Food and Drug Administration

The Food and Drug Administration (FDA) of the United States is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics, and blood products in the United States.

Description
The FDA is a division of the Department of Health and Human Services (DHHS), which itself is part of the Executive Office of the President of the United States. The FDA is divided into five major Centers: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Each center has its own origins and history, the oldest being the Center for Biologics, which oversees blood products, vaccines and newer therapeutics related to stem cells and gene therapy. The Center for Drugs, the center that receives the most public scrutiny, regulates pharmaceutical medicines.

Today, the FDA is headed by acting Commissioner, Dr. Andrew von Eschenbach, who succeeds Dr. Lester Crawford who resigned on September 23, 2005 only two months after his final Senate confirmation.

The over-arching mandate of the FDA is to regulate the multitude of medicinal products in a manner that ensures the safety of the American public and the efficacy claims (label) of marketed drugs. The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. "Review teams" employ around 1,300 employees to approve new drugs. The "safety team" has 72 employees to determine whether new drugs are hurting people. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires clinical testing in populations of about 3,000 people.

One aspect of its jurisdiction over food is regulation of the content of health claims on food labels. However, because regulating the content of labels implicates the First Amendment, FDA must balance concerns about the public health with the right to free speech. Dan Troy, a lawyer who was Chief Counsel of the Food and Drug Division from August 2001 to November 2004, raised the agency's focus on First Amendment issues.

The FDA does not pre-approve dietary supplements on their safety and efficacy, unlike drugs. In contrast, the FDA can only go after dietary supplement manufacturers after they have put unsafe products on the market. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements.

According to the Small Business Guide to FDA, "Anyone may request or petition FDA to change or create an Agency policy or regulation under 21 CFR Part 10.30." This is called a Citizen's Petition and it is one method used to challenge specific approvals by the FDA.

Criticism
The FDA has come under much criticism from many groups, including the Government Accountability Office. FDA regulations are blamed for causing high drug prices, keeping life-saving drugs off the market, prohibiting access to emergency contraceptives, and censoring health information about nutritional supplements and foods. Some propose that the FDA be relegated to a voluntary inspection agency in order to remedy these problems.

Regarding high drug prices
Many maintain that FDA regulations and policy cause unnecessarily high drug prices in America. One concern is what some believe to be an excessively costly approval process that, in effect, keeps potentially beneficial drugs from being brought to market and requires that companies charge unnecessarily-high prices to recoup their investment. Critcs of the FDA cite 1995 and 2002 studies by Joseph A. Dimasi which claim that it costs, on the average, approximiately 800 million dollars to bring a drug to market in the U.S.. Dimasi's critics argue that these figures are inflated by the inclusion of massive "opportunity costs," the use of unverified data from drug manufactures themselves (who are the major sponsors of the center that employs Dimasi), and a failure to take into consideration government research grants and tax rebates; such critics suggest that these considerations reveal that the actual average cost to develop a new drug is under 200 million dollars, about 29% of which is spent on FDA required clinical trials. 

A second way in which the FDA is seen to be responsible for high drug prices is by opposing the 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 U.S. where import is allowed. 

Defenders of the FDA's position point out that importation is not banned by FDA, so long as the imported drug complies with FDA regulations regarding importation. They observe that the FDA requires imported drugs to meet the same safety, efficacy, and manufacturing standards as those manufactured in the United States. This practice is not different from that of European regulatory agencies. Many drugs that are approved by European regulatory agencies are not approved in the U.S. due to a stricter regulatory environment.

Some offer the observation that prices of nutritional supplements in Europe are much more expensive in than in the U.S. They note that nutritional supplements are regulated in Europe, but not in the U.S. (as a result of the result of the passage of the Dietary Supplement Health and Education Act that severely limits the ability of the FDA to regulate them). Many nutritional supplements require a prescription in Europe, but not in the U.S. Hence, they reason that a cause of high pharmaceutical costs in the U.S. is regulation. Consequently, they reason that if the FDA discontinued regulating pharmaceuticals that they would be much more affordable. Requiring individuals to pay to visit a doctor to obtain a prescription for a drugs further increases costs to the consumer. Many countries have much less strict regulations on what drugs may be dispensed without a prescription. These drugs are available for importation without a prescription in the underground economy through the internet, but few take advantage of this due to legal fears.

Lower drug prices in Europe and Canada are widely attributed to price controls imposed by governments, rather than to less stringent regulatory requirements. Those who hold this view also contend that these price controls contribute to artificially low revenues, which in turn lead to less available capital for research and development. Because of this, many contend, the international (non-U.S.) pharmaceutical industry spends less on research and development than the U.S. pharmaceutical industry.

Regarding drug approval
One of the key issues of drug safety dealt with by the FDA, and responsible for much recent controversy, is related to the concept of patents. When a patent is awarded, the drug's creator is given exclusive manufacturing rights. If the drug is extremely popular, this motivates other companies to invent their own (different) drugs which accomplish the same effect. (Because a drug is patented, they cannot produce the exact same drug). For example, Cialis was created because of the popularity of Viagra. However, the question is, when new, competing substances come out should they be approved, not because of their absolute safety, but because of their relative safety compared to an approved drug. For example, say "drug b" was created to compete with "drug a". Now if "drug b" was the first one out, and it had a 5 percent chance of heart attack, the FDA might find this acceptable. However if "drug a" was already out, and it had a 2.5 percent chance of heart attack, then the FDA would be reluctant to approve "b". Only people who were ignorant of that higher risk would take drug b -- unless it were significantly cheaper, and the purchaser preferred the price savings of "b" to the relative safety of "a".

This phenomenon is at the center of a present controversy over the recall of Vioxx, which is causing more attention to be brought to the FDA. David J. Graham, a scientist with the FDA, says he was pressured by his supervisors not to warn the public about dangers of drugs like Vioxx, and so recommended to congress that a separate agency be created which is dedicated to continuously monitoring drug safety.

The FDA charges fees to pharmaceutical companies that wish to "expedite" the drug approval process. This is considered by many to be a conflict of interest, as the companies who are supposed to be regulated by the FDA are those who are paying them to speed up approvals. They reason that this "pay-off" to expedite the process may sacrifice the quality of studies. These concerns are based on an inadequate understanding of the process, however. Several options exist for bringing additional focus to the review and approval of a drug. All of these options require the drug company to show that the proposed drug meets several criteria, all designed to ensure the priority or expedited review is in the interest of the public health. The user fees charged by FDA are meant to offset FDA staff costs and expenses related to the review and approval. These fees are charged regardless of the priority or expedited status of the review. This process is governed by the Prescription Drug User Fees Act.

Regarding incentive to delay approval of new drugs
Many economists who study the FDA are critical. Their views; however, are controversial. Economists Milton Friedman, Daniel B. Klein and Alexander Tabarrok are three economists who argue that the FDA causes a net harm.

Friedman (1979) notes that the FDA can make two types of errors. Type 1 is to approve a drug that has deadly or harmful side effects in a large number of people. If you make this error, like approving a thalidomide, you will be blasted by the news media, and your reputation will be ruined.

Type 2 is refusing approval of a drug that is capable of saving many lives or relieving great distress and that has no untoward side effects. If you make a type 2 error, few will know it, as the people whose lives might have been saved will not be around to protest, and their families will have no way of knowing that their loved ones lost their lives because of the caution of an unknown FDA official.

The following table from http://www.fdareview.org/incentives.shtml illustrates the two types of error and the reason for systematic bias toward type 2 errors.

This dichotomy was brought to the fore in the early days of AIDS. Noted AIDS author Randy Shilts published a future timeline analysis in the San Francisco Chronicle showing a minimum delay of 20 years to approve the new AIDS drugs and get them to patients. Standard industrial project expediting techniques of identifying critical paths and starting tasks in parallel were foreign to the medical bureaucracy. A massive demonstration by ACT UP and other groups occupied FDA headquarters, hanging a "Silence = Death" banner over the entrance. Afterwards, the "Pert chart" for approval of protease inhibitors and other drugs was given a major rework and procedures introduced for expediting timelines for both normal and compassionate/experimental drug introduction.

Friedman theorizes that the harm the FDA causes results from the nature of the bureaucracy and would happen even with the best intentioned and benevolent individuals in charge: "With the best will in the world, you or I, if we were in that position, would be led to reject or postpone approval of many a good drug in order to avoid even a remote possibility of approving a drug that will have newsworthy side effects." Friedman recommends that the FDA be abolished to remedy the problem. 

Regarding Wilhelm Reich
The early reputation of the FDA was tarnished by directing one of the few government book-burnings ever to take place in the United States. Acting against the interstate shipment of "orgone accumulators", an experimental device built by an aging Dr. Wilhelm Reich the FDA went to court in 1956. Reich refused to appear in court to debate scientific matters, writing to the court: "My factual position in the case as well as in the world of science of today does not permit me to enter the case against the Food and Drug Administration, since such action would, in my mind, imply admission of the authority of this special branch of the government to pass judgment on primordial, pre-atomic cosmic orgone energy." The FDA and the court responded by jailing Reich and ordering the burning of his published works, including those that had no reference to the orgone accumulator, at the Gansevoort Destructor Plant in Manhattan.

Regarding Blood Donation
In the past, it was the practice in America and other countries to separate blood donations on the basis of race, ethnicity, or religion, or to exclude certain groups from the donor pool on those bases. Currently, in the US, these practices have been eliminated, although American Red Cross and Food & Drug Administration policies prohibit accepting blood donations from gay men, specifically from any "male who has had sex with another male since 1977, even once," or from IV drug users or recent immigrants from certain nations with high rates of HIV infection. While the inclusion of gay men on the prohibited list has created some controversy, the FDA & Red Cross cite the public policy need to protect the blood supply from HIV & similar diseases as justification for the ban.

Regarding Nutritional Supplements
The FDA has been criticized for engaging in censorship because it prohibits dietary supplement manufacturers from making drug claims. Supplements manufacturers are only allowed to make limited claims regarding how the supplement affects the structure or function of the body, i.e., structure/function claims and are prohibited by law from making drug claims that the supplement could prevent, cure, or mitigate a disease or condition, which are drug claims. A bill was introduced in the US House of Representatives on May 12, 2005 by Congressman Ron Paul to prevent the FDA from censoring this information. It is currently pending. Julian Walker, M.D. of the Health Freedom Action Network says: "This rogue agency illegally prohibits manufacturers of food and dietary supplements from giving accurate information about their products' health benefits." Life Extension Foundation claims that the prohibitions are a violation of the Constitutional Right to Free Speech. On November 10, 2005, Ron Paul introduce a bill for the Health Freedom Protection act (H.R. 4284) 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.from censoring consumer information (Free Speech and Dietary Supplements)

The FDA was also criticized for banning the essential amino acid Tryptophan after a manufacturing incident in Japan contaminated one batch. Regardless of the origin of the toxicity, Trp was banned from sale in the US, and other countries followed suit. Critics claim that such bureaucratic action neglects that Trp is an essential amino acid that humans cannot live without eating, and have led some to renewed questioning as to whether the FDA was a science based or political agency.

The FDA prohibits information on health benefits for substances for which there is ample scientific evidence. For example, those who sell calcium are prohibited from mentioning that it reduces the risk of bone fractures. (FDA and FTC Censorship of Health Information Must End by Jonathan W. Emord (pdf))

The FDA has also been criticized for intervening in the controversial nutritional supplement business. A raid against one supplement company, the "Life Extension Foundation," garnered criticism from critics for their entrance into a store by smashing through a glass doors with a battering ram. After a costly and lengthy legal battle, the Life Extension Foundation was cleared of all charges.

Food
The FDA censors providers of foods from providing information on health benefits. For example, the FDA has threatened the cherry industry with legal measures unless it stops mentioning health benefits. The FDA has sent letters to cherry distributors saying that when health benefits are mentioned, the cherries then become "drugs" that are subject to seizure. (FDA Threatens to Raid Cherry Orchards, William Faloon, Life Extension Magazine, March 2006)

Medicines
The FDA censors health claims for medicines, including over-the-counter remedies. For instance, The FDA prohibits asprin packages from containing the research-backed information that taking an asprin every day reduces the risk of heart attack. Some argue that the restrictions save consumers from having bad information, but the counter argument is that they are also prohibited from having good information. Some medicine manufactures have proposed a compromise, where the FDA could say what they want on the label of a medicine while the manufacturer could say what they want as well. However, this proposal has been rejected by the FDA. 

History

 * 1927 &mdash; The "Bureau of Chemistry" is reorganized into two separate entities. Regulatory functions are located in the "Food, Drug, and Insecticide Administration", and nonregulatory research is located in the "Bureau of Chemistry and Soils".


 * 1930 &mdash; The name of the "Food, Drug, and Insecticide Administration" is shortened to "Food and Drug Administration" (FDA) under an agricultural appropriations act.


 * 1938 &mdash; Over 100 people died after consuming a raspberry-flavored sulfa elixir which had been rushed to market by the S.E. Massengill Company without any testing. About 70 percent of the elixir was diethylene glycol, which is now known to be poisonous.  The resulting scandal and public outcry led to the passage of the Federal Food, Drug, and Cosmetic Act of 1938, which gave the FDA the power to preapprove all new drugs introduced into interstate commerce.
 * 1990 &mdash; FDA promulgates regulations banning "gifts of substantial value" from drug companies to doctors. Minor gifts (like meals, tickets, and travel) are not banned.


 * 1992 &mdash; Congress passes a new law creating a faster approvals process to legalize new drugs. The FDA must hire more reviewers and speed up reviews without sacrificing proper study and testing. The drug industry must pay "user fees" with every new drug application. Approval times drop from 30 to 12 months on average. 60% of new drugs come on the market in the U.S. first, before other countries. Before this law, when the approval process was slower, more new drugs came out in other countries first.


 * 1997 &mdash; FDA loosens restrictions on consumer advertising. Drug companies are allowed to spend less time describing risks and side effects on TV commercials. A large increase in TV drug ads caused a large increase in drug sales within months.


 * Year unknown &mdash; The Naval Ordnance Laboratory White Oak site was apportioned to the FDA to become its new headquarters. However, budget reductions have delayed the move to White Oak for many FDA offices.

Related legislation

 * 1906 &mdash; Pure Food and Drug Act
 * 1938 &mdash; Federal Food, Drug, and Cosmetic Act
 * 1944 &mdash; Public Health Service Act
 * 1951 &mdash; Food, Drug, and Cosmetics Act Amendments PL 82–215
 * 1953 &mdash; Flammable Fabrics Act PL 83–88
 * 1960 &mdash; Federal Hazardous Substances Labeling Act PL 86–613
 * 1962 &mdash; Food, Drug, and Cosmetics Act Amendments PL 87–781
 * 1965 &mdash; Federal Cigarette Labeling and Advertising Act PL 89–92
 * 1966 &mdash; Fair Packaging and Labeling Act PL 89–755
 * 1966 &mdash; Child Protection Act PL 89–756
 * 1970 &mdash; Federal Cigarette Labeling and Advertising Act Amendments PL 91–222
 * 1972 &mdash; Consumer Products Safety Act PL 92–573
 * 1976 &mdash; Medical Device Regulation Act PL 94–295
 * 1986 &mdash; Comprehensive Smokeless Tobacco Health Education Act PL 99–252
 * 1988 &mdash; Anti&mdash;drug Abuse Act PL 100–690
 * 1990 &mdash; Nutrition Labeling and Education Act PL 101–535
 * 1992 &mdash; Prescription Drug User Fee Act PL 102–571

Articles

 * US drug safety checks 'slack'