Public pressure

An official product assessment and registration system for pharmaceuticals exists in each of the 10 countries. Their functions are determined by legal provisions. Systems for registration of pharmaceutical products came into operation at quite different times in the 10 countries — as early as 1942 in Tunisia and as late as 1993 in Uganda. Some of the systems have evolved in response to dmg-related crises such as the thalidomide disaster, public pressure to expand the scope of dmg assessment and the pressure from industry and consumers to expedite the registration process. 

At the same time, the public s faith in science and technology was eroding. Radioactive fallout from atomic bomb tests was poisoning cows milk, and the thalidomide antinausea medicine prescribed to pregnant women in Europe had caused severe birth defects in 8000 children. Above all, the enormous growth of the chemical industry and pollution after World War II put public pressure on Congress to clean up the nation s air and water. 

Hazardous properties published public pressure against further use... 

Even under tremendous public pressure, the planning committee would not commit itself wholeheartedly to the proposal and gave only tentative approval to the waterfront development plan. 

The Palo Verde nuclear power station near Phoenix, Arizona, was originally intended to have 10 nuclear reactors with a generating capacity of 1,243 megawatts each. As a result of public pressure, construction at Palo Verde was stopped after three operating reactors were completed. This installation is on 4,000 acres and is cooled by waste water from the city of Phoenix, which is nearby. An area of 4,000 acres is 6.25 square miles or 2.5 miles square. The power generating facilities occupy a small part of this area. 

Saccharin found to cause cancer in rats banned by the FDA temporarily, but Congress placed a moratorium on this ban because of public pressure saccharin is still available. 

The police was under tremendous public pressure to find the perpetrators. Following the explosions, several people who later became known as the Birmingham Six were detained. 

The recognition of the considerable influence of public pressure is particularly intriguing, where public scandals motivated both commercial enterprises and state institutions to take action in some instances. This raises the question as to what extent the power of public interest groups and the media can be influenced in a positive way in order to promote the public discussion of guiding principles that could orientate the development and design of new substances and technologies. 

The artificial sweetener cyclamate was banned because of a study linking it to bladder cancer in rats when large doses were fed. At least 20 subsequent studies have failed to confirm this result but cyclamate remains banned. In 1977 saccharin was found to cause cancer in rats. It was banned by the FDA temporarily, but Congress placed a moratorium on this ban because of public pressure. In 1992 it was found that saccharin may cause cancer in rats but not in humans. Saccharin is still available today. A more recent sweetener, aspartame (Nutrasweef ), has also come under attack but has not been proven to be a problem since its introduction in 1981. 

Anhydrous perchloric acid is not sold commercially, Aqueous solutions of perchloric acid are sold at low concentrations foi analytical standard applications and at concentrations up to 70%. The price for 70% perchloric acid varies and starts at 2.70/kg, depending on the quantity and level of impurities. The U.S. domestic capacity of ammonium perchlorate is roughly estimated at 31,250 t/yr. The actual production vanes, based on the requirements for solid propellants. Environmental effects of the decomposition products, which result from using solid rocket motors based on ammonium perchlorate-containing propellants, are expected to keep increasing public pressure until consumption is reduced and alternatives are developed. Approximately 450 t/yr of NH+ClCXt-equivalent cell liquor is sold to produce magnesium and lithium perchlorate for use in the production of batteries. 

Society is playing a growing role in determining the conditions under which the chemical industry will operate its plants transport, store, and market its products and handle its wastes. This role is expressed in legislation, in product judgment, and in the sheer weight of public pressure which can affect the chemical plant s ability to function. 

While the FDA is under intense congressional and public pressure to shorten the approval process, however, more profound responsibilities and pressures assure that an abbreviated process does not compromise safety and quality. Therefore, there is an inverse relationship between the amount of outside referral in a 505(b)2 and the skepticism it engenders. Subjectively viewing the process, a 505(b)2 that relies entirely on published studies and Agency findings would face maximum opposition (and, without at least a BE/ BA study, no real patent projection). A 505(b)2 that represents a combination of outside published studies and/or FDA findings with applicant-conducted studies can reduce costs, shorten the research process, and stand an excellent chance in the NDA review. 

An amicus curiae, (friend of the court) brief is intended to bring to the attention of the court relevant matters not already brought to its attention by the parties involved. Such a brief is usually filed by an interested group or institutions and constitutes a form of public pressure. 

Potential for social conflict and mobilisation (degree of political or public pressure on risk regulatory agencies). 

Mr. Kennedy. . . We Have No Right to Test. Everything he did was done to attract maximum attention and keep public pressure on the government to discontinue its bomb tests and stop the fallout. 

The objective is to enable needs to be defined so that available resources may be deployed according to priorities set by society which has an interest in fairness between its members. The question is whether resources are to be distributed in accordance with and unregulated power struggle between professionals and associations of patients and public pressure groups — all, no doubt, warm-hearted towards deserving cases of one kind or another, but none able to view the whole scene or whether there is to be a plarmed evaluation that allows division of the resources on the basis of some visible attempt at fairness. 

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