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 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.
[10] 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.
[20] 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.
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.
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.
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.
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."
Rezulin (troglitazone) and Vioxx (rofecoxib) are high-profile examples of drugs approved by the FDA which were later withdrawn from the market for posing unacceptable risks to patients.
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.
[31] 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.
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.
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.
[38] The FDA has received criticism for its approval of certain coal tar derived food dyes such as FDC yellow 5 and 6, which are banned in most European countries.
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 agency, in his opinion, did not have the motivation to protect consumers, faced budget shortfalls, and lacked support from the Department of Health, Education, and Welfare.
He said he had done everything by the book, both in the FDA and the Department of Health, Education, and Welfare, and he thinks that what the Administration was really wishing, was that he would stonewall the whole Academy report because it was goring too many pharmaceutical companies.
[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.
Despite an apparent discrepancy that deeply concerned the anesthesia and emergency room physician community, the FDA persisted in keeping the black box warning, while at the same time did not place any restrictions on the more expensive 5-HT3 antagonists.
The inclusion of homo- and bisexual men on the prohibited list has created some controversy,[63] but the FDA and Red Cross cite the need to protect blood recipients from HIV as justification for the continued ban.
[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.
Any non-monogamous individuals (regardless of sexual orientation) who have anal sex are automatically deferred to 3 months - Canada and the UK has implemented the same blood donation policy.
It will take a while to be fully implemented, due to the American Red Cross donation centers and hospital computer systems and data needing to be upgraded with the new information.
[69] In April 2005, the FDA issued a statement asserting that cannabis had no medical value and should not be accepted as a medicine, despite a great deal of research suggesting the opposite.
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.
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.