How the Black Market Impacts Patients

Jim Dahl, Board Member, PSM

How does the US regulate medicine distribution to keep patients safe?

The FDA regulates manufacturers of medicines wherever the production facilities are, in the US and beyond.

Wholesalers are regulated by the US states, each with different rules. A voluntary cross-state licensing program (VAWD) helps ease license verification.

How does the US regulate medicine distribution to keep patients safe?

Doctors, pharmacists and pharmacies purchase from wholesalers, and are themselves regulated by each state. Patients are protected by the closed, secure supply chain. Every entity in the chain is answerable to a regulator.

How a closed supply chain gets broken

● Patients buy directly from unlicensed sources, i.e. flea markets, non-pharmacy stores, individuals or the Internet.

● Wholesalers forge documentation to pass counterfeit drugs off as authentic.

● Doctors and pharmacists buy from counterfeit distributors.

How a closed supply chain gets broken

● Stolen and partially used medicines are sold as safe drugs through clearinghouses back into the legitimate supply chain.

● Counterfeiters send mass quantities through customs in disguised packages (i.e. speakers full of fake aspirin) and distribute them to pharmacies and stores looking for discounted products.

Ads for cheap prescription medicines are ubiquitous

97% of websites selling prescription drugs do not follow safe practices

1 in 6 Americans buys drugs on theinternet without a prescription

How common is black market medicine?

Are we overstating the problem?

What is the acceptable risk?

Let’s Compare Another Highly Regulated Industry: Air Travel

In April 2014, IAD and DCA’s average daily commercial flight operations

averaged 1527 take offs and landings every day.

source: www.mwaa.com/file/ATS_April_2014.pdf

What if 1% of those flights (153) had

planes with substandard or counterfeit parts?

Would you fly out of IAD or DCA today?

What if just 0.1% of the flights in and out of DCA and IAD – just 15 flights - might have a

counterfeit part that could cause a catastrophic event?

Would you fly today?

(canadian slide)

Panelists:

● Jim Dahl, Board Member, PSM; Asst. Director of the FDA's Office of Criminal Investigations (retired)

● Kimberly New, National Association of Drug Diversion Investigators

● Gaurvika Nayyar, Program Manager for Asia, US Pharmacopeia’s Promoting the Quality of Medicines Program

● Eric Sampson, Advisor to the CDC Foundation