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.