U.S. Food and Drug Administration

From SourceWatch

The U.S. Food and Drug Administration (FDA) is the government agency responsible for the regulation of food and drugs manufactured and sold in the U.S.

Contents 1 "Food safety czar" 2 Animal testing 2.1 Government funded vivisection 2.2 FDA testing requirements 2.3 Food, Drug & Cosmetic Act 3 Agriculture, meat & dairy issues 3.1 Waste products fed to farm animals 3.2 Hormones 3.3 Bovine growth hormones (rBGH) 3.4 EU ban on hormones & imports from U.S./Canada 4 Soy foods health labeling 5 Leadership 5.1 Former FDA Chief pleads guilty in stock case 6 FDA partnerships with industry 6.1 Lobbying 6.2 Funding fees from pharmaceutical industry 7 Articles & resources 7.1 SourceWatch articles 7.2 References 7.3 External articles

"Food safety czar"

On May 1, 2007, Dr. David W.K. Acheson, a "former University of Maryland medical school professor who had been chief medical officer at the Food and Drug Administration's food safety center," was appointed by President George W. Bush to the new position of "food safety czar". Acheson was directed "to develop a plan for addressing shortcomings exposed by recent scares in the human food supply." [1]

"The appointment came just before the House Oversight and Government Reform Committee held a hearing on the challenges facing the FDA, including protecting the food supply, that was attended by three former agency commissioners.

"Dr. David A. Kessler, FDA commissioner under former Presidents George Bush and Bill Clinton, called the food safety system 'broken' and said the FDA needs to restore research and other efforts to prevent foodborne illness." [2]

Animal testing

Government funded vivisection

U.S. agencies that fund animal testing includes the FDA.

Government funded vivisection spends billions of dollars every year and kills millions of animals in an essentially unregulated industry. Hundreds of institutions and thousands of individuals profit off vivisection. Furthermore, the government pays for the same experiments to be done over and over. In the fiscal year ending in 2005, seven government agencies funded over 28,937 projects for experiments on 27 species, including: monkeys, dogs, cats and rodents. These included: 1200 separate projects (at up to $495,600,000) examining drug addiction. 778 projects studying "neural information processing" in 11 species racked up approximately $321,314,000. No experiment, however ridiculous, useless or painful; is illegal. The majority of animals used in experimentation receive absolutely no protection under current laws. Government funded animal testing costs U.S. taxpayers over $12 billion annually. ^[1] See also U.S. Government's War on Animals, section 5.

FDA testing requirements

The FDA requires massive amounts of animal testing for the marketing of industrial chemicals, vaccines, and drugs. For example, companies marketing fluoride products swab the teeth of 200 rats with the test substance for two weeks. The animals are subsequently killed and their heads baked in an oven for an hour. ^[2] The FDA is responsible for ensuring the safety, effectiveness, and quality of pharmaceuticals, biologicals, and medical devices intended for human use. Also the safety, efficacy and quality of pharmaceuticals for animals, food, cosmetics and radiation emitting products. Thousands of rats, mice, rabbits, dogs, and primates are killed in "pre-clinical" tests to for new drugs (including all ingredients and even minor differences in formulas). Following an extensive battery of animal testing, drugs generally undergo three phases of clinical trials. The fact that months or years of human studies are also required suggests health authorities do not trust the results. ^[3] The FDA recently reported that 92 out of every 100 drugs that successfully pass animal trials subsequently fail human trials.^[4], ^[5] See also U.S. Government's War on Animals, section 6 & animal testing, section 3 on product testing.

Food, Drug & Cosmetic Act

The Federal Food, Drug, and Cosmetic Act (FD&C Act) ^[6] does not specifically require the use of animals in testing cosmetics for safety, nor subject cosmetics to FDA premarket approval. ^[7] For current lists of U.S., Canadian and international companies which do not test on animals, visit the Coalition for Consumer Information on Cosmetics. ^[8]

Agriculture, meat & dairy issues

Waste products fed to farm animals

The FDA finally banned the practice of feeding cow meat and bone meal back to cows in 1997 (after the Mad cow disease epidemic in Great Britain). However, dried poultry waste and sewage sludge are routinely fed to cattle. Pigs and chickens are still routinely fed the bones, brains, meat scraps, feathers, and feces of their own species. Furthermore, tens of millions of shelter animals are also picked up by rendering plants. Thus commercial meat, dairy, and egg products often come from animals whose diet included the ground up remains of cats and dogs, including the euthanasia drugs injected into their bodies. ^[9] 40 billion pounds a year of slaughterhouse wastes (blood, bone, viscera) and euthanized cats and dogs from veterinarians and animal shelters, are rendered annually into livestock feed. ^[10] Moreover, the FDA has been using inaccurate, incomplete, and unreliable data to track and oversee feed ban compliance. ^[11], ^[12] See also U.S. Department of Agriculture, section 9.

Hormones

Over 90% of beef cattle in the U.S. receive hormones and in larger feedlots the figure is 100%, according to the National Cattlemen's Beef Association (NCBA). ^[13]

Bovine growth hormones (rBGH)

The FDA approved the use of recombinant bovine growth hormone (rbGH) being injected into cows on February 4th, 1994. Both Europe and Canada turned down Monsanto's application for approval. Developed and manufactured by the Monsanto, this genetically engineered hormone forces cows to artificially increase milk production by 10 to 15%. ^[14] Monsanto spent approximately half a billion dollars on a hormone to increase milk production (for an already glutted, taxpayer-subsidized market). Additionally, Posilac creates additional Growth Factor One (IGF-1) in milk (a growth hormone which is identical in cows and humans). IGF-1 is considered to be a fuel cell for cancer growth and has been identified in the rapid growth cancer. The FDA insists that IGF-1 is destroyed in the stomach. ^[15] However, if that were true, the FDA has proven that breast feeding cannot work. ^[16] It is worth noting that rBGH is banned in every industrialized country in the world except for the U.S., Mexico and Brazil. According to Dr. Michael Hanson of the Consumers Union of the U.S., there is strong scientific evidence to support potential health hazards of rBGH and a case for labeling dairy products that contain rBGH. ^[17]

The need for such for an increase in milk production has been questioned since the dairy industry has been overproducing for 60 years. Between 1986 and 1987, under the Dairy Termination Program, dairy farmers were paid over 1.3 billion dollars to slaughter their cows. 144 dairy producers received over one million apiece to refrain from dairy farming for five years and one California producer received 20 million dollars. However, according to the General Accounting Office (GAO); "Total milk production did not decrease because nonparticipating farmers increased their production". ^[18] Additionally, cows injected with rBGH also have a 25% increase in udder infections and a 50% increase in lameness. ^[19] In August 2008, Monsanto sold their Posilac division to Eli Lilly ^[20] See also meat & dairy industry, section 4.

EU ban on hormones & imports from U.S./Canada

Since 1995, the European Union (EU) has prohibited the treatment of any farm animals with sex hormones, which includes a ban on hormone treated meat from the U.S. and Canada. ^[21] See also European Union, section 9.

Soy foods health labeling

According to the FDA website, Crawford was acting Commissioner credited with the biggest boom in soy history due to the 1999 FDA approval of health claim for soy and heart health which resulted in over 1600 new foods with soy ingredients, averaging 400 new products per year. During Crawford-Henney 1999 tenure the FDA approved the use of heart health claims for soy and soya foods. Since 85% of the soy grown in the US, is geneticaly modified -GMO variety, the dramatic increase in the consumption of soy, or soya as the GMO varieties must be labeled in the EU, was welcomed by Monsanto, Dow, DuPont and the big seed suppliers. The impact Henney's approval is noted on the website for Soyfoods Association of North America(SANA). It says, "Dramatic growth in soy sales are due to the 1999 FDA approval of health claim for soy and heart health which resulted in over 1600 new foods with soy ingredients, averaging 400 new products per year. From 2001 to 2004, food manufacturers in the US introduced over 1600 new foods with soy as an ingredient, averaging 400 new products per year. leading to 460 new products in 2001, 321 in 2002, 386 in 2003, and 443 in 2004, according to the Mintel’s Global New Products Database.

From 1992 to 2003, soyfoods sales have experienced a 15% compound annual growth rate, increasing from $300 million to $3.9 billion over 11 years, as new soyfood categories have been introduced, soyfoods have been repositioned in the market place, and new customers have selected soy for health and philosophical reasons. Dramatic growth followed the FDA approval of a health claim linking soy with heart disease reduction." The United Soybean Board(USB) and American Soy Association(ASA), as lobbyists for the soybean industry, expressed deep thanks to the FDA and the USDA for helping to weaken the EU bans on the Frankenfood soy. ASA credited these moves "that allowed the United States to win the WTO case against the EU moratorium on the approval of new biotech-enhanced crops."

Leadership

Jane Henney served as Commissioner of the FDA from December 1998 until the newly-inaugurated President Bush asked for her resignation in January 2001. ^[22] Dr. Henney has been a Director of CIGNA Corporation since 2004. Her current term expires in April 2007. She has been Sr. Vice President of Health Affairs at the University of Cincinnati Medical Center since July 2003 and was a Sr. Scholar at the Association of Academic Health Centers from 2001 until June 2003. Dr. Henney was Director of AmerisourceBergen and AstraZeneca, PLC. She is a member of CIGNA's Audit Committee and Corporate Governance Committee.

The chief position at the FDA remained vacant until the confirmation of Mark McClellan in November 2002. McClellan left the FDA in March 2004 to head the Centers for Medicare and Medicaid Services. President Bush then appointed FDA acting commissioner and longtime deputy commissioner Lester Crawfordin February of 2005. ^[23] Crawford was confirmed in July of 2005. After Dr. Crawford's abrubt resignation on September 26, 2005; Andrew von Eschenbach was appointed as acting commissioner. ^[24] von Eschenbach was nominated in March 2006 and confirmed as the FDA Commissioner in December 2006.

Former FDA Chief pleads guilty in stock case

In October of 2006, Lester Crawford pleaded guilty to conflicts of interest and false reporting of stocks he owned in companies he was in charge of regulating. Dr. Crawford had "abruptly resigned" in September of 2005 after admitting to filing false financial reports. Beginning in 2002, Crawford filed seven false reports with a government ethics office and Congress. As deputy, then commissioner and later commissioner of the FDA, Crawford oversaw product regulations accounting for approximately 25 cents of every dollar spent by U.S. consumers. Crawford earned nearly $42,000 in dividends from illegally held shares while at FDA. Nearly $29,000 came from FDA regulated Embrex Inc., where he was the director. He and Mrs. Crawford also owned between $188,000 and $336,000 in shares for Pepsico, Sysco, Kimberly-Clark and Wal-Mart; all of which are "significantly regulated" by the FDA. Since January of 2006, Lester Crawford has worked as a Sr. Counsel for Policy Directions Inc. ^[25]

FDA partnerships with industry

Lobbying

Policy Directions Inc. is a Washington, DC based public relations and lobbying firm for the animal testing, animal breeding, pharmaceutical, agribusiness and processed food industries, as well as universities and institutions receiving government grants for animal research. ^[26], ^[27] Incredibly, Dr. Crawford's firm, is in the business of writing legislation for government regulatory agencies, among other things. Their list of accomplishments includes:

• "Industry coalition draft of legislative authority for a regulatory agency" whose language was "included in the final bill."
• Leading a "coalition" of universities, research institutions, pharmaceutical and biotechnology companies to lobby Congress against "costly and ineffective rule making."
• Leading a "broad industry coalition" to stop several "negative amendments to agriculture/FDA appropriations bills".
• Worked with legislators in supporting and drafting the "Best Pharmaceuticals for Children Act."
• Achieved FDA support for a product that had originally been voted down.
• Interceded on behalf of a client when the FDA final approval. ..Our client's product was approved in a timely manner.
• Successfully lobbied Congress to secure a 20 million dollar, four year pilot program for our client's product.
• Secured a 10% increase in funding and "administrative flexibility" to ensure our agency approval of our client's products.
• Secured language in pending legislation that assured our client's would benefit from government-funded alternative fuels.
• Secured funds for nutrition and medical research programs.
• Creating a coalition of six leading biotechnology firms to promote advantageous legislation and meeting with agency officials to prevent "onerous rule making."
• Drafting an Op-ed on a "controversial research issue" which was printed in a regional paper. ^[28]

Funding fees from pharmaceutical industry

Regulators don't negotiate their budgets with industries they oversea, with the exception of the FDA. In the early 1990s, the pharmaceutical industry began paying the FDA millions of dollars in user fees in order to speed up the drug approval process. These fees "now fund more than half the agency's critical drug-review process." Industry groups and the FDA renegotiate the fees and how they're used every five years, giving drug makers "considerable input into which programs receive funding." In 2006 the FDA negotiated an agreement with the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization. Industry groups pushed for even faster decisions on labeling and other "conditions" of new drugs and the FDA negotiated more funding to monitor drug safety following approval. ^[29]

Articles & resources

SourceWatch articles

• Animal testing
• Bush administration cronyism and incompetence
• Direct-to-consumer advertising
• Drug companies and clincial trials
• Lester Crawford
• Pharmaceutical industry
• Pharmaceutical Research and Manufacturers of America
• Policy Directions Inc.
• processed food industry
• Meat & Dairy industry
• Mad cow disease
• Stalling Cheap Generic Drugs With Citizen Petitions
• U.S. Department of Agriculture
• U.S. Government's War on Animals
• War on Animals

References

External articles

• Gardiner Harris, "At F.D.A., Strong Drug Ties and Less Monitoring", New York Times, December 6, 2004.
• M. Asif Ismail, "FDA: A Shell of its Former Self: The Food and Drug Administration lacks the power to regulate pharmaceuticals and keep you safe", Center for Public Integrity, July 7, 2005.
• "New FDA Appointee. FDA Announces Yet Another Acting Director To the Office of Women's Health," Planned Parenthood, September 16, 2005.
• Marc Kaufman, "FDA Rethinks Women's Chief. Toigo Is Acting Head; Agency Denies Naming Veterinary Official", Washington Post, September 20, 2005.
• Laura Donnelly, "FDA Shenanigans," Tom Paine.Common Sense, September 20, 2005.
• Nico, "Google Cache Thwarts Bush Spin Machine," Think Progress, September 20, 2005.
• Laura Donnelly, "Good News From Crawford," Tom Paine.Common Sense, September 26, 2005.
• Anna Wilde Mathews, "An FDA Reviewer Battles the Drug His Boss Approved: Private Letter Gets Dr. Misbin Pulled From Diabetes Case But He Pursues It Anyway: 'I Get to Count the Bodies'", Wall Street Journal, October 26, 2005; Page A1. (Sub req'd)
• Beth Herskovits, "FDA seeking contractor to focus on effectiveness of promotions", PR Week, January 5, 2006. (Sub req'd).
• Brian Tokar, et al., BRIEFING REPORT: Deficiencies in Federal Regulatory Oversight of Genetically Engineered Crops, Institute for Social Ecology, June 2006.
• Ricardo Alonso-Zaldivar, "FDA Enforcement Actions Fall, Yet Violation Reports Haven't: Warning letters dip 54%, says Rep. Waxman. But the agency disputes the relevance of his count.", Los Angeles Times, June 27, 2006.
• Andrew Bridges, "Lawmaker Alleges FDA, Merck Collaborated", Newsday, July 19, 2006. (This is an Associated Press story).
• Jonathan D. Rockoff, "Criticism of FDA resurfaces in survey of agency scientists: A third of respondents say public health is not adequately protected", Baltimore Sun, July 21, 2006.
• Anna Wilde Mathews, "Drug Firms Use Financial Clout To Push Industry Agenda at FDA," Wall Street Journal (sub req'd), September 1, 2006.
• Avram Goldstein, "FDA Stent Experts Have Financial Ties to J&J, Boston Scientific," Bloomberg, December 4, 2006.
• "FDA Expected to Rule on Cloned Food This Week," ABC News, December 27, 2006.
• Marcia Angell, "Taking back the FDA", Boston Globe, February 26, 2007.
• "New produce-safety rules called 'unenforceable'. FDA issues totally voluntary guidelines to avert food poisoning," Associated Press (MSNBC), March 12, 2007.
• Jonathan D. Rockoff, "'Food safety czar' named. Ex-UM medical school professor to probe faults in supply network," Baltimore Sun, May 2, 2007.
• Julie M. Donohue, Ph.D., Marisa Cevasco, B.A., and Meredith B. Rosenthal, Ph.D., "A Decade of Direct-to-Consumer Advertising of Prescription Drugs," New England Journal of Medicine, Volume 357:673-681, Number 7, August 16, 2007.
• "Drug Trade Group Spent $10.7M Lobbying", Associated Press, August 17, 2007.
• Matthew Perrone, "FDA to Study Images' Impact in Drug Ads," Associated Press, August 21, 2007.
• "FDA to Look Into Claim of Toxic Lipstick," Associated Press, October 13, 2007.
• Robert Cohen Genetic Engineering: Paying The Price With Increased Cancer Deaths, The Notmilkman.com, accessed January 2009
• Makers of US feed fail to heed rules on mad cow disease, FDA warns livestock feed makers, Madcow.org, accessed Sept 2009.