Most drug crimes in Indianapolis and its neighboring communities involve so-called street crimes, in which illicit drugs are sold by the dealer to the user in secretive, cash only transactions. Occasionally, however, a manufacturer of prescription drugs can run afoul of the law by ignoring federal or state laws governing the industry. A recent indictment issued against Pharmakon Pharmaceuticals, Inc., located in nearby Noblesville, charges that the company's executives deliberately violated federal laws that regulate the labeling and sale of prescription drugs.
The indictment alleges that the company regularly shipped drugs to hospitals before tests of the drugs' strength were completed. If the tests showed that the potency of the drug was lower or higher than the dosage stated on the package, the company allegedly ignored the test results and failed to recall the mislabeled drugs. The indictment alleges that at least three infants became ill after receiving the mislabeled medicine. One child was rushed to the hospital by helicopter.
The indictment does not state whether the company notified hospitals or physicians of the mislabeling. However, the company's compliance officer allegedly received approximately 70 notices of test results that showed the drugs to have been mislabeled. The indictment further alleges that the company's compliance officer told the FDA during an inspection in 2014, stating that the company had never received test results showing that its products were outside of the targeted strength. Two of the company's executives are now facing charges of engaging in commerce with adulterated drugs. One of the executives expressed an early intention to plead guilty. The other executive, who is the company's owner, has not made a similar statement.
An indictment is not evidence. It is merely a series of allegations of criminal behavior that must be proven at trial beyond a reasonable doubt. Nevertheless, the defendants in this case are facing serious criminal charges. Anyone facing similar charges may wish to seek advice from an attorney who has defended federal criminal cases.
Source: Indianapolis Star, "Noblesville pharmaceutical company sold drugs that sickened babies, feds allege," Madeline Buckley, June 22, 2017