A Report On Pharmaceutical Sales Representative Job

The job of a pharmaceutical sales representative is to educate physicians and other medical professionals about developments and pharmaceutical products in the industry. Pharmaceutical sales representatives are also known as PSRs or pharma reps who connect providers with knowledge, treatments, and drugs that are needed to give care to their patients. PSRs are very knowledgeable about pharmacology. To be a successful PSR, it is important to develop personal relationships with other doctors/physicians. They are trained to be helpful, observant, and personable. Pharmaceutical sales reps are encouraged to ask and remember details about a physician/doctors personal life and interests in order to build a good relationship and develop trust.

Credentials

Although it’s possible to become a pharmaceutical sales representative with a high school diploma, most positions require a bachelor’s degree. A bachelor’s in business, marketing, biological science are some different options of the type of degree’s recommended in order to become a pharma rep. In addition to obtaining a bachelor’s, a certification or vocational training may be required depending on the employer. Advanced communication skills are a must for this career (study).

Professional Organization

A professional organization that is associated with PSRs is the National Association of Pharmaceutical Sales Reps. This association helps entry level PSRs, sales trainers, and pharmaceutical sales managers who work in the pharmaceutical industry. This association also can provide education, certification, online career center, referrals and job alerts, membership, and regulation updates ever since the year of 2002. The main purpose for this association is to prepare members and candidates who are striving for the PSR career.

The National Association of Pharmaceutical Sales Reps is mostly known for their CNPR Pharmaceutical Sales Training Program which educates candidates about the pharmaceutical industry, FDA regulations, clinical pharmacology, laws governing the pharmaceutical industry, pharmaceutical terms and abbreviations, questions to answer during an interview, etc. This program is available online. It is extremely important to be knowledgeable about these things in order to be successful in the PSR career.

Laws

There are federal, state, and local laws/policies that a PSR must abide by. Pharmaceutical sales representatives must follow policies from the Food and Drug Administration (FDA) and the Office of the Inspector General (OIG) at the federal level. Laws are more restrictive at the state level. At the state level, The District of Columbia’s SafeRx Amendment Act o 2008 requires PSRs to be licensed by the District in order to sell products. At the local level, Academic Medical Centers (AMCs) and healthcare institutions have created their own policies about PSR access and interactions with professionals in healthcare. There are consequences for PSRs that fail to follow these laws/policies. If they violate these policies/laws, then they can be fined and can result in Corporate Integrity Agreements (CIAs). PSRs can easily lose access to providers. Violating these laws can also damage the reputation of a pharmaceutical company which can further result in losing public trust.

United States V. Caronia

Orphan Medical, Inc. received the approval from the FDA to market a drug called Xyrem in 2002. Xyrem is a central nervous system depressant that is used to treat catalepsy in patients that have been diagnosed with narcolepsy. Side effects from this drug include seizures, coma, depression, and death. The FDA put an extremely important and serious warning on this prescription medication called “black box” labeling to protect against these risks. In 2005, Orphan Medical, Inc. hired Alfred Caronia as a pharmaceutical sales consultant to promote Xyrem. After this, the federal government started a criminal investigation of alleged off-lable promotion of this drug. It turns out that Caronia was promoting Xyrem through unapproved uses. He promoted this medicine to patients that were under the age of 16 and to patients with insomnia and chronic pain. He was caught on a recording when he was exchanging this information with physician customers. Caronia was charged with two misdemeanor offenses under the United States Federal Food, Drug, and Cosmetic Act (FDCA). The government charged him with these misdemeanors for introducing a misbranded drug into interstate commerce. This drug was Xyrem. Caronia filed a motion to dismiss. He argued that the government was violating his First Amendment right, the right to free speech. His motion was denied by the federal district court because it did not violate the First Amendment.

Pharmaceutical sales representatives may also feel the need to promote off-label drugs if their on-label sales do not reach their annual target. Caronia was under pressure when he was selling Xyrem for off-label uses. He was expected to sell 520 bottles of Xyrem annually. Unfortunately, he was not reaching his annual target of 520, so he started to promote this drug for off-label uses in order to reach his quota.

Changes Made

Ever since the United States Vs. Caronia case, there has been many changes that the FDA has made to off-label drug use. For example, in a journal called, The Next Forum for Unraveling FDA Off-label Marketing Rules: State and Federal Legislatures, Michael Sinha and Aaron Keeselheim explain that, “Under the 21st Century Cures Act of 2016, manufacturers are now allowed to provide healthcare economic information about off-label drug uses to formulary committees or other similar entities that help insurers make drug coverage decisions” (2018). In addition to this, the Free Speech in Medicine Act was also passed in Arizona which permits manufacturers to communicate with PSRs about off-label uses. This was passed in March 2017.