Prescription Drug Laws

Legislation surrounding prescription drug usage has been put in place to prevent unauthorized manufacturing and distribution of licensed pharmaceuticals. The Drug Enforcement Administration shows statistics for unauthorized prescription sales that nearly equal those of illegal substances. And while laws regulating the use of pharmaceuticals have benefited public safety, issues surrounding drug distribution are still under question.

Identification

• Prescription drugs fall under a specific classification as defined by the Federal Food, Drug and Cosmetic Act. As of 1938. These laws assign food, drug and cosmetic safety and distribution responsibilities to the Food and Drug Administration. Responsibilities include defining what types of conditions require a prescription, and determining over-the-counter drug classifications. "Rx-only" or "legend" must appear on any drug packaging that falls within this category. As these are considered licensed medications, only medical practitioners, optometrists, dentists and veterinarians are authorized to write prescriptions for consumers. Licensing measures were enacted to regulate their manufacturing, sales and distribution.

Function

• The Prescription Drug Marketing Act of 1988 was put in place to regulate drug safety and effectiveness. Pharmaceutical drugs are put through a testing process by the U.S. Food and Drug Administration prior to being offered to the public. In an effort to protect consumers, prescription packaging must list dosage amounts, dosage instructions and possible side effects as well as the name of the drug and its potency level. This process works to protect consumers from substandard, and counterfeit medications, and regulates how they're distributed. And while the specific uses for each drug are clearly stipulated, physicians are legally authorized to prescribe a drug for alternative or "off label" uses.

Features

• The government's role in testing new pharmaceuticals was first laid out in the Prescription Drug User Fee Act of 1992. This is a program designed to speed up the approval process for newly created drugs. Drug manufacturers are required to pay a substantial fee to have their products tested and approved. Amendments to the act have been added since then to incorporate additional measures that monitor a drug's safety after it's been offered to the public. Application fees can run anywhere from $500,000 to $1 million depending on what testing procedures are needed to meet approval standards.

Effects

• As part of a healthcare initiative, the Medicare Prescription Drug Improvement and Modernization Act of 2003 was enacted in an attempt to improve prescription drug availability for senior citizens. This law addressed the high costs of prescription drugs by offering a special program in which senior could receive discount prices. Designed to work in conjunction with Medicare Parts A and B, the program allowed seniors to purchase drug plans through independent insurance companies. Participating insurance companies and doctors were required to select and offer medications according to defined lists that only include certain brands and certain drug classifications. The passage of this law brought about significant changes in how medications were to be prescribed and distributed to a large sector of the population.

Considerations

• As a result of the Prescription Drug User Fee Act of 1992, approval times for new pharmaceuticals has been reduced considerably. However this speed in testing and approval may be placing consumers at risk. Attempts to apply a portion of program funds towards monitoring direct-to-consumer drug advertisements have been unsuccessful due to inadequate government funding. As a result, consumers are at risk of receiving inaccurate, or incomplete information regarding a prescription medication through direct advertising mediums. Certain requirements are in place to ensure that drug information is presented accurately. However contraindications or drug effectiveness as compared to other brands may be omitted.