PRESCRIPTION DRUG DIVERSION
The Firm represents individuals and entities under investigation or accused of prescription drug diversion. The Prescription Drug Marketing Act (PDMA) is the statute used to prosecute drug diversion and the FDA Office of Criminal Investigation and the Office of Inspector General for HHS (OIG-HHS) are the agencies primarily responsible for conducting these investigations and assisting federal prosecutors.
Prescription drug diversion generally occurs when prescription drugs, for example, Asthma or HIV medications are sold or distributed outside of the legal chain of distribution by a person not licensed as a wholesaler. Subject to certain limited exceptions, a person seeking to distribute a drug requiring a prescription is required to have a license, as a wholesaler, to sell or “distribute” prescription drugs. The Prescription Drug Marketing Act (PDMA) was enacted to ensure that patients receive drugs from reliable wholesalers and distributors. Without safeguards to verify who the distributor is, patients might receive counterfeit or expired medication from persons or entities operating outside of the chain of distribution without a license to distribute prescription drugs.
The Firm is experienced in defending individuals accused of prescription drug diversion. The Firm will formulate possible defenses, interview witnesses, and retain experts to rebut the Government’s findings.
Common diversion schemes that the Government is investigating are as follows:
- Distribution of HIV and Asthma drugs by unlicensed persons for sale.
- Purchases of expensive prescription drugs by pharmacies from unlicensed wholesalers typically to avoid payment of the wholesale price.
- Failure to properly document pedigree paperwork showing from whom the prescription drugs were purchased.
The Government also frequently attempts to leverage persons with prior criminal histories or arrests to assist in the investigation of violations of the PDMA by using these persons to engage in controlled sales or purchases.
If you suspect that you are a target of a prescription drug diversion or have been contacted by the FDA, FBI, or OIG in connection with a diversion investigation, the Firm would be glad to schedule a consultation.