, yet federal agencies such as the Occupation Safety and Health Administration have been loath to act.

But what about diacetyl exposure for consumers? Are we at risk when we eat artificially flavored popcorn? Evidence of adverse health effects for consumers is less conclusive, and the Bush administration seems content on keeping it that way.

For more on this, read a post on The Pump Handle blog by public health expert Dr. David Michaels: "Popcorn Lung Coming to Your Kitchen? The FDA Doesn't Want to Know"