An article in The Washington Post, dated March 17, 2017, describes the effort to legalize the importation of drugs from other countries into the United States. Its headline points out that the four recent commissioners of the Food and Drug Administration (FDA) have come out in opposition to this effort. The thrust of their objections center around the safety of prescription drugs that are not produced within the rules and regulations of the FDA.
The former commissioners are Robert Califf and Margaret Hamburg, both of whom hold this position while Barack Obama was President. They are supported by Andrew von Eschenbach and Andrew McClellan, whose time was during the administration of President George W. Bush. Their opposition to importation of drugs from outside the United States came to light in a letter to members of Congress. The letter was sent in response to legislation introduced to allow importation from licensed agencies in Canada, and perhaps later, from Europe.
The purpose of the letter was twofold. One was to inform members of Congress of the opinions of the former commissioners, and to encourage them to not support the legislation. The other purpose was to inform the public, and hopefully encourage the American people to contact their members of Congress, and urge them to not support this bill. The commissioners made clear their opposition to importation. The FDA regulates drugs in the United States, but has no way to regulate or guarantee the safety of drugs imported from other countries. The former commissioners consider this to be a public safety issue.
The impetus behind the legislation is the cost of prescription medicines. In other countries like Canada, the same drug is much less expensive than in the United States. Of course, that is the heart of the former commissioner’s objections. They say that there is no guarantee than the drug that purports to be the same is really the same. It is really a question of quality control, or lack thereof.
Backers of the legislation say that the safety concerns can be met with appropriate regulations, and that the drugs would only come from reputable sources. The former commissioners counter that such regulations would drive up the price of imported drugs, and thus cancel out any savings.
This argument which pits safety against lower prices is not likely to be settled by this letter, and will be one that will be continued to be debated in the future.