Criticism of the Food and Drug Administration
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Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation. The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from animals sold as pets to donations of human blood and tissue.[1]
A $1.8 million 2006
Charges of over-regulation
A group of critics claim that the FDA possesses excessive regulatory authority.
Alleged problems in the drug approval process
The economist Milton Friedman has claimed that the regulatory process is inherently biased against approval of some worthy drugs, because the adverse effects of wrongfully banning a useful drug are undetectable, while the consequences of mistakenly approving a harmful drug are highly publicised and that therefore the FDA will take the action that will result in the least public condemnation of the FDA regardless of the health consequences.[5][6]
Friedman and others have argued that delays in the approval process have cost lives.
Concerns about the length of the drug approval process were brought to the fore early in the
Allegations that FDA regulation causes higher drug prices
Studies published in 2003 by Joseph DiMasi and colleagues estimated an average cost of approximately $800 million to bring a new drug to market,
Economist
Charges of under-regulation
In addition to those who see the FDA as a source of excessive regulation, other critics believe that the FDA does not regulate some products strictly enough. According to this view, the FDA allows unsafe drugs on the market because of pressure from pharmaceutical companies, fails to ensure safety in drug storage and labeling, and allows the use of dangerous
A $1.8 million 2006
Allegations that the FDA covered up exportation of unsafe products
In the 1980s, Cutter Laboratories introduced a heat-treated version of Factor VIII concentrate in the US, designed to eliminate the risk of HIV transmission. However, Cutter continued to market the untreated product overseas, potentially spreading HIV while the safer product was marketed in the US.
Cutter initially had a voluntary agreement with the FDA to stop marketing the untreated product. However, when it became clear that Cutter was not complying with the agreement, the FDA ordered the company to cease marketing untreated blood products, stating: "It was unacceptable for them to ship that material overseas." At the same time, the FDA, according to Cutter's internal documents, asked that the issue be "quietly solved without alerting the Congress, the medical community and the public", leading to charges that the FDA was complicit in covering up Cutter's actions.[28]
Allegations that unsafe drugs are approved
Some critics believe that the FDA has been apt to overlook safety concerns in approving new drugs, and is slow to withdraw approved drugs once evidence shows them to be unsafe. Rezulin (
Troglitazone is a diabetes drug that was also available abroad at the time the FDA approved it. Post-marketing safety data indicated that the drug had dangerous side-effects (in this case liver failure). The drug was pulled off that market in the UK in 1997, but was not withdrawn by the FDA until 2000, before which time it is claimed that thousands of Americans were injured or killed by the drug.[29]
In the case of
Allegations that unsafe food additives and processing technologies are approved
Food safety advocates have criticized the FDA for allowing meat manufacturers to use carbon monoxide gas mixtures during the packaging process to prevent discoloration of meat, a process that may hide signs of spoilage from the consumer.[34]
The FDA has been criticised for allowing the use of recombinant bovine growth hormone (rBGH) in dairy cows. rBGH-treated cows secrete higher levels of insulin-like growth factor 1 (IGF-1) in their milk than do untreated cows. IGF-1 signalling is thought to play a role in sustaining the growth of some tumors, although there is little or no evidence that exogenously absorbed IGF could promote tumor growth. The FDA approved rBGH for use in dairy cows in 1993, after concluding that humans drinking such milk were unlikely to absorb biologically significant quantities of bovine IGF-1.[35] A 1999 report of the European Commission Scientific Committee on Veterinary Measures relating to Public Health noted that scientific questions persist regarding the theoretical health risks of milk from rBGH-treated cows, particularly for feeding to infants.[36] Since 1993, all EU countries have maintained a ban on rBGH use in dairy cattle.
The FDA has also been criticised for permitting the routine use of antibiotics in healthy domestic animals to promote their growth, a practice which allegedly contributes to the evolution of antibiotic-resistant strains of bacteria.[37] The FDA has taken recent steps to limit the use of antibiotics in farm animals. In September 2005, the FDA withdrew approval for the use of the
The FDA has received criticism for its approval of certain coal tar derived food dyes such as FDC
Professor Jim Stevenson from Southampton University and author of the report said: "This has been a major study investigating an important area of research. The results suggest that consumption of certain mixtures of artificial food colours and sodium benzoate preservative are associated with increases in hyperactive behaviour in children.
The following additives were tested in the research:
- Sunset yellow(FD&C Yellow #6) – Reddish-yellow coloring used in many foods and cosmetics
- Carmoisine – Red coloring used in jellies
- Tartrazine (FD&C Yellow #5) – Yellow coloring
- Ponceau 4R – Red coloring
- Sodium benzoate – Preservative
- Quinoline yellow – Food coloring
- Allura red AC (FD&C Red #40) – Orange / red food dye[39]
On April 10, 2008, the Food Standards Agency called for a voluntary removal of the colors (but not sodium benzoate) by 2009.[40] In addition, it recommended that there should be action to phase them out in food and drink in the European Union (EU) over a specified period.[41]
UK ministers have agreed that the six colorings will be phased out by 2009.[42] A Japanese group found in 1987 that tartrazine was not carcinogenic after being fed to mice for two years.[43] A German group found in 1989 that Sunset Yellow did not induce mutations that could lead to cancer in laboratory animals.[44]
The FDA has also been criticized for giving permission for cloned animals to be sold as food without any special labeling, although "cloned products may not reach the U.S. market for years." and "Authorities lack the authority to require labeling of products from cloned animals."[45]
In August 2013, a study released by The Pew Charitable Trusts found that of the 8105 additives that the FDA allows in food only 19% (1367) have toxicology information.[46]
Charges of FDA bias
Allegations of undue pharmaceutical industry influence
Pressure to allow pharmaceuticals
After his resignation, from his post as Commissioner of the Food and Drugs Administration in December 1969, Dr.
Viewing the pharmaceutical industry as FDA clients
In a 2005 interview, Dr. David Graham, associate director of the FDA's Office of Drug Safety, stated that "FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed"[50][51]
The Prescription Drug User Fee Act allows the FDA to augment its budget by charging fees to pharmaceutical firms.[52] Over $800 million was collected from 1993 to 2001 and rising each year.[53] It also has been shown that oftentimes, the FDA expert advisory panels had direct financial interests in the drugs or products being evaluated.[54] Former Editor of The New England Journal of Medicine, Marcia Angell, has stated that "It's time to take the Food and Drug Administration back from the drug companies.... In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster."[55] Critics have disputed the claim that the Prescription Drug User Fee Amendment has improved the speed of drug approvals.[56]
On April 14, 2017, House and Senate leaders announced a bipartisan agreement to extend the FDA's ability to collect high user fees from drug companies and medical device manufacturers. This allows the FDA to charge huge licensing fees to drug manufacturers, which has led to enormous increases in generic drug pricing. In 2013 and 2014, generic drug pricing for over 200 drugs increased over 100%. Many of those drugs had price hikes over 1000%. It has been reported that 75% of the FDA generic drug oversight budget comes directly from private drug companies.[57]
Bias toward more expensive drug
A historical example of how the FDA seemingly favors the pharmaceutical industry either from clandestine direct money payments to FDA directors and scientific advisers or other undisclosed or unknown means was seen with the generic drug
Allegations of bias against gay men in blood donation process
Blood collecting organizations, such as the
However, in 2006, the AABB, America's Blood Centers and American Red Cross recommended to the FDA that the deferral period for men who had sex with other men should be changed to be equivalent with the deferral period for heterosexual's judged to be at risk.[66] The FDA chose to uphold the blood ban. Female sexual partners of MSM (men who have sex with men) are deferred for one year since the last exposure. This is the same policy used for any sexual partner of someone in a high-risk group.[67] The intent of these policies is to ensure that blood is collected from a population that is at low risk for disease, since the tests are not perfect and human error may lead to infected units not being properly discarded. The policy was first put in place in 1985.[68]
In 2015, gay and bi men were allowed to donate blood after a one-year deferred period. In 2020 during the
Criticism of FDA's rejection of medical cannabis
In April 2005, the FDA issued a statement asserting that
Allegations regarding management and FDA scientists
Nine FDA scientists appealed to President George W. Bush and at the time, President-elect Barack Obama over pressure from management to manipulate data, mainly in relation to the review process for medical devices. These concerns were highlighted in a 2006 report[2] on the agency as well.[74]
Monsanto-case: Mrs. Miller from Monsanto applies at FDA for product safety, changes her job to FDA and confirms her own safety application as FDA manager. 5th GcMAF Conference - 2017 Moscow - Speaker: Scott Tipps - National Health Federation[unreliable source?]
Abolitionism
Libertarians such as American television personality John Stossel and editor-in-chief of Reason Katherine Mangu-Ward have advocated in favor of abolishing the FDA.[75][76]
See also
References
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External links
- Stockton, Nick. Infoporn: Proof That the FDA Isn’t Protecting Americans’ Health (2015), Wired