ASBA Update From Washington

As an ASBA member, you now have free access to news and updates on important issues from our legislative team in Washington DC.

April 2008
by James C. Musser, ASBA Washington Representative

Billions of prescriptions are filled in the United States every year with very few complaints about the safety of the medications. In fact, the United States' prescription drug supply chain is the envy of the world for its safety and efficiency in meeting patients' needs. Unfortunately, there are real threats to the continued security of the drug supply chain and one of them is from our own Congress.

The FDA, state boards of pharmacy and the pharmaceutical companies have worked together over the years to develop a tightly controlled system that largely insures the quality, potency and purity of prescription drugs. The system makes sure that the FDA inspects all manufacturing facilities and any prescription drug has undergone between twelve and fourteen years of study before it is offered to the public. Government and the pharmaceutical industry have worked closely together to make sure the chain of custody for prescription medicines is clear and tightly controlled through regimes of licensing and inspection. In the rare cases in which a consumer is injured by a prescription drug, the consumer has legal recourse to seek compensation for the injury and the system is designed to track the drug back to the point of manufacture to correct the problem. The United States has developed a safe and clear system for our distribution of prescription medicines and it is the gold standard for the world.

In a move prompted more by election-year politics than real need, two bills have been introduced in Congress that would endanger the security of our prescription drug supply chain. In the Senate, Senator Byron Dorgan (D-ND) has introduced S. 242 along with 35 cosponsors from both political parties. In the House, Representative Rahm Emanuel (D-IL), along with 108 cosponsors, has introduced a nearly identical version H.R. 380. The bills would allow for the importation of drugs from Canada for both personal and commercial uses. The problem is that these drugs have not been inspected or tested for their safety, potency and purity.

In fact, Health Canada, the Canadian version of our FDA, has specifically said it does not have the resources to inspect drugs that are purely for export. Health Canada's job is to insure the safety of drugs for use by Canadians not to protect the rest of the world. Anyone wanting to export drugs to the United States could, and in many instances have, set up warehouses in Canada to sell prescription drugs to unsuspecting Americans who do not realize the “medications” are actually from China, Russia, India and other countries even though they have a Canadian shipping address.

There is no good reason for this legislation and the danger it introduces into our secure prescription drug supply chain is completely unacceptable. In 2005, the FDA and the Customs Bureau conducted operations at multiple airports around the country and found that nearly half of the prescription drugs they intercepted were shipped to fill orders Americans thought were made to Canadian pharmacies but, in fact, 85% of the drugs intercepted were from twenty-seven countries other than Canada. Even worse, most of the products were counterfeit. The drugs were a combination of placebos, expired, stored in ways that destroyed their potency or adulterated in ways that made them dangerous. Clearly, such drugs should not be allowed to come into our otherwise highly secure supply chain.

The safety of our prescription medicines is too important to allow politics to endanger our health and well-being. Congress should not adopt this poorly designed legislation.

ASBA closely monitors the government's actions affecting you and your family. Check back each month for the latest news from Washington, D.C.

James C. Musser, Esq. is a legislative consultant based in Falls Church, Virginia. His reports are updated monthly.