Rep. Michael Burgess (R-Texas) said on Thursday that the current prescription drug distribution system cannot prevent the introduction of substandard or counterfeit drugs into the marketplace.
Burgess, the vice chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, delivered his comments at a hearing entitled, “Counterfeit Drugs: Fighting Illegal Supply Chains.”
“American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective,” Burgess said. “This is not to say that the shelves of the nation’s pharmacies are lined with substandard products, or that there are inadequate controls in the manufacturing process. Rather, the integrity of the distribution system is insufficient to prevent the introduction and eventual retail sale of substandard, ineffective or even counterfeit pharmaceuticals.’
There were $75 billion in counterfeit drug sales in 2010, a 90 percent increase over the previous five years, according to the World Health Organization.
“Detecting a counterfeit drug is very difficult, if not impossible,” Burgess said. “No field test can be performed to indicate whether a drug is fake or real, and even trained experts are often unable to detect whether a drug is what it purports to be. Counterfeit and other altered drugs present an unreasonable risk to Americans.”
Burgess said the United States has the best drug supply chain in the world, but as medications become more advanced, the supply chain faces constant, sophisticated attacks from rogue distributors.
“Maintaining the integrity of the United States’ prescription drug supply is a compelling national priority that requires national solutions involving business, healthcare providers and government coming together and being vigilant in the face of these threats,” Burgess said.