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.
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.
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.
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.