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This paper argues that the criminalization of drugs, via the criteria the FDA [Food and Drug Administration] uses to put drugs into different schedules, is illegitimate on scientific and philosophical grounds. The most contemporary developments in the study of drug use and drug addiction, undermine the legitimacy of the FDA scheme (as embodied in the Controlled Substances Act of 1970); these developments suggest that addiction to a drug is a result, not a cause, of the psychological difficulties a person may be experiencing while using the drug(s). What is known about drugs suggests that the way a drug is experienced, including whether someone has an addictive relationship with a drug, depends on the “setâ€, or “one’s internal environment and personality characteristicsâ€, and “setting†“the external social and physical environment.†Therefore, it is far more than the pharmacological properties of a drug—and those properties’ impact on the neurochemistry of an individual—that are responsible for the way a drug is experienced. The FDA scheme ignores “set†and “setting;†it magnifies the role of the drug’s pharmacological properties to the drug experience and conflates physical and psychological addiction. The FDA scheme is illegitimate, and through its use in controlling drugs, violates the right animating the spirit of the Constitution and our laws: to stimulate, control, and manipulate one’s own brain and body. This paper addresses the way in which drug prohibition violates the fundamental right to cognitive liberty, and in doing so fills in some holes in the legal basis for the right to use drugs currently being formulated by attorney Richard Glen Boire.

The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and reauthorized twice (referred to as PDUFA II and PDUFA III), gives the Food and Drug Administration (FDA) a revenue source -- fees paid by the pharmaceutical manufacturers -- to supplement, not replace, direct appropriations. The impetus behind the 1992 law was the length of time from a manufacturer's submission of a New Drug Application (NDA) or a Biologics License Application (BLA) to FDA and the agency's issuing its decision on approval or licensure, which FDA attributed to constrained review-staff time. This delay affected patients and the drug manufacturers. PDUFA I goals were to diminish the backlog of applications at FDA and to increasingly shorten the time from submission to decision. PDUFA II expanded the goals to include activities related to the investigational phases of a new drug's development; it also added the goal of increasing FDA communications with industry and consumer groups. PDUFA III authorized activities both at earlier (preclinical development) and at later (up to three years after drug approval) stages of drug research and development. FDA set these performance goals in conjunction with the drug manufacturers, and the Secretary of Health and Human Services (HHS) submitted them in letters to the chairs of the relevant congressional authorizing committees. The Secretary also submits annual PDUFA performance and financial reports. Based on its stated goals, PDUFA has generally been viewed as a success. FDA has added review staff and reduced its review times. It has also standardized the information required for applications and developed computer tools to use electronically submitted data. Criticism of PDUFA fits into three categories. First, the fees have not fully covered FDA's increased costs, despite the provisions that Congress implemented. Second, because PDUFA has directed a majority of the collected fees toward premarket review of applications, some people see PDUFA as responsible for what they view as the agency's increasing focus on premarket activities in contrast to the relatively slower increase in postmarket surveillance and safety studies and enforcement. They point to the fees' funding 20% of the salaries and expenses in FDA overall and 30% within the human drug program (with a yet higher proportion among the premarket drug review staff). Finally, some critics think that, through its provision of fees, the industry has too much influence over FDA actions. In January 2007, FDA released its proposal for PDUFA IV. The goals, developed through consultation with Congress, industry, and healthcare consumers and professionals, focus on securing FDA's sound financial footing, and enhancing both premarket review and the postmarket safety system. [ABSTRACT FROM AUTHOR]

The article presents a report of the Congressional Research Service which provides an overview Medicare Part D enacted as part of the U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 which offers voluntary, outpatient prescription drug benefit. It mentions that Part D provides coverage through private prescription drug plans that offer only drug coverage, or through Medicare Advantage prescription drug plans that offer coverage as part of broader, managed care plans.

The Prescription Drug User Fee Act (PDUFA, now called PDUFA I) was reauthorized as PDUFA VI by the Food and Drug Administration Reauthorization Act of 2017 (FDARA, P.L. 115-52). First passed by Congress in 1992, PDUFA gave the Food and Drug Administration (FDA) the authority to collect fees from the pharmaceutical industry and to use the revenue to support "the process for the review of human drug applications." FDA regulates the safety and effectiveness of drug and biological products sold in the United States. Prior to marketing a drug, a manufacturer must submit to FDA a new drug application (NDA) or a biologics license application (BLA) demonstrating that the product is safe and effective for its intended use. FDA's review of NDAs and BLAs is funded through a combination of annual discretionary appropriations from Congress and user fees collected from the pharmaceutical industry. Prior to FDARA, Congress had last reauthorized PDUFA, for a five-year period, through September 30, 2017, via Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144). User fees provided 65% of the Human Drugs Program funding for FY2016, accounting for 3,351 full-time equivalent employees. Therefore, as each reauthorization deadline approaches, FDA, industry groups, and many Members of Congress generally see PDUFA and the other human medical product user fees as must-pass legislation. Congress originally intended PDUFA to diminish the backlog of new drug applications at FDA and shorten the time from submission to decision. The general view is that PDUFA has succeeded. FDA has added review staff and reduced its review times. Throughout the reauthorizations, stakeholders (e.g., FDA, industry, and patient groups) have raised different concerns in the context of PDUFA, resulting in changes to the scope of activities covered by PDUFA. For example, • PDUFA II expanded the user fee program's scope to include activities related to the investigational phases of a new drug's development, and to increase FDA communications with industry and consumer groups. • PDUFA III again expanded the scope of activities that user fees could support to include a three-year postapproval period. • PDUFA IV removed the three-year limitation on postapproval activities and concentrated on new measures concerning postmarket drug safety. PDUFA V and VI maintained the scope of activities that PDUFA fees could support, and these fees now generally cover the full lifecycle of the drug product. Each reauthorization has connected prescription drug user fees to performance goals and targets, negotiated between FDA and the pharmaceutical industry. Over time, these goals have changed to reflect advancements in the regulatory science surrounding drug development. Similar to previous reauthorizations, the PDUFA VI package consists of two parts: (1) statutory language that reauthorizes the program and (2) the performance goals and procedures agreement between FDA and industry for FY2018 through FY2022. Title I of FDARA reauthorizes PDUFA, allowing FDA to collect fees and use the revenue to support specified activities for the review of prescription brand-name drugs and biologics. Additionally, FDARA includes eight other titles that reauthorize the medical device, generic drug, and biosimilar user fee programs through FY2022; modify the drug and device regulatory processes to encourage the development of drugs and devices for pediatric use; amend the law regarding medical device, prescription drug, and generic drug regulation; and make changes in several cross-cutting areas, such as annual reporting on inspection and analysis of use of funds. [ABSTRACT FROM AUTHOR]

The article discusses the use of several organizational treatment strategies including Treatment Access Center and Medication Assisted Treatment in Community Corrections Environments in the treatment of substance-dependent offenders. Topics include the percentage of convicted offenders who violated drug laws, the increase of drug arrests involving the use of cocaine and heroine, and the increase of opioid dependence which had brought problems for criminal justice systems.

The article discusses the legal status of industrial hemp, an agricultural commodity that is cultivated for use in producing a range of products, in the U.S., including federal drug laws, farm bill and other federal actions, and state laws. Topics mentioned include the Controlled Substances Act of 1970, the Drug Enforcement Administration (DEA) permit requirements, and DEA's 2003 rules on hemp. It also details the dispute over hemp food imports from 1999 to 2004 and the so called "Cole memo."

The article discusses the primary drug control policy strategies of the U.S. as of 2013. These strategies include combating drug production at the source, combating drug flow in transit, dismantling illegal drug networks and creating incentives to encourage international cooperation on drug control. The Andean Trade Preference Act (ATPA) and the 2002 Andean Trade Promotion and Drug Eradication Act (ATPDEA) passed by the U.S. Congress are tackled.

Teen drug consumption is on the rise in the United States after years of decline. Marijuana is the major substance involved, but use of the hallucinogen Ecstasy also has risen. The trends are reported in "Monitoring the Future," an annual survey of high school students conducted since 1975 by University of Michigan researchers. The latest survey results are adding fuel to the ongoing national debate over drug policy. Some experts argue that a recent wave of state medical-marijuana laws, as well as statutes that eliminate criminal penalties for personal use of pot, have persuaded teens that drugs such as marijuana are innocuous. That notion is especially dangerous to young people predisposed to addiction, specialists in teen drug use say. Proponents of drug legalization counter that no hard evidence exists of a connection between teen use and drug-law changes. [ABSTRACT FROM AUTHOR]

Drug-related violence in Mexico has spiked in recent years as drug trafficking organizations (DTOs) have competed for control of smuggling routes into the United States. Drug trafficking issues are prominent in Mexico because the country has for at least four decades been among the most important producers and suppliers of heroin, marijuana and (later) methamphetamine to the U.S. market. Today it is the leading source of all three drugs and is now the leading transit country for cocaine coming from South America to the United States. Although previous Mexican governments had accommodated some drug trafficking in the country, when President Felipe Caldern came into office in December 2006 he made battling the Mexican drug trafficking organizations a top priority. He has raised spending on security and sent thousands of troops and federal police to combat the DTOs in states along the U.S.-Mexico border and throughout the country. In response to the governments crackdown, the DTOs have responded with escalating violence. In recent years, drug trafficking violence in Mexico has claimed thousands of lives and reached a level of intensity and ferocity that has exceeded previous periods of drug-related violence. The governments intensified campaign against the DTOs resulted in changes in the structure of these criminal organizations. The seven major DTOs in Mexico have reconfigured. The fracturing of some of the most powerful drug trafficking syndicates and the reemergence of once powerful DTOs have led to bloody conflict within and among the DTOs. Today a small number of DTOs control the lucrative drug trafficking corridors through which drugs flow north from Mexico into the United States and high-powered firearms and cash flow south fueling the narcotics trade. President Caldern has demonstrated what has been characterized as an unprecedented willingness to cooperate with the United States on counterdrug measures. In October 2007, both countries announced the Mrida Initiative to combat drug trafficking, gangs and organized crime in Mexico and Central America. To date, the U.S. Congress has appropriated a total of $700 million for Mexico under the Mrida Initiative. The program, which combines counternarcotics equipment and training with rule of law and justice reform efforts, is still in its initial stages of implementation. The scope of the drug violence and its locationmuch of it in northern Mexico near the U.S.-Mexico borderhas been the subject of intense interest in Congress. The 111th Congress has held more than a dozen hearings dealing with the increased violence in Mexico as well as U.S. foreign assistance and border security efforts. This report examines the causes for the escalation of the violence in Mexico. It provides a brief overview of Mexicos counterdrug efforts, a description of the major DTOs, the causes and trends in the violence, the Caldern governments efforts to crackdown on the DTOs, and the objectives and implementation of the Mrida Initiative as a response to the violence in Mexico. For related information about Mexico and the Mrida Initiative, see CRS Report RL32724, Mexico-U.S. Relations: Issues for Congress, and CRS Report R40135, Mrida Initiative for Mexico and Central America: Funding and Policy Issues. For more information on international drug policy, see CRS Report RL34543, International Drug Control Policy. This report will be updated as events warrant. Related Reports: RL32724 R40135 RL34543 [ABSTRACT FROM AUTHOR]

Biologics, which are sometimes termed biopharmaceutials or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. A number of patents pertaining to certain biological products will expire in the near future. Some congressional concern has been voiced over the possibility that these patent expirations may not be accompanied by the introduction of competing, lower-cost biologics in the marketplace. With respect to traditional pharmaceuticals, the Drug Price Competition and Patent Term Restoration Act of 1984, a statute commonly known as the "Hatch-Waxman Act," is widely believed to have encouraged the availability of generic substitutes for brand-name pharmaceuticals upon patent expiration. The Hatch-Waxman Act in part permitted the Food and Drug Administration to expedite its marketing approval proceedings with respect to generic drugs. Some observers believe that the Hatch-Waxman Act's accelerated marketing approval provisions do not comfortably apply to biologics, however. Biologics differ significantly from traditional small-molecule pharmaceuticals in their size, structural complexity, and method of manufacture. Competitors who wish to develop followon biologics may face difficult, and even insurmountable difficulties in demonstrating that their product is equivalent to a particular brand-name biologic. Other commentators assert that different kinds of biologics vary considerably in their size and structure, and believe that existing Hatch-Waxman mechanisms are appropriately applied to many biologics. The patent system also plays a role in regulating competition in the biologics market. Patent protection is available for biologics in many circumstances, although the scope of protection may be limited by legal principles that restrict the availability of proprietary rights in naturally occurring substances. Legislation has been introduced in the 110th Congress that would create an expedited marketing approval pathway in the Public Health Service Act. The Access to Life-Saving Medicine Act, introduced as H.R. 1038 and S. 623, would grant the Secretary of Health and Human Service certain discretion to determine, on a case-bycase basis, what studies were necessary to establish comparability. A comparable biologic would have been required to have comparable principal structural features with the corresponding brand-name product; the same mechanism of action, if known; and the same route of administration, dosage form, and strength, among other factors. Under these bills, an applicant for a comparable biological product would be allowed optionally to elect to establish "interchangeability" with the brand-name product, a status indicating that the follow-on pharmaceutical can be expected to produce the same clinical results as the innovative drug. Both bills also address the patent consequences of follow-on generics practice. [ABSTRACT FROM AUTHOR]

Provides information on the legislative changes to the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 affecting pharmaceutical patents, made during the 108th Congressional Session in April 30, 2004. Aim of the significant changes to the patent laws as they apply to pharmaceutical products; Effect of the Hatch-Waxman Act on the availability of generic substitutes for brand name drugs; Concerns expressed by Members of Congress concerning the passage of the Hatch-Waxman Act in 1984.

The international traffic in illicit drugs contributes to terrorist risk through at least five mechanisms: supplying cash, creating chaos and instability, supporting corruption, providing "cover" and sustaining common infrastructures for illicit activity, and competing for law enforcement and intelligence attention. Of these, cash and chaos are likely to be the two most important. Different drugs, different trafficking routes, and different organizations have different relationships to terrorist threats. Therefore it might be possible to improve domestic security by targeting drug law enforcement on those drugs, routes, and organizations with the strongest known or potential links to terror. However, doing so would require new analytic capacities and decision-making strategies for all the agencies involved in drug law enforcement and there is no assurance that the policies that best implement the mission of protecting Americans from drug abuse will also perform best in protecting the country from terrorism. Indeed, the interests of ideology-driven terrorists and money-driven drug traders can sometimes diverge , as when increased resources deployed against terrorists adversely affect the activities of drug traders with no ties to terrorists. Any terrorist threats exacerbated by the illicit drug markets might be reduced by shrinking the markets themselves, both in physical volume and financial revenue. It is not clear that increased drug law enforcement alone can succeed in that respect; the cocaine and heroin markets have proven stubbornly resistant to vigorous enforcement efforts. Reducing demand for illicit drugs can also shrink the markets. The total number of users is much less important in determining drug volumes and revenues than the behavior of a relatively small number of chronic, high-dose drug-takers. Most of that "hard core" group consists of people who are repeatedly arrested, not only for drug offenses but for a wide range of property, violent, and public-order offenses. Acting to reduce the population of hard-core user-offenders, through treatment, drug courts, or testing-and-sanctions programs, may offer a better prospect for reducing the size of the drug markets, and thus potentially the contribution of drug trafficking to the terrorist threat. [ABSTRACT FROM AUTHOR]

The relatively high prices of prescription drugs was a major issue for the 106th Congress and will likely remain an issue during the 107th Congress. In particular, legislative discussion of the issue has focused on the uninsured elderly. High prescription drug prices can impose significant financial hardship on low-income seniors who do not have insurance coverage for prescription drugs. Medicare, which provides health insurance for most of the Nation's elderly, does not cover most outpatient prescription drugs. Various factors play a role in prescription drug pricing, such as the policy of patenting innovative drugs and the degree to which therapeutically equivalent drugs are available. Discussions of prescription drug pricing tend to emphasize the ability of many third party buyers (e.g. health maintenance organizations, hospitals, and pharmacy benefit managers) to obtain discounted prices for pharmaceuticals. Other buyers (e.g. many retail pharmacies and uninsured consumers) do not tend to receive such discounts. The net effect of such discounts is that buyers such as retail pharmacies and uninsured consumers usually pay the highest prices for drugs while third-party buyers usually pay lower prices for drugs. Third-party buyers are able to receive discounts at both the manufacturing level and at the retail pharmacy level, although third-party payers who do not use a formulary to manage outpatient drug benefits also pay higher prices for drugs. Economic analysis of the pharmaceutical market provides some insight into the reasons third-party buyers are able to obtain lower prices while other buyers are not. Third-party buyers negotiate prices and can exclude high-priced sellers (essentially manufacturers) from their portion of the pharmaceutical market. Conversely, other buyers (including uninsured consumers) do not negotiate over prices and are therefore unable to exclude sellers from the market. It is the ability to exclude sellers that tends to determine who pays the lowest prices for prescription drugs. Critics of this differential pricing in the pharmaceutical market have raised a number of issues, including fairness, equity and access to drugs, and how to end the price discrimination that the elderly face when they must pay for their own prescription medicines. Congress has been exploring several options for easing the financial burden that high prescription drug prices can impose on the elderly. One approach would be to create a drug benefit for the Medicare population. Another approach is to require pharmaceutical manufacturers to offer discounts on drugs sold to the uninsured elderly. A third approach is to facilitate the importation of prescription drugs from countries where prices are lower. This report will be updated as warranted. [ABSTRACT FROM AUTHOR]

The article presents information on several developments related to pharmaceutical companies in the U.S.. It states that Schering-Plough Corp. will acquire Organon BioSciences NV, the human and animal care businesses of Akzo Nobel NV, for nearly $14.4 billion. It discusses the U.S. Food and Drug Administration strengthening safety warnings for a class of anemia drugs. Information is provided on a surprise raid, conducted by federal officers, at the New Jersey offices of Ranbaxy Laboratories Ltd.