The federal False Claims Act broadly prohibits anyone who does business with the federal government from engaging in fraudulent behavior. Accordingly, there are innumerable circumstances where such fraud may occur, and in which a Whistleblower may bring an action to expose the fraud and recover appropriate damages. An example of such fraud includes:
Pharmaceutical fraud may apply to a variety of occurrences as specified below:
- Charging for drugs not used and returned to pharmacy providers;
- Marketing, promoting, and selling drugs for uses other than those approved by the FDA;
- Marketing drugs to Physicians through illegal means, such as providing financial remuneration or other benefits, expense-paid consulting trips for Doctors and Providers who participate in drug marketing promotional meetings; and Charging prices to the Government that are higher than allowable by law.
The two most prevalent illegal schemes employed by the pharmaceutical industry are “off-label marketing,” and the use of “kickbacks.” Off label marketing involves marketing the drug for purposes beyond the Food & Drug Administration’s approved “indication.” The term kickbacks is in reference to providing a benefit, monetary or other, as a bribe, or quid pro quo.
When a company engages in any of the following conduct, it may be evidence of “off-label marketing:”
- Paying bonuses to Representatives for sales that involve the “off-label” use of the drug;
- Encouraging Representatives to solicit or convince Doctors to “convert” patients from a drug that may have a different indication;
- Guiding Doctors to studies that demonstrate “off-label” uses;
- Using studies or parts of studies to hint that a drug may have “off-label” uses;
- Using Speakers to promote the idea that a drug can be used for “off-label” purposes;
- Requesting Doctors to ask for information from the company where the information may hint at, or encourage “off-label” uses; and
- Selecting materials that are “on label” or written to comply with FDA requirements for the purpose of encouraging “off-label” uses.
Evidence of illegal “kickback” schemes may include the following:
- Speaker programs, where the choice of the speaker is influenced by the marketing or sales department;
- Selecting a speaker, absent any investigation of the speaker’s professional qualifications including ascertaining:
- (a) Medical license;
- (b) Published in the area, or an expert for the topic;
- (c) Under investigation by any regulatory bodies, or has been sanctioned, reprimanded, or suspended by any regulatory bodies.
- Grants to universities, doctors, or medical establishments for research or work where the marketing department of the company had an influence over the grant or funding;
- Any type of rebate program based on drug utilization;
- Any type of monetary benefit given to universities, hospitals, doctors, or medical establishments based on drug utilization.
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