Compliancy with government oversight is a huge part of this area of law. The following are some of the areas of focus in pharmaceutical law: research and development (R&D); new drug applications; product licensing; compliance with testing, clinical trials, packaging and ingredients; prosecution and defense of IP claims; marketing and distribution.
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Pharmaceutical Law - US
- Cyber Pharmaceuticals
In today's fast growing world of e-commerce, prescription drugs have joined the ever-expanding list of products customers can conveniently order online and have delivered to their front doors. But unlike most other consumer items available for purchase online, pharmaceutical sales present a discrete mix of legal, social and medical issues.
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials
Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency's proposal.
- Federal Food, Drug, and Cosmetic Act
The FDA's online reference edition of the Federal Food, Drug and Cosmetic Act is based on the publication Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and Commerce; Food, Drug, and Related Law, As Amended Through December 31, 2004, prepared for the use of the Committee on Energy and Commerce, U.S. House of Representatives, March 2005.
- Food and Drug Law Institute
The Food and Drug Law Institute, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. The scope of FDLI includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. As a not-for-profit 501(c)(3) organization, FDLI does not engage in advocacy activities.
- Hatch-Waxman Act
The Hatch-Waxman Amendments amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created a statutory generic drug approval process with section 505(j). Section 505(j) established the abbreviated new drug application (ANDA) approval process, which permits generic versions of previously approved innovator drugs to be approved without submitting a full new drug application (NDA). An ANDA refers to the previously approved NDA (the “listed drug”) and relies on the Agency’s finding of safety and effectiveness for the listed drug product.
- IRS - Pharmaceutical Industry Overview of Significant Laws
This overview is designed to provide industry-related information to all Large Business and International (LB&I). This is the first step in the effort of LB&I to develop a greater level of expertise in the industry or industries to which you will be assigned. This overview is one of a series of industry specific overviews.
- Pharmaceutical Market Access Act
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes.
- Pharmacist Code of Ethics and Oath
Pharmacists are health professionals who assist individuals in making the best use of medications. This Code, prepared and supported by pharmacists, is intended to state publicly the principles that form the fundamental basis of the roles and responsibilities of pharmacists. These principles, based on moral obligations and virtues, are established to guide pharmacists in relationships with patients, health professionals, and society.
- Prescription Drug User Fee Act
For nearly 20 years, the mission of the Prescription Drug User Fee Act has been to advance public health, safeguard patient safety and give patients more timely access to new, life-saving medicines. The program was created in response to a perilous regulatory bottleneck that slowed patient access to the medicines.
- The Office of Prescription Drug Promotion (OPDP)
OPDP reviewers have responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. Formerly Division of Drug Marketing, Advertising, and Communications (DDMAC).
- United States Drug Enforcement Agency
The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.
Organizations Related to Pharmaceutical Law
- American Association of Colleges of Pharmacy (AACP)
Founded in 1900, the American Association of Colleges of Pharmacy (AACP) is the national organization representing pharmacy education in the United States. The mission of the Association is to both represent and be an advocate for all segments of the academic community in the profession of pharmacy.
- American Pharmacists Association (APhA)
The American Pharmacists Association (APhA) is the organization whose members are recognized in society as essential in all patient care settings for optimal medication use that improves health, wellness, and quality of life.
- American Pharmacists Association Foundation
The American Pharmacists Association Foundation is a not for profit 501(c)(3) organization headquartered in Washington, DC and is affiliated with the American Pharmacists Association (APhA), the oldest and largest national professional society of pharmacists in the United States. The APhA Foundation looks to create a new medication use system where patients, pharmacists, physicians and other health care professionals collaborate to dramatically improve the cost effectiveness and quality of consumer health outcomes.
- Department of Health and Human Services (HHS)
The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide.
- International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
The IFPMA was founded in 1968 as a global, non-profit, non-governmental organization. With members across the world and a secretariat based in Geneva, Switzerland, the IFPMA represents the research-based pharmaceutical industry, including the biotechnology and vaccine sectors. Our members comprise leading international companies as well as national and regional industry associations, in both developed and developing countries, across all five continents. Our primary role is to represent our members' views in dialogue with global intergovernmental organizations, the diplomatic missions of national governments and specialized non-governmental organizations.
- National Association of Boards of Pharmacy
The National Association of Boards of Pharmacy is an impartial professional organization that supports the state boards of pharmacy in creating uniform regulations to protect public health.
- National Council for Prescription Drug Programs
NCPDP creates and promotes the transfer of data related to medications, supplies, and services within the healthcare system through the development of standards and industry guidance. The organization provides a forum and support wherein our diverse membership can efficiently and effectively develop and maintain these standards and guidance through a consensus building process in collaboration with other industry organizations. NCPDP also offers its members resources, including educational opportunities and database services, to better manage their businesses.
- Pharmaceutical Research and Manufacturers of America (PhRMA)
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $45.8 billion in 2009 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.3 billion in 2009.
- United States Food and Drug Administration
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.
Publications Related to Pharmaceutical Law
- American Journal of Pharmaceutical Education
The American Journal of Pharmaceutical Education (AJPE) is the official publication of the American Association of Colleges of Pharmacy (AACP). Its purpose is to document and advance pharmaceutical education in the United States and Internationally. The Journal considers material in all areas related to pharmaceutical education. Through open-access Internet publication the Journal intends to take full advantage of the electronic medium; this includes the publication of articles with multimedia features, encompassing 3D graphics, video, interactive figures and databases, and sound.
- FDA - Prescription Medicine Online - Consumer Safety Guide
The Internet has changed the way we live, work and shop. The growth of the Internet has made it possible to compare prices and buy products without ever leaving home. But when it comes to buying medicine online, it is important to be very careful. Some Web sites sell medicine that may not be safe to use and could put your health at risk.
- FDA Drug Development and Approval Process
American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER). The center's best-known job is to evaluate new drugs before they can be sold. The center's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely.
Articles on HG.org Related to Pharmaceutical Law
- Current Problems on the Pricing of Pharmaceuticals For Human Use in TurkeyThis article addresses the reference pricing system used for the pricing of the pharmaceuticals for human use in Turkey and the current problems arising from such system.
- Product Liability Cases of Interest from 2011 and 2012New Jersey federal and state courts and the U.S. Supreme Court, in addition to a federal court in New York, have issued a number of opinions regarding products liability and related issues since the beginning of 2011. Below is a synopsis of some of the more interesting and important of those decisions.
- Fungal Meningitis: What You Need to KnowThe New England Compounding Center, has recalled more than 17,000 doses of contaminated steroid injections and experts worry that as many as 14,000 patients could be at risk of contracting meningitis. As of this week, the deadly fungal meningitis outbreak has spread to 15 states, including Ohio. It has already infected 230 victims and killed at least 15 people.
- Turkey Pharmaceutical Sector: New Regulation of Promotion of Medicinal Products for Human UseA new regulation has been published on Official Gazette dated 14 October 2012 that contains a number of changes have been made on Regulation on Promotion of Medicinal Products For Human Use to ensure that the companies promoting a medicinal product is monitored by the Ministry of Health in wide range of their promotion activities. The main changes to the regulation include:
- Birth Control And Blood Clots: The Dangers of Yaz, Yasmin, Beyaz and OcellaBy July 2012, Bayer Pharmaceuticals had spent over $400 million to settle claims that its ‘wonder drug’ Yasmin-line of birth control is actually a very dangerous drug. In 2011, Yasmin was the 4th most-prescribed oral contraceptive in the United States and brought in $1.1 billion in sales for Bayer.
- Life Sciences Law in SwitzerlandThis Q&A guide gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This article was first published in the PLC Multi-jurisdictional guide to Life Sciences 2011 and is reproduced with the permission of the publisher, Practical Law Company.
- Manufacturing Opportunities in Malta for the Generics Drugs Industry: History and Legislative FrameworkWithout doubt Malta offers significant opportunities for the generics drugs Industry and the evidence for this lies in the pharmaceutical patenting history of the country and in its legislative framework. The following events have played a major role in the history of patenting in Malta, and have actually shaped the present scenario regarding generic drugs in the country.
- Pfizer Agrees to Pay $14.5 to Settle False Claims Act Lawsuit for Improperly Marketing DetrolPfizer has agreed to pay $14.5 million to settle a lawsuit alleging that it violated the False Claims Act by improperly marketing its prescription drugs Detrol and Detrol LA.
- Transvaginal Mesh ComplicationsTransvaginal Mesh products have been associated with a number of complications. Lawsuits have been intiated in multiple courts. In 2011, the United States Food and Drug Administration (FDA), have issued a warning to inform patients and healthcare providers of serious complications associated with implantation of surgical mesh for transvaginal repair of Pelvic Organ Prolapse.
- New Study Confirms Actos Bladder Cancer LinkThe diabetes drug Actos has been linked to Bladder Cancer. Litigation is now underway as a new study confirms the actos bladder cancer link. Pioglitazone (Actos) is an antidiabetic agent in the thiazolidinedione drug class. The British Medical Journal published an article May 31, 2012, stating that pioglitazone has been found to be associated with an increased risk of bladder cancer development according to a case-control study.
- All Health Care and Social Law Articles
Articles written by attorneys and experts worldwide discussing legal aspects related to Health Care and Social including: defective drugs, failure to diagnose, informed consent, medical law, medical malpractice, medication errors, pharmaceutical law, social security, social services law, surgical errors.