The Food and Drug Administration has finalized guidelines it contends will improve the independence of the expert panels it uses to receive advice on pending decisions for both food and drug policy. But the final guidelines are weaker than the proposed version first unveiled in March 2007.

The guidelines define new FDA policies for financial conflicts of interest. If a potential member of an advisory committee has a financial interest in the issue the panel is considering — for example, ties to a pharmaceutical industry which has a new drug under review — that person's objectivity is compromised.

Under the March 2007 proposal, potential members with a financial conflict totaling more than $50,000 would be prohibited from serving on panels except in the rarest of cases. That part of the guidance has gone unchanged.

But potential members with a conflict of less than $50,000 will potentially have more influence under the final guidance than they would have under the proposed version. Originally, persons with a financial interest less than $50,000 would have been allowed to serve but prohibited from voting. FDA decided to strip the voting prohibition in the final version.

Allowing members with a financial conflict to cast deciding votes could have real consequences, especially in the area of drug approval. A 2006 study published in the Journal of the American Medical Association finds "the overall amount of conflict in a meeting could have an influence on overall voting behavior." The study finds, in hearings held on specific drugs where the advisory committee contains members with a financial interest in the approval of the drug, the committee is likely to recommend approval.

Moreover, even the strict $50,000 cutoff won't have much impact on the number of conflicted panel members providing the agency with advice. An investigation by the Center for Science in the Public Interest found the $50,000 threshold "would eliminate just one of every ten panelists who currently gets a waiver" to serve despite a financial conflict.

The FDA and the CDC have identified a source of the salmonella outbreak that has sickened more than 1,000 since April, according to The Washington Post:

Investigators discovered the Salmonella saintpaul strain in irrigation water and serrano peppers on a farm in Mexico, where jalapeno peppers are also grown…

The Food and Drug Administration, which earlier issued a warning about jalapeno peppers, is now warning consumers also to avoid raw serrano peppers grown and packed in Mexico.

FDA had initially linked the massive outbreak to tomatoes and issued a nationwide warning against the consumption of certain types of tomatoes. Then, the list of risky produce grew to include jalapeno peppers. Now, it turns out serrano peppers are to blame.

But serranos may not be the only culprit. The Post reports that officials "still believe tomatoes could have been involved as well, even though they have not found a contaminated tomato."

So the investigation will continue, but at least consumers have regained a modicum of confidence that their food safety system can come up with results.

As the investigation winds down and the salmonella story fades from the headlines, let's hope the experience does not similarly fade from the memories of food safety officials and the food industry.

The salmonella outbreak has made clear that American consumers need a robust food tracking system. One of the subplots of this story has been the revelation that the food industry lobbied the Bush administration in 2003 and 2004 while regulators were developing a congressionally-mandated food traceability regime.

The product of that cozy relationship, a feckless tracking system, caused some major headaches for both federal officials and the food industry. FDA was the subject of much criticism for its handling of the situation, even though investigators on the ground were probably working as diligently as they could with the resources they had.

But criticism aimed at FDA higher-ups was warranted, since the salmonella crisis was at least partly preventable. According to the Associated Press, "Tommy Thompson, who was health secretary during the industry's lobbying campaign, acknowledged that a more robust food-tracking system — opposed by business groups as too expensive — could have helped stem the current illnesses and business losses."

And those business losses were pretty serious. Representatives from the tomato industry estimate they lost hundreds of millions of dollars as a result of the outbreak. The Bush administration and industry lobbyists should both remember this lesson the next time the door closes and the backroom negotiations over federal policy begin.

Congress is attempting to formulate and pass legislation to address problems that have become apparent at the Food and Drug Administration (FDA). After increasing questions in recent years about the safety of prescription drugs and imported food, we've learned about the limited ability of FDA to regulate effectively some of the products.

Legislation in Congress, particularly in the House Energy and Commerce Committee, that addresses ways to reform how FDA protects us from harmful products in the marketplace is being strongly opposed by lobbyists for the food and drug industries. According to an article in POLITICO, the lobbyists are trying to delay the legislation and run the clock out in this abbreviated election year session of Congress.

One of the lobbying groups active in the fight is the Grocery Manufacturers Association (GMA). It represents agribusiness and food processing companies. GMA last year put forth its own proposal calling on FDA to adopt a foreign supplier quality assurance program after FDA announced an import ban on five different types of Chinese farm-raised seafood products. Apparently, GMA thinks Congress wants to go too far in moving to protect consumers at the expense of its members.

The Energy and Commerce Committee seems undeterred, according to POLITICO: "Our plan is still to do a comprehensive overhaul of FDA to equip it to deal with an increasingly globalized market," said spokeswoman Jodi Seth. "We're interested in cleaning up the whole mess, including contaminated heparin and tainted tomatoes. Consumers want all the products they consume to be safe."

It may not be easy to get anything meaningful passed to enhance FDA's powers this session, but one would think the lobbyists would be less resistant to getting a bill completed this year — while they still have their friend in the White House.

Late last week, FDA's lead scientist asked the agency's science board to convene a subcommittee to study the effects of bisphenol-A (BPA), a chemical commonly found in hard plastics and food containers. The science board is an advisory committee of non-governmental scientists who provide expert advice to FDA decision makers.

From the FDA press release, it appears as though the primary responsibility of the subcommittee will be to review an FDA task force report on BPA exposure and effects. "In April 2008, the FDA formed an agency-wide BPA Task Force to facilitate review of current research and new information on BPA," FDA says. After the subcommittee reviews the report this summer, "the task force will make recommendations" to the FDA commissioner.

The increased activity at FDA comes less than two months after a report by the National Toxicology Program (NTP), which, like FDA, is part of the Department of Health and Human Services, raised concern about the possible health effects of BPA.

The NTP report finds most humans are exposed to BPA and retain it in their bodies. The panel looked at studies of laboratory rodents exposed to BPA and found a wide variety of adverse health effects at high doses and other possible health effects at low doses — mostly developmental and reproductive abnormalities.

NTP concluded bisphenol-A is of "some concern" — a qualitative designation. Other options available to the panel included "serious concern" and "concern" for riskier substances, and "minimal concern" and "negligible concern" for less risky substances.

But FDA, which, unlike NTP, has the authority to regulate the chemical, isn't so sure. FDA has said on past occasions that BPA does not pose a "safety concern at the current exposure level."

A renewed effort within the agency to study BPA is a wise move, as is the decision to seek review from the agency's independent science advisors. FDA says its agency investigation will consult the NTP report as well as "available information on BPA in numerous other risk assessment documents from scientific and regulatory bodies worldwide."

Let's hope FDA keeps its pledge to limit its search to work from "scientific and regulatory bodies." In the past, FDA has relied on industry studies, according to congressional investigators. The House Energy and Commerce Committee wrote to FDA in January asking the agency to identify the basis on which it has made its decision that BPA is not harmful. FDA identified two studies, both of which were funded by the American Chemistry Council. One study had never been published or subjected to peer review.

Reg•Watch Update: "FDA Would Regulate BPA If Found Harmful, Official Says"

An article in The Daily News (Galveston County, TX) provides yet another example of industry groups asking for federal regulation, realizing that safety is good for business. (Thanks to the Government Accountability Project blog for pointing this out.)

Domestic shrimpers — whose share of the American market has fallen to ten percent, according to the article — want new laws that will empower the Food and Drug Administration (FDA) to inspect imported shrimp:

The industry is pressuring the federal government to revamp the way the U.S. Food and Drug Administration inspects shipments — only a tiny fraction are inspected, much less tested — and some in the industry want new laws requiring better disclosure of the origins of seafood.

If a foreign supplier refuses entry to American inspectors, the FDA has no legal authority to deny imports from that supplier, said Michael Taylor, a former FDA policy commissioner and professor of health policy at George Washington University….

The FDA has standards for imported seafood, but even if it did have legal authority to inspect every foreign supplier, government audits reveal the FDA is spread so thin that foreign firms can send potentially harmful seafood to the United States almost at will.

The story also underscores the problems with the bureaucratic morass that governs food safety in the United States. While FDA is responsible for regulating seafood, USDA regulates other kinds of meat like beef and poultry. Although USDA has been under fire recently, its track record on food safety is much better than that of the FDA.

Comparatively, USDA is better resourced and more properly authorized by Congress to conduct the kind of inspections necessary to ensure food safety. Before slaughter, USDA is legally required to inspect every head of cattle and every chicken for health and safety. USDA also inspects imported beef and poultry before it can be placed into commerce. While USDA needs more inspectors, its regulatory regime is intended to be exhaustive.

FDA, on the other hand, conducts risk-based inspections. Essentially, the agency makes educated guesses about where it can make the best use of its resources. FDA inspected just 1.2 percent of imported seafood, according to the article.

As a result, there is increasing concern about both domestic and foreign products under FDA's jurisdiction. In the past couple years, seafood, spinach, pet food, and peanut butter have all made headlines. In each instance, it has seemed that a better-resourced or better-functioning FDA could have reduced the chances of those products becoming contaminated.

Yesterday, after a period of long delay, the Department of the Interior announced it would list the polar bear as a "threatened" species under the Endangered Species Act. Designating a species as threatened is not as serious as calling it endangered, but it still affords the species federal protections and special considerations.

The debate over whether to list the polar bear has been a hot button issue, because the main threat to the species is global climate change which is affecting the ice cover and sea conditions the bear needs to subsist.

Interior Secretary Dirk Kempthorne said that the decision to list the polar bear under the Act does not permit the federal government to regulate greenhouse gas emissions. "Protecting the polar bear under the Endangered Species Act is a major step forward, but the Bush Administration has proposed using loopholes in the law to allow the greatest threat to the polar bear — global warming pollution — to continue unabated," said Andrew Wetzler, Director of the Endangered Species Project at the Natural Resources Defense Council (NRDC).

Although Kempthorne is passing the buck on climate change, that doesn't mean the decision is a hollow one. Climate change is not the only threat to the polar bear. Man's physical intrusion into polar bear habitats can add unnecessary peril to a sensitive situation; industrial activities can disrupt any species' lifestyle.

In fact, the reason the Interior Department delayed the decision to deem the polar bear as threatened was because it needed to hurriedly approve permits for oil and gas extraction in parts of Alaska where the polar bear lives. The department was legally required to make its decision in January but stalled while its division in charge of minerals extraction doled out permits to big polluters. Environmentalists sued, and a court ordered Interior to make the decision by May 15.

Because of the listing decision, future actions that benefit special interests at the polar bear's expense will not be so easy. According to NRDC, "Listing the polar bear guarantees federal agencies will be obligated to ensure that any action they authorize, fund, or carry out will not jeopardize the polar bears' continued existence or adversely modify their critical habitat, and the U.S. Fish and Wildlife Service will be required to prepare a recovery plan for the polar bear, specifying measures necessary for its protection." That's good news for the polar bear.

The U.S. Fish and Wildlife Service is once again changing its tune on when it will announce plans to protect the polar bear under the Endangered Species Act. The agency has said it needs 10 more weeks to make the decision, according to the Associated Press.

The legal deadline for making the decision was Jan. 9. At that time, FWS, which is an agency within the Department of the Interior, said it would make its decision in early February. The latest announcement of delay indicates the decision may be pushed into early July at the earliest.

How could FWS's estimates be so off? In early January, FWS thought it only needed about another month to decide. But apparently, it needed another six months. That's quite the miscalculation.

Meanwhile, another agency within the Interior Department (the Minerals Management Service) has been working hastily to hand out permits to oil and gas companies to drill in areas in Alaska where the polar bear lives. Because FWS has yet to list the polar bear under the Endangered Species Act, the companies do not legally have to take into consideration the effects of their operations on the bears' habitats.

Kassie Siegel of the Center for Biological Diversity, a group which has filed suit to force the agency to make a decision, recognizes that FWS is callously delaying its decision to help out the oil and gas industry. According to the AP, "The request for more time, Siegel said, is probably a tactic to delay a decision until the Minerals Management Service can finish issuing offshore petroleum leases in the Chukchi Sea off Alaska's northwest shore, home to one of two polar bear populations in Alaska."

The Interior Department's Inspector General is investigating the delay.

The National Institutes of Health's National Toxicology Program (NTP) released a report today that acknowledges adverse health effects associated with exposure to Bisphenol-A, according to The Washington Post. Bisphenol-A is a chemical substance common in plastics and in the lining of food cans.

According to the Post, the report, released in draft form, "Says exposure to the chemical may be linked to breast cancer, prostate cancer, early puberty in girls and such behavioral changes as hyperactivity."

NTP's findings are significant because, until now, the federal government has downplayed the effects of Bisphenol-A. The U.S. Food and Drug Administration — which, like the National Institutes of Health, is part of the Department of Health and Human Services — has said Bisphenol-A does not pose a "safety concern at the current exposure level."

But an ongoing investigation by the House Energy and Commerce Committee has shown that FDA relied on industry-funded studies to make its determination. Meanwhile, public health advocates and scientists outside of government have raised concern for years about the safety of Bisphenol-A.

Unfortunately, because NTP cannot regulate chemicals, FDA still holds all the power on this issue. Stay tuned to Reg•Watch to see if FDA issues a response.

Reg•Watch Update: In Response to Bisphenol-A Studies, Retailers Will Remove Products"

The USDA is preparing to finalize a rule that would help consumers identify grocery stores that recalled meat has been sold to. Typically, under current regulations, neither USDA nor slaughterhouses and processors disclose the names of retailers who have received potentially contaminated meat. USDA does disclose the brand and type of meat but, by failing to name retailers, leaves consumers in the dark as to whether their community might be at risk.

While the rule would be a step in the right direction, the devil is in the details (as it so often is with the Bush administration). Insiders say the new rule may only apply to Class I recalls. USDA classifies recalls based on the potential risk to public health; Class I recalls are for products which pose the highest risk, Class II and III recalls are for products which pose lower risks.

Most meat recalls are Class I (50 of 58 in 2007), but consumers have a right — and a need — to know about Class II and III recalls as well. For example, USDA classified an April 2007 recall of more than 5,000 pounds of salami as a Class II recall but also called the health risk "high."

February's record-breaking recall of 143 million pounds of beef was also deemed a Class II recall. USDA and Hallmark/Westland Meat Packing Co. recalled the meat because "the cattle did not receive complete and proper inspection" and nonambulatory, or downer, cows were allowed into the food supply. Downer cows are at greater risk for carrying mad cow disease. USDA's new policy would still leave consumers uninformed if a similar incident occurred in the future.

USDA has sent the rule to the Office of Information and Regulatory Affairs (OIRA) at the White House Office of Management and Budget for review. OIRA is friendly with lobbyists from the meat producing and packaging industries who oppose USDA's rule. Seattle Post-Intelligencer reporter Andrew Schneider has more:

The pressure on the agencies to conceal the retailers is coming from industry lobbyists for food chains, meat packers and importers. In fact, USDA first proposed a regulation requiring disclosure of where dangerous recalled food is being sold in February 2005. Nothing has happened since.

Tony Corbo of public advocacy group Food & Water Watch told me, "The main impediment has been the White House Office of Management and Budget which is responsible for clearing major regulation changes.

"The food industry has effectively lobbied OMB thus far to prevent the implementation of this rule."

As the clock runs out on the Bush presidency, OIRA may finally let USDA finalize the rule in its weakest form possible for fear that a new administration may push for tougher regulations. Stay tuned to Reg•Watch for updates.

The House yesterday took a step toward regulating tobacco products, as the Energy and Commerce Committee voted 32-12 in favor of giving oversight authority to the Food and Drug Administration.

Among other things, the Family Smoking Prevention and Tobacco Control Act (H.R. 1108) would allow FDA to set standards for nicotine content in cigarettes and to exert control over the marketing and advertising of tobacco products. The bill would not permit FDA to ban nicotine outright. The bill would allow FDA to collect user fees — a controversial process whereby regulated companies pay the federal government to inspect and oversee their products — in order to fund a new tobacco regulation office. (More info here.)

The federal government can regulate lots of products that have the potential to do harm including food, pharmaceuticals, and vehicles. Yet on tobacco, a product certain to do harm, government is completely powerless.

Industry pressure has kept tobacco off the government's regulatory radar, as a New York Times editorial states this morning: "For years, the industry greedily fought off regulation with mendacious denials and addictive donations to lawmakers' re-election kitties."

This time around, the tobacco industry is divided. Phillip Morris has expressed support for the bill, but Reynolds American is opposed. Reynolds claims that FDA is ill-equipped to handle the additional regulatory challenge.

If you're waiting for FDA to set the record straight on its ability to regulate tobacco, don't hold your breath. FDA Commissioner Andrew von Eschenbach said last year that placing tobacco under the agency's purview would be a burden, according to The Wall Street Journal (subscription). The Journal also reports President Bush may veto the bill if Congress finalizes it this year.

FDA is an underfunded agency, and the lack of funding has made it difficult for FDA to fulfill its mission. However, the user fee program should provide a steady source of income. According to the Journal, "The House panel estimates that the FDA will collect $85 million from tobacco companies in the first year and eventually assess fees of $712 million in the next decade."

Moreover, FDA should not shy away from the responsibility to regulate tobacco because it cannot afford to do so. Instead, it should embrace tobacco regulation, then zealously push Congress to provide robust funding for all the agency's activities.

An investigation by the Milwaukee Journal Sentinel examines a little-known EPA program which is supposed to study the effects of common chemicals on children's health. Journal Sentinel reporters Susanne Rust and Meg Kissinger found major flaws.

Among other things, the investigation finds the program (the Voluntary Children's Chemical Evaluation Program) is relying on advisory panels stacked with industry scientists, has had little luck in getting chemical makers to cooperate with requests for data, and has been broke since August.

Instead of regulating the chemical companies, the EPA invited them to interpret and present data to a panel of scientists on the risks and exposures of chemicals they made. The approach was hailed by chemical company lobbyists as "breathtakingly significant." …

The format was simple. Companies were to present data about their chemicals' toxic properties and likely exposure to a panel of scientists. That panel would then determine if the chemical was safe to use around children. If not enough was known, the EPA would ask the company to provide more information. …

The voluntary nature of the program has proved to be a problem with enforcing safety, children's health advocates say. Although the EPA can request more information about a chemical from the compound makers, companies are not required to answer. And many don't.

"The EPA has no hammer," said Melanie Marty, chairwoman of the EPA's Children's Health Protection Advisory Committee.

The investigation also finds a gross lack of transparency in the program. EPA does not publicly announce the dates of meetings, and the agency does not separate out the program's budget, making it nearly impossible to determine the program's cost to taxpayers.

Jay Berkelhamer, former president of the American Academy of Pediatrics, last year urged EPA Administrator Stephen Johnson to abandon the program in favor of "a mandatory program with stricter deadlines and a more transparent, accountable review system." Meanwhile, Johnson "repeatedly points to the program in public statements as proof that his agency is committed to protecting children," according to the Journal Sentinel.

The House Energy and Commerce Committee's investigation into the use of Bisphenol-A — a chemical substance common in plastics and in the lining of food cans — continues to turn up startling information. The Food and Drug Administration (FDA) says Bisphenol-A is safe, but studies have shown the chemical is associated with a host of adverse health effects including breast and prostate cancer, according to the Environmental Working Group.

The committee wrote to FDA in January asking the agency to identify the studies it used to make its determination that Bisphenol-A does not pose a "safety concern at the current exposure level." In response, FDA identified two studies. Both studies were funded by industry and were absent the usual scientific rigor characteristic of regulatory decision making, according to The Milwaukee Journal-Sentinel.

The Journal-Sentinel has the full story:

In response to a congressional inquiry, Stephen Mason, the FDA's acting assistant commissioner for legislation, wrote in a letter that his agency's claim relied on two pivotal studies sponsored by the Society of the Plastics Industry, a subsidiary of the American Chemistry Council.

One of the studies has never been published, and therefore never subjected to peer review; the second has been heavily criticized by researchers who say the results are inconclusive because of flawed experimental methods….

According to the letter, the FDA based its claim that there is no "safety concern at the current exposure level" on its own studies, conducted in the 1990s, which indicated that people were exposed to small amounts of the chemical.

They gathered that information by testing products such as aluminum cans and baby bottles to see how much of the chemical was leaching. Then they looked to the two chemical industry studies to see if those exposure levels could cause harm.

The two studies said the chemical caused no harm to rodents at low doses.

Wall Street Journal reporter Joseph Pereira writes today about state government efforts to limit the presence of certain substances in children's toys, particularly lead. Both the U.S. Congress and U.S. Consumer Product Safety Commission (CPSC) have been unable to quickly enact policies to respond to public concern over toy safety.

Numerous past congresses and presidents have allowed CPSC's budget and staffing levels to whither. As a result, the agency is unable to handle the rising tide of imported products on our store shelves. In the light of last year's record number of toy recalls and growing public concern, state legislatures and administrations have grown impatient:

Many state lawmakers are upset that Congress and federal regulators haven't done more since the recalls. "If the federal government would do something I would gladly defer to them, but they aren't, so we have to," says Illinois Rep. Elaine Nekritz…

The article breaks down toy standards in a handful of states that have chosen to pursue legislation or regulation stricter than federal requirements. Two notable substances which have become the target of regulation are lead and phthalates, a chemical used to soften plastics which studies have associated with developmental abnormalities.

Because of the differences among state standards, industry lobbyists are now complaining about the multiple requirements toy makers will have to meet. In the article, Carter Keithley, the president of the Toy Industry Association (TIA), the national lobbying arm for toy makers, says, "Having different standards for different states is just going to create complete chaos." The article also reports, "The TIA says it has hired lobbyists to battle legislative proposals in 10 states."

However, regardless of states' efforts, toy makers will find it harder and harder to sell their products to major retailers if those products contain phthalates or more than trace amounts of lead. Toys "R" Us has announced it will enforce a standard for lead in toys sold at its stores that will be stronger than the federal standard. The retailer has also announced it will phase out phthalates in its products by the end of the year. Target Corp. told The Wall Street Journal it will eliminate the use of phthalates in Target brand toys.

The TIA supports bills in both the U.S. House and Senate that would tighten the federal standard for lead and provide more resources for CPSC. TIA does not support standards for phthalates, claiming there is "no solid, scientific evidence that any person has ever been harmed by the presence of phthalates in toys." (Click here for TIA statements.)

Ultimately, getting lead, phthalates, and other harmful substances out of toys will be a great victory for consumers. But we should also take note as to who guided us on that path to victory. Instead of the federal government leading the way, strong action by concerned states and responsible retailers has relegated Congress and CPSC to mere followers.

The White House's interference in EPA's revision to the national standard for ozone, a.k.a. smog, which the agency announced Wednesday, ignores public health and welfare. OIRA Administrator Susan Dudley, with President Bush in her corner, pushed forward with her industry friendly, anti-regulatory ideology in the face of overwhelming scientific evidence and in violation of the law.

Read more

Posted by Matt Madia, 02:51:26 PM

Thursday, March 13, 2008