Criticism of the Food and Drug Administration

Main article: Food and Drug Administration

The Food and Drug Administration (FDA) of the United States has regulatory oversight over products purchased by 25 cents of every consumer dollar in the U.S. In particular, these products include many which are necessary for the sustenance and preservation of human life and health.^[1] As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. There have been many criticisms and complaints lodged against the FDA from patients, economists, regulatory bodies, and the pharmaceutical industry.

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Weighing the right way

Over-regulation

A diverse group of critics claim that the FDA possesses excessive regulatory authority.

Criticism: FDA rejects or delays approval of useful drugs

The economist Milton Friedman 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.^[2]

Friedman has also argued that delays in the approval process have cost lives.^[3] 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.^[4] 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.^[5]

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 infections, and staged large protests, such as a confrontational October 11 1988 action at the FDA campus which resulted in nearly 180 arrests.^[6] 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.^[7] 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.^[8] 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.^[9] Three of the first 5 HIV medications were approved in the United States before they were approved in any other country.^[10]

Criticism: FDA regulation contributes to the high cost of drugs

Studies published in 2003 by Joseph DiMasi and colleagues estimated an average cost of approximately $800 million to bring a new drug to market,^[11][12] while a 2006 study estimated the cost to be anywhere from $500 million to $2 billion.^[13] The consumer advocacy group 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 trials.^[14][15] Dimasi himself rejects the claim that high drug development costs are responsible for high drug prices. As he wrote in a published letter, "At the time that drug prices are determined, the associated R&D spending for a drug is a sunk cost. Basic economic logic tells us that R&D costs do not determine prices."^[16]

In contrast, 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, and that dropping these requirements would hasten the development of new drugs because they would be cheaper to bring to market.^[17][18]

Criticism: FDA regulations disallow drug reimportation

Some claim that the FDA unjustly opposes importation of cheaper drugs from foreign sources, which is held to be an anti-competitive policy that keeps drug prices artificially high in the United States. Prices of almost all pharmaceutical drugs in Europe are significantly lower than in the United States.^[19]

Representatives of the pharmaceutical industry, which supports importation restrictions, respond that the lower prices are often due to government imposed price caps, not because of "competition" between markets.^[20]

Criticism: FDA is slow in granting over-the-counter status

An article in the libertarian magazine Reason argued that the FDA should be more aggressive about switching medications to over-the-counter status. They argue that the prescription requirement causes consumers to spend time and money on unnecessary doctor's visits.^[21] In the past, the FDA has lagged behind regulator agencies in other major industrialized nations in switching drugs from prescription to over-the-counter status. Unlike some nations, the U.S. does not have a pharmacist-dispensed "behind the counter status" for drugs which are not yet deemed appropriate for over-the counter status, but which do not require a doctor visit for safe and effective usage by patients.^[22]

Criticism: FDA restricts free speech in food and drug labeling

The FDA has been criticized for prohibiting dietary supplement 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),^[23] 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."^[24] Other critics, such as the Life Extension Foundation, claim that the prohibitions are a violation of the Constitutional right to free speech.^[25]

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.

Criticism: FDA approves unsafe drugs

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. Troglitazone and rofecoxib (trade name Vioxx) 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.^[26]

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.^[27] 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.^[28] 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.^[26] 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."^[29]

Criticism: FDA approves unsafe food additives and processing technologies

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 which may hide signs of spoilage from the consumer.^[30] The irradiation of food for purposes of safety and longer shelf life is regulated by the FDA. The FDA has concluded that such irradiation is safe, but places a consumer advisory label on all irradiated food.^[31]

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.^[32] 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.^[33] Since 1993, all EU countries have maintained a moratorium on rBGH use in dairy cattle.

The FDA has also been criticised for permitting the routine use of antibiotics in healthy domestic animals to promote their growth, a practice which contributes to the evolution of antibiotic-resistant strains of bacteria.^[34] 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.^[35]

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. However, many studies of these compounds have failed to demonstrate heath risks. For example, a Japanese group found in 1987 that tartrazine was not carcinogenic even after being fed to mice for two years.^[36] In addition, a German group found in 1989 that Sunset Yellow did not induce mutations that could lead to cancer in laboratory animals.^[37]

FDA bias

Criticism: Pharmaceutical companies have excessive influence over the FDA

Critics have disputed the claim that the Prescription Drug User Fee Amendment has improved the speed of drug approvals.^[38] 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,^[39] similar to the effect meat industry user fees have had on the USDA.^[40]

A 2005 investigation by reporters from the prestigious science journal Nature found 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.^[41] On March 21, 2007, the FDA announced new guidelines for disqualifying experts from serving or voting on advisory committees if they had received financial compensation from a drug company potentially affected by the committee's recommendations.^[42]

The FDA has been criticized regarding its delayed approval of foreign drugs to protect the US pharmaceutical companies from foreign competition. Eli Lilly's Fluoxetine was the first SSRI to be approved by the FDA. Kali-Duphar, the Dutch manufacturer of another antidepressant fluvoxamine, 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.^[43]

Criticism: FDA discriminates against homosexuals in blood donation

Blood collecting organizations, such as the American Red Cross, 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,^[44] but the FDA and Red Cross cite the need to protect blood recipients from HIV as justification for the continued ban.^[45] 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.^[46]

Criticism: FDA's rejection of medical cannabis is politically motivated

In April 2005, the FDA issued a statement asserting that cannabis plant had no medical value and should not be accepted as a medicine, despite a great deal of research suggesting the contrary.^[47] 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 jointly 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.^[48]

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