Pharmaceutical & FDA Fraud

Any organization that does business with the federal government can also defraud them, and there is no shortage of methods that these organizations will employ to reach that goal. Much like other industries, fraudulent practices, such as overbilling and double-billing, plague the pharmaceutical arena, but there are also other fraud schemes that affect the industry specifically, such as the off-label marketing of drugs. However, all fraud will look differently depending on the facility it’s occurring within. Here are a few examples of common fraud schemes in the pharmaceutical industry:

It’s illegal for pharmaceutical companies to offer compensation, benefits, or discounts in exchange for prescribing the company’s drugs. For example, some companies have been found to have offered golf outings, tickets to special events, and even direct payments of cash to persuade another organization into purchasing their medication. Additionally, the federal government also prohibits the business practice of “tying” drugs, which is when a pharmaceutical company provides a discount on one medication to encourage the purchase of a different drug. Any instance of a kickback creates a very hazardous environment for patients everywhere, as the fraud encourages doctors to make decisions based on money rather than on what medication is right for that individual.

Medications and medical equipment must first gain approval by the FDA before they’re allowed to be used in practice. This approval is determined through clinical trials, where the FDA will test the product for its intended purpose. If it’s determined to be safe and effective, doctors can begin prescribing it to their patients, but it can only be given for the purpose that the FDA tested. While some medications can treat a number of different ailments, all doctors and medical professionals are strictly prohibited from prescribing drugs for any purpose other than FDA-approved use.

The Food, Drug, and Cosmetic Act (FDCA) strictly prohibits the “adulteration” of drugs, which is when the methods or quality control procedures used in the manufacturing, packing, processing, or holding of the drug fails to adhere to the current Good Manufacturing Practice (cGMP) regulations. Any instance of adulteration significantly decreases the trustworthiness of medications and medical equipment, as doctors and regulatory agencies need to know that the product was made correctly before administering it to a patient. cGMP regulations also mandate that pharmaceutical manufacturers maintain adequately equipped facilities, thoroughly trained staff, and strict control over their drug manufacturing process. Instances of cGMP violations can include keeping incomplete testing records and failing to keep investigation data, manufacturing goods for sale that the FDA disapproves, and employing individuals prior to their training completion.
 

Pharmaceutical companies and medical device manufacturers must obtain FDA approval prior to the sale of their products. If the company submits false data during any stage of the clinical trial to obtain approval, they are breaking the law and can be held responsible through their crime with the help of a brave whistleblower. Some companies choose to withhold negative side effects, misrepresent the effectiveness, or falsify documentation related to the performance of their medical device. While they might think that their actions have no consequence, they’re truly hurting the people their products are supposed to help, and it’s only a matter of time until they’re held accountable.