Modernizing the FDA: an incremental revolution

The U.S. Food and Drug Administration (FDA) is responsible for protecting consumers from unsafe or ineffective drugs and medical devices. The agency's role is defined by a growing and increasingly complex set of statutes, which reflect Congress's desires, on the one hand, to prevent product hazards and, on the other, to expedite FDA review and approval of promising new medical technologies. Congress's latest attempt to calibrate regulation to achieve these goals, the 1997 Food and Drug Administration Modernization Act, endorses certain of the FDA's own innovations and changes in the agency's ways of doing business.     

Legislation to regulate medical devices.

The history of medical device regulation began with the need to rid the marketplace of bogus inventions which were either harmful in themselves or harmful because they delayed meaningful treatment of illness. Since World War II, sophistication in medical technology and development of electronic and other types of medical devices has created a new need for regulation of safety and performance of devices used to cure and mitigate disease in man. The 1938 amendments to the Food, Drug, and Cosmetic Act gave FDA authority over labeling and advertising of devices, enforceable only after devices were marketed. In 1969 a study by an HEW commission documented the need for further legislation. The commission recommended three categories of medical devices: those requiring premarket clearance or scientific review, those for which standards could be established to protect the public, and those which are generally recognized as safe and for which nor standards would be necessary. In 1974 the Senate unanimously approved Senator Kennedy's "Medical Device Amendments of 1973" legislation which fulfills the recommendations of the HEW commission report. The House of Representatives failed to pass their version of the legislation in the 93rd Congress. Senator Kennedy re-introduced the bill in the 94th Congress and it passed the Senate in April 1975. Representative Rogers re-introduced an amended bill. The bill is expected to become law in 1975.     

The therapeutic partnership: legal and ethical aspects of consumer health information

Patients' rights to information in the UK are based on a mixture of statute (including legislation on access to medical records) and case law (principally revolving around the issue of informed consent). These rights are set out in the Patient's Charter, which is itself a mixture of rights based on legislation and those enforced by management practice. Failure to provide adequate information to a patient could expose a medical practitioner to action for negligence or battery. Negligent information-giving could also expose consumer health information services to damages, for which the best defence is a high standard of professional competence and adequate professional indemnity insurance. Sharing information about the risks and benefits of treatment to enable truly informed decision making and consent by the patient is a key element of an ethical relationship between care giver and consumer--the therapeutic partnership.     

Managing pesticide chronic health risks: U.S. policies

This paper provides an overview of U.S. government pesticide risk management efforts over time and in recent years, relevant to chronic health risks of pesticides. Pesticides are in widespread usage in the U.S. With hundreds of active ingredients and thousands of products on the market, management of pesticide risks has been a daunting challenge. The first legislation providing federal authority for regulating pesticides was enacted in 1910. With the establishment of the U.S. Environmental Protection Agency in 1970 and amendments to the pesticide law in 1972, the federal government was for the first time given the authority to regulate health and environmental risks of pesticides. However, older pesticide risks were not addressed until legislation was enacted in 1988, requiring "reregistration" and 1996, requiring that pesticide food standards are safe for children. In result, the U.S. has seen an expansion of development of pesticide products that are registered as "reduced risk" or are biologicals. Additionally a large number of older pesticides have been cancelled or reduced from the market and/or from individual food uses. Through biomonitoring data, the U.S. may now be seeing trends in reduction of exposure to certain pesticides, the organophosphate insecticides. However, pesticide sales data through 2001 do not provide evidence for such trends.     

New FDA drug approval policies and HIV vaccine development.

The need for new drugs to treat AIDS has caused the federal Food and Drug Administration to modify its procedures for reviewing and approving investigational drugs. Even researchers with reservations about the FDA's new policies are receptive to the idea that the drug review process in the United States could be improved, and the same may be true for the procedures by which vaccines are reviewed. Mariner explains why, because of the differences between drugs and vaccines, the FDA's new drug review policies should not be applied to investigational vaccines to prevent HIV infection. Experimental vaccines warrant separate treatment to protect the healthy subjects who receive them. Mariner argues that the FDA should make an explicit decision to continue to review candidate HIV vaccines in its vaccine unit, separately from drugs, with stricter standards of safety and efficacy.     

The bootstrap procedure in individual bioequivalence

A bootstrap-type hypothesis test procedure for assessing individual (or population) bioequivalence between two drug formulations is suggested in a draft guidance from the United States Food and Drug Administration (FDA). The purpose of this article is to study the unknown properties of this test procedure and propose some improved test procedures. We find that: the FDA's bootstrap computation is not correct; the power of the FDA's test can be very low; the use of the REML method suggested in the draft guidance does not have any advantage over the use of simpler methods such as the moment method; and the method of sample size determination in the draft guidance is inappropriate. We study the size and power of different bootstrap test procedures and suggest a method for sample size determination. It is our hope that this article will draw some attention to further research in this area, and eventually a satisfactory statistical method can be implemented for assessing individual (or population) bioequivalence.     

2017版和2009版国家医保药品目录的对比研究

目的：探索新版医保目录的调整方向，为指导各省制定省级增补目录提供依据。方法：运用EXCEL和SPSS18.0对2009版《药品目录》和2017版《药品目录》进行对比分析，比较二者差异。结果：新版目录中药品种数增加明显，医保新增谈判药品目录；新版目录西药的分类方式发生改变；目录增补品种多，剔除药品少；医保目录新增剂型多为颗粒剂、口服液体制剂；甲乙类药品增长比例基本一致；国家增强了药品适应症支付限制，减少了对医保门诊的报销限定。结论：本次医保目录调整重点扶持中药和民族药，关注高值药品和儿童药，药品分类更为细化，目录管理日趋严格。     

我国药品安全监管：制度变迁和现实挑战（1949—2005）

药品存在多种风险,随着工业化的推进,各国都对药品安全实行严格的政府监管。我国政府从建国伊始就设立药政、药检机构,并对医药行业进行指令性的行政管理,以确保人民群众的药物安全和可及。成立于1998年的国家药监局是国务院机构改革的产物,其在形式上解决了医药领域多头管理、职权交叉、政企不分等问题,并运用行政许可、信息公开等手段对药品安全进行监管,试图达到“以监管为中心,监、帮、促相结合”的政策目标。然而从国家药监局成立至2005年,我国药监领域出现诸多问题,表现为药害事故频发,低水平新药泛滥,行政许可领域腐败现象严重,民族制药工业经济效益不佳,药品使用环节监管无力等。政策目标多元,法律地位模糊,机构声誉不佳,监管能力不足和内部认同度低可以部分地解释这一“没有赢家”的政策结果。     

对美国FDA电子产品辐射控制（EPRC）监管体系的调查分析

由美国食品药品监督管理局（Foodand Drug Administration，文中简称FDA）制定的监督管理法规具有很高的水平，堪称是世界上最为完善的管理制度，在国际上赢得了极高的声望和广泛的认可。本文系统介绍了美国FDA对电子产品辐射的控制监管体系，供业内相关人员学习和参考。     

Permissive nicotine regulation as a complement to traditional tobacco control

Background  

Cigarette smoking takes a staggering toll on human health and attracts considerable public health attention, yet real solutions seem distant. The 2004 Family Smoking Prevention and Tobacco Control Act (US Senate bill S2461) would have given the US Food and Drug Administration limited authority to regulate cigarettes to "protect the public health." However, such legislation is unlikely to substantially reduce smoking or related deaths.     

医疗质量精细化管理的措施与成效

实行医务处、护理部每日对全院危重患者交接班制度和每周组织职能部门全方位督查医护质量,加强医疗质量的精细化管理,可以及时发现潜在不安全因素,降低医疗风险,确保患者的安全。     

Science, Law, and Politics in FDA's Genetically Engineered Foods Policy: Scientific Concerns and Uncertainties

The Food and Drug Administration's (FDA's) 1992 policy statement granted genetically engineered foods presumptive GRAS (generally recognized as safe) status. Since then, divergent views have been expressed concerning the scientific support for this policy. This paper examines four sources to better understand the basis for these claims: 1) internal FDA correspondence; 2) reports from the National Academy of Sciences; 3) research funded by US Department of Agriculture from 1981 to 2002; and 4) FDA's proposed rules issued in 2001. These sources reveal that little research has been conducted on unintended compositional changes from genetic engineering. Profiling techniques now make this feasible, but the new debate centers on the functional meaning of compositional changes.     

Digital mammography. Why hasn't it been approved for U.S. hospitals?

Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.     

Management of clandestine drug laboratories: need for evidence-based environmental health policies

Clandestine drug laboratories (CDLs) have been emerging and increasing as a public health problem in Australia, with methamphetamine being the dominant illegally manufactured drug. However, management and remediation of contaminated properties are still limited in terms of regulation and direction, especially in relation to public and environmental health practice. Therefore, this review provides an update on the hazards and health effects associated with CDLs, with a specific look at the management of these labs from an Australian perspective. Particularly, the paper attempts to describe the policy landscape for management of CDLs, and identifies current gaps and how further research may be utilised to advance understanding and management of CDLs and inform public health policies. The paper highlights a significant lack of evidence-based policies and guidelines to guide regulatory authority including environmental health officers in Australia. Only recently, the national Clandestine Drug Laboratory Guidelines were developed to assist relevant authority and specialists manage and carry out investigations and remediation of contaminated sites. However, only three states have developed state-based guidelines, some of which are inadequate to meet environmental health requirements. The review recommends well-needed inter-sectoral collaborations and further research to provide an evidence base for the development of robust policies and standard operating procedures for safe and effective environmental health management and remediation of CDLs.     

Pharmaceutical Restrictions

Restrictions on the use of pharmaceuticals (such as those for low molecular weight heparins) are commonly imposed by healthcare organizations to combat rising health care costs. These restrictions can be system-based which are established by imposing specific coverage policies by insurance companies and payors or can be patient-based which are those that limit certain therapeutic agents to specified patient populations.Disease management (DM) programs are implemented by healthcare organizations to improve patient care while utilizing resources efficiently. From a payor perspective, restricted use of pharmaceuticals would conform to the goals of DM. However, from a practitioner’s perspective, restrictions on the use of medications could sometimes be viewed as conflicting with their goal of providing appropriate patient care. Formularies and prior-authorization programs may sometimes impede physicians’ clinical autonomy and may hinder physicians’ willingness to participate in DM protocols with such drug restrictions. Furthermore, direct-to-patient advertisements and patient education are encouraging patients to participate actively in the drug selection process. When pharmaceutical restrictions prevent patients from receiving their drug of choice, patients may perceive that their treatment is suboptimal and unfavorable.Despite implementing a fine disease management protocol, imposing rigid drug-use restrictions could hinder physicians’ and patients’ buy-in of DM programs.     

Settling for less? Tobacco industry

In November 1998, a coalition of state negotiators and five tobacco companies reached an agreement in which the cigarette makers would pay out the biggest financial settlement in history, $206 billion over the next 25 years to 46 states, to compensate for the medical treatment of patients suffering from tobacco-related health problems. Critics of the settlement say the tobacco companies are getting off the hook too easily, and that the deal's public health provisions are unacceptably riddled with loopholes. But the attorneys general who negotiated the settlement defended it as a good deal-but clearly not as a panacea. Ultimately, they feel, Congress should pass legislation to provide essential reforms, including full Food and Drug Administration authority over tobacco.     

Killing with kindness: why the FDA need not certify drugs used for execution safe and effective.

In 1977, Texas and Oklahoma became the first states to legalize administration of the death penalty by lethal injection; by late 1985, 14 other states had followed suit. Opponents of the death penalty petitioned the Food and Drug Administration in 1980 to declare drugs specified for use in executions as "not approved," and to prevent their use for that purpose. When the FDA denied their request, the petitioners took legal action against the agency, eventually arguing their case before the U.S. Supreme Court, which ruled against them in Heckler v. Chaney (1985). Annas discusses the Court's action, which dealt only with the judicial reviewability under federal statute of the FDA's decision not to exercise its authority over the use of drugs in interstate commerce. He notes that, by dealing only with procedural issues, the Court avoided ruling on the death penalty itself.     

Enforcement Provisions of Indoor Tanning Bans for Minors: An Analysis of the First 6 US States

Several states have passed legislation banning minors from indoor tanning; however, concern has been raised regarding enforcement. We explored the statutes pertaining to enforcement in the first 6 US states to pass legislation banning minors younger than 18 years from indoor tanning. The findings reflect significant variability in enforcement provisions across the 6 states. Further investigations are needed to determine whether the statutes are successful in curbing indoor tanning among youths and ultimately whether indoor tanning bans among minors help to reduce skin cancer incidence.Since 2011, 11 US states have passed indoor tanning bans for minors younger than 18, and many other states are currently considering similar legislation.1 Although there is unprecedented momentum for indoor tanning legislation that protects youths, the recent US Surgeon General’s Call to Action, among others, has raised concerns over whether these new statutes will be enforced.2Policy initiatives for tobacco control can provide important lessons for control of indoor tanning, including enforcement.3 Federal tobacco enforcement policies are set forth in the Synar Amendment, an amendment to the Alcohol, Drug Abuse, and Mental Health Administration Act enacted in 1992 and implemented by the Substance Abuse and Mental Health Services Administration in 1996.4 Notably, the amendment tasks US states with enacting and enforcing legislation aimed at prohibiting the sale and distribution of tobacco to minors younger than 18 years.4 In addition to laws banning tobacco sales to people younger than 18 years, states have enacted legislation requiring licensure of tobacco retailers; random, unannounced inspections; specification of state enforcement authority; and creation of a graduated system of civil or criminal penalties for outlet owners and clerks.4Similar to age restrictions on tobacco sales, legislation banning minors from indoor tanning may play an important role in educating the public about the risks posed by indoor tanning and may denormalize indoor tanning by children. Legislation can also counter the indoor tanning industry’s history of deceptive marketing claims that tend to understate risks and broadly overstate any potential benefits of tanning.5