Copyright

Prescription Drug Marketing Act of 1987

Instructor: Patricia Jankowski

Patricia is an experienced registered nurse who has worked in various acute care areas as well as in legal nurse consulting. She also has a BSChE.

The Prescription Drug Marketing Act of 1987 (PDMA) is a law that was written to protect American consumers from the dangers of counterfeit prescription drugs. This lesson is about the PDMA and the circumstances that led to its creation.

Counterfeit Drugs

To the surprise and shock of many fans, the beloved pop star, Prince, died in April of 2016. Prince suffered from chronic pain due to a hip and back disorder. Daily pain medication was a part of his life. After his death, police found pain pills that were mislabeled, containing fentanyl, a synthetic opioid that is much stronger than morphine and heroin. The fentanyl that was in these counterfeit pills was also found in his system after death.

The tragic circumstances at the root of Prince's death are not all that uncommon. Pills laced with fentanyl are often pressed and made to look like legitimate medication, such as OxyContin or Xanax, and then sold on the American black market, formally called the diversion market. This is only one example in a very large network of drug tampering and illegal sales.

Genuine drugs and counterfeit drugs often look the same to the naked eye.
counterfeit drugs

The counterfeit drug problem doesn't just happen in the United States. It is a global problem. This makes it difficult to manage, since different countries have different regulations. Prescription drugs circulate through a chain of custody from the manufacturer to the retailer who sells it to the patient, with stops in between. Within that chain, there are many opportunities for criminals to intervene and replace legitimate drugs with fakes. When there is a shortage of a drug, it can be replaced by a cheaper or more plentiful drug in the guise of the prescribed drug, and the counterfeiter makes a profit.

Counterfeit Drugs Online

The prices of many prescription drugs in the U.S. are often higher than anywhere else in the world. Because of this, patients often seek a way to obtain their medications more inexpensively. For example, one 90-day supply of the Serevent Diskus, an inhalation treatment used for asthma and chronic pulmonary disease, costs about $900 in the U.S. But it can be purchased from some Canadian websites for about $200. So, patients look to the Internet as a resource, using websites originating in Canada and other countries as well.

But the drugs that are ''from Canada'' are not always truly from Canada. They may come from New Zealand and pass through Singapore or India while being shipped. This leaves a great opportunity for a criminal to divert the real drug and replace it with a counterfeit whose label looks quite realistic.

An Interpol task force has shown how serious the counterfeit drug problem has become. Their pharmaceutical investigation known as Operation Pangea confiscated 2.4 million counterfeit pills in 2011. In 2015, that number jumped to 20.7 million.

Prescription Drug Marketing Act

The Prescription Drug Marketing Act (PDMA), known as H.R. 1207, is an amendment of the Federal Food, Drug and Cosmetic Act. It was created in response to the development of the diversion market for prescription drugs. The PDMA became law on April 22, 1988. The law places regulations and industry guidelines on the journey that prescription drugs make from the manufacturer to the retailer or dispenser. It makes criminal activity less likely to interfere with this journey in several ways.

Prescription Drug Samples and Donations

The PDMA prohibits the sale of prescription drug samples that are given by the manufacturer to doctors' offices and hospitals. These samples, intended to be given away free either for a try-out or to those in need, are sometimes illegally resold at a price cheaper than retail, and may be subpotent or expired. Under the PDMA, this is illegal. The law also prohibits the sale or trade of prescription drugs that have been donated to charities unless it involves a medical emergency.

Authorized Distributor of Record (ADR)

The PDMA encourages wholesale distributors of prescription drugs to become Authorized Distributors of Record, or ADRs. To become an ADR, a distributor must have an ''ongoing relationship'' with the drug manufacturer to distribute his products. This means that the manufacturer and distributor must have a written agreement that gives authorization to the wholesaler to distribute the manufacturer's products for a given period of time or a specific number of shipments.

Pedigree

Wholesale distributors of prescription drugs that do not have an ADR must have a pedigree for the drugs they sell. A pedigree is a chain of custody statement provided to the purchaser of the drug. This statement must include the entire history of sale of the drug, all the way back to the first sale by the manufacturer. It must also include the date of each transaction and the names and addresses of all those party to the transaction.

To unlock this lesson you must be a Study.com Member.
Create your account

Register to view this lesson

Are you a student or a teacher?

Unlock Your Education

See for yourself why 30 million people use Study.com

Become a Study.com member and start learning now.
Become a Member  Back
What teachers are saying about Study.com
Try it risk-free for 30 days

Earning College Credit

Did you know… We have over 200 college courses that prepare you to earn credit by exam that is accepted by over 1,500 colleges and universities. You can test out of the first two years of college and save thousands off your degree. Anyone can earn credit-by-exam regardless of age or education level.

To learn more, visit our Earning Credit Page

Transferring credit to the school of your choice

Not sure what college you want to attend yet? Study.com has thousands of articles about every imaginable degree, area of study and career path that can help you find the school that's right for you.

Create an account to start this course today
Try it risk-free for 30 days!
Create an account
Support