SECRETARY THOMPSON DETERMINES THAT SAFETY PROBLEMS MAKE DRUG REIMPORTATION UNFEASIBLE
HHS Secretary Tommy G. Thompson today told members of Congress that the safety of prescription drugs could not be adequately guaranteed if drug reimportation were allowed under the Medicine Equity and Drug Safety Act (MEDS Act).
In a letter to Sen. James Jeffords of Vermont, Secretary Thompson said the law enacted last year cannot be implemented, especially because of safety concerns. His findings reaffirm the decision made last December by former HHS Secretary Donna E. Shalala.
"I believe very strongly that seniors should have access to affordable prescription drugs," Secretary Thompson said in today's letter. "However, I do not believe we should sacrifice public safety for uncertain and speculative cost savings."
Reimportation of prescription drugs by pharmacies and drug wholesalers would remove products from the thorough safety and effectiveness monitoring overseen by HHS' Food and Drug Administration, Secretary Thompson found. "Opening our borders as required under this program would increase the likelihood that the shelves of pharmacies in towns and communities across the nation would include counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired drugs, contaminated drugs, and drugs stored under inappropriate and unsafe conditions," he said in the letter.
The MEDS Act would allow prescription drugs manufactured in the United States and exported to certain foreign countries to be reimported from those countries for sale to American consumers. The law was based on the hope that lower pricing of drugs by those countries would be passed on to American consumers for drugs that were manufactured in the U.S. and, therefore, had met strict safety and effectiveness standards maintained under FDA regulation. A provision of the law required the HHS Secretary to determine that adequate safety could be maintained and that costs would indeed be expected to be reduced significantly. Secretary Thompson's finding today, like Secretary Shalala's, concluded that neither condition could be adequately assured.
"Our drug approval and monitoring system, overseen by the FDA, is what ensures that the American consumer has the safest and most effective pharmaceutical products in the world. It would be short-sighted to compromise that system," Secretary Thompson said.
Today's finding's included:
Moving from the current "closed" distribution system with relatively few importers to an "open-border" distribution system would significantly increase the risk that counterfeit, misbranded, and adulterated drugs would show up on U.S. drug store shelves and in American homes.
It would not be possible to maintain the same level of drug supply protections in place today even with the MEDS Act requirements for chain-of-sales documentation, drug product sampling, and product testing.
A likely outcome would be a lowering of consumer confidence in the safety of the drug supply.
Costs of documenting previous sales, sampling and testing, and product relabeling are likely to offset much, if not all, of the potential savings. These costs are difficult to estimate and adequate information does not exist for the Secretary to predict that net savings will result to the American consumer.