Criticism of the Food and Drug Administration
Encyclopedia
Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration of either over- or under- regulation
. The U.S. Food and Drug Administration
(FDA) is an agency of the United States Department of Health and Human Services
and is responsible for the safety regulation of most types of food
s, dietary supplement
s, drug
s, vaccine
s, biological medical products
, blood products
, medical device
s, radiation
-emitting devices, veterinary products, and cosmetics
. The FDA also enforces section 361 of the Public Health Service Act
and the associated regulations, including sanitation
requirements on interstate travel as well as specific rules for control of disease on products ranging from animals sold as pets to donations of human blood and tissue.
A $1.8 million 2006 Institute of Medicine
report on pharmaceutical regulation in the U.S. found major deficiencies in the FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.
has claimed that the regulatory process is inherently biased against approval of some worthy drugs, because the adverse effects of wrongfully banning a useful drug are undetectable, while the consequences of mistakenly approving a harmful drug are highly publicised and that therefore the FDA will take the action that will result in the least public condemnation of the FDA regardless of the health consequences.
Friedman has also argued that delays in the approval process have cost lives. Prior to passage of the Kefauver Harris Amendment
in 1962, the average time from the filing of an investigational new drug application (IND) to approval was 7 months. By 1998, it took an average of 7.3 years from the date of filing to approval. Prior to the 1990s, the mean time for new drug approvals was shorter in Europe than in the United States, although that difference has since disappeared.
Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the late 1980s, ACT-UP and other HIV
activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infection
s, and staged large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in nearly 180 arrests. In August 1990, Louis Lasagna
, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer
and AIDS
. Partly in response to these criticisms, the FDA introduced expedited approval of drugs for life-threatening diseases and expanded pre-approval access to drugs for patients with limited treatment options. All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT
, in 1985, and approval was granted 2 years later, in 1987. Three of the first 5 HIV medications were approved in the United States before they were approved in any other country.
, using a different methodology, estimated the average cost for development to be under $200 million, about 29% of which is spent on FDA-required clinical trial
s. DiMasi rejects the claim that high R&D costs alone are responsible for high drug prices. Instead, in a published letter, DiMasi writes, "...longer development times increase R&D costs and shorten the period during which drug companies can earn the returns they need to make investment financially viable. Other things being equal, longer development times reduce innovation incentives. As a consequence, fewer new therapies might be developed."
Nobel prize
-winning economist Gary S. Becker has argued that FDA-required clinical trials for new drugs do contribute to high drug prices for consumers, mainly because of patent protection that provides a temporary monopoly which disallows cheaper alternatives from entering into the market. He advocates dropping many FDA requirements, many of which provide no additional safety or valuable information, as this would hasten the development of new drugs, because they would be faster to bring to market, thereby increasing supply, and as a consequence would lead to lower prices. In 2011, the experience with Makena showed that a previously inexpensive drug could increase in price dramatically, from about $10 to $1,500 after the FDA regulated its marketing, approved it as orphan drug
, and granted it a temporary monopoly status, although it had been on the market for five decades. After criticism, the FDA indicated that previous providers could continue to provide the medication, and Makena's price was reduced.
manufacturers from making unsupported claims of effectiveness on the labels of their products. Manufacturers of supplements, which are considered foods for regulatory purposes, are allowed to make only limited "structure/function claims" and are prohibited from claiming that the supplement can prevent, cure, or mitigate a disease or condition unless the supplement undergoes actual testing of its safety and efficacy. Such unsupported claims of effectiveness are considered false advertising
.
One critic, Representative Ron Paul
(R
-TX
), introduced a bill on November 10, 2005 titled the "Health Freedom Protection Act" (H.R. 4284), which proposes to stop "the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements, and adopts the federal court’s suggested use of disclaimers as an alternative to censorship."
A $1.8 million 2006 Institute of Medicine
report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.
introduced a heat-treated version of Factor VIII
concentrate in the US, designed to eliminate the risk of HIV
transmission. However, Cutter continued to market the untreated product overseas, potentially spreading HIV while the safer product was marketed in the US.
Cutter initially had a voluntary agreement with the FDA to stop marketing the untreated product. However, when it became clear that Cutter was not complying with the agreement, the FDA ordered the company to cease marketing untreated blood products, stating: "It was unacceptable for them to ship that material overseas." At the same time, the FDA, according to Cutter's internal documents, asked that the issue be "quietly solved without alerting the Congress, the medical community and the public", leading to charges that the FDA was complicit in covering up Cutter's actions.
) and Vioxx (rofecoxib) are high-profile examples of drugs approved by the FDA which were later withdrawn from the market for posing unacceptable risks to patients.
Troglitazone
is a diabetes drug that was also available abroad at the time the FDA approved it. Post-marketing safety data indicated that the drug had dangerous side-effects (in this case liver failure
). The drug was pulled off that market in the UK in 1997, but was not withdrawn by the FDA until 2000, before which time it is claimed that thousands of Americans were injured or killed by the drug.
In the case of Vioxx, a pre-approval study indicated that a group taking the drug had four times the risk of heart attacks when compared to another group of patients taking another anti-inflammatory, naproxen
. The FDA approval board accepted the manufacturer's argument that this was due to a previously unknown cardioprotective effect of naproxen, rather than a risk of Vioxx, and the drug was approved. In 2005, the results of a randomized, placebo-controlled study showed that Vioxx users suffered a higher rate of heart attacks and other cardiovascular disorders than patients taking no medication at all. Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market in 2004. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition.
David Graham, a scientist in the Office of Drug Safety within the CDER, testified to Congress that he was pressured by his supervisors not to warn the public about dangers of drugs like Vioxx. He argued that an inherent conflict of interest exists when the office responsible for post-approval monitoring of drug safety is controlled by the same organization which initially approved those same drugs as safe and effective. In a 2006 survey sponsored by the Union of Concerned Scientists, almost one-fifth of FDA scientists said they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."
The FDA has been criticised for allowing the use of recombinant bovine growth hormone
(rBGH) in dairy cows. rBGH-treated cows secrete higher levels of insulin-like growth factor 1
(IGF-1) in their milk than do untreated cows. IGF-1 signalling is thought to play a role in sustaining the growth of some tumors, although there is little or no evidence that exogenously absorbed IGF could promote tumor growth. The FDA approved rBGH for use in dairy cows in 1993, after concluding that humans drinking such milk were unlikely to absorb biologically significant quantities of bovine IGF-1. A 1999 report of the European Commission Scientific Committee on Veterinary Measures relating to Public Health noted that scientific questions persist regarding the theoretical health risks of milk from rBGH-treated cows, particularly for feeding to infants. Since 1993, all EU countries have maintained a ban on rBGH use in dairy cattle.
The FDA has also been criticised for permitting the routine use of antibiotic
s in healthy domestic animals to promote their growth, a practice which allegedly contributes to the evolution
of antibiotic-resistant strains of bacteria.
The FDA has taken recent steps to limit the use of antibiotics in farm animals. In September 2005, the FDA withdrew approval for the use of the fluoroquinolone antibiotic enrofloxacin
(trade name Baytril) in poultry, out of concern that this practice could promote bacterial resistance to important human antibiotics such as ciprofloxacin
.
The FDA has received criticism for its approval of certain coal tar derived food dyes such as FDC yellow 5
and 6
, which are banned in most European countries. On September 6, 2007, the British Food Standards Agency
revised advice on certain artificial food additives, including tartrazine.
Professor Jim Stevenson from Southampton University, and author of the report, said: "This has been a major study investigating an important area of research. The results suggest that consumption of certain mixtures of artificial food colours and sodium benzoate preservative are associated with increases in hyperactive behaviour in children.
The following additives were tested in the research:
On April 10, 2008, the Food Standards Agency called for a voluntary removal of the colors (but not sodium benzoate) by 2009. In addition, it recommended that there should be action to phase them out in food and drink in the European Union (EU) over a specified period.
UK ministers have agreed that the six colorings will be phased out by 2009. A Japanese group found in 1987 that tartrazine was not carcinogenic after being fed to mice for two years.
A German group found in 1989 that Sunset Yellow did not induce mutations that could lead to cancer in laboratory animals.
The FDA has also been criticized for giving permission for cloned animals
to be sold as food without any special labelling, although "cloned products may not reach the U.S. market for years." "Authorities lack the authority to require labeling of products from cloned animals."
The journal Nature
reported in 2005 that 70% of FDA panels writing clinical guidelines on prescription drug usage contained at least one member with financial links to drug companies whose products were covered by those guidelines. In the most egregious instance, every member of a panel which recommended the use of epoeitin alfa in HIV patients had received money from a manufacturer of that drug. On March 21, 2007 the FDA announced new guidelines disqualifying experts from serving on advisory committees if they had received financial compensation from a drug company potentially affected by the committee's recommendations.
The FDA has been criticized regarding delayed approval of foreign drugs to protect the US pharmaceutical companies from foreign competition. Eli Lilly and Company
's drug fluoxetine
(Prozac) was the first serotonin-specific reuptake inhibitor to be approved by the FDA. Kali-Duphar, the Dutch manufacturer of another antidepressant fluvoxamine
(Luvox), had first attempted to apply for FDA review in the early 1980s (much earlier than Eli Lilly) but fluvoxamine was not approved until the rights were bought by the US pharmaceutical company Reid Rowell
. Critics have suggested that the FDA was attempting to protect Eli Lilly's fluoxetine so it could gain a foothold in the US market before approving fluvoxamine.
Similarly, some critics argue that the FDA delayed the approval of Meroxyl (terephthalylidene dicamphor sulfonic acid), the most effective UV protectant (particularly against UV A) in clinical use to allow for US companies to develop competing products. Meroxyl has been available in Europe since 1991 but it only was approved in 2006 by the FDA and this delay allowed for Neutrogena to release helioplex which is a competitor for meroxyl. Helioplex differs from meroxyl in that it prevents the breakdown of avobenzone enhancing its UV protection.
, have policies in accordance with FDA guidelines that prohibit accepting blood donations from any "male who has had sex with another male since 1977, even once". The inclusion of homo- and bisexual men on the prohibited list has created some controversy, but the FDA and Red Cross cite the need to protect blood recipients from HIV as justification for the continued ban. Even with PCR-based testing of blood products, a "window period
" may still exist in which an HIV-positive unit of blood would test negative. All potential donors from HIV high risk groups are deferred for this reason, including men who have sex with men. The issue has been periodically revisited by the Blood Products Advisory Committee within the FDA Center for Biologics Evaluation and Research, and was last reconfirmed on May 24, 2007. Documentation from these meetings is available.
However, in 2006, the AABB, America's Blood Centers and American Red Cross recommended to the FDA that the deferral period for men who had sex with other men should be changed to be equivalent with the deferral period for heterosexual's judged to be at risk. The FDA chose to uphold the blood ban. Female sexual partners of MSM
(men who have sex with men) are deferred for one year since the last exposure. This is the same policy used for any sexual partner of someone in a high risk group. The intent of these policies is to ensure that blood is collected from a population that is at low risk for disease, since the tests are not perfect and human error may lead to infected units not being properly discarded. The policy was first put in place in 1985.
plant had no medical value and should not be accepted as a medicine, despite a great deal of research suggesting the opposite. The supporters of medical cannabis
legalization criticized the FDA's statement as a politically motivated one instead of one based on solid science. A group of congressmen led by Maurice Hinchey
wrote a letter to FDA's commissioner Andrew von Eschenbach
, expressing their disapproval of the FDA's statement and pointed out the FDA's rejection of medical cannabis was inconsistent with the findings of the Institute of Medicine
, which stated cannabis does have medical benefits. While the FDA has not approved marijuana it has approved THC (a compound found in cannabis) as an active ingredient for medicinal use. Critics argue that this approval is a politically motivated attempt to allow special interest groups to have patents over the substance, perhaps because the patents on previously patented competing substances have expired.
- February 2010 issue of Mercatus On Policy
Regulation
Regulation is administrative legislation that constitutes or constrains rights and allocates responsibilities. It can be distinguished from primary legislation on the one hand and judge-made law on the other...
. The U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) is an agency of the United States Department of Health and Human Services
United States Department of Health and Human Services
The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...
and is responsible for the safety regulation of most types of food
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...
s, dietary supplement
Dietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
s, drug
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
s, vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
s, biological medical products
Biopharmaceutical
Biopharmaceuticals are medical drugs produced using biotechnology. They include proteins , nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic...
, blood products
Blood transfusion
Blood transfusion is the process of receiving blood products into one's circulation intravenously. Transfusions are used in a variety of medical conditions to replace lost components of the blood...
, medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
s, radiation
Electromagnetic radiation
Electromagnetic radiation is a form of energy that exhibits wave-like behavior as it travels through space...
-emitting devices, veterinary products, and cosmetics
Cosmetics
Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...
. The FDA also enforces section 361 of the Public Health Service Act
Public Health Service Act
The Public Health Service Act is a United States federal law enacted in 1944. The full act is captured under Title 42 of the United States Code "The Public Health and Welfare", Chapter 6A "Public Health Service"....
and the associated regulations, including sanitation
Sanitation
Sanitation is the hygienic means of promoting health through prevention of human contact with the hazards of wastes. Hazards can be either physical, microbiological, biological or chemical agents of disease. Wastes that can cause health problems are human and animal feces, solid wastes, domestic...
requirements on interstate travel as well as specific rules for control of disease on products ranging from animals sold as pets to donations of human blood and tissue.
A $1.8 million 2006 Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
report on pharmaceutical regulation in the U.S. found major deficiencies in the FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.
Charges of over-regulation
A group of critics claim that the FDA possesses excessive regulatory authority.Alleged problems in the drug approval process
The economist Milton FriedmanMilton Friedman
Milton Friedman was an American economist, statistician, academic, and author who taught at the University of Chicago for more than three decades...
has claimed that the regulatory process is inherently biased against approval of some worthy drugs, because the adverse effects of wrongfully banning a useful drug are undetectable, while the consequences of mistakenly approving a harmful drug are highly publicised and that therefore the FDA will take the action that will result in the least public condemnation of the FDA regardless of the health consequences.
Friedman has also argued that delays in the approval process have cost lives. Prior to passage of the Kefauver Harris Amendment
Kefauver Harris Amendment
The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval...
in 1962, the average time from the filing of an investigational new drug application (IND) to approval was 7 months. By 1998, it took an average of 7.3 years from the date of filing to approval. Prior to the 1990s, the mean time for new drug approvals was shorter in Europe than in the United States, although that difference has since disappeared.
Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the late 1980s, ACT-UP and other HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infection
Opportunistic infection
An opportunistic infection is an infection caused by pathogens, particularly opportunistic pathogens—those that take advantage of certain situations—such as bacterial, viral, fungal or protozoan infections that usually do not cause disease in a healthy host, one with a healthy immune system...
s, and staged large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in nearly 180 arrests. In August 1990, Louis Lasagna
Louis Lasagna
Louis Lasagna was an American physician and professor of medicine, known for his revision of the Hippocratic Oath.-Early life and education:...
, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
and AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
. Partly in response to these criticisms, the FDA introduced expedited approval of drugs for life-threatening diseases and expanded pre-approval access to drugs for patients with limited treatment options. All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT
Zidovudine
Zidovudine or azidothymidine is a nucleoside analog reverse-transcriptase inhibitor , a type of antiretroviral drug used for the treatment of HIV/AIDS. It is an analog of thymidine....
, in 1985, and approval was granted 2 years later, in 1987. Three of the first 5 HIV medications were approved in the United States before they were approved in any other country.
Allegations that FDA regulation causes higher drug prices
Studies published in 2003 by Joseph DiMasi and colleagues estimated an average cost of approximately $800 million to bring a new drug to market, while a 2006 study estimated the cost to be anywhere from $500 million to $2 billion. The consumer advocacy group Public CitizenPublic Citizen
Public Citizen is a non-profit, consumer rights advocacy group based in Washington, D.C., United States, with a branch in Austin, Texas. Public Citizen was founded by Ralph Nader in 1971, headed for 26 years by Joan Claybrook, and is now headed by Robert Weissman.-Lobbying Efforts:Public Citizen...
, using a different methodology, estimated the average cost for development to be under $200 million, about 29% of which is spent on FDA-required clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s. DiMasi rejects the claim that high R&D costs alone are responsible for high drug prices. Instead, in a published letter, DiMasi writes, "...longer development times increase R&D costs and shorten the period during which drug companies can earn the returns they need to make investment financially viable. Other things being equal, longer development times reduce innovation incentives. As a consequence, fewer new therapies might be developed."
Nobel prize
Nobel Prize
The Nobel Prizes are annual international awards bestowed by Scandinavian committees in recognition of cultural and scientific advances. The will of the Swedish chemist Alfred Nobel, the inventor of dynamite, established the prizes in 1895...
-winning economist Gary S. Becker has argued that FDA-required clinical trials for new drugs do contribute to high drug prices for consumers, mainly because of patent protection that provides a temporary monopoly which disallows cheaper alternatives from entering into the market. He advocates dropping many FDA requirements, many of which provide no additional safety or valuable information, as this would hasten the development of new drugs, because they would be faster to bring to market, thereby increasing supply, and as a consequence would lead to lower prices. In 2011, the experience with Makena showed that a previously inexpensive drug could increase in price dramatically, from about $10 to $1,500 after the FDA regulated its marketing, approved it as orphan drug
Orphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease...
, and granted it a temporary monopoly status, although it had been on the market for five decades. After criticism, the FDA indicated that previous providers could continue to provide the medication, and Makena's price was reduced.
Allegations of censorship in food and drug labeling
The FDA has been criticized for prohibiting dietary supplementDietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
manufacturers from making unsupported claims of effectiveness on the labels of their products. Manufacturers of supplements, which are considered foods for regulatory purposes, are allowed to make only limited "structure/function claims" and are prohibited from claiming that the supplement can prevent, cure, or mitigate a disease or condition unless the supplement undergoes actual testing of its safety and efficacy. Such unsupported claims of effectiveness are considered false advertising
False advertising
False advertising or deceptive advertising is the use of false or misleading statements in advertising. As advertising has the potential to persuade people into commercial transactions that they might otherwise avoid, many governments around the world use regulations to control false, deceptive or...
.
One critic, Representative Ron Paul
Ron Paul
Ronald Ernest "Ron" Paul is an American physician, author and United States Congressman who is seeking to be the Republican Party candidate in the 2012 presidential election. Paul represents Texas's 14th congressional district, which covers an area south and southwest of Houston that includes...
(R
Republican Party (United States)
The Republican Party is one of the two major contemporary political parties in the United States, along with the Democratic Party. Founded by anti-slavery expansion activists in 1854, it is often called the GOP . The party's platform generally reflects American conservatism in the U.S...
-TX
Texas
Texas is the second largest U.S. state by both area and population, and the largest state by area in the contiguous United States.The name, based on the Caddo word "Tejas" meaning "friends" or "allies", was applied by the Spanish to the Caddo themselves and to the region of their settlement in...
), introduced a bill on November 10, 2005 titled the "Health Freedom Protection Act" (H.R. 4284), which proposes to stop "the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements, and adopts the federal court’s suggested use of disclaimers as an alternative to censorship."
Charges of under-regulation
In contrast to those who see the FDA as a source of excessive regulation, other critics believe that the FDA does not regulate strictly enough. According to this view, the FDA allows unsafe drugs on the market because of pressure from pharmaceutical companies, fails to ensure safety in drug storage and labelling, and allows the use of dangerous agricultural chemicals, food additives, and food processing techniques.A $1.8 million 2006 Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.
Allegations that the FDA covered up exportation of unsafe products
In the 1980s, Cutter LaboratoriesCutter Laboratories
Cutter Laboratories was a pharmaceutical company located in Berkeley, California. They were bought by the Bayer pharmaceutical company in the 1970s.-The Cutter incident:...
introduced a heat-treated version of Factor VIII
Factor VIII
Factor VIII is an essential blood clotting factor also known as anti-hemophilic factor . In humans, Factor VIII is encoded by the F8 gene...
concentrate in the US, designed to eliminate the risk of HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
transmission. However, Cutter continued to market the untreated product overseas, potentially spreading HIV while the safer product was marketed in the US.
Cutter initially had a voluntary agreement with the FDA to stop marketing the untreated product. However, when it became clear that Cutter was not complying with the agreement, the FDA ordered the company to cease marketing untreated blood products, stating: "It was unacceptable for them to ship that material overseas." At the same time, the FDA, according to Cutter's internal documents, asked that the issue be "quietly solved without alerting the Congress, the medical community and the public", leading to charges that the FDA was complicit in covering up Cutter's actions.
Allegations that unsafe drugs are approved
Some critics believe that the FDA has been too willing to overlook safety concerns in approving new drugs, and is slow to withdraw approved drugs once evidence shows them to be unsafe. Rezulin (troglitazoneTroglitazone
Troglitazone is an anti-diabetic and antiinflammatory drug, and a member of the drug class of the thiazolidinediones. It was developed by Daiichi Sankyo Co.. In the United States, it was introduced and manufactured by Parke-Davis in the late 1990s, but turned out to be associated with an...
) and Vioxx (rofecoxib) are high-profile examples of drugs approved by the FDA which were later withdrawn from the market for posing unacceptable risks to patients.
Troglitazone
Troglitazone
Troglitazone is an anti-diabetic and antiinflammatory drug, and a member of the drug class of the thiazolidinediones. It was developed by Daiichi Sankyo Co.. In the United States, it was introduced and manufactured by Parke-Davis in the late 1990s, but turned out to be associated with an...
is a diabetes drug that was also available abroad at the time the FDA approved it. Post-marketing safety data indicated that the drug had dangerous side-effects (in this case liver failure
Liver failure
Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease , and indicates that the liver has sustained severe damage . The complications are hepatic encephalopathy and impaired protein synthesis...
). The drug was pulled off that market in the UK in 1997, but was not withdrawn by the FDA until 2000, before which time it is claimed that thousands of Americans were injured or killed by the drug.
In the case of Vioxx, a pre-approval study indicated that a group taking the drug had four times the risk of heart attacks when compared to another group of patients taking another anti-inflammatory, naproxen
Naproxen
Naproxen sodium is a nonsteroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as:...
. The FDA approval board accepted the manufacturer's argument that this was due to a previously unknown cardioprotective effect of naproxen, rather than a risk of Vioxx, and the drug was approved. In 2005, the results of a randomized, placebo-controlled study showed that Vioxx users suffered a higher rate of heart attacks and other cardiovascular disorders than patients taking no medication at all. Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market in 2004. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition.
David Graham, a scientist in the Office of Drug Safety within the CDER, testified to Congress that he was pressured by his supervisors not to warn the public about dangers of drugs like Vioxx. He argued that an inherent conflict of interest exists when the office responsible for post-approval monitoring of drug safety is controlled by the same organization which initially approved those same drugs as safe and effective. In a 2006 survey sponsored by the Union of Concerned Scientists, almost one-fifth of FDA scientists said they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."
Allegations that unsafe food additives and processing technologies are approved
Food safety advocates have criticized the FDA for allowing meat manufacturers to use carbon monoxide gas mixtures during the packaging process to prevent discoloration of meat, a process that may hide signs of spoilage from the consumer.The FDA has been criticised for allowing the use of recombinant bovine growth hormone
Bovine somatotropin
Bovine somatotropin , or BGH, is a chain of amino acids produced by the cow's pituitary gland. Like other hormones, it is produced in small quantities and is used in regulating metabolic processes...
(rBGH) in dairy cows. rBGH-treated cows secrete higher levels of insulin-like growth factor 1
Insulin-like growth factor 1
Insulin-like growth factor 1 also known as somatomedin C is a protein that in humans is encoded by the IGF1 gene. IGF-1 has also been referred to as a "sulfation factor" and its effects were termed "nonsuppressible insulin-like activity" in the 1970s.IGF-1 is a hormone similar in molecular...
(IGF-1) in their milk than do untreated cows. IGF-1 signalling is thought to play a role in sustaining the growth of some tumors, although there is little or no evidence that exogenously absorbed IGF could promote tumor growth. The FDA approved rBGH for use in dairy cows in 1993, after concluding that humans drinking such milk were unlikely to absorb biologically significant quantities of bovine IGF-1. A 1999 report of the European Commission Scientific Committee on Veterinary Measures relating to Public Health noted that scientific questions persist regarding the theoretical health risks of milk from rBGH-treated cows, particularly for feeding to infants. Since 1993, all EU countries have maintained a ban on rBGH use in dairy cattle.
The FDA has also been criticised for permitting the routine use of antibiotic
Antibiotic
An antibacterial is a compound or substance that kills or slows down the growth of bacteria.The term is often used synonymously with the term antibiotic; today, however, with increased knowledge of the causative agents of various infectious diseases, antibiotic has come to denote a broader range of...
s in healthy domestic animals to promote their growth, a practice which allegedly contributes to the evolution
Evolution
Evolution is any change across successive generations in the heritable characteristics of biological populations. Evolutionary processes give rise to diversity at every level of biological organisation, including species, individual organisms and molecules such as DNA and proteins.Life on Earth...
of antibiotic-resistant strains of bacteria.
The FDA has taken recent steps to limit the use of antibiotics in farm animals. In September 2005, the FDA withdrew approval for the use of the fluoroquinolone antibiotic enrofloxacin
Enrofloxacin
Enrofloxacin is a fluoroquinolone antibiotic sold by the Bayer Corporation under the trade name Baytril. Enrofloxacin is currently FDA-approved for treatment of individual pets and domestic animals in the United States...
(trade name Baytril) in poultry, out of concern that this practice could promote bacterial resistance to important human antibiotics such as ciprofloxacin
Ciprofloxacin
Ciprofloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class.It is a second-generation fluoroquinolone antibacterial. It kills bacteria by interfering with the enzymes that cause DNA to rewind after being copied, which stops synthesis of DNA and of...
.
The FDA has received criticism for its approval of certain coal tar derived food dyes such as FDC yellow 5
Tartrazine
Tartrazine is a synthetic lemon yellow azo dye used as a food coloring...
and 6
Sunset Yellow FCF
Sunset Yellow FCF is a synthetic yellow azo dye, manufactured from aromatic hydrocarbons from petroleum. When added to foods, it is denoted by E Number E110...
, which are banned in most European countries. On September 6, 2007, the British Food Standards Agency
Food Standards Agency
The Food Standards Agency is a non-ministerial government department of the Government of the United Kingdom. It is responsible for protecting public health in relation to food throughout the United Kingdom and is led by a board appointed to act in the public interest...
revised advice on certain artificial food additives, including tartrazine.
Professor Jim Stevenson from Southampton University, and author of the report, said: "This has been a major study investigating an important area of research. The results suggest that consumption of certain mixtures of artificial food colours and sodium benzoate preservative are associated with increases in hyperactive behaviour in children.
The following additives were tested in the research:
- Sunset yellowSunset Yellow FCFSunset Yellow FCF is a synthetic yellow azo dye, manufactured from aromatic hydrocarbons from petroleum. When added to foods, it is denoted by E Number E110...
(FD&C Yellow #6) - Coloring found in squashes - CarmoisineAzorubineAzorubine, carmoisine, Food Red 3, Azorubin S, Brillantcarmoisin O, Acid Red 14, or C.I. 14720 is a synthetic red food dye from the azo dye group. It usually comes as a disodium salt. It is a red to maroon powder. It is used for the purposes where the food is heat-treated after fermentation. It has...
- Red coloring in jellies - Tartrazine (FD&C Yellow #5) - Yellow coloring
- Ponceau 4RPonceau 4RPonceau 4R , SX purple) is a synthetic colourant that may be used as a food colouring. It is denoted by E Number E124...
- Red coloring - Sodium benzoateSodium benzoateSodium benzoate has the chemical formula NaC6H5CO2; it is a widely used food preservative, with E number E211. It is the sodium salt of benzoic acid and exists in this form when dissolved in water. It can be produced by reacting sodium hydroxide with benzoic acid.-Uses:Sodium benzoate is a...
- Preservative - Quinoline yellowQuinoline Yellow WSQuinoline yellow, Quinoline Yellow WS, C.I. 47005, or Food Yellow 13, is a yellow food dye. Chemically it is a mixture of disulfonates , monosulfonates and trisulfonates of 2- indan-1,3-dione....
- Food coloring - Allura red ACAllura Red ACAllura Red AC is a red azo dye that goes by several names including: Allura Red, Food Red 17, C.I. 16035, FD&C Red 40, 2-naphthalenesulfonic acid, 6-hydroxy-5--, disodium salt, and disodium 6-hydroxy-5--2-naphthalenesulfonate. It is used as a food dye and has the E number E129...
(FD&C Red #40) - Orange / red food dye
On April 10, 2008, the Food Standards Agency called for a voluntary removal of the colors (but not sodium benzoate) by 2009. In addition, it recommended that there should be action to phase them out in food and drink in the European Union (EU) over a specified period.
UK ministers have agreed that the six colorings will be phased out by 2009. A Japanese group found in 1987 that tartrazine was not carcinogenic after being fed to mice for two years.
A German group found in 1989 that Sunset Yellow did not induce mutations that could lead to cancer in laboratory animals.
The FDA has also been criticized for giving permission for cloned animals
Cloning
Cloning in biology is the process of producing similar populations of genetically identical individuals that occurs in nature when organisms such as bacteria, insects or plants reproduce asexually. Cloning in biotechnology refers to processes used to create copies of DNA fragments , cells , or...
to be sold as food without any special labelling, although "cloned products may not reach the U.S. market for years." "Authorities lack the authority to require labeling of products from cloned animals."
Allegations of undue pharmaceutical industry influence
Critics have disputed the claim that the Prescription Drug User Fee Amendment has improved the speed of drug approvals. The advocacy group Consumer Union has claimed that the primary effect of this program has been to increase the influence of the pharmaceutical industry on FDA policy, similar to the effect meat industry user fees have had on the USDA.The journal Nature
Nature (journal)
Nature, first published on 4 November 1869, is ranked the world's most cited interdisciplinary scientific journal by the Science Edition of the 2010 Journal Citation Reports...
reported in 2005 that 70% of FDA panels writing clinical guidelines on prescription drug usage contained at least one member with financial links to drug companies whose products were covered by those guidelines. In the most egregious instance, every member of a panel which recommended the use of epoeitin alfa in HIV patients had received money from a manufacturer of that drug. On March 21, 2007 the FDA announced new guidelines disqualifying experts from serving on advisory committees if they had received financial compensation from a drug company potentially affected by the committee's recommendations.
The FDA has been criticized regarding delayed approval of foreign drugs to protect the US pharmaceutical companies from foreign competition. Eli Lilly and Company
Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States...
's drug fluoxetine
Fluoxetine
Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor class. It is manufactured and marketed by Eli Lilly and Company...
(Prozac) was the first serotonin-specific reuptake inhibitor to be approved by the FDA. Kali-Duphar, the Dutch manufacturer of another antidepressant fluvoxamine
Fluvoxamine
Fluvoxamine is an antidepressant which functions as a selective serotonin reuptake inhibitor . Fluvoxamine was first approved by the U.S. Food and Drug Administration in 1993 for the treatment of obsessive compulsive disorder . Fluvoxamine CR is approved to treat social anxiety disorder...
(Luvox), had first attempted to apply for FDA review in the early 1980s (much earlier than Eli Lilly) but fluvoxamine was not approved until the rights were bought by the US pharmaceutical company Reid Rowell
Rowell Laboratories, Inc.
Rowell Laboratories, Inc., a pharmaceutical manufacturing company, was founded in 1929, was located in Baudette, Minnesota, and later included facilities in Marietta, Georgia and Orlando, Florida. Rowell Laboratories, Inc...
. Critics have suggested that the FDA was attempting to protect Eli Lilly's fluoxetine so it could gain a foothold in the US market before approving fluvoxamine.
Similarly, some critics argue that the FDA delayed the approval of Meroxyl (terephthalylidene dicamphor sulfonic acid), the most effective UV protectant (particularly against UV A) in clinical use to allow for US companies to develop competing products. Meroxyl has been available in Europe since 1991 but it only was approved in 2006 by the FDA and this delay allowed for Neutrogena to release helioplex which is a competitor for meroxyl. Helioplex differs from meroxyl in that it prevents the breakdown of avobenzone enhancing its UV protection.
- "Why Is the Best Sunscreen Blocked by FDA?", John Stossel, 20/20 abcnews.com, June 17, 2005
- Helioplex in the news
Allegations of bias against gay men in blood donation process
Blood collecting organizations, such as the American Red CrossAmerican Red Cross
The American Red Cross , also known as the American National Red Cross, is a volunteer-led, humanitarian organization that provides emergency assistance, disaster relief and education inside the United States. It is the designated U.S...
, have policies in accordance with FDA guidelines that prohibit accepting blood donations from any "male who has had sex with another male since 1977, even once". The inclusion of homo- and bisexual men on the prohibited list has created some controversy, but the FDA and Red Cross cite the need to protect blood recipients from HIV as justification for the continued ban. Even with PCR-based testing of blood products, a "window period
Window period
In medicine, the window period for a test designed to detect a specific disease is the time between first infection and when the test can reliably detect that infection...
" may still exist in which an HIV-positive unit of blood would test negative. All potential donors from HIV high risk groups are deferred for this reason, including men who have sex with men. The issue has been periodically revisited by the Blood Products Advisory Committee within the FDA Center for Biologics Evaluation and Research, and was last reconfirmed on May 24, 2007. Documentation from these meetings is available.
However, in 2006, the AABB, America's Blood Centers and American Red Cross recommended to the FDA that the deferral period for men who had sex with other men should be changed to be equivalent with the deferral period for heterosexual's judged to be at risk. The FDA chose to uphold the blood ban. Female sexual partners of MSM
MSM
MSM may refer to:in science and technology:* Methylsulfonylmethane, a chemical compound* Markov switching multifractal, a financial model of asset returns* Method of simulated moments, a statistical estimation technique...
(men who have sex with men) are deferred for one year since the last exposure. This is the same policy used for any sexual partner of someone in a high risk group. The intent of these policies is to ensure that blood is collected from a population that is at low risk for disease, since the tests are not perfect and human error may lead to infected units not being properly discarded. The policy was first put in place in 1985.
Criticism of FDA's rejection of medical cannabis
In April 2005, the FDA issued a statement asserting that the cannabisCannabis
Cannabis is a genus of flowering plants that includes three putative species, Cannabis sativa, Cannabis indica, and Cannabis ruderalis. These three taxa are indigenous to Central Asia, and South Asia. Cannabis has long been used for fibre , for seed and seed oils, for medicinal purposes, and as a...
plant had no medical value and should not be accepted as a medicine, despite a great deal of research suggesting the opposite. The supporters of medical cannabis
Medical cannabis
Medical cannabis refers to the use of parts of the herb cannabis as a physician-recommended form of medicine or herbal therapy, or to synthetic forms of specific cannabinoids such as THC as a physician-recommended form of medicine...
legalization criticized the FDA's statement as a politically motivated one instead of one based on solid science. A group of congressmen led by Maurice Hinchey
Maurice Hinchey
Maurice Dunlea Hinchey , is the U.S. Representative for , serving since 1993. He is a member of the Democratic Party...
wrote a letter to FDA's commissioner Andrew von Eschenbach
Andrew von Eschenbach
Andrew C. von Eschenbach was the Commissioner of the United States Food and Drug Administration from 2006–2009. He became acting Commissioner on September 26, 2005, after the resignation of his predecessor Lester Crawford, and was confirmed as Commissioner by the Senate on December 7, 2006...
, expressing their disapproval of the FDA's statement and pointed out the FDA's rejection of medical cannabis was inconsistent with the findings of the Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
, which stated cannabis does have medical benefits. While the FDA has not approved marijuana it has approved THC (a compound found in cannabis) as an active ingredient for medicinal use. Critics argue that this approval is a politically motivated attempt to allow special interest groups to have patents over the substance, perhaps because the patents on previously patented competing substances have expired.
Allegations regarding management and FDA scientists
Nine FDA scientists appealed to President George W. Bush over pressure from management to manipulate data, mainly in relation to the review process for medical devices. These concerns were highlighted in a 2006 report on the agency as well.External links
— June 2007 report from the Competitive Enterprise InstituteCompetitive Enterprise Institute
The Competitive Enterprise Institute is a non-profit think tank founded on March 9, 1984 in Washington, D.C. by lobbyist Fred L. Smith, Jr to advance economic liberty and fight over-regulation by big government...
- February 2010 issue of Mercatus On Policy