http://www.nytimes.com/2010/08/25/business/25eggs.html?scp=3&sq=egg%20recall&st=cse

The story notes that whether we are talking about a recall of eggs, peanuts, lettuce or hamburger patties, ”consumer groups say that federal oversight too often falls short.”

One of the problems is that policing food safety is handled by two federal agencies, the Food and Drug Administration and the Agriculture Department, and the way that they divvy out the responsibilities “can seem so illogical that some of the bureaucrats themselves have called for change,” according to The Times.

The egg recall, which followed a salmonella outbreak, offers a case study of the problems. The FDA regulates eggs that are still “in the shells,” while the agriculture department handles liquid eggs used for making food, grades eggs and is responsible for chickens.

The recalled eggs were hatched in Iowa, and the state’s agriculture department monitors what farmers do with the chicken litter that they spread on fields.

But according to The Times, no agency inspected the Iowa farms to check that the eggs were safe for us to eat.

There is a bright note. There are new safety rules for egg production that would likely have prevented the current salmonella outbreak and egg recall. That regulation only became effective last month.

The regulation mandates that egg producers get their chicks and hens from companies that monitor for salmonella; that they set up a system to stop rodents from spreading disease; and that they test their hen houses for salmonella on a regular basis, The Times reported.

And there’s another important point in the story. Consumer groups think that the egg recall and salmonella outbreak may prompt Washington to finally enact a food safety bill that gives the FDA more authority and resources. 

That bill would also give the FDA the power to do what you probably think it can do already: Recall foods. Right now, the FDA doesn’t have the authority to make companies recall potentially dangerous foodstuffs. The FDA can only try to convince food makers to voluntarily recall contaminated food.

The comprehensive food safety bill has been passed by the House but is stuck in the Senate, according to The Times. Let’s hope that it gets some traction after this egg scare.

FDA Commissioner Margaret Hamburg made the rounds of the morning network news shows to warn Americans about eating eggs and to plead for more authority for her agency to safeguard the public.   

http://www.aolnews.com/nation/article/amid-massive-egg-recall-fda-chief-margaret-hamburg-calls-for-more-authority/19603999

Hamburg’s TV appearances came in the wake of the recall of eggs by two major suppliers in the past week, with 380 million recalled by Wright County Egg Aug. 13 and 170 million eggs by Hillandale Farms a week later. The eggs have been linked to about 1,300 salmonella cases since May.

This week Hamburg warned the public not to eat their eggs “runny,” to cook them thoroughly and to keep them refrigerated.

And on “The Today” Show, Hamburg said of the FDA, “We need greater abilities to trace back products to their source.  We neeed better abilities and authorities to put in place these preventive controls and hold companies acccountable.”

AOL News pointed out that it’s been a year since a large peanut butter recall, and yet the FDA’s authority remains limited. The FDA is fairly powerless in this egg recall, for example. It doesn’t have the power to recall eggs, only the egg industry can announce a recall.   

The agency is still trying to track down the source of the salmonella, with this outbreak prompting the biggest egg recall in history. 

http://www.google.com/hostednews/ap/article/ALeqM5imhQxoC38eZsccOCB3oRHh0vjfzgD9HLBLSO0

On Tuesday the FDA made public its review of Eli Lilly’s bid for approval to market Cymbalta for chronic pain, including back pain. But the federal agency seemed wary of widening the use of the drug, which an estimated 15 million people are taking now.

AP reported that Thursday the FDA will ask several outside experts whether they believe Cymbalta should get the go-ahead to treat pain.

Currently Cymbalta has FDA approval to treat depression, fibromyalgia and diabetic nerve pain. But the drug’s side effects, including it’s toxic impact on the liver, are among the reasons why the FDA hasn’t given Cymbalta the go-ahead as a pain killer, acording to AP.

The FDA is also questioning Eli Lilly’s methodology for trials last summer that tested Cymbalta’s use to control pain caused by osteoarthritis.  

Cymbalta is a serotonin-norepinephrine reuptake inhibitor, and researchers don’t exactly undertand how it eases pain. 

the   

http://www.usatoday.com/news/health/2010-08-03-recall03_ST_N.htm

More than three out of four people were confident in the safety of prescription drugs made in the United States, according to a poll released Monday by the Pew Charitable Trust’s Prescription Project. But less than 10 percent were confident in pharmaceuticals made in China or India.    

It’s no wonder that Americans are skittish about pharmaceuticals made outside of the states. In 2007 and 2008, there were what I believe to be hundreds of deaths of those who took contaminated heparin, a tragedy that made national headlines. That deadly blood thinner was made with a tainted active ingredient from China.

But what most Americans don’t know is that about 80 percent of the materials used to manufacture drugs that are sold in the United States are made in other countries, Allan Coukell, a pharmacist for the Pew Health Group, told USA Today.

He stated what many of us know: That the Food and Drug Administration doesn’t have the resources to inspect and keep its eye on drug factories around the globe.

Monday Sen. Michael Bennet, D-Colo., was expected to intoduce a bill that wouild permit the FDA to order recalls of dangerous lots of drugs, USA Today reported.

In Pew’s poll, in which 802 registered voters were questioned, 55 percent said that the government should take more steps to make sure that drugs made in other countries are safe. The survey also found that almost 90 percent of those polled approved of new laws on drug safety.       

http://www.iom.edu/Reports/2010/Enhancing-Food-Safety-The-Role-of-the-Food-and-Drug-Administration/Report-Brief-Enhancing-Food-Safety-The-Role-of-the-Food-and-Drug-Administration.aspx

 The agency’s abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by its limited resources and a piecemeal approach to gathering and using information on risks, the report concludes. 

The report, done by the Institute of Medicine and National Research Council, is a lot to digest.

It says that to more proactively tackle food safety problems, the FDA should implement a risk-based approach in which data and expertise pinpoint where along the production, distribution, and handling chains there is the greatest potential for contamination and other problems, according to a press release issued on the document. 

 http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12892

The agency would then be able to direct appropriate amounts of its resources and attention to those high-risk areas and increase the chances of catching problems before they turn into widespread outbreaks, said the committee that wrote the report.  

The report offers FDA a blueprint for developing a risk-based model, and outlines several organizational steps the agency should take to improve the efficiency of its many food safety activities, such as increasing coordination with state and other federal agencies that share responsibility for protecting the nation’s food supply. 

In addition, the report says Congress should consider amending the Federal Food, Drug, and Cosmetic Act to explicitly provide the authority FDA needs to fulfill its food safety mission.

 ”As recent illnesses traced to produce underscore, foodborne diseases cause significant suffering, so it’s imperative that our food safety system functions effectively at all levels,” committee chair Robert Wallace, professor at the College of Public Health, University of Iowa, Iowa City, said in a press release.

  “FDA uses some risk assessment and management tactics, but the agency’s approach is too often reactive and lacks a systematic focus on prevention,” Wallace said . ”Our report’s recommendations aim to help FDA achieve a comprehensive vision for proactively protecting against threats to the nation’s food supply.”

 The FDA is responsible for ensuring the safety of approximately 80 percent of the nation’s food supply, including seafood, dairy products, and fruits and vegetables.

 Although it is not the sole organization overseeing food safety — the U.S. Department of Agriculture handles meat, poultry, and egg products, and state and local agencies share in conducting food production facility inspections, surveillance, and investigations of outbreaks — recent outbreaks of foodborne illness led to a congressional request for a review of gaps in the FDA’s food safety system. 

The agency has been criticized for not adequately monitoring and inspecting food suppliers and distributors and for not taking a proactive approach to food safety overall, according to the official press release on the report.

 However, given that the FDA is responsible for more than 150,000 food facilities, more than 1 million restaurants and other retail food establishments, and more than 2 million farms, as well as millions of tons of imports, it lacks the resources to sufficiently monitor the entire food supply, the committee noted. 

 A risk-based approach would give the FDA’s food safety officials the strategic vision needed to evaluate and plan for food safety concerns rather than tackling problems on a case-by-case basis, the report says.

 Without good information, agency officials cannot identify where its resources are needed most or determine which policy interventions are most effective.  The FDA has insufficient analytical expertise and infrastructure to gather, manage, and use data effectively.  The agency should identify its data needs and review its policies for sharing data with other agencies and organizations. 

 The federal government should establish a centralized food safety data center outside of the regulatory agencies to collect information and conduct rapid, sophisticated assessments of food safety risks and appropriate policy interventions. 

This center would go a long way toward developing much-needed capacity and would reduce interagency competition for resources, the committee said.  It could also serve as an intermediate step toward consolidating food safety activities within a single agency, which many individuals and organizations have called for. 

 To enhance its efficiency, the FDA should explore alternative approaches to regulating food safety, such as delegating food facility inspections to the states, the report says. And the agency should establish national standards for the intensity and frequency of these facility reviews and help states and local municipalities bring their safety programs up to those standards. 

 Once all programs are standardized, the FDA should train and certify state inspectors with the goal of turning over the majority of inspections to them under the agency’s supervision.  This change would build on current practices in which roughly 60 percent of inspections are already conducted by state inspectors under contract with FDA.  This integration and leveraging of resources would increase the quality of inspections and eliminate duplication of effort, the committee said. 

Despite the dramatic developments in food production and distribution that have occurred over the years, the main statutory provisions under which the FDA carries out its food safety responsibilities remain largely unchanged, the report says. 

Although various provisions give the agency broad discretion and flexibility through which it has been able to control potential problems, there are instances in which the FDA lacks specific authority, which can make its actions vulnerable to court challenge, the report says.

 Congress should examine how the legislation could be revised to detail FDA’s authorities in facility registration, preventive controls, risk-based inspection, mandatory recall, reporting of adulteration, and banning of food imports if the public’s health is at risk, among other areas, according to the report.

Congress requested the report on the FDA. 

The House Energy and Commerce Committee Republicans put out a press release about the heparin matter last Friday. http://republicans.energycommerce.house.gov/news/PRArticle.aspx?NewsID=7832

And that press release includes a link to a copy of the letter.

U.S. Reps. Joe Barton, R-Texas, ranking member on the House Energy and Commerce Committee, and Michael Burgess, R-Texas, ranking member of the panel’s Oversight and Investigations subcommittee, didn’t mince words with FDA Commissioner Dr. Margaret Hamburg.

The headline on their press release alone was “Barton, Burgess Reveal FDA Missteps in Unsolved Heparin Whodunnit.”

Then in their 10-page letter, the two lawmakers detailed what their investigation into the heparin tragedy has discovered, basically accusing the FDA of dropping the ball when it didn’t follow up on leads linking Chongqing Imperial and other Chinese drug suppliers to lots of contaminated heparin identified during the 2008 recalls.

“We are very troubled by how FDA has handled the investigation to find out who was responsible for the contaminated heparin,” wrote Barton and Burgess. “The staff has learned that FDA has specific and credible information about certain Chinese heparin firms that warrants further investigation as suspect entities responsible for contaminating the heparin supply.”

Barton, an ardent watchdog on the heparin issue, and Burgess asked Hamburg to provide details about the agency’s strategy regarding the unresolved investigation. And they want to know the FDA plans to do when it identifies manufacturers responsible for producing the contaminated blood thinner.

“Unfortunately, the case of who contaminated the heparin remains unsolved,” the letters says of the tainted blood thinner that killed in 2008, resulting in hundreds of lawsuits.

Barton and Burgess want answers to seven questions from Hamburg by the end of May.

Those questions include:

1.    What is FDA’s strategy for solving the question of who caused the contamination of the heparin supply? Please detail the strategy and when it was developed, the names and positions of the FDA officials who developed the strategy, and the names and positions of the FDA officials responsible for implementing the strategy.

2.    To what extent can FDA conduct a traceability investigation of various heparin supply chains in China on its own without the assistance of the Chinese government?

3.    Assuming FDA could solve the case on its own, what would FDA do with this information?

4.    What actions is FDA taking to follow up on the Chongqing Imperial issues raised in this letter?

5.    Does the FDA agree there is a basis to make another request to the Chinese government about the heparin contamination investigation? If not, why not?

6.    Is the FDA willing to cooperate and even share information with the Chinese government in an effort to solve the heparin contamination case? Would FDA be able to do this under current law and under the current agreement with the SFDA (State Food and Drug Administration)? If not, why not?

7.    Does FDA agree that the contamination of the heparin supply is an international issue? If so, why hasn’t the FDA sought international support from the World Health Organization and/or other countries to get more transparency and cooperation from the Chinese government, or to provide assistance to the Chinese government, in the heparin contamination-source investigation?

 It looks like Hamburg has her work cut out for her in the next few weeks.

The correct dosing of heparin has always been highly individualized and requires intense monitoring, which is a protocol that will remain in effect, officials said.

“The use of heparin is closely tied into monitoring and doses adjusted based on that,” said Dr. Dwaine Rieves, director of CDER’s Division of Medical Imaging and Hematology Products. “That procedure will not change.”