Federal marijuana policy is constantly changing. This research analyzes the political forces behind these changes, emphasizing the policy per se rather than emphasizing the process by which policy-making occurs. The research is based on a policy-making framework that includes the following concepts: perception of the problem, pluralism, incrementalism, and policy cycles. Of major concern is the "problem perception" stage of this cycle, i.e., how perceptions of marijuana have affected policies toward that drug. Other drugs, particularly opiates, are analyzed only to the extent they affect marijuana policy. In the early 1800's drugs were widely used in America, and they were not perceived as a problem. Later, they were perceived as a medical problem. The Harrison Act of 1914 reflected these medical perceptions. But narcotics soon were perceived as a source of crime, and federal narcotics officials, through court procedures, used the Harrison Act to apply criminal sanctions to narcotics users, and to exclude doctors in private practice from treating drugs as a medical problem. In the 1930's marijuana was perceived by federal officials as a narcotic drug, and marijuana consumption was perceived as a criminal phenomenon. Therefore, the Marijuana Tax Act of 1937 was modeled after the Harrison Act of 1914, with penalties for marijuana violations similar to those of narcotics violations. In 1951 and 1956, the Federal Bureau of Narcotics successfully lobbied to increase the criminal sanctions for marijuana violations, despite opposition presented by the Department of Health, Education, and Welfare. In the 1960's new perceptions began to emerge. The 1962 White House Conference called by President Kennedy critically evaluated existing policies toward narcotics and marijuana, and it suggested that drug consumption should be treated as a medical and social problem rather than as a criminal problem. A content analysis of Presidential messages in the 1960's indicates President Kennedy probably viewed drugs as a medical problem, and Presidents Johnson and Nixon viewed drugs as a criminal problem. The 1960's saw changes in perceptions toward drugs that subsequently led to policy changes. The Narcotic Addict Rehabilitation Act of 1966 provided for emphasis on medical treatment rather than criminal sanctions for narcotics users. This act reflects a change in perceptions of marijuana by allowing probation and suspended sentences for marijuana violations, thus drawing a distinction between the consequences of narcotics consumption and marijuana consumption. The Marijuana Tax Act of 1937 was held to be a valid tax act by the Supreme Court, Litigants continued to attack the constitutionality of the act in their attempts to reverse convictions for violations of marijuana laws. Arguments based on freedom of religion, the right to privacy, the Equal Protection Clause, and cruel and unusual punishment were rejected. Timothy Leary's conviction was overturned, based on a self-incrimination argument, but the Court declined to expand this ruling. The Comprehensive Drug Abuse Prevention and Control Act of 1970 includes provisions indicating a change in perceptions toward marijuana. Of particular importance is the provision allowing federal courts to grant probation for certain marijuana offenses, and then to expunge the offender's record of any reference to criminal sanctions for such offenses. Changes in marijuana policy have been incremental, even in recent legislation. Two groups have been responsible for most of the political conflict and policy related to marijuana. These are the Bureau of Narcotics and the Department of Health, Education, and Welfare. Private groups have been vocal but not influential. Litigants have had limited success in courts due to the lack of a united effort.

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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, Technology and Policy Program, 2004. / Includes bibliographical references (p. 59-61). / Published findings report that it takes approximately eight years to bring a novel drug to market at an average cost of $800 million. Over the last ten years, the Food and Drug Administration (FDA) has helped to reduce the time from filing a new drug application (NDA) to granting marketing approval (i.e. the approval phase). However, there has been no alteration in the time required to progress from an investigational new drug application (IND) to an NDA filing (i.e. the clinical phase) over this same period. Since approval times began to decrease upon the initiation of the Prescription Drug User Fee Act (PDUFA), in this thesis I analyze the impact of PDUFA and calculate its benefits to companies. Due to the importance of getting new drugs to the market faster, I also investigate why there has been no significant change in the time required to test a drug clinically, and attempt to identify steps that could be taken to improve the clinical trial process. To investigate this, I evaluated ways in which the FDA and industry can work together to reduce clinical development times, without compromising safety. The results from this study show that PDUFA has had a significant impact on reducing approval times. More importantly, I determined that the direct costs of PDUFA are small in irmlparison to its benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug development has revealed potential steps both the FDA and industry can take to facilitate a more efficient process for assessing the safety and efficacy of drugs. Thus, this study represents an important step towards improving the development of medicines for the world. / by Matthew W. Strobeck. / S.M.

Background: Drugs have become an essential necessity in public health, people and the government has become willingly to spend more money on the country’s healthcare system to restore health, save lives, preventing disease and epidemics. Drugs should be properly regulated throughout development, production, importation and subsequent distribution to ensure it is prescribed with safe, effective and of good quality standards. The structure of drug regulations today has evolved over time. During the process, the scope of legislative and regulatory power expanded in result of a series of disastrous events related to pharmaceutical products, the adoption of more restrictive legislative were put in place for stronger safeguard to the public. In comparison to Singapore, Taiwan, US and EU where the drug regulatory system is highly structured, flexible and innovative, Hong Kong (HK) has a relatively simple and stubborn drug regulatory system and drug approval is greatly dependent on the approval status of the advance countries. According to the current registration system in HK, a new drug usually takes about 18-24 months to obtain an approval, and this figure is far behind the standard of Singapore in which medicine could be registered in 60 days. It is vital to have speedy approval process with high standards in safety, efficacy and quality on all approved drugs. If drugs are approved in a rush manner, it will lead to serious adverse drug reactions (ADR), or even deaths in consumption of unsafe, and ineffective drugs. On the other hand, slow approval will make patients suffer and increase the mortality rate to due inaccessibility of appropriate medicines to sustain life and combat diseases. With reference to the initiatives and innovative regulatory frameworks in the abovementioned countries, the modification of the local drug regulatory system is strongly recommended. Aim: 1. To examine the regulatory frameworks between Singapore, Taiwan, US and EU which affect the evaluation timeline required for new drugs approval. 2. As the first study to examine the drug regulations in HK, the regulatory barriers for new drugs submission will be explored and whether the regulatory initiatives from the abovementioned countries may result in an improvement in the overall drug regulation system HK. Method: This dissertation is a literature review and it will employ concentration in the drug regulation systems in Singapore, Taiwan, US and EU with varying levels of pharmaceutical regulation capacities. Search engines including Google, MedLine, PubMed (database up to 2012) with key words search of “Department of Health (DoH), Food and Drug Administration (FDA), European Union (EU), Taiwan FDA, Health Sciences Authority, evaluation routes, drug registration requirement, review timeline, Centre for Drug Evaluation, Pharmaceutical Evaluation Reports, risk management systems, pharmacovigilance, drug legislation”. Results: With an in-depth evaluation of the HK’s guideline and supporting document required for new drug submission, it is highly recommended that unnecessary documents at new drug submission (NDA) should be elimination to facilitate the new drugs approval process. The regulatory frameworks between all studied countries vary significantly in which implementation of initiatives (e.g. multiple evaluation routes, in-house evaluation system) from individual country affects the standards of new drugs approval and the evaluation timeline required to grant approvals. Conclusion: The regulatory frameworks in HK shall be revised with reference to numerous initiatives developed in the regulatory systems in Singapore, Taiwan, Us and EU. The possible key regulatory barriers which leads to the delays in new drugs approvals in HK includes duplication of certificates, limited number of Pharmacy and Poison Board meetings, the requirement of endorsement of new drugs approvals at the legislative council , absence of in-house evaluation system which allows full assessment of submission dossier, deficiency of clinical trials with the inclusion of local population, absence of electronic submission, multiple evaluation routes and rigorous post-marketing pharmacovigilance monitoring system. If the Department of Health (DoH) in Hong Kong could scrutinize the current regulatory frameworks with referenced to these countries, it will improve the overall drug regulatory system and reduce drug lag due to unnecessary barriers. / published_or_final_version / Public Health / Master / Master of Public Health