Washington, D.C.—Congressman Steve Buyer (R-IN) and Congressman Jim Matheson (D-UT) have introduced bipartisan legislation to protect Americans from counterfeit drugs.  Tens of thousands of counterfeit packages attempt to enter the U.S. mail system daily, on the way to unsuspecting customers who believe the medicines are safe when many contain foreign substances or are watered down.

Congressmen Buyer and Matheson introduced H.R. 5839, the Safeguarding America’s Pharmaceuticals Act, which seeks to stop counterfeit, adulterated or misbranded medicines coming into the hands of consumers.

“Our nation has become a safe heaven to bad actors who market counterfeit drugs to innocent buyers,” commented Buyer.  “I have traveled to several of the twelve U.S. Post Offices’ international facilities as well as hubs for UPS and FedEx that serve as international points of entry for package distribution.  The number of  unregulated packages with unsafe medicines that are sent through our domestic mail system, containing counterfeit medications, is exuberant.” 

“Counterfeit drugs hurt people and this is a growing problem. The victims are often people who need real, quality drugs the most – cancer patients, AIDS patients and people being treated for heart disease.   Even though bogus drugs account for a small fraction of the 3 billion prescriptions filled in this country each year, it’s time to fill the gaps in our regulatory system before the situation gets worse,” said Matheson.

In 1988, Congress passed the Prescription Drug Modernization Act (PDMA) to create our nation’s current drug pedigree system—a vital component in providing for the safety of drugs as they pass through our nation’s complex distribution system.  Since PDMA, there has been the expansion of the internet, and consequently the insurgence of rogue internet pharmacies.  Of the thousands of internet pharmacies selling drugs to Americans today, only 15 are licensed by the National Association of Boards of Pharmacy.  Many of these non-licensed internet pharmacies purchase the drugs they sell from areas of the world where counterfeit drug manufacturers are prolific, such as China and India, and the safety of these drugs is largely unknown.  Unfortunately, our nation’s current adverse event reporting system does not provide us with an accurate assessment of the problems attributable to counterfeit drugs in our nation.

“Due to the costs of some prescription drugs, some have turned to alternative sources for their drugs such as internet pharmacies.  However, Hoosiers need to be aware that most of these internet pharmacies are not regulated and prey on consumers who think they are receiving real medicines when in fact they are not,” Buyer said.

Congressman Buyer said he understands the desire for lower cost prescription drugs.  He has been a proven leader in Congress to help provide more choices to seniors for prescription drugs, resulting in the Medicare Drug Discount Card, which have saved seniors thousands of dollars.  In addition, he authored legislation which was signed into law, delivering the promise to military retirees for Tri-Care for Life and a pharmacy benefit plan—which has been called the greatest expansion of health care for a generation.

“I am proud of my efforts to help reduce costs of medicine for our military retirees and our seniors.  Millions of military retirees have benefited from this expansion of the pharmacy benefit—saving them thousands of dollars annually.  I took the successes and what I learned there and helped create the Medicare Drug Discount Card and Indiana seniors have told me they too have saved thousands of dollars in medicine costs,” Buyer said.

Congressman Buyer said that we need to do more to ensure that those who cannot pay for their medications learn about federal and state assistance programs.  In addition, we must protect our borders from unsafe counterfeits entering our country,” Buyer said.

In one day, up to 360,000 packages containing counterfeit drugs enters our 12 international mail facilities—that is up to 10 million packages a month and 130 million counterfeit drug packages in a year.  The Food and Drug Administration (FDA) screens less than one percent of these packages before they are sent through our domestic mail system.  The less then one percent of the packages that are screened and found to contain counterfeit drugs are returned to the sender by the FDA.  Time and time again, FDA screeners see packages make a one to two week turn around for re-entry into the mail facilities, after initially being rejected and returned to the sender, making way to unassuming Americans.

America’s domestic drug supply chain is also threatened by people motivated by profit, not health, diverting legitimate pharmaceuticals out of the supply chain and introducing drugs which have been diluted; containing the wrong level of active ingredients, containing the wrong ingredients all together, or placebos.  Due to adverse reporting systems the health effects of counterfeit or adulterated drugs are not accurately reported, therefore leaving many consumers unknowingly in danger.

The Safeguarding America’s Pharmaceuticals Act will secure the prescription drug supply chain, both foreign and domestic.   Under this Act the FDA will be given authority to destroy all adulterated, misbranded, and inadmissible drugs at each of our nation’s 12 ports of entry.

Congressman Buyer said an update to our nation’s pedigree system is needed.  He noted that new technology will allow for members of the supply chain to authenticate drugs and track their paths from the time they leave the manufacturing facility to the time they reach the pharmacy, hospital, nursing home, or doctor’s office.  H.R. 5839 seeks to provide for an immediate advancement of our nation’s drug pedigree system—moving toward a more advanced serialization and track-and-trace system.

“One national system will allow for the supply chain to monitor the flow of prescriptions in our country, ensuring patients receive safe and effective mediations— avoiding the burden of compliance costs of 50 separate state pedigree programs.  The Buyer-Matheson bill erases the patchwork of regulations that increases costs of pharmaceuticals and significantly burdens the supply chain,” Buyer said.

Additionally, federal standards are to be increased for drug wholesalers under the Safeguarding America’s Pharmaceuticals Act.  States must be encouraged to continue increasing requirements for wholesalers who distribute our nation’s pharmaceuticals; ensuring that criminal interests do not gain access to the drug supply chain.  Many states have been actively engaged in this issue and have raised their own standards for drug wholesalers but all states need to follow suit.  Congress must provide incentives for States to assist federal authorities in tracking down those who violate laws pertaining to the safety of our pharmaceutical market.

H.R. 3859 provides for a study to be constructed by the Secretary of Health and Human Services on how the U.S. can better protect itself from counterfeit drugs in future developments.  The study is also to be conducted by federal health and security agencies including the Departments of Homeland Security and Justice on the threats to the domestic prescription drug supply.

“This bill which has already received broad bipartisan support will make it more difficult for drug counterfeiters to profit from the lucrative American market.  We protect our nation’s gold standard pharmaceutical system and ensure that only the Food and Drug Administration’s approved drugs reach Americans’ hands,” Buyer said. 

H.R. 5839 strengthens the regulations for business manufacturing and distributing pharmaceuticals in the U.S.  A prescription drug will then be tracked from the time it leaves the manufacturer to the time it reaches U.S. consumers.

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