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Food and Drug Administration (FDA)

Self Description

February 2002: "Every day, every American comes in contact with a host of products regulated by the Food and Drug Administration (FDA), everything from the most common food ingredients to complex medical and surgical devices, lifesaving drugs, and radiation-emitting consumer and medical products. In fact, FDA-regulated products account for about 25 cents of every consumer dollar spent in the United States. Stated most simply, FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. Our work is a blending of law and science aimed at protecting consumers."

Third-Party Descriptions

December 2013: "The Food and Drug Administration has cited every major A.D.H.D. drug — stimulants like Adderall, Concerta, Focalin and Vyvanse, and nonstimulants like Intuniv and Strattera — for false and misleading advertising since 2000, some multiple times."

September 2013: 'Under "Compassionate Use" or "Expanded Access", the Food and Drug Administration allows an unapproved drug still in development to go to a patient with few alternatives remaining, also absolving the drug maker of liability should the drug not work or cause harm.'

November 2012: "The outlines of the Avandia case — in which the drug’s dangers had been recognized within the company long before the FDA pulled it from retail shelves — are well known."

March 2012: 'Public Citizen, a consumer advocacy group, has petitioned the Food and Drug Administration to give generic companies greater control over their labels, a rule change that could allow users of generic drugs to sue, but the agency said earlier this month that it needed more time to decide. “Congress can make this problem go away, and the F.D.A. could, too,” said Allison Zieve, the director of Public Citizen Litigation Group. “But we haven’t seen signs that either of them is paying much attention.” A spokeswoman for the F.D.A. declined to comment.'

August 2011: "The Food and Drug Administration is reviewing the safety of the chemical, which was created more than 40 years ago as a surgical scrub for hospitals. Triclosan is now in a range of consumer products, including soaps, kitchen cutting boards and even a best-selling toothpaste, Colgate Total. It is so prevalent that a survey by the Centers for Disease Control and Prevention found the chemical present in the urine of 75 percent of Americans over the age of 5."

July 2011: "Oversight bodies like the Food and Drug Administration generally don’t view seeding trials as research scandals: seeding trials are not illegal, and the drugs in question have already received F.D.A. approval. But even after particularly egregious seeding trials have been exposed, the F.D.A. has not issued sanctions. Take the notorious Advantage study, a seeding trial of the pain reliever Vioxx conducted by Merck. According to a 2008 report in the Annals of Internal Medicine, litigation documents show that the Advantage study was conceived and managed by Merck’s marketing department. Three subjects died in the Advantage trial; five more subjects experienced heart attacks. Oversight bodies should treat the Advantage study as a violation of research ethics."

July 2011: 'So far, the Food and Drug Administration “has generally not enforced” its regulation of tests created by individual labs because, until recently, such tests were relatively simple and relied heavily on the expertise of a particular doctor, said Erica Jefferson, a spokeswoman for the agency. But now, with labs offering more complex tests on a large scale, the F.D.A. is taking a new look at enforcement.'

July 2011: "Thanks to the new rules, doctors and patients will be able to make informed choices about sunscreen. Given how central pharmaceuticals have become to the everyday health of millions of Americans, the Food and Drug Administration must enable them to do the same for prescription drugs."

June 2011: "In a highly unusual move, the Food and Drug Administration last month ordered manufacturers of all metal hips to undertake emergency studies of patients. And lawmakers and others are now calling for a tightening of how the F.D.A. scrutinizes new implants — both before and after they are sold."

June 2011: "The Obama administration was backing the plaintiffs, concerned that if state lawsuits are pre-empted by federal law, that will reduce the incentive for generic drug makers to provide the most current safety information to the FDA."

June 2011: 'But by the early 1990s, the Food and Drug Administration had become uneasy about the growing number of exotic product and health claims, particularly after more than 20 deaths were attributed to a “natural” sleep remedy. After the agency conducted raids across the country to confiscate supplements deemed unsafe or sold for unapproved uses. Mr. Hatch came to the rescue.'

June 2011: "WASHINGTON — After 33 years of consideration, the Food and Drug Administration took steps on Tuesday to sort out the confusing world of sunscreens, with new rules that specify which lotions provide the best protection against the sun and ending claims that they are truly waterproof."

December 2010: "The House of Representatives gave final approval on Tuesday to a long-awaited modernization of the nation’s food safety laws, voting 215 to 144 to grant the Food and Drug Administration greater authority over food production."

December 2010: "The brief and troubled life of DePuy’s A.S.R. hip points to a medical implant system that is piecemeal and broken on many fronts, critics say. Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients."

October 2010: "She complained to top company executives, but she was ignored even after warning that she would call the F.D.A. So she called the F.D.A. and sued. The agency began a criminal investigation and used armed federal marshals in 2005 to seize nearly $2 billion worth of products, the largest such seizure in history. Unable to fix the plant, GlaxoSmithKline closed it in 2009."

May 2010: "The Johnson & Johnson unit that recalled millions of bottles of liquid children’s Tylenol and other pediatric medicines last month may face criminal penalties, product seizures or other sanctions, an official from the Food and Drug Administration said Thursday."

April 2010: "The Food and Drug Administration has received about 300 reports of early replacement operations involving ASR patients since 2008. Safety experts say that the actual number of such procedures is most likely far higher, because many implant failures are not reported to the agency."

March 2010: "It was January 2004, and the lawyers were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney's Office. One of Pfizer's units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved."

October 2009: "Meanwhile, the Food and Drug Administration has mounted an aggressive campaign against products making unproven or unapproved claims to fight swine flu."

October 2009: "In a review of 18 proceedings, investigators for the Government Accountability Office found that the F.D.A. took from 1 to 11 years to complete its process to ban researchers. This means many who were convicted of fraud remained eligible to conduct experiments for years."

September 2009: "WASHINGTON — The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting."

April 2009: "In January, the Government Accountability Office issued a report scolding the Food and Drug Administration for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976."

July 2009: "Officials at the FDA and other public health experts cautioned consumers against using the products, saying that the health effects of electronic cigarettes are unknown."

June 2009: "In a press briefing called on short notice yesterday, FDA officials said that given the seriousness of ADHD and the rarity of sudden death -- which strikes fewer than 1 in 10,000 children -- the benefits of the drugs outweigh their risks. Agency officials urged parents to discuss concerns with doctors rather than deciding on their own to discontinue a child's medication. The study's lead author, Madelyn Gould, a professor in child psychiatry and epidemiology at Columbia University, said she agreed with the FDA's advice."

July 2009: '5. “Our supplements are a mystery wrapped in an enigma.” Dietary supplements are a booming business in this country, with sales of about $17.5 billion in 2007. Since the fallout surrounding the FDA’s ban of ephedra years ago, many consumers have already learned that manufacturers of these supplements don’t have to submit evidence of effectiveness, since they don’t make overt claims of curing or preventing a particular disease. Indeed, there are few controls to make certain that supplements even contain what they claim to. “Assume that nothing is guaranteed [about content] or the appropriate dosage advice,” says Ron Buchheim, deputy health editor at Consumer Reports, which has tested numerous supplements since 1995. Though the products are more consistent these days, “We still sometimes find significant variation” in the concentration of the active ingredient, he says, “sometimes more than 20 percent outside the amount on the label.”'

July 2009: "Federal drug regulators warned Wednesday that patients taking two popular drugs to stop smoking should be watched closely for signs of serious mental illness....Analysts said the F.D.A. action would have little effect on sales because of previous indications of the drugs’ psychiatric risks."

June 2009: "The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products."

June 2009: "The legislation, which comes 50 years after the surgeon general first warned about the health effects of tobacco, gives broad new authority to the Food and Drug Administration to regulate the manufacturing and marketing of tobacco products."

February 2009: "Problems emerged in southwest Georgia’s peanut country in 2004, when a whistleblower reported that the food-product giant ConAgra Foods had found salmonella in peanut butter at its plant in Sylvester, Ga., 75 miles from Blakely. But when plant officials declined to release their laboratory tests, the Food and Drug Administration did not pursue the records and was unable to confirm the report of salmonella."

June 2009: "Fifteen years after the U.S. Food and Drug Administration banned them for elective use and after massive class-action lawsuits bankrupted their manufacturer, silicone breast implants have gotten the green light again. Though there’s no conclusive evidence that silicone from ruptured implants causes the problems once associated with it, the FDA is staying cautious, recommending that patients undergo a long list of expensive follow-up tests over the long term. Due to concern about leaks, the FDA has required labeling..."

March 2009: "But in December, Merck asked the FDA to approve the vaccine for males ages 9 to 26, and in February it presented the results of a large study that tested the vaccine in men to the federal Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, in the hopes of winning the panel's endorsement. The committee's recommendations influence which vaccines schools require and whether private insurance companies and state programs will pay."

February 2009: "The Georgia peanut company at the center of one of our nation’s worst food-contamination scares has officially reached a revolting new low: a recent inspection by the Food and Drug Administration discovered that the salmonella-tainted plant was also home to mold and roaches....In its (falsely) reassuringly subtitled booklet “The Food Defect Action Levels: Levels of Natural or Unavoidable Defects in Foods That Present No Health Hazards for Humans,” the F.D.A.’s Center for Food Safety and Applied Nutrition establishes acceptable levels of such “defects” for a range of foods products, from allspice to peanut butter."

January 2009: 'WASHINGTON (CNN) -- Nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk."'

November 2008: 'FDA officials updated their interim risk assessment yesterday after finding what they described as "extremely low amounts" of melamine and cyanuric acid, a related chemical, in samples of two popular brands of domestically made infant formula.'

October 2008: "The MammoSite system is among the thousands of devices the F.D.A. lets onto the market each year after only cursory review and with no clear evidence that they help patients. Doctors are free to use those products as they see fit, without telling patients that the devices are not proved. And because the doctors are frequently paid more by Medicare as a way to compensate them for the extra time and expense of adopting new procedures, these unproven products can become widely adopted."

October 2008: "Responding to concerns about the presence of the contaminant melamine in numerous foods made in China and exported to the United States and elsewhere, the Food and Drug Administration said yesterday that consuming a very small amount of the chemical poses no serious risk."

September 2008: "That is the crux of the issue. Do the F.D.A. and other federal regulators set minimum safety standards that states are free to augment? Or do they make judgments about the optimal balance between risks and benefits that states must follow?"

September 2008: "Although the researchers described them as preliminary, the findings were the buzz of a public hearing the Food and Drug Administration held yesterday to discuss whether BPA is safe for continued use in food packaging and liquid containers."

September 2008: "Patients dart across the border to Mexico or jet to the Caribbean, India, China and elsewhere for injections of stem cells from embryos, fetuses, umbilical cords and the patients' own fat, blood and bone marrow. These shots would be illegal in the United States, where the Food and Drug Administration has yet to approve any such treatments."

August 2008: "In receiving expedited consideration from the Food and Drug Administration, Gardasil took six months from application to approval and was recommended by the C.D.C. weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Dr. Harper said, and then 5 to 10 more for universal acceptance."

July 2008: 'The government, for its part, is very aware of how misleading some marketing claims can be. In a statement drafted in 2006, the Food & Drug Administration recognized that consumers could be confused by unqualified "whole grain" claims for products that contain a mixture of whole grain and refined grain.'

July 2008: "For patients with a fatal disease, who have no other options, being denied a promising drug can often mean losing all hope. One group, the Abigail Alliance for Better Access to Developmental Drugs, lost a lawsuit last year against the Food and Drug Administration in which it sought essentially unlimited access to experimental drugs for terminally ill patients. The group was founded by a man whose daughter, Abigail, died of cancer after a long battle to use experimental drugs that the regulators subsequently approved."

July 2008: "A bill currently pending in Congress would give the Food and Drug Administration the authority to regulate or remove cigarette additives, including menthol. But while the legislation would immediately ban many other flavorings, it specifically exempts menthol."

July 2008: "The situation has proved so frustrating that in January the commissioner of the Food and Drug Administration attended a Red Cross board meeting — a first for a commissioner — and warned members that they could face criminal charges for their continued failure to bring about compliance, according to three Red Cross officials who attended the meeting and requested anonymity because Red Cross policy prohibits public discussion of its meetings with regulators."

July 2008: '(CNN) -- The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendonitis.'

June 2008: 'the agency warned 23 American companies and 2 foreign ones to stop claiming to prevent or cure cancer with their various “tablets, teas, tonics, black salves, and creams.” '

June 2008: "WASHINGTON — The Food and Drug Administration has failed to carry out much of its own plan to protect the nation’s food supply, Congressional investigators say in a report that is to be released on Thursday."

May 2008: "The Food and Drug Administration halted exports from Scientific Protein’s Chinese lab in February, after discovering the problem during an inspection."

May 2008: "The new system, called the Sentinel Initiative, will allow officials from the Food and Drug Administration for the first time to monitor almost immediately how drugs affect health. As it stands now, months or even years must pass before officials learn of unexpected side effects that can cost dozens or even thousands of lives."

May 2008: "Although the F.D.A. currently does not scrutinize advertising for medical devices as closely as for prescription drugs, it does regulate ads for so-called high-risk medical devices, which include stents."

May 2008: 'Even when used for its intended patients, people with psychosis, Haldol has drawn warnings from the U.S. government. In September, the Food and Drug Administration issued an alert citing "a number of case reports of sudden death" and other reports of dangerous changes in heart rhythm. It is, important, the FDA warned, to inject Haldol only into muscles, not veins, and to avoid doses that are too high.'

May 2008: "The legislation, which would give the Food and Drug Administration the power to oversee tobacco products, would try to reduce smoking’s allure to young people by banning most flavored cigarettes, including clove and cinnamon."

April 2008: "Despite more than 100 published studies by government scientists and university laboratories that have raised health concerns about a chemical compound that is central to the multibillion-dollar plastics industry, the Food and Drug Administration has deemed it safe largely because of two studies, both funded by an industry trade group."

April 2008: 'By law, generics must have the same active ingredient and the same action as the brand-name version, which allows them to piggyback on the original safety and efficacy trials. But generics do have different inactive ingredients, which can affect how they are absorbed into the body. Generics can produce blood levels as much as 20% below or 25% above that of the original drug and still be considered "bioequivalent," according to Food and Drug Administration guidelines.'

March 2008: "This is the world of direct-to-consumer genetic testing, a peculiar mix of modern science, old-fashioned narcissism and innovative entrepreneurialism....virtually no one is watching over the industry. The Food and Drug Administration does not regulate most gene-based tests, and there is no federal proficiency-testing system for companies offering them."

March 2008: "Indeed, in the years since the last China drug scandal, the share of drugs coming from that country has soared while the F.D.A.’s inspections of overseas drug plants have dropped. There are 566 plants in China that export drugs to the United States, but the agency inspected just 13 of them last year."

January 2008: 'The United States Food and Drug Administration declined to answer questions about Shanghai Hualian, because of security concerns stemming from the sometimes violent opposition to abortion. But in a statement, the agency said the RU-486 plant had passed an F.D.A. inspection in May. “F.D.A. is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone,” the statement said.'

January 2008: "The F.D.A.’s rules allow clinical investigators to have financial ties with the maker of the device or drug they are studying — on the condition that such relationships are fully disclosed. Lawyers who have worked with the F.D.A. say that when it becomes aware of potential conflict, it tends to subject research to a higher level of scrutiny."

January 2008: "discriminatory policies banning most gay and bisexual men from giving blood....The Food and Drug Administration, which writes the screening questions and requires that blood centers maintain deferral lists, said that restriction is to protect the national blood supply from HIV."

January 2008: "The stents are tiny metal scaffolds inserted in blood vessels to improve circulation. But regulators have approved them only for helping to drain digestive fluids from the bile duct in cancer patients. Dr. Maisel said reports to the Food and Drug Administration of problems with the devices, known as biliary stents, suggest that their off-label use in arteries is injuring hundreds and perhaps thousands of patients."

January 2008: "Dr. Thomas P. Laughren, director of the division of psychiatry products at the F.D.A., said the agency had long been aware that favorable studies of drugs were more likely to be published."

January 2008: "The Supreme Court yesterday declined to consider whether dying patients have a right to be treated with experimental drugs not yet approved by the Food and Drug Administration."

January 2008: "Despite the controversy, the American College of Rheumatology, the Food and Drug Administration and insurers recognize fibromyalgia as a diagnosable disease. And drug companies are aggressively pursuing fibromyalgia treatments, seeing the potential for a major new market."

November 2007: '"Pediatric patients were always the orphans. People didn't pay enough attention to them. They're just not a big enough market share," said Lisa Mathis, associate director for the pediatric and maternal health staff at the Food and Drug Administration's office for new drugs.'

November 2007: In addition, the Food and Drug Administration approved the PolyHeme trial even though it saw the unreleased data from the earlier test, and many other medical centers participated in it, he said, adding, “We’re not irresponsible people going out and doing evil experiments on small groups of patients.”

November 2007: The Food and Drug Administration, the Consumer Product Safety Commission and the Environmental Protection Agency often lack the authority and resources to monitor and control tobacco smoke, asbestos, tanning salons and the cancer-causing agents in food, water and the everyday products we use on our bodies and in our homes. Under antiquated laws, chemical and radiation hazards are examined one at a time, if at all. Of the nearly 80,000 chemicals regularly bought and sold today, according to the National Academy of Sciences, fewer than 10 percent have been tested for their capacity to cause cancer or do other damage.

October 2007: Julie Zawisza, a spokeswoman for the Food and Drug Administration, said the agency stood by its warnings about seafood high in mercury. “We think we are pretty much aware of everything that is out there in terms of scientific studies and data,” Ms. Zawisza said, “and we haven’t seen any data that we believe would support a change in our current recommendations.”

September 2007: Last month, the Food and Drug Administration approved one of the medications, Risperdal, to treat bipolar in children. Experts say they expect that move will increase the use of Risperdal and similar drugs for young people.

July 2007: Recent reports of tainted imports from China have focused new attention on a little-known trend: In today's global economy, more food items are being produced in this country with some ingredients from other lands. But the FDA inspects less than 1 percent of all food imports - and that means consumers must trust food makers to guarantee the safety of their products.

July 2007: According to testimony Tuesday before a House subcommittee, they have been able to bring tainted products into this country because the F.D.A. has neither enough resources nor inspectors to stop them. And each year it has become easier: since 2003, the number of inspectors has decreased while imports of food alone have almost doubled.

July 2007: The Food and Drug Administration came under withering criticism by a House panel yesterday for its handling of recent food-safety violations, and the Bush administration later disclosed plans to establish a working group to review the safety of food and other imports.

July 2007: Yet there is a growing push in medical, legislative, and legal circles -- both liberal and conservative -- to recognize an expansive new right that some are describing as 'medical self-defense.' The movement is rooted in a desire to help patients who have run out of options. Some medical experts, including Dr. Emil Freireich, director of a leukemia research program at the University of Texas, have called on the Food and Drug Administration to let terminally ill patients try unapproved drugs that might offer their last chance at survival. And Republican Senator Sam Brownback of Kansas is working to introduce legislation that would force the FDA to do just that.

June 2007: The issue is largely in the labeling—the Food and Drug Administration does not have any regulations on how sunscreens can accurately indicate their level of UVA protection, no quick and easy number like SPF. The agency began developing guidelines in 1978 but they have largely been at a standstill since 1999, when today's requirements were finalized.

June 2007: An array of agencies, including the Food and Drug Administration, the National Highway Traffic Safety Administration and the Consumer Product Safety Commission, have proposed or adopted rules that would make it more difficult for consumers to bring lawsuits under state laws that are more favorable to victims than are federal regulations.

June 2007: Over the past seven years, amid explosive growth in imports from India and China, the FDA conducted only about 200 inspections of plants in those countries, and a few were the kind that U.S. firms face regularly to ensure that the drugs they make are of high quality.

June 2007: A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.

June 2007: Questions about the safety of Avandia and how regulators have dealt with its risks are to be the subject of a Congressional hearing today. The data could intensify criticism, expected at the hearing, that the Food and Drug Administration should have warned about the potential heart risks years ago.

June 2007: Asked about the Minnesota analysis, the deputy commissioner and chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, said the federal government needed to overhaul regulations governing clinical trials and the doctors who oversaw them.

May 2007: In 2006, the Food and Drug Administration received reports of at least 29 children dying and at least 165 more suffering serious side effects in which an antipsychotic was listed as the “primary suspect.” That was a substantial jump from 2000, when there were at least 10 deaths and 85 serious side effects among children linked to the drugs. Since reporting of bad drug effects is mostly voluntary, these numbers likely represent a fraction of the toll.

May 2007: WASHINGTON, May 9 — By a vote of 93 to 1, the Senate passed a bill on Wednesday that would give the Food and Drug Administration new power to police drug safety, order changes in drug labels, regulate advertising and restrict the use and distribution of medicines found to pose serious risks to consumers.

May 2007: Yet the FDA is able to inspect only 0.7 percent of all imported food products, down from 1.1 percent the previous year. In 2006, that means the FDA inspected just 20,662 shipments out of more than 8.9 million that arrived in US ports – employing about 1,750 food inspectors for ports and domestic food-production plants.

April 2007: The Food and Drug Administration has known for years about contamination problems at a Georgia peanut butter plant and on California spinach farms that led to disease outbreaks that killed three people, sickened hundreds, and forced one of the biggest product recalls in U.S. history, documents and interviews show.

April 2007: 'It adds to the theory when you see other products that are labeled as protein supplements, in this case rice protein, and in South Africa corn gluten and in the previous case wheat gluten,' said Stephen Sundlof, FDA chief veterinarian. 'That melamine was found in all three of those, it would certainly lend credibility to the theory that this was intentional.'

March 2007: The Food and Drug Administration warned yesterday that anemia-fighting drugs called erythropoietins, which had $10 billion in U.S. sales last year, are being used so aggressively that they may be harming some patients.

March 2007: The changes are intended to respond to a growing chorus of critics who contend that drug and device makers have hijacked the Food and Drug Administration’s approval process by paying those who serve on the agency’s advisory panels.

January 2007: Officials outlined plans to better monitor safety problems after drugs are approved and to make internal changes to increase the profile of agency scientists who raise red flags about drugs. The steps were announced in response to a report last year by the congressionally chartered Institute of Medicine (IOM) that called for an overhaul of the FDA's culture and structure following safety controversies over drugs such as the painkiller Vioxx.

January 2007: That's a question being raised by scientists, activists and government bureaucrats since the Food and Drug Administration concluded in December that meat and milk from cloned animals should be allowed on the market.

January 2007: The consumer ads will be on the griddle early in this session at hearings on the user fees that manufacturers pay to speed the reviewing of new drugs by the Food and Drug Administration. The user fee law will die in the fall unless Congress acts to renew it.

January 2007: The number of deaths may be far higher. In April 2004, the Food and Drug Administration said it had received 260 reports of deaths associated with herbs and other nonvitamin, nonmineral supplements since 1989. But an unpublished study prepared in 2000 for the agency by Dr. Alexander M. Walker, then the chairman of epidemiology at the Harvard School of Public Health, concluded: ''A best estimate is that less than 1 percent of serious adverse events caused by dietary supplements is reported to the F.D.A. The true proportion may well be smaller by an order of magnitude or more.''

November 2006: The Food and Drug Administration ended its 14-year ban on the cosmetic use of silicone breast implants yesterday, despite lingering safety concerns from some health advocates.

November 2006: At a time when more and more products are being marketed as healthy, the fact that so many items seemed to flunk Hannaford’s inspection raises questions about the integrity of the nutrition claims, which are regulated by the Food and Drug Administration — or possibly about whether Hannaford made its standards too prissy or draconian. Either way, the results do seem to confirm the nagging feeling that the benefits promoted by many products have a lot more to do with marketing than nutrition.

October 2006: Five experts who have advised the Food and Drug Administration on drug safety yesterday threw their weight behind mounting criticism that the agency does not adequately protect the public from unsafe drugs.

August 2006: The Food and Drug Administration said yesterday that it was moving toward endorsing sale of the morning-after pill without a prescription for women 18 and older, signaling what may be the end of one of the most stubborn health policy debates of the Bush administration.

July 2006: In March, for example, the House of Representatives passed, and the Senate is considering, the benign-sounding 'National Uniformity for Food Act,' which would bar states from addressing food-borne hazards, leaving food safety solely to the Food and Drug Administration. Thirty-nine state attorneys general signed a letter opposing the act.

May 2006: Before the early 1990s, most drugs given to pets were human medications that appeared to help animals as well. But with dogs in particular living longer and being treated increasingly as members of the family, the demand for better drugs has grown, along with the public's willingness to pay for them. Most companies that now develop and sell pet drugs are subsidiaries or divisions of the major brand-name drug companies, and they must seek FDA approval to market their products much as they do with drugs intended for people.

February 2006: At a time when the use of low-cost generic drugs is being embraced as one of the few ways to rein in skyrocketing health care costs, the Food and Drug Administration has a backlog of more than 800 applications to bring new generic products to the market -- an all-time high.

February 2006: The user-fee proposal is controversial because many makers of generic drugs believe the FDA has been underfunding the Office of Generic Drugs for years and is allowing the manufacturers of brand-name medications to use procedural gimmicks to block final approval of their products.

January 2006: People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts, the agency said yesterday in a formal policy statement.

January 2006: Food and Drug Administration regulations have long allowed drug companies to give educational grants to individuals or groups that discuss or promote off-label uses. But in recent years, federal prosecutors have been investigating whether these activities have strayed beyond educational purposes and violated antikickback statutes or resulted in the government's spending money in its Medicare and Medicaid health programs for prescriptions that were not warranted.

November 2005: Senior Food and Drug Administration officials were told that the application to sell the 'morning-after pill' without prescription was going to be rejected before the staff completed its scientific review and months before the decision was made public, government investigators reported yesterday.

October 2005: A long-awaited report on the 2004 Food and Drug Administration decision to reject an application to allow easier access to the 'morning after pill' concludes that the decision was highly unusual, was made with atypical involvement from top agency officials, and may well have been made months before it was formally announced.

April 2005: The ads are regulated by the FDA's Division of Drug Marketing, Advertising and Communications. The office, which has barely three dozen employees, must review 30,000 to 40,000 ads a year. Acting commissioner Lester M. Crawford said recently that "our patience is sometimes worn thin" by the advertising claims.

January 2005: The revelations already have driven Vioxx from the market and led to a high-profile Senate hearing where the Food and Drug Administration was sharply criticized for its handling of numerous drug approvals and for its oversight of direct-to-consumer advertising. The agency will hold an unusual three-day meeting next month to assess the safety and benefits of the entire COX-2 class. It also includes Pfizer's drug Bextra, approved by the FDA in 2001.


RoleNameTypeLast Updated
Owner of (partial or full, past or present) Center for Drug Evaluation and Research (CDER) Organization Feb 4, 2007
Owner of (partial or full, past or present) Center for Food Safety and Applied Nutrition (CFSAN) Organization Jan 14, 2004
Owner of (partial or full, past or present) Center for Veterinary Medicine (CVM) Organization May 12, 2006
Owner of (partial or full, past or present) Drug Safety Oversight Board (DSB) Organization Jun 8, 2005
Opponent (past or present) McNeil Consumer Healthcare Organization Mar 13, 2011
Owner of (partial or full, past or present) Office of Drug Safety (ODS) Organization Jun 15, 2006
Owner of (partial or full, past or present) Office of Food Additive Safety Organization Sep 17, 2008
Owner of (partial or full, past or present) Office of Women's Health (WH) Organization Feb 28, 2007
Opponent (past or present) SFBC International Organization Mar 22, 2008
Owned by (partial or full, past or present) US Federal Government - Independent Agencies Organization May 4, 2005
Opponent (past or present) Xango Organization Jun 22, 2011
Research/Analysis Subject Prof. David Burnham Person Aug 7, 2006
Organization Executive (past or present) Mitchell A. Cheeseman Ph.D. Person Apr 29, 2008
Organization Head/Leader (past or present) Dr. Lester M. Crawford Person May 7, 2005
Opponent (past or present) Rep. Rosa DeLauro Person Aug 12, 2007
Advised by (past or present) Prof. Curt D. Furberg Person Oct 24, 2007
Organization Executive (past or present) Dr. Steven Galson MD,MPH Person May 10, 2005
Organization Executive (past or present) Dr. Jesse Goodman Person Apr 10, 2010
Organization Executive (past or present) Dr. David J. Graham M.D. Person Nov 19, 2004
Organization Executive (past or present) Dr. Victoria Hale Person Aug 2, 2006
Organization Head/Leader (past or present) Dr. Margaret A. Hamburg M.D. Person Mar 4, 2010
Organization Executive (past or present) William K. Hubbard Person Jul 27, 2007
Organization Head/Leader (past or present) Dr. David Aaron Kessler M.D. Person Jul 11, 2008
Possible/Unclear Lisa A. Krinsky M.D. Person Mar 22, 2008
Cooperation (past or present) Arthur A. Levin M.P.H. Person Nov 16, 2008
Organization Head/Leader (past or present) Dr. Mark B. McClellan Person
Organization Executive (past or present) Dr. Richard Pazdur M.D. Person Apr 11, 2010
Research/Analysis Subject Prof. Alex Tabarrok Ph.D. Person Jul 11, 2013
Organization Executive (past or present) Prof. Michael R. Taylor Person Jul 11, 2008
Employee/Freelancer/Contractor (past or present) Organization Executive (past or present) Prof. Michael "Mike" R. Taylor Esq. Person Aug 12, 2007
Organization Executive (past or present) Dr. Robert Temple M.D. Person May 24, 2006
Employee/Freelancer/Contractor (past or present) Anne Trontell Person
Organization Executive (past or present) Daniel E. Troy Esq. Person Jul 25, 2004
Research/Analysis Subject Opponent (past or present) Dr. Sidney M. Wolfe Person Feb 15, 2008
Organization Executive (past or present) Prof. Susan F. Wood Person Dec 4, 2006
Organization Executive (past or present) Dr. Janet Woodcock M.D. Person Jun 15, 2011

Articles and Resources

404 Articles and Resources. Go to:  [Next 20]   [End]

Date Resource Read it at:
Dec 14, 2013 The Selling of Attention Deficit Disorder: The Number of Diagnoses Soared Amid a 20-Year Drug Marketing Campaign

QUOTE: “The numbers make it look like an epidemic. Well, it’s not. It’s preposterous,”....The rise of A.D.H.D. diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. With the children’s market booming, the industry is now employing similar marketing techniques as it focuses on adult A.D.H.D., which could become even more profitable.

New York Times
Sep 28, 2013 In cancer drug battle, both sides appeal to ethics

QUOTE: Andrea Sloan is dying of ovarian cancer. Having exhausted all standard treatment options, her doctors say her best hope now is a new class of cancer drugs called PARP inhibitors....But she's not getting the treatment because the company is refusing to give it to her. That's because this drug she wants is still in clinical trials, and the company says hasn't been proven effective.

CNN (Cable News Network)
Dec 11, 2012 Scientists Propose Central Database for Disclosing Conflicts of Interest

QUOTE: a lack of standardization in COI disclosures increases the administrative burden on physicians and increases the chances of being accused of incomplete and misleading statements. As a solution, their committee — facilitated by the Institute of Medicine — recommends the creation of a centralize database for the disclosure and reporting of interests.

Scholarly Kitchen
Nov 24, 2012 As drug industry’s influence over research grows, so does the potential for bias

QUOTE: What only careful readers of the article would have gleaned is the extent of the financial connections between the drugmaker and the research.Whether these ties altered the report on Avandia may be impossible for readers to know. But while sorting through the data from more than 4,000 patients, the investigators missed hints of a danger that, when fully realized four years later, would lead to Avandia’s virtual disappearance from the United States: The drug raised the risk of heart attacks....

Washington Post
Mar 20, 2012 Generic Drugs Proving Resistant to Damage Suits

QUOTE: Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs. Now, what once seemed like a trivial detail — whether to take a generic or brand-name drug — has become the deciding factor in whether a patient can seek legal recourse from a drug company.

New York Times
Aug 19, 2011 Antibacterial Chemical Raises Safety Issues

QUOTE: a battle over the active ingredient in Dial Complete and many other antibacterial soaps, a chemical known as triclosan...Several studies have shown that triclosan may alter hormone regulation in laboratory animals or cause antibiotic resistance...F.D.A. has already said that soap with triclosan is no more effective than washing with ordinary soap and water, a finding that manufacturers dispute.

New York Times
Jul 28, 2011 Useless Studies, Real Harm (Op-Ed)

QUOTE: In an age of for-profit clinical research, this is the new face of scandal. Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naïvely sign up, unaware of the ways in which they are being used.

New York Times
Jul 07, 2011 How Bright Promise in Cancer Testing Fell Apart

QUOTE: as patients and their doctors try to make critical decisions about serious illnesses, they may be getting worthless information that is based on bad science. The scientific world is concerned enough that two prominent groups, the National Cancer Institute and the Institute of Medicine, have begun examining the Duke case; they hope to find new ways to evaluate claims based on emerging and complex analyses of patterns of genes and other molecules.

New York Times
Jul 04, 2011 Think Inside the Box

QUOTE: Bombarded with pharmaceutical ads listing what seems like every conceivable side effect, American consumers might think they are already getting too much information. But they — and their doctors — are not getting what arguably matters most: independent, plain-English facts about the medication. Fortunately, there is a simple model for getting such information across.

New York Times
Jun 25, 2011 In Medicine, New Isn’t Always Improved

QUOTE: the promise of innovation can also prove a trap, a situation now playing out with dire consequences for possibly tens of thousands of people who received artificial hips intended to let them remain active. The implants, known as metal-on-metal hips, were regarded by device makers and surgeons as a major advance over previous designs that used both metal and plastic. Now federal regulators and medical researchers are scrambling to determine how many implant recipients have been injured by the devices, which can shed dangerous metallic debris through wear.

New York Times
Jun 23, 2011 High Court sides with generic drug makers in narrow ruling

QUOTE: The justices in a 5-4 ruling said generic drug companies do not share the same level of responsibility as makers of brand-name equivalents, to update their warning labels when significant new risks emerge.

CNN (Cable News Network)
Jun 20, 2011 Support Is Mutual for Senator and Utah Industry

QUOTE: [Sen. Hatch] was the chief author of a federal law enacted 17 years ago that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market.... Mr. Hatch has been rewarded with hundreds of thousands of dollars in campaign contributions, political loyalty and corporate sponsorship of his favorite causes back home. His family and friends have benefited, too...

New York Times
Jun 14, 2011 F.D.A. Unveils New Rules About Sunscreen Claims

QUOTE: After 33 years of consideration, the Food and Drug Administration took steps on Tuesday to sort out the confusing world of sunscreens, with new rules that specify which lotions provide the best protection against the sun and ending claims that they are truly waterproof. The F.D.A. said sunscreens must protect equally against two kinds of the sun’s radiation, UVB and UVA, to earn the coveted designation of offering “broad spectrum” protection.

New York Times
May 13, 2011 Google Is Said to Have Broken Internal Rules on Drug Ads

QUOTE: Google allowed rogue online pharmacies to advertise on its site in violation of its own advertising policies, according to one of the companies subpoenaed in the federal investigation of Google’s drug ad sales.

New York Times
Apr 07, 2011 10 things that could ruin your day if the government shuts down

QUOTE: Roughly 800,000 federal workers won't get paid because they're considered nonessential and therefore, the first to be furloughed... Troops, including those serving in Iraq and Afghanistan, may not be paid on time... A government shutdown doesn't actually save taxpayers money.

CNN (Cable News Network)
Mar 10, 2011 U.S. Regulators and J.&J. Unit Reach a Deal on Plant Oversight

QUOTE: Federal regulators reached an agreement on Thursday with a unit of Johnson & Johnson that would impose greater federal oversight at three manufacturing plants responsible for recalls of children’s Tylenol and many other popular over-the-counter medicines... Last year, the company’s (Johnson & Johnson) DePuy unit recalled two different hip implants, affecting tens of thousands of patients worldwide. Its Animas unit recalled tens of thousands of insulin pump cartridges last month because they had the potential to leak and deliver too little insulin, the company said.

New York Times
Dec 21, 2010 House Passes Overhaul of Food Laws

QUOTE: food manufacturers will be required to examine their processing systems to identify possible ways that food products can become contaminated and to develop detailed plans to keep that from happening. Companies must share those plans with the F.D.A., and provide the agency with records, including product test results, showing how effectively they carry them out. The agency, which has sometimes been criticized for its failure to check up on risky food producers, will be required to conduct more frequent inspections in the United States and abroad.

New York Times
Dec 16, 2010 The Implants Loophole

QUOTE: The brief and troubled life of DePuy’s A.S.R. hip points to a medical implant system that is piecemeal and broken on many fronts, critics say. Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients.

New York Times
Oct 27, 2010 Glaxo to Pay $750 Million for Sale of Bad Products

QUOTE: GlaxoSmithKline, the British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant — the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.

New York Times
May 27, 2010 F.D.A. Weighs Penalties in Drug Recall

QUOTE: [The FDA] is considering further actions against McNeil Consumer Healthcare, the Johnson & Johnson unit, after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls...

New York Times

404 Articles and Resources. Go to:  [Next 20]   [End]