Pharmaceutical Law



What is Pharmaceutical Law?

Pharmaceutical Laws relate to the creation, sale, distribution, and use of pharmaceutical drugs. These laws include intellectual property rights to protect drug manufacturers’ research, safety standards to protect the public from harmful side effects, restrictions on marketing drugs to the public, and rules regarding how drugs may be prescribed and distributed.

Intellectual Property

Pharmaceutical discoveries, and advances in biomedical research, have created a multi-billion dollar industry. With stakes so high, it is important for companies to be able to protect their investments. This is typically done through the use of patents. Patents can apply to the method of synthesizing a drug, the chemical makeup of a new molecule, or possibly even to certain genetic discoveries. There are many other potential uses for patents in the field of pharmaceutical law, as well.

Trademarks and copyrights also play a role in pharmaceutical law. After all, just as with any product, brand identification can be a key to success in marketing and brand loyalty.

Safety and Marketing

Another important area of pharmaceutical law is in product safety and marketing. Pharmaceuticals are among the most highly regulated products in the U.S., and must pass stringent testing by organizations such as the Food and Drug Administration (FDA) before they are even allowed onto the market. However, these products could still be misused, even if approved for their intended purpose. As such, strict laws regarding how these drugs can be marketed both to individuals and to doctors prevent false and misleading claims. If, as has often been the case, later research discovers a product is not safe, other laws are in place to immediately compel the recall of the product from the marketplace and prevent its further sale.

Distribution

Of course, many drugs are considered controlled substances in the U.S. As a result, very strict guidelines exist for which drugs may be sold without a prescription (i.e., over-the-counter) and which may only be given if approved of by a licensed medical practitioner. Other laws make it a crime to prescribe medications that are in quantities that are intended for distribution on the black market or that would be harmful to the patient. Still others criminalize the resale of prescription drugs.

More Information

For more information about pharmaceutical law, please visit the resources listed below. You can also find an attorney who can answer your questions or assist you with your pharmaceutical law issues by visiting our Law Firms page and searching for a lawyer in your area.

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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

  • Disqualifying an Expert Witness Due to Bias
    Expert witnesses are hired to provide details, remove confusion or connect certain evidence and persons to the incident where someone has been wronged or injured. However, sometimes these professionals are disqualified because they have bias with the other party, a conflict of interest or a bias with the case itself.
  • Drug Company Priced a Life-Saving Drug Out of My Budget. Do I Have a Lawsuit?
    Drugs for various diseases may save the lives of those with these ailments, and when the drug companies hike the prices to amounts that are not payable by the average person, the victims in these actions may be able to pursue a case. It is important to hire a lawyer to determine if there is sufficient information, evidence and material to attempt to litigate.
  • Expert Witness on Opioid Lawsuits
    Opioid usage, abuse and prescription issues have become such a problem that some persons are addicted and may become injured through use and abuse. Because these drugs are both used in the medical world and through illegal personal purchase, many are harmed when the drugs are not consumed properly.
  • Failure to Disclose Rare and Serious Side Effects of a Prescribed Medication
    Every year individuals are injured by prescription medications that they use to treat another condition. Injured victims may consider seeking monetary compensation for the damages that they sustained because of these drugs. However, it is important that they understand the steps leading up to a lawsuit and whether they have a viable claim.
  • Using a Forensic Scientist as an Expert Witness
    Forensic science is useful when criminal or civil court cases arise from various complications. With the assistance of a forensic scientist expert witness, it may be possible to determine multiple factors, who is liable for damages and what occurred during the incident.
  • Importance of Using a Medical Oncology and Hematology Expert Witness
    When someone has contracted cancer or has a blood disorder, he or she may be victim of a medical malpractice claim. This usually means that an expert in these matters needs to be hired to assist with evidence, medical procedures, processes and treatment as well as to assist in understanding how the injuries or further healthcare issues may have occurred.
  • AbbVie Hit With $15 Million Jury Verdict in Depakote Spina Bifida Case
    Plaintiff claims the child’s spina bifida was due to his mother taking Depakote during her pregnancy.
  • Pharmacologist Expert Witness on Warning Label Defects
    Expert witnesses are needed most often when there is an aspect about a case that needs clarification for the judge or jury. In pharmacology cases where there are defects in warning labels, these experts are uniquely qualified in detailing the effects that these defective labels may cause in the health of the public either for an individual or a group.
  • The Rising Costs of Prescription Drugs Are Impacting Workers Compensation Claims
    Each year, the Express Scripts Workers Compensation Drug Trend Report evaluates changes in medication use and associated costs for injured workers in the U.S. The latest study shows that spending on prescription drugs by insurers quadrupled between 2003 and 2014, while the number of filled prescriptions tripled.
  • The Important Work Expert Witnesses Do Before Testifying
    Expert witnesses accomplish much work before the act of testifying is needed. They work up a report, analyze evidence, connect the incident to certain persons and actions and many other tasks long before they are called in the court room. Many of these professionals adhere to scientific methods to determine certain aspects of a case.
  • 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.




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