Ratings & Reviews

A prescription drug is a licensed medication that is regulated by legislation.  As opposed to over-the-counter drugs, one must obtain a prescription from a health care provider in order to obtain the drug.  The Federal Food, Drug and Cosmetic Act (the “Act”) defines which drugs require a prescription.  The Act defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”  Prescriptions are generally issued by dentists, optometrists, medical practitioners and advanced practice nurses.

The Federal Prescription Drug Marketing Act of 1987 regulates the safety and effectiveness of prescription drugs.  The Food and Drug Administration (“FDA”) administers this law.  The FDA reviews the safety and efficacy of new prescription drugs before those drugs are approved for sale.  A drug that is approved is deemed to be “safe and effective when used as directed.”  The FDA also regulates the manner in which prescription drugs are advertised and promoted.  With regard to advertising, a pharmaceutical company may only advertise a drug for the specific indication or medical use for which it was approved.  In addition, an advertisement must maintain a “fair balance” between the benefits and risks of the drug.  After a prescription drug has been approved, the FDA monitors adverse effects that are potentially linked to the prescription drug.

The FDA’s continued regulation of prescription drugs is important given the number of people who use prescription drugs.  Over the past decade, the percentage of Americans who were prescribed at least one prescription drug in the past month increased by 10%.  The percentage of people who had multiple prescription drugs increased by 20%, while the percentage of those who used five or more drugs increased by 70%.  In 2009, prescription drug sales in the United States grew by 5.1%, reaching $300.3 billion in sales.  The four highest grossing classes of prescription drugs were antipsychotics, lipid regulators, proton pump inhibitors and antidepressants.  A total of 3.9 billion prescriptions were dispensed in the United States in 2009 alone.