Wholesalers take a stand for uniform national licensure

November 7, 2005

In the past five years, network TV has brought news of counterfeit pharmaceuticals to the American public at a seemingly increasing rate. Reports about the counterfeiting of drugs such as gentamicin, Lipitor (atorvastatin, Parke-Davis), Epogen (epoetin alfa, Amgen), Procrit (epoetin alfa, Ortho Biotech), and Viagra (sildenafil, Pfizer Inc.) have been big news. The public has seen photos of counterfeit drugs next to authentic agents, their nearly identical appearance graphically demonstrating the counterfeiters' sophistication.

In the past five years, network TV has brought news of counterfeit pharmaceuticals to the American public at a seemingly increasing rate. Reports about the counterfeiting of drugs such as gentamicin, Lipitor (atorvastatin, Parke-Davis), Epogen (epoetin alfa, Amgen), Procrit (epoetin alfa, Ortho Biotech), and Viagra (sildenafil, Pfizer Inc.) have been big news. The public has seen photos of counterfeit drugs next to authentic agents, their nearly identical appearance graphically demonstrating the counterfeiters' sophistication.

According to a CBS report, 110,000 vials with only 1/20 the concentration of active drug were relabeled as Procrit and Epogen. FDA investigations of counterfeit drug cases jumped from an average of about eight per year between 1997 and 2000 to 26 per year between 2001 and 2003-and jumped again, to 58 in 2004.

The Healthcare Distribution Management Association (HDMA), is well aware of this problem. At the recent opening session of the 2005 HDMA Leadership Forum, HDMA president and CEO John Gray announced his organization's support of federal licensure of healthcare distributors with strict standards for supply-chain security. He spoke to an audience of primarily pharmaceutical distributors at the annual meeting, held in San Diego.

Chuck Austin, president, Global Pharmaceutical Supply Group, Johnson & Johnson, in his talk "Channel Integrity Strategies for the Adaptive Business," carefully laid out an argument in support of increased criminal penalties for drug counterfeiting, using the example of Procrit, which was involved in one of the most widely publicized counterfeiting cases. The drug is used to stimulate the replenishment of red blood cells in patients receiving chemotherapy for cancer. Receiving an inactive substitute can lead directly to death in some cases, said Austin. "Why is the crime not murder?" he asked.

Counterfeiting a prescription drug is punishable by a maximum of three years in prison; counterfeiting a prescription drug label is punishable by up to 10 years. "The punishment for counterfeiting ethical pharmaceuticals does not fit the crime," Austin contended. He further asserted that one reason so many people get into counterfeiting pharmaceuticals is that the penalties pose so little risk.

In 2003, HDMA encouraged its members to support its voluntary program to combat counterfeit drugs. Gray also announced the creation of the new HDMA Foundation, launched by a million dollar grant from HDMA reserve funds and recently approved by the HDMA board of directors. The HDMA Foundation will give financial support to research and education to help further secure the healthcare supply chain, improve business efficiencies, and communicate the value of healthcare distribution to the public.

Another highlight of this meeting was the keynote address by Vice Admiral Richard Carmona, M.D., MPH, and FACS, U.S. Surgeon General. Admiral Carmona gave an introduction to his improbable and inspiring life story, which included growing up poor, dropping out of high school, enlisting in the U.S. Army and becoming a Special Forces medic in Southeast Asia, then attending community college in New York City. On his way to becoming Surgeon General, he was a paramedic, police officer, registered nurse, physician's assistant, vascular surgeon, CEO of a hospital, and CEO of a health system.

Carmona then spoke about the challenges of his current job. The mandate of the Surgeon General, defined by statute, is to protect and advance the health, safety, and security of the nation. He shared his ideas about ways the U.S. healthcare system can improve, in particular in the four general areas of prevention, preparedness, healthcare disparities among minorities, and health illiteracy.

Changes in our approach to preventive medicine could have a significant impact on human suffering and medical costs. According to Carmona, "The majority of what we care for every day in this country is preventable." He went on to say, "We have become a nation that embraces treatments, and we do that very well, at a very high cost. We must become a nation that embraces prevention, health, and wellness."

THE AUTHOR is a writer based in San Diego.