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.
A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.
Charges of over-regulation A group of critics claim that the FDA possesses excessive regulatory authority.
Alleged problems in the drug approval process
Bias against approving worthy drugs Economist Milton Friedman has claimed that the FDA 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.
Increased costs and delays from Kefauver Harris Amendment Friedman and others have argued that delays in the approval process have cost lives. The thalidomide birth defects crisis led to passage of the 1962 Kefauver Harris Amendment, which required proof of efficacy in addition to safety for approval of new drugs — despite the fact that the thalidomide crisis was entirely a safety issue. Proving efficacy is much more expensive and time-consuming than proving safety. By requiring proof of efficacy in addition to safety, the Kefauver Harris Amendment added considerable cost and delay to the drug approval process — which critics say may well have cost many more lives than it was said to save. Prior to passage of the Kefauver Harris Amendment, the average time from the filing of an investigational new drug application (IND) to approval was 7 months. By 1998, it took an average of 7.3 years from the date of filing to approval.FDAreview.org. Theory, Evidence and Examples of FDA Harm, citing Reprinted in Chicago Studies in Political Economy, edited by George J. Stigler, 303–48. Chicago, University of Chicago Press, 1988. and Prior to the 1990s, the mean time for new drug approvals was shorter in Europe than in the United States, although that difference has since disappeared.
Delays in HIV/AIDS drug approvals and subsequent reforms Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988, action at the FDA campus which resulted in nearly 180 arrests. In August 1990, Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.Faster Approval of AIDS Drugs Is Urged. The New York Times, August 16, 1990, Thursday, Late Edition – Final, Section B; Page 12, Column 4; National Desk, 830 words, By ROBERT PEAR, Special to The New York Times, WASHINGTON, Aug. 15 Partly in response to these criticisms, the FDA introduced expedited approval of drugs for life-threatening diseases and expanded pre-approval access to drugs for patients with limited treatment options.FDA Website: Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted 2 years later, in 1987. FDA report on accelerated approval process Three of the first 5 HIV medications were approved in the United States before they were approved in any other country.FDA press release on 3TC approval
Allegations that FDA regulation causes higher drug prices
High R&D costs from FDA-required clinical trials and delays Studies published in 2003 by Joseph DiMasi and colleagues estimated an average cost of approximately $800 million to bring a new drug to market,. while a 2006 study estimated the cost to be anywhere from $500 million to $2 billion. The consumer advocacy group Public Citizen, using a different methodology, estimated the average cost for development to be under $200 million, about 29% of which is spent on FDA-required clinical trials. DiMasi rejects the claim that high R&D costs alone are responsible for high drug prices. Instead, in a published letter, DiMasi writes, "...longer development times increase R&D costs and shorten the period during which drug companies can earn the returns they need to make investment financially viable. Other things being equal, longer development times reduce innovation incentives. As a consequence, fewer new therapies might be developed."
Patent protection and FDA requirements creating monopolies Economist Gary S. Becker, who won the Nobel Memorial Prize in Economics, has argued that FDA-required clinical trials for new drugs do contribute to high drug prices for consumers, mainly because of patent protection that provides a temporary monopoly which disallows cheaper alternatives from entering the market. He advocates dropping many FDA requirements, many of which provide no additional safety or valuable information, as this would hasten the development of new drugs, because they would be faster to bring to market, thereby increasing supply, and as a consequence would lead to lower prices.Becker, Gary. Power to the Patients . AEI-Brookings Joint Center Policy Matters 04-15. Originally published in The Milken Institute Review, 2nd quarter 2004.Becker, Gary S. Get the FDA Out of the Way, and Drug Prices Will Drop, Business Week Magazine, September 16, 2002.
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 agricultural chemicals, food additives, and food processing techniques.
A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Executive Summary of the 2006 IOM Report The Future of Drug Safety: Promoting and Protecting the Health of the Public
Allegations that the FDA covered up exportation of unsafe products
Failure to enforce export restrictions on unsafe blood 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."
Alleged cover-up of exportation issues Following Cutter's non-compliance, critics allege that the FDA sought to cover up Cutter Laboratories' non-compliance with its agreement to stop exporting unsafe Factor VIII blood products, even after issuing a mandatory order to cease. According to Cutter's internal documents, the FDA 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.
Allegations that unsafe drugs are approved
Oversight of safety concerns in drug approvals 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) and Vioxx (rofecoxib) are high-profile examples of drugs approved by the FDA which were later withdrawn from the market for posing unacceptable risks to patients.
Delays in withdrawing unsafe drugs Critics argue that the FDA is slow to withdraw approved drugs once evidence shows them to be unsafe. 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. David Graham's 2004 testimony to Congress
In the case of Vioxx, a pre-approval study indicated that a group taking the drug had four times the risk of heart attacks when compared to another group of patients taking another anti-inflammatory, naproxen. The FDA approval board accepted the manufacturer's argument that this was due to a previously unknown cardioprotective effect of naproxen, rather than a risk of Vioxx, and the drug was approved.
In 2005, the results of a randomized, placebo-controlled study showed that Vioxx users suffered a higher rate of heart attacks and other cardiovascular disorders than patients taking no medication at all. The manufacturer, Merck, withdrew the drug after disclosures that it had withheld information about its risks from doctors and patients for over five years, resulting in between 88,000 and 140,000 cases of serious heart disease of which roughly half died.
Conflicts of interest and pressure on FDA scientists David Graham, a scientist in the Office of Drug Safety within the CDER, testified to Congress that he was pressured by his supervisors not to warn the public about dangers of drugs like Vioxx. He argued that an inherent conflict of interest exists when the office responsible for post-approval monitoring of drug safety is controlled by the same organization which initially approved those same drugs as safe and effective. He said that after testifying against Vioxx, he was "marginalized by FDA management and not asked to participate in the evaluation of any new drug safety issues. It's a type of ostracism." In a 2006 survey sponsored by the Union of Concerned Scientists, almost one-fifth of FDA scientists said they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in an FDA scientific document."
Allegations that unsafe food additives and processing technologies are approved
Inadequate long-term safety testing for additives