Overview:
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Located within the Department of Health and Human Services, the Food and Drug Administration (FDA) regulates a wide range of medical and food products. From reviewing new medicines to inspecting food processing centers, the FDA plays a role in approximately $1 trillion worth of products each year. The FDA is comprised of chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers and other professionals. Despite all of the expertise employed by the agency, the FDA has struggled to carry out its mission to protect Americans from harmful drugs and foods. In recent years, the agency’s reputation has plummeted amid controversies involving the approval of certain pharmaceutical drugs and allowing tainted foods to reach consumers.
History:
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The Progressive Era of the early 20th Century was the backdrop for the founding of the Food and Drug Administration. From 1879 until 1906, nearly 100 bills were introduced in Congress to regulate food and drugs, but it wasn’t until the publishing of Upton Sinclair’s The Jungle, which depicted the deplorable working and sanitary conditions of the meat packing industry, that leaders in Washington were moved to bolster federal regulations in this area.
On June 30, 1906, President Theodore Roosevelt signed the Food and Drugs Act. The Bureau of Chemistry, located in the Department of Agriculture, was charged with administering the act, which prohibited the interstate transport of unlawful food and drugs. The basis of the law rested on the regulation of product labeling rather than pre-market approval, as the latter-day FDA would do.
At first the bureau’s regulatory emphasis centered on food, which was believed to be a greater public health problem than adulterated or misbranded drugs. This changed in the succeeding years as the bureau began focusing more on drug regulation, with some emphasis on patent medicines.
The Bureau of Chemistry’s name changed to the Food, Drug, and Insecticide Administration in July 1927 when the non-regulatory research functions of the bureau were transferred elsewhere in the Agriculture department. In July 1930 the name was shortened to the present version, Food and Drug Administration.
During the 1920s and 1930s, misbranded and adulterated drugs became a growing problem, culminating in 1937 when a Tennessee drug company marketed a form of a new sulfa wonder drug that appealed to sick children. The solvent, Elixir Sulfanilamide, was a highly toxic chemical analogue of antifreeze and wound up killing more than 100 people, many of whom were children. The public outcry prompted Congress to take action and pass the 1938 Food, Drug, and Cosmetic Act. The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. Moreover, it mandated pre-market approval of all new drugs, such that a manufacturer would have to prove to FDA that a drug was safe before it could be sold. While this was taking place, the FDA was moved out of the Department of Agriculture in June 1940 and placed under the authority of the new Federal Security Agency.
As the 1940s progressed, the FDA began to identify drugs that would now require a prescription from a physician before patients could legally attain them. A debate soon ensued among the FDA, industry and health practitioners over what constituted a prescription and an over-the-counter drug, which resulted in the Durham-Humphrey Amendment of 1951 to resolve the matter. From the 1940s to the 1960s, the abuse of amphetamines and barbiturates required more regulatory effort by FDA than all other drug problems combined. Furthermore, the pharmaceutical industry began to flood the FDA with new drugs applications, more than 6,000 in the first nine years after 1938, and 13,000 by 1962.
In April 1953, the FDA was again transferred, this time to the Department of Health, Education, and Welfare (HEW). By then, the agency was involving itself more in the food industry. The first food standards to be issued under the 1938 act were for canned tomato products. By the 1960s about half of the food supply was subject to a standard. As food technology changed and the number of possible ingredients, including fortifying nutrients, grew, FDA officials developed recipe standards for foods—lists of ingredients that could lawfully be included in a product. A food that varied from the recipe would have to be labeled an imitation.
Following hearings in the early 1950s, a series of laws addressing pesticide residues (1954), food additives (1958) and color additives (1960) gave the FDA much tighter control over the growing list of chemicals entering the food supply, putting the onus on manufacturers to establish their safety. Responding to the proliferation of pesticides after World War II, FDA pharmacologists developed the fly bioassay, a rapid and sensitive test that could be used in conjunction with chromatographic procedures to screen a variety of chemicals. This helped lead to new federal rules banning any carcinogenic additive in foods.
Cosmetics and medical devices, which the Post Office and the Federal Trade Commission had overseen to a limited extent, came under FDA authority as a result of the 1938 Food, Drug, and Cosmetic Act. While pre-market approval did not apply to medical devices, the new law did equate them to drugs for regulatory purposes. The Secretary of HEW commissioned the Study Group on Medical Devices, which recommended in 1970 that medical devices be classified according to their comparative risk, and regulated accordingly. The 1976 Medical Device Amendments, which came on the heels of a therapeutic disaster in which thousands of women were injured by the Dalkon Shield intrauterine device, provided for three classes of medical devices, each requiring a different level of regulatory scrutiny.
In May 1980, the education component of HEW was removed, creating a new Department of Education and leaving behind the newly decreed Department of Health and Human Services (HHS). The FDA remained under HHS, which continues to oversee the agency.
History of Federal Regulation: 1902-Present
(Independent Institute)
What it Does:
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The Food and Drug Administration (FDA) is a scientific, regulatory and public health agency that oversees the manufacture, import, transport, storage and sale of approximately $1 trillion worth of products annually. These products include human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics and animal feed. The FDA is comprised of chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers and other professionals. About one-third of the agency’s employees are stationed outside of Washington, DC, staffing more than 150 field offices and laboratories, including five regional offices and 20 district offices. Investigators and inspectors visit more than 16,000 facilities a year and arrange with state governments to help increase the number of facilities checked.
FDA’s key centers and offices are as follows:
Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the safety of 80% of all food consumed in the United States except for meat, poultry and some egg products, which are regulated by the Department of Agriculture. Food-borne illness has been estimated to cause approximately 76 million illnesses, 325,000 hospitalizations and 5,000 deaths a year in the United States. CFSAN has pioneered widespread use of the Hazard Analysis and Critical Control Point (HACCP) system, which places preventive controls at the most contamination-prone points in the production of food. HACCP is required for the processing of seafood and has been incorporated into the Food Code for state health authorities. HACCP requirements were established for fruit and vegetable juice production in January 2001. In addition, CFSAN’s food scientists have developed methods for the detection of microbial and viral food contaminants, and the FDA works closely with public- and private- sector partners to complete and operate two nationwide high-tech systems for rapid identification and control of outbreaks of food-borne diseases.
Center for Drug Evaluation and Research (CDER) conducts one of FDA’s most critical and high-profile tasks: assuring the safety and effectiveness of prescription and over-the-counter drugs. CDER evaluates all new drugs before they are sold and is supposed to serve as a consumer watchdog for the more than 10,000 drugs on the market to make sure they continue to meet the federal safety standards. The center also monitors TV, radio and print drug ads to ensure truthfulness, and it is responsible for providing health professionals and consumers with information about the appropriate and safe use of drugs.
Center for Veterinary Medicine (CVM) evaluates the safety and effectiveness of drugs used to treat more than 100 million pets owned by Americans. Nearly 300 drugs currently on the market have been approved by the FDA for dogs, cats and horses. CVM has two top priorities: Prevent the establishment of bovine spongiform encephalopathy (BSE), “mad cow disease;” and counter the risk of antibiotic resistance in humans from food animals.
Office of Regulatory Affairs (ORA) consists of approximately one-third of FDA’s staff stationed in more than 160 offices, resident posts and laboratories. ORA represents the “eyes, ears and the long arm” of the FDA to ensure the implementation of public health standards. Consumer safety officers and inspectors conduct about 22,000 domestic and foreign inspections a year to ensure that regulated products destined for the US market meet the FDA’s standards. Plants are inspected both before the FDA approves a product, to make sure that the firm has the capacity for high-quality production, and periodically afterwards, to ascertain that it follows appropriate manufacturing processes. ORA scientists analyze more than 41,000 product samples each year to determine their adherence to the FDA’s standards. Public affairs specialists communicate with consumer groups, health care professionals and state health authorities to explain FDA policies and encourage compliance with FDA standards.
Center for Biologics Evaluation and Research (CBER) regulates biological products for disease prevention and treatment that are inherently more complex than chemically synthesized pharmaceuticals. These products include: Blood and blood products, such as plasma, blood-derived proteins including clotting factors for hemophilia, tests used to screen blood donors and devices used to make blood products; vaccines and allergenic products; protein-based drugs, such as monoclonal antibodies and cytokines that stimulate the immune system to fight cancer and enzyme therapies that stop heart attacks.
CBER’s scientists also evaluate the safety and effectiveness of biomedical research, including: Human gene therapy; xenotransplantation (the technique in which organs, tissues or cells from animals are transplanted into humans); cellular and tissue transplants, including stem cell therapy; transgenic plants and animals whose products will result in new biotech vaccines and therapeutics; genomics, proteomics and bioinformatics techniques; methods for testing and removal from blood products of infectious particles that cause the human illness; and nucleic acid testing.
CBER also plays a role in helping protect the country from bioterrorism. The center encourages the development and licensing of products to diagnose, treat or prevent outbreaks from exposure to bioterrorist pathogens. Furthermore, the center is developing procedures and protocols to make possible the safe use of promising experimental products when there is no approved medication for the treatment of victims of terrorism.
Center for Devices and Radiological Health (CDRH) regulates new medical devices to ensure safety and effectiveness before they reach patients. Many of these devices are the first of a kind, such as robotic arms for surgery and other high-tech devices designed to prevent, diagnose or treat cancer, heart disease, impaired vision and hearing. CDRH also monitors devices throughout the product life cycle, including a nationwide post-market surveillance system. It also keeps watch of radiation-emitting products, such as microwave ovens, TV sets, cell phones and laser products to make sure they meet radiation safety standards.
National Center for Toxicological Research (NCTR) conducts scientific research and provides expert technical advice to FDA officials on critical biological events that produce toxicity. It also develops methods and incorporates new technologies to improve the assessment of human exposure, susceptibility and risk to toxicity.
is composed of litigators and counselors. Litigators handle both civil and criminal cases. Counselors provide legal opinions to the major programs of the agency—drugs, foods, biologics, devices, veterinary products and enforcement. They participate in rulemaking proceedings, legislative matters, policy deliberations and international negotiations. In addition, FDA attorneys are involved in explaining agency programs to Congress, regulated industry and the public. The office consists of about 80 lawyers and 20 support staff.
Where Does the Money Go:
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The Food and Drug Administration spent a little more than $2 billion from 2000 to 2008 on 7,115 contractors, according to USAspending.gov. The largest expenditures were for computer and telecommunications equipment and services, which totaled $436 million. Not surprisingly, the top 10 recipients of FDA contracts included computer giants Hewlett-Packard and Oracle, along with:
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Booz Allen Hamilton
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$225,118,332
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Northrop Grumman
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$50,933,879
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PSI International
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$47,644,707
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SRA International
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$47,488,739
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Afognak Native Corp.
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$43,325,672
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Battelle Memorial Institute
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$42,814,412
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Hewlett-Packard
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$40,843,844
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Oracle
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$37,141,837
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Herman Miller
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$34,814,550
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Compaq Federal
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$30,400,358
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Other contractors hired to perform computer-related work include High Performance Technologies, which received a $50 million contract in 2006 to provide information technology services to the FDA. The five-year contract will support the FDA’s effort to develop an agency-wide framework that “links IT investments to business goals, objectives and structures.” High Performance Technologies is joined on the FDA contract by CGI-Federal, Data Networks, Claraview and Troux Technologies.
Kaiser Permanente, United Health Group Inc., Vanderbilt University and Harvard Pilgrim Health Care won first-of-their-kind contracts from the FDA to help research the effects of pharmaceuticals on large patient populations after drugs go on the market. The decision by FDA was made following the Vioxx controversy, during which drug manufacturer Merck pulled Vioxx off the market. Each contractor will get $1.3 million over the next five years to provide data to the FDA from their databases. The four contracting organizations track data on more than 20 million Americans’ health.
North Carolina State University’s Golden LEAF Biomanufacturing Training and Education Center (BTEC) was
to help train FDA employees. BTEC will design, develop and deliver pharmaceutical and biomanufacturing training for the agency’s Office of Regulatory Affairs field and operational personnel. The contract will pay BTEC $161,000 in the first year and includes four additional option years which would bring the total value of the contract to $455,000.
Controversies:
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FDA Failing to Keep Up with Import Inspections
In addition to regulating new drugs, a key responsibility of the Food and Drug Administration is to monitor the importation of foods into the country. Increasingly, however, the FDA is falling down on this important task. The agency reportedly inspects only 1% of the imported foods it regulates, down from 8% in 1992 when imports were far less common. In contrast, the Department of Agriculture, which is responsible for meat and poultry, inspected almost 16% of those imported foods in Fiscal Year 2006.
The FDA also does not require that exporting countries have safety systems equivalent to those in the US. The Agriculture Department, meanwhile, does that for countries that export meat and poultry, and the Government Accountability Office has said for at least a decade that the FDA should, too.
According to one former FDA commissioner, “The FDA has so few resources, all it can do is target high-risk things, give a pass to everything else and hope it is OK. The public probably has the perception that they’re more protected than they really are.”
The number of FDA food inspectors has declined about 20% in the past five years, while food imports have soared about 50%. Also, more food imports are coming from developing countries where pesticide use is often higher than in the US, water quality is often worse and workers may be less likely to be trained in food safety.
A 2003 FDA study found pesticide violations in 6.1% of imported foods sampled vs. 2.4% of domestic foods.
U.S. food imports outrun FDA resources (by Julie Schmit, USA Today)
FDA Fails to Warn Doctors about Vioxx
During the controversy over the arthritis medication Vioxx, the drug’s manufacturer, Merck & Co., wasn’t the only party that was publicly ridiculed. The FDA also was heavily criticized for its part in the scandal after it was revealed the agency failed to heed safety concerns about the medication and even tried to halt a published report on the drug.
The FDA’s biggest mistake was failing to warn doctors sooner about potential health risks once they became known to agency officials. During Congressional investigations, one FDA official admitted his agency took too long to get information about Vioxx’s heart risks into the prescribing label that is provided to physicians. More than a year passed between an advisory panel’s conclusion that those risks should be highlighted and the label changes.
Millions of people took Vioxx after its risks to the heart became apparent. As a result, as many as 55,000 patients may have died from heart attacks and strokes induced by the drug, according to the FDA. Merck withdrew the drug from the market in September 2005 after tests showed that it doubled the risk of heart attack and stroke.
To make matters worse for the FDA, it also was revealed that the watchdog agency had tried to suppress a critical report by one of its own scientists on Vioxx. In 2004, the British medical journal, The Lancet, was set to publish a Food and Drug Administration-sponsored study that raised concerns about the safety of Vioxx. But then an FDA official took the unusual step of calling the editor of The Lancet to question the study’s findings.
The report’s lead author, David Graham, said the call was part of an effort to block publication of his research, which consisted of an analysis 1.4 million Kaiser Permanente members that revealed those who took Vioxx were more likely to suffer a heart attack or sudden cardiac death than those who took Celebrex, Vioxx’s rival. Graham, who worked for FDA’s Office of Drug Safety, said he pulled his paper at the last minute because he feared for his job.
Scientist says FDA called journal to block Vioxx article (by Rita Ruben, USA Today)
F.D.A. Official Admits 'Lapses' on Vioxx (by Gardiner Harris, New York Times)
FDA Accused of Stifling Anti-Depressant Findings
When concerns over the efficacy of anti-depressants with children surfaced in 2004, the FDA tried blocking attempts by its own experts and even drug manufacturers to disclose information. Several times agency officials urged pharmaceutical companies not to tell physicians and the public that some clinical trials of the medications in children found the drugs were no better than sugar pills - and had caused some to ponder suicide.
In their defense, FDA leaders said they were concerned that the negative information might scare families and physicians away from the drugs. In three instances, the FDA blocked industry plans to reveal the negative studies in drug labels, and in one case the agency reversed a manufacturer’s decision to amend its drug label to say that the drug was associated with increased hostility and suicidal thinking among children. FDA leaders also prevented one of their scientists from testifying at a public hearing about the dangers of giving anti-depressants to children.
Dr. Andrew D. Mosholder, an FDA epidemiologist, led an examination that analyzed 22 studies involving 4,250 children and seven drugs. Mosholder concluded that children given antidepressants were almost twice as likely as those given placebos to become suicidal.
As a result of the FDA’s actions, many physicians weren’t aware of the negative data and kept on prescribing drugs like Prozac and Zoloft to millions of American children largely because the drugs had proved effective among adults.
Expert Kept From Speaking At Antidepressant Hearing (by Gardiner Harris, New York Times)
FDA Urged Withholding Data on Antidepressants (by Shankar Vendantam, Washington Post)
Secret US report surfaces on antidepressants in children (by Jeanne Lenzer, BMJ)
Suggested Reforms:
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Vioxx Scandal Leads to FDA Changes
In the wake of the Vioxx and anti-depressants controversies, numerous changes were proposed or implemented for the FDA process. The agency created a new process for dealing with disagreements among FDA scientists over approval of new drugs. Under the new system, an ad hoc panel will be convened if FDA experts can’t reach an agreement. The panel members will be scientists who were not involved in the original decision-making process, including some from outside the agency. The panel will have 30 days to make a recommendation to the director of FDA’s Center for Drug Evaluation & Research. FDA also commissioned the Institute of Medicine (IOM) to do a comprehensive review of the effectiveness of the agency’s safety monitoring procedures.
In addition, Congress adopted legislation that made several key changes to the FDA process. One change increased the amount of money drug manufacturers must pay to the government to help finance FDA’s budget. The increase amounted to $400 million, a 25% hike for drug companies. Fees for makers of medical devices also increased. Furthermore, drug makers would be required to post publicly the results of all clinical trials involving approved medicines. The bill also granted the FDA the power to require drug makers to undertake clinical trials of medicines that the agency has already approved to better monitor the effects drugs may have on patients. Companies that don’t comply will be subject to fines by the FDA. Another change granted the agency the authority to force drug makers to change the labels on their products.
House Passes Bill Giving More Power to the F.D.A. (by Gardiner Harris, New York Times)
Heading Toward Reform of the F.D.A. (Editorial, New York Times)
House Passes Prescription Drug Safety Reforms (Dr. Cox, Cognality.com)
Privatize FDA
In contrast to expanding FDA’s power, some conservatives have called for privatizing many of the agency’s functions. One such example is Henry I. Miller, a former FDA official who went to work for the Hoover Institution, a conservative think tank. Miller published a book, To America's Health: A Proposal to Reform the Food and Drug Administration, in which he reviewed the current system, accused the FDA of failing to reform itself and Congress of failing to adequately bring about reform, and made a recommendation for privatization and competition in the approval process. According to Miller, the answer lies in having pharmaceutical companies contract with independent firms who would be responsible for the drug development process and make a final recommendation to the FDA about the approvability of drugs.
Debate:
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Morning-After Pill
For three years the FDA found itself in the thick of a hotly-debated issue over allowing pharmaceutical companies to sell so-called “morning after” pills without a prescription.
The debate began when Barr Pharmaceuticals filed for permission to sell its Plan B pill over the counter to women of all ages. The pill had been available as a prescription-only drug since 1999. Plan B prevents pregnancy by stopping the ovary from releasing an egg and may also prevent fertilization, if taken within 72 hours after having sex.
When the FDA first balked at approving Plan B, the decision came as a surprise because a panel of independent experts assembled by the FDA voted to recommend that the drug be sold over the counter. The majority concluded that the drug was not only effective but that women could be trusted to use it correctly without a doctor. The FDA normally followed the recommendations of its advisory panels.
Barr Pharmaceuticals then revised its application to sell Plan B to consumers 16 and older. The FDA countered by saying 17 and older was okay, then rescinded that plan and raised the age restriction to 18 and up. At one point, a top FDA scientist resigned in protest over what she claimed was political interference in the approval process. Susan F. Wood, assistant FDA commissioner for women’s health and director of the Office of Women’s Health, said she left because then Commissioner Lester M. Crawford acted on instructions from within the administration to stall Plan B’s approval. Crawford himself wound up leaving the FDA before the controversy was resolved, which led to a delay in a replacement taking over because Plan B supporters in Congress held the nomination hostage as leverage to force the Bush administration to grant FDA approval.
Those involved in the Plan B debate mirrored many of the same groups involved in the debate over abortion.
For
Supporters of the effort to allow over-the-counter sales of “morning after” pills included many Democrats in Congress, including U.S. Senators Hillary Rodham Clinton and Patty Murray. Other supporters included pro-choice advocates, liberal women’s organizations and even some FDA scientists. They claimed there was no harm in removing the prescription requirement for Plan B and other pills like it since the FDA had already vetted the medication when it was first approved for sale in the late 1990s. Allowing the pills sales without a prescription would help reduce unwanted pregnancies and, thus, abortions, argued proponents.
Against
Opponents of allowing non-prescription sales of morning-after pills included Concerned Women for America, a conservative women’s organization, American Association of Physicians and Surgeons, Family Research Council, Safe Drugs for Women, religious organizations and many Republicans. President Bush never publicly opposed FDA approval of Plan B, but some suspected that the President may have exerted pressure on the agency to delay its decision. Many opponents were opposed entirely to morning-after pills, with or without a prescription, because of their belief that pregnancy begins with the fertilizing of the egg—thus, Plan B represented just another form of abortion. Opponents also claimed that non-prescription use of Plan B would create a public health hazard by causing an increase in sexually transmitted disease.
Background
FDA approves sale of 'morning-after' pill (by Diedtra Henderson, Boston Globe)
FDA Official Quits Over Delay on Plan B (by Marc Kaufman, Washington Post)
U.S. Rules Morning-After Pill Can't Be Sold Over the Counter (by Gardiner Harris and Robin Toner, New York Times)
Morning-After Pill: Politics and the F.D.A. (by Gardiner Harris, New York Times)
GAO Questions FDA Decision on 'Morning-After' Pill (by Julie Rovner, NPR)
FDA Sued Over Unlawful Approval of Morning-After Pill
(LifeSiteNews.com)
- Table of Contents
- Overview
- History
- What it Does
- Where Does the Money Go
- Controversies
- Suggested Reforms
- Comments
- Leave a Comment
Food and Drug Administration (FDA)
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