Food and Drug Administration: Benefits It Offers to Americans - Research Paper Example

ID No. Food and Drug Administration: Benefits it Offers to Americans Overview The Food and Drug Administration (FDA) is an agency of the US government that regulates the use and distribution of food, drug and other products which are meant for human consumption and use. It is a consumer protection agency that ensures that drugs, medical treatment procedures and equipment, cosmetics, biological goods, etc. are safe for humans and effective as well (Lee and Sprague par. 1). It is responsible in ensuring that domestic and imported drugs comply with the quality standards set for safety and health of human beings (United States Government 3). FDA is a federal agency headed by a commissioner who is appointed by the President of the US (Whittaker and Walter, The Purpose par. 1). Its precursor agency was the Food, Drug, and Insecticide Administration which was reorganized from the Bureau of Chemistry in 1927 (Lee and Sprague, History par. 3). In 1930, the name of the agency was changed to Food and Drug Administration (par. 3). It was said to protect not only the interest of the consumers but also the pharmacology industry due to some complexities that it has encountered in the process of regulation (Jacobs and Carson-Dewitt par. 1). The earliest functions of the FDA were set forth in the Food, Drug, and Cosmetic Act of 1938 which was passed after the poisoning of more than a hundred people from a drug sold by a Tennessee-based company (Lee and Sprague, History par. 3). The Act mandated that all drugs should pass the FDA approval before being released into the market (par. 3). Moreover, FDA was required to provide a set of safety standards for food and drugs, and that drugs should contain detailed labels and proper instructions for use (par. 3). Its scope of functions increased with the passage of other laws (e.g. Food Additives Amendment of 1958, Drug Abuse Control Amendments of 1965, 1976 Medical Devices Amendments) (par. 5). One-fourth of all the products in the US market are regulated by FDA as of 2008 (Lee and Sprague, FDA Approvals par. 3). Benefits of FDA Regulation Pharmaceutical firms are allowed by law to advertise their products which may not be accurate since adverts are made to exaggerate in order to convince consumers to buy their products. The FDA has the power to regulate the contents of the advertisements so that only a “balanced perspective” will be presented to consumers and end-users (DiLascio, FDA Regulations par. 1). Pharmaceuticals firms have also resorted to the DTC strategy in marketing their products. DTC refers to the Direct-to-Consumer approach that tends to reach consumers directly through the mass media, the print, television, radio, and the present technology of the internet (Griswold par. 3). Pfizer and Merrell Dow applied DTC approach in the 1980s that pushed end-users to doctors on the subtle suggestion that the latter have found new health treatments on the patients’ physical concerns (Griswold, History par. 4). This advertising approach mentions a number of symptoms and advises the consumers to visit their doctors if they experience any of them (par. 4). There is no mention though of any brand name (par. 4) but it can be gleaned from the sponsors the ads. FDA countered DTC advertising by placing on hold all drug adverts in 1983 and 1985 (par. 5). Moreover, the regulatory agency required the drug firms to include in the ads all side effects associated with drug use (par. 5). This move started the “reminder ads” epoch wherein good images of individuals are projected without referring to the physical condition being treated (par. 5). Later, FDA laid down the guidelines in 1987 that specify the standards to be followed in television adverts, and that includes listing of the possible side effects (par. 5). Current developments require drug manufacturing firms to submit their advertisements to the FDA for approval before being released into the public (par. 6). The adverts must include the identified side effects, the effectiveness of the drug and the problems that may arise from usage (par. 6). Violators will receive warnings and other heavier penalties (par. 6). However, due to the understaffed agency units, a written notice to the advertiser to withdraw the adverts can be served only after a year when the ads have been broadcasts for about eight months (Griswold, Pharmaceutical Advertising par. 1). The remedy suggested by the Institute of Medicine is to delay advertising of the drug within the first two years of its release so that the side effects can be determined during that period (par. 1). The FDA has initiated moves in order to know the impact of DTC advertising upon the doctors. It its 2002 survey, it was found out that a sizable number of physicians revealed that patients pressured them to prescribe the advertised drugs to them (par. 2). FDA has been able to execute its mandate since the 1930s that includes seizure of counterfeit goods for being adulterated, underweight, improperly labeled or fraudulently labeled, and below the required standard (Facts for Consumers 77). FDA recognizes that the demands in processing requirements (e.g. taking measurements, taking pictures, identification) are time consuming and affects its ability to conduct more inspections (United States Government 12). Thus, the agency is trying to address this concern by putting up a uniform system throughout all facilities (i). In the recent events that involved Chinese products, FDA has efficiently performed its part. It enhanced it testing procedures so that tainted products would not reach the stores (DiLascio, Chinese Exports par. 6). FDA has also coordinated with its counterpart agencies in China, the Chinese State Food and Drug Administration (SFDA) and the General Administration for Quality Supervision, Inspection, and Quarantine (both oversee the safety and standard of the products in China) so that goods that enter US would be safe for people (par. 6). The products identified by FDA which are harmful are children’s toys (that contain lead paint), toothpaste (with toxic chemicals) and pet food (with poisonous substances) (par. 5). Some Concerns with FDA It can be said that the FDA implements policies that are harmful to the people. The blame may not be totally pointed to the FDA since it is Congress that passes laws which the agency has to implement. For instance, the Prescription Drug User Fee Act passed by Congress in 1992 charged new fees on pharmaceutical firms that shortens approval period from 30 months to around 6 months (Driscoll & Newton, User Fees or Bribes par. 1). It is not uncommon that such expedited approved drugs would be withdrawn from the market a few months later due to adverse effects (par. 1). However, Congress reauthorized the Act in 1997, 2002 and 2007 amid criticisms (par. 1). FDA likewise approves some drugs that have not passed the one-year period for testing, such as the Redux (for weight loss, removed from market due to association with heart valve injury); Trovan (oral antibiotic, associated with liver infection, not withdrawn from market) (Driscoll & Newton, Taken Off the Shelf par. 2); Vioxx (painkiller, removed due to association with around 100,000 heart attacks and strokes); Ketek (antibiotic, use was limited to pneumonia after being linked with liver damage) (par. 3); those relabeled or removed due to injury or death (e.g. Baycol, Seldane, Lotronex, etc.) (par. 2); antidepressants that increase the risks to suicide and violent behavior in teens and younger adults (e.g. Zoloft, Luvox, Remeron, FDA did not require doctors to stop prescribing them to teens and younger adults) (Driscoll & Newton, The Depressing Side par. 2), etc. FDA personnel cannot assure the public that all incoming drugs ordered through the internet can be known and regulated by them (United States Government 3). Thus, consumers may well purchase counterfeit products along with genuine drugs (3). FDA was able to identify the sources of these prescription drugs to be Mexico, India, Pakistan, Argentina, Costa Rica, Philippines, Spain, Thailand, Fiji and Turkey (8). The entry of drugs through the internet from Canadian online pharmacies has really posed a big concern to FDA. But American citizens still patronize these online drugs due to the wide price difference compared with US produced or sold drugs (Jacobs and Carson-Dewitt par. 3). FDA has staunchly resisted importation of drugs into the country, and this includes the reimportation of US produced drugs already exported, on the ground that they are considered health risks (par. 5). Entry back into the US soil of drugs already sold outside the country costs lesser than the ones sold in the country in the first instance (5). For that reason, many Americans would prefer to buy them through online pharmacies. Canada has a policy that enables it to bring the prices of medicine at the lowest; thus, Canadian online pharmacies can sell drugs from the US at lower prices (5). The older adults are also the recipients of maintenance medicines which are priced higher than the rest (11). Therefore, those who live near the border of Canada would just cross the border everyday to purchase their prescribed drugs (11). In this type of scenario, the FDA cannot monitor and control the entry of drugs already bought by the older adults (11). The agency has not formulated a policy yet to address this specific situation. The agency has also fallen into medical, political and economics concern instead of merely concentrating on its mandate of regulation of food and drugs (6). Reports have been circulated that the top leadership of the FDA receives financial contribution from drug companies (7). The regulations issued by the FDA would become suspect whether they were made for the people’s health and safety or for the interests of the pharmaceutical industry (7). Conclusion The Food and Drug Administration, as reorganized, was established for the purpose of protecting the health and safety of American citizens. As part of its reorganization and evolving functions, it has laid down stringent measures so that the tragic experiences of the past that resulted to death and injury would not occur again. Food processing firms and drug manufacturers have complained of the stringent measures laid down by the agency which may have posed difficulty on them. The rules and regulations being passed by FDA though are meant for the protection of people and must be complied with regardless of being difficult to comply with. Death or impaired organs and limbs cannot be restored back once destroyed by toxic chemicals. The FDA has performed its mandate with efficiency. However, it faces challenges on all fronts as groups want it to reform or to be strengthened. The Coalition for a Stronger FDA (composed of patient organizations, public health proponents, NGOs) lobbies for more budget appropriation from the federal government (Lee and Sprague, FDA Approvals par. 3). The FDA is likewise undergoing reform in order to be more responsive to the rapidly changing environment. The 2004 Critical Path Initiative, established for such responsive reformation, will have a closer working relationship with drug manufacturers, scholars and researchers in order to make drug evaluation and approval more precise and efficient (Whittaker and Walter, The Future par. 2). Works Cited DiLascio, Tracey M. Chinese Exports: Overview. Points of View Reference Center. EBSCOhost. 2009. 20 April 2011. . Driscoll, Sally, and Heather Newton. The FDA Must Reduce its Dependence on the Pharmaceutical Industry. Points of View Reference Center. EBSCOhost. 2009. 20 April 2011. . Facts for Consumers. The Nation. 142.3680. (1936) : 7. 22 April 2011. . Jacobs, W. E, and Rosalyn Carson-Dewitt. Importing Drugs from Canada is a Complicated Issue that involves Economics, Government, and Health. Points of View Reference Center. EBSCOhost. 2009. 22 April 2011. . Lee, M., and Nancy Sprague. FDA Approvals & Regulations: An Overview. Points of View Reference Center. EBSCOhost. 2009. 20 April 2011. . Tracey M. DiLascio. Pharmaceutical Advertising Is Safe and Beneficial To Patients. Points of View Reference Center. EBSCOhost. 2009. 22 April 2011. . United States Government Accountability Office. Prescription Drugs: Preliminary Observations on Efforts to Enforce the Prohibitions on Personal Importation. Testimony before the Permanent Subcommittee on Investigations, Committee on Governmental Affairs, U.S. Senate. 22 July 2004. 22 April 2011. . Whittaker, Anne, Andrew Walter. The FDA Must Reform Itself to Keep Pace With the Food and Drug Industries. Points of View Reference Center. EBSCOhost. 2009. 20 April 2011. . Read More