With the help of whistleblowers acting under Federal and State False Claims Acts, cases alleging pharmaceutical fraud have accounted for some of the largest recoveries of money for the government. Sometimes employees of these companies face financial pressure to skirt the law. Other times the industry has caused employees to unwittingly engage in wrongful conduct.
Pharmaceutical fraud can take a variety of forms. Cases have involved:
- 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 or other benefits, like 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.” If your 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 ask or convince doctors to “convert” patients from a drug that may have a different indication.
- Pointing 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.
- Asking doctors to request information from the company where the information requested may hint at or encourage off-label uses.
- Cherry picking 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:
- Speakers programs where the choice of speaker is influenced by the marketing or sales department.
- Speakers programs where the choice of speaker is influenced by the speaker’s prescription writing habits.
- Selecting speakers absent any investigation of the speaker’s professional qualifications including ascertaining: a) whether the speaker has a bona-fide medical license, b) whether the speaker has published in the area, and c) whether the speaker is 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.