The United States Food and Drug Administration (FDA) 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 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 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.

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.

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, censoring information about nutritional supplements. Some propose that the FDA be relegated to a voluntary inspection agency in order to remedy these problems.

FDA and the public

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.^[1]

Controversy

Regarding high drug prices

Many maintain that FDA regulations and policy cause unnecessarily high drug prices in America. They argue that regulations against importing cheaper drugs from foreign sources is anti-competitive which 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. [2] Also, at issue, 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 companiess charge unnecessarily-high prices to recoup their investment.

Others 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. [3] 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. [4]

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 [5].

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

A controversial concept. Economists Milton Friedman, Daniel B. Klein and Alexander Tabarrok are three economists who argue that the FDA causes harm. Many economists who study the FDA are critical.^[6]

Friedman (1979) notes that the FDA can make two types of errors.^[7] 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?"

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. 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," [8] 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 also been criticized for intervening in the controversial nutritional supplement business. It has conducted at least one well-publicized raid on an establishment that sold and manufactured such products, the "Life Extension Foundation," which is a significant player in the industry. The FDA gained entrance to a store by smashing through the glass doors with a battering ram [9]. After a costly and lengthy legal battle, the Life Extension Foundation was cleared of all charges.

The FDA has been criticized for engaging in censorship when it forbids makers of nutritional supplements from making claims that have been supported by scientific studies. A bill was introduced in the US House of Representatives on May 12, 2005 by Congressman Ron Paul to allow consumers 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. Such bureaucratic action neglecting the most important fact established regarding the biochemistry of Trp: that it is an essential amino acid that humans cannot live without eating, led to renewed questioning as to whether the FDA was a science based or political agency.

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.

• 1990 FDA passes laws 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. 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.

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

External links

• http://www.fda.gov/ Official FDA website
• http://www.fdareview.org/ Is the FDA Safe and Effective?
• End the FDA's Monopoly by David R. Henderson "Pare back the FDA's powers to that of an information agency"
• Consumers Against High Drug Prices - an organization blames the FDA for High Drug Prices
• Death By Regulation Asserts that the FDA regulations defrauding Americans out of health and money
• The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the leading research-based pharmaceutical and biotechnology companies in the United States
• Pharmaceutical Price Controls in OECD Countries Implications for U.S. Consumers, Pricing, Research and Development, and Innovation by U.S. Department of Commerce
• Free Speech and Dietary Supplements A speech given before the U.S. House of Representatives by Ron Paul on Nov 10, 2005, introducing the Health Freedom Protection Act (H.R. 4282) and criticizing the FDA for censoring consumer information

Articles

• US drug safety checks 'slack'

References

1. ^  CHI World Pharmaceutical Congress 2005 Website and final agenda in print form. Verified 03-07-2005.
2. ^  How to Petition the FDA. Retrieved 2005-03-20.
3. ^  FDAReview.org
4. ^  Friedman, Milton & Rose (1979). Free to Choose. New York: Harcourt Brace Jovanovich. ISBN 0-15-133481-1.de:Food and Drug Administration