Food and Drug Administration

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Template:Expert Template:Redirect Image:Food and Drug Administration logo.png 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.

The FDA is a division of the Department of Health and Human Services (HHS), which itself is one of the 15 Cabinet-level Departments of the United States Government. 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 CBER, which oversees blood products, vaccines, and newer therapeutics related to stem cells and gene therapy. CDER, which regulates human pharmaceuticals, receives considerable public scrutiny.

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 and a stormy tenure as deputy commissioner and acting commissioner, prior to his 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 effectiveness 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 unsafe or present risks not disclosed in the product's labeling. 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 a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.

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. Daniel Troy, 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.<ref>How to Petition the FDA. Retrieved 2005-03-20.</ref>

The FDA Consumer magazine was first issued in 1989 to spread information on how to get and stay healthy.

Contents

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History

  • 1927 — 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 — The name of the "Food, Drug, and Insecticide Administration" is shortened to "Food and Drug Administration" (FDA) under an agricultural appropriations act.
  • 1938 — 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. [1]
  • 1990 — FDA promulgates regulations banning "gifts of substantial value" from drug companies to doctors. Minor gifts (like meals, tickets, and travel) are not banned.
  • 1992 — 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. A drug is given "fast-track" status if it meets a medical need not currently being met by any medication. 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 — 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 — 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.
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Related legislation

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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, allowing unsafe drugs on the market because of pressure from pharmaceutical companies, and censoring health information about nutritional supplements and foods.

It has been proposed that the FDA be relegated to a voluntary inspection agency in order to remedy these problems. Others disagree with the proposition to leave the agency with only authority to do voluntary inspections because that could create new problems. They believe that consumers would not demand food and pharmaceutical products to be tested and that therefore they would not be evaluated for health and safety risks. And, they believe advertising claims of drugs would be uncontested in a court of law. They fear that the industry would essentially be left to regulation by corporations with a heavily invested future in the production and sale of these untried and untested pharmaceuticals.

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Regarding high drug prices

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The Cost of Drug Development

Many maintain that FDA regulations and policy contribute to unnecessarily high drug prices in America. One concern is that the cost of the approval process may provide a disincentive for firms to develop new drugs, and require high prices to recoup their investment. This argument however, shows a basic misunderstanding of the economics behind pricing. Prices are not based directly on cost, but are set with the goal of maximizing profit. (Whether the derived profits are 'fair' is another issue; see Pharmaceutical company.) In a monopolistic market where demand is relatively inelastic, a decrease in fixed cost will have little effect on the optimal price. Put simply, lowering the price dramatically wouldn't attract enough new customers to make up for the lost revenue. The expected effect of decreasing regulatory costs would be to add to industry profitability, and possibly to encourage increases in R&D expenditure. However, the magnitude of these effects would depend upon the amount of the costs that could reasonably be cut, compared to the total cost of drug research and development.

1995 and 2002 studies by Joseph A. Dimasi claim that it costs, on the average, approximiately 800 million dollars to bring a drug to market in the U.S. [2]. This figure includes the high cost of failed research programs (which it is presumed must be pursued in order that some may suceed), and the drug company's opportunity cost of capital, which is very high because it is compounded over long (15-20 year) development cycles. Dimasi's critics question whether this is a fair allocation of costs, and have alleged that conflicts of interest exist because the data was obtained from drug manufactures, and the center which employs Dimasi is partially funded by pharmaceutical companies. More specifically, they point out that he failed to consider government research grants and tax rebates, and claim that the scope of the research was too narrow because it only included New chemical entities (NCEs). Such critics suggest a revised cost that is under 200 million dollars, about 29% of which is spent on FDA required clinical trials. [3] However, the objective of the DiMasi paper was not to determine "out of pocket" costs for individual projects, but to acertain the "price of innovation" in terms that reflect a firm's incentive to perform research and development of novel pharmaceuticals. Furthermore, under no circumstance would it be reasonable to forgo clinical trials entirely, and a marginal decrease in their cost would have a correspondingly small effect on total drug development costs.

Competition

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 United States. [4]

With regard to patented drugs, this argument fails to suggest any beneficial policy changes. If there is a single supplier of a drug the difference in prices is simply a variable pricing strategy which benefits both the drug manufacturers, and consumers in less-affluent markets. If unhindered re-importation were allowed, either shortages would occur in cheaper markets (likely without satisfying U.S. demand), or companies would have to set the same price in all markets. Because a large proportion of the industry's revenue comes from the U.S., Europe, and Japan, a univeral price would likely be close to the current prices in those markets (excluding countries with price caps). Not only would the industry's ability to conduct research be crippled by reduced profitability, but also consumers in many markets would be unable to afford the drugs. Where price differences do exist for patented drugs, the lower prices are often due to government imposed price caps, not because of "competition" from the manufacturer's other markets. These price controls result in artificially low margins in these markets, which in turn lead to less available capital for research and development. Because of this, many contend that through higher prices, U.S. consumers pay a disproportionate amount of the cost of developing new medicines.[5]

It is common for generic manufacturers to enter the market very soon after a drug's patent protection is lost, and for both companies to begin selling at dramatically lower prices. 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. These standards are similar in the United States, the European Union, Japan, and most of the world (represented by the WHO), all of which observe guidelines set forth by the International Conference on Harmonisation (ICH). Although some drugs that are approved by European regulatory agencies are not approved in the U.S., this would not be expected to affect the prices of approved drugs.

Some offer the observation that prices of nutritional supplements in Europe are much more expensive than in the U.S. [6] They note that nutritional supplements are regulated in Europe, but not in the U.S. (as a result of the passage of the Dietary Supplement Health and Education Act, which 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. [7] 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.

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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 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.

Under the Prescription Drug User Fees Act, the FDA charges fees to pharmaceutical companies in order to shorten the average length of the drug approval process. These fees are meant to offset FDA staff costs and related expenses. This can be considered 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 conduct the approval process. Some critics further allege that this "pay-off" may sacrifice the quality of studies. However, these concerns are often based on an inadequate understanding of the process. These fees are charged to all companies (except for orphan drug submissions and first-time small business applicants), regardless of the priority or expedited status of the review. Several options do exist to speed the review of a proposed drug, but the criteria for priority status are designed in the interest of public health and are not tied in any way to monetary payments.

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Regarding incentive to delay approval of new drugs

Many economists who study the FDA are critical.<ref>FDAReview.org Is the FDA Safe and Effective?</ref> 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.<ref>Friedman, Milton & Rose (1979). Free to Choose. New York: Harcourt Brace Jovanovich. ISBN 0-15-133481-1.</ref> 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.

Drug is beneficial Drug is harmful
FDA allows the drug Correct decision

Type 1 error:
Allowing a harmful drug.
Victims are presumably identifiable and traceable.
Error is self-correcting

FDA does not allow the drug

Type 2 error:
Disallowing a beneficial drug. Victims are not identifiable.
Error is not self-correcting

Correct decision

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. [8]

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Regarding Wilhelm Reich

FDA was involved in an incident that involved one of the few government book-burnings that ever to take place in the United States. The FDA went to court in 1956 to act against the interstate shipment of "orgone accumulators", an experimental device built by an aging Dr. Wilhelm Reich. 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 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.

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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," [9] 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.

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Censorship

The Federal Food, Drug, and Cosmetic Act ("FDCA") defines a drug, in part, as any article intended to prevent, cure, or mitigate a disease or condition. Any claim that a product could prevent, cure, or mitigate a disease or condition are referred to as "drug claims." Any seller that makes a drug claim about their product would be, by definition under the FDCA, claiming that their product is a drug. Once defined as a new drug under the FDCA, the seller would have to ensure that their product adhere to all the standards of a new drug including obtaining a new drug application from FDA through the use of clinical trials to prove safety and efficacy. Thus, the FDA is often criticized for restricting the ability of certain products (e.g., nutritional supplements, foods, cosmetics, etc.) from making certain claims related to the products impact on overall health of the consumer. FDA defends its ability to restrict these claims based on the definition of a drug under the FDCA and its ability to regulate new drugs. Dietary supplements and certain foods are allowed to make structure/function claims and health claims that resemble drug claims, but are regulated differently.

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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. [10] 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." [11] Life Extension Foundation claims that the prohibitions are a violation of the Constitutional Right to Free Speech. [12] 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 found in most foods, 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 [13]. After a costly and lengthy legal battle, the Life Extension Foundation was cleared of all charges.

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Food

The FDA censors providers of foods from making certain drug claims. For example, the FDA has threatened the cherry industry with legal measures unless it stops mentioning certain health benefits. [14] [15] 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. [16]

See also Health claims on food labels

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Medicines

The FDA approves the labeling information to appear on the labeling of both over-the-counter (OTC) products as well as prescription products. Some have critized FDA's restriction of certain information on OTC products as being counterproductive. 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. [17]

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See also

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References

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External links

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News coverage

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Academic critiques

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General criticism

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