Term Paper on "Admin Law"

Term Paper 5 pages (1598 words) Sources: 5

[EXCERPT] . . . .

Vaccines

The issue at hand is why federal agencies will not take liability for the use of the Swine Flu Vaccine or the Anthrax Vaccine, both of which are clearly needed and could save many lives if administered in a wide basis. The issue was first raised with the swine flu epidemic in 1976, at which time President Gerald Ford wanted to immunize the entire country. The program faced many delays and critical newspaper articles, and only some 24% of the population was vaccinated before the program was canceled in the face of growing concern about the vaccine. One reason why the program was stopped was because of evidence that the use of the vaccine was connected to an increase in Guillain-Barreacute Syndrome (GBS), a rare paralytic disease similar to polio. It was not clear that the vaccine was causing GBS, but it was thought that the vaccine might be a trigger for GBS (Warner, 1999, para. 11).

A vaccine for anthrax was considered after the terrorist use of anthrax in letters to various persons and institutions in 2001, not long after the 9-11 attacks. The threat of anthrax as a weapon caused the Department of Defense to undertake a program of vaccination for the troops in Afghanistan and Iraq, a move challenged by lawsuits claiming scientific evidence of the ineffectiveness of the vaccine. The Center for Disease Control, however, suggests the use of the vaccine when warranted and states,

There is a vaccine to prevent anthrax, but it is not yet available for the general public. Anyone who may be exposed to anthrax, including certain members of the U.S. armed forces, laboratory workers, and workers who may enter or re-enter contaminated areas, may get the vaccine. Also, in the event of an attack using anthrax as a weapon, people exposed would get the vaccine (Anthrax: What You Need to Know, 2003).

The process for approval of a vaccine is stringent and keeps errors to a minimum. Approval is sought from the Food and Drug Administration. The basic mission of the FDA has remained "to assure that the products it regulates are safe and truthfully labeled" (Hutt & Merrill, 1996, p. 2). However, the current role of the agency encompasses a much larger mandate, that including a role in the development, testing, introduction, and marketing of these products. At one time, the actions of the agency focused on the enforcement of clear-cut statutory prohibitions, while it now includes choosing among alternatives in controlling advanced technologies (Hutt & Merrill, 1996, p. 2).

The regulatory responsibilities of the FDA are embodied in the Food, Drug, and Cosmetic Act from 1938, since amended. This legislation was passed in response to a need for "legally mandated quality and identity standards for foods, prohibition of false therapeutic claims for drugs, coverage of cosmetics and medical devices, clarification of the FDA's right to conduct factory inspections, and control of product advertising" (Swann, 1998, section 2).

A primary role for the FDA exists in the introduction of new drugs, and this is covered in the Code of Federal Regulations 21CFR310.303, which states, new drug may not be approved for marketing unless it has been shown to be safe and effective for its intended use(s). After approval, the applicant is required to establish and maintain records and make reports related to clinical experience or other data or information necessary to make or facilitate a determination of whether there are or may be grounds under section 505(e) of the act for suspending or withdrawing approval of the application (Title 21, 2005, Part 310).

This latter provision can be difficult given the fact that some drugs may have to be taken for a lifetime, so that the acquisition of the necessary data for determining the safety and effectiveness of long-term use of such drugs requires extensive animal and clinical testing as a condition of approval. The act goes on to note,

Nonetheless, the therapeutic or prophylactic usefulness of such drugs may make it inadvisable in the public interest to delay the availability of the drugs for widespread clinical use pending completion of such long-term studies. In such cases, the Food and Drug Administration may approve the new drug application on condition that the necessary long-term studies will be conducted and the results recorded and reported in an organized fashion (Title 21, 2005, Part 310).

This provision has created a number of controversies over the years because of the failure of companies to fulfill the requirement in a timely manner or because critics believe the FDA has been either too harsh or too lenient in enforcing this provision.

The rigorous approval process is designed to assure safety and also to reduce subsequent lawsuits, and the federal government in recent years has seemed more concerned with liability issues than with assuring the health of citizens. This has been especially true with respect to vaccines that the government might have to mandate, and this concern has increased with concerns about terrorism and the possible use of disease as a weapon. In 2005, legislation was considered under the heading Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S. 1873), intended to strip

Americans of the right to a trial by jury if harmed by an experimental or licensed drug or vaccine that they are forced by government to take whenever federal health officials declare a public health emergency. The claim was that this legislation would speed up the adoption of drugs and vaccines and would give the Secretary of the Department of Health and Human Services the sole authority to decide if a manufacturer violated laws on drug safety while preventing citizens from challenging this decision in the civil court system. The law would establish the Biomedical Advanced Research and Development Agency (BARDA) as the agency concerned with advanced research and development of drugs and vaccines in response to terrorism or flu outbreaks. The agency would also operate in secret to keep any damaging information about vaccines from the public (Congress Set to Pass Law Eliminating Liability for Vaccine Injuries, 2005).

Part of the impetus for such legislation was the annual changes in the flu vaccine, caused by the fact that the strains of flu undergo rapid mutation so that a new vaccine is needed each year. The government believes that many drug companies avoid manufacturing flu vaccine out of liability concerns and thus wants to eliminate those concerns. A news report finds that no company "wants to invest hundreds of millions of dollars and five-to-seven years in building an egg-based vaccine plant when the whole industry is on the verge of switching to a radically new way of making the product.... Sometime in the next decade, flu vaccine will start to be grown in cell cultures, not eggs. It is a technology far more clean, predictable and expandable than the egg-based way of old" (Brown, 2004).

However, Mello (2005) notes that there are many reasons to believe that the flu vaccine is not considered an attractive product for drug manufacturers for reasons other than liability and that shortages are likely to continue because of these other reasons even if liability were removed from the process (p. 1820). In addition, the drug industry is already protected from liability for the production of seasonal flu vaccines and other childhood vaccines by the Childhood Vaccine Injury Act of 1986, which denies more than 75% of claims.

The Biomedical Advanced Research and Development Authority (BARDA) is within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services and provides "an integrated, systematic and approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies" (Biomedical Advanced Research and Development Authority, 2007, para. 1). BARDA manages Project BioShield,… READ MORE

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