ICYMI: Jim Greenwood’s Letter in NYT on Drug Importation

Yesterday, the New York Times published a letter to the editor from BIO’s President and CEO, Jim Greenwood. In the letter, Greenwood addresses drug importation concerns which were overlooked in a previously published NYT op-ed – concerns which are shared by many others, including former FDA Commissioners from both Democrat and Republican Administrations.

The full letter can be viewed on nytimes.com or read below:

To the Editor:

Re “How to Stop Drug Price Gouging” (Op-Ed, April 20)

Tim Wu’s call to open the American market to foreign drug supplies is cavalier in its dismissal of the safety risks of his proposal, and wildly optimistic about the potential savings such a move would create.

A bipartisan group of four former commissioners of the Food and Drug Administration wrote to Congress recently expressing concern over the idea. Such a move, they wrote, “is likely to harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.”

How about the purported savings? A Department of Health and Human Services task force on importation found that “total savings to drug buyers from legalized commercial importation would be 1 to 2 percent of total drug spending and much less than international price comparisons might suggest.” The task force wrote, “The savings going directly to individuals would be less than 1 percent of total spending.”

There is no silver bullet for rising health costs. But exposing American patients to potentially counterfeit, unapproved or adulterated drugs — for what would probably be scant savings — is not the answer.

Four Former FDA Commissioners Warn About Drug Importation Dangers

Last week, four former FDA Commissioners – Robert M. Califf, Margaret B. Hamburg, Mark B. McClellan, and Andrew Von Eschenbach – wrote an open letter to members of Congress warning them about the risk of legalizing importation of drugs. The Washington Post outlines how these former FDA heads – who served in both Democrat and Republican administrations – advise against proposals to expose U.S. consumers to foreign medicines. The Commissioners write that a broad-based importation scheme would:

Harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.

Robert Califf, in an interview with the Post, expressed concern that consumers would have no dependable way of knowing where drugs are coming from, what’s in them, or their safety overall. The letter warns that:

Global experience confirms that illicit, ineffective, or adulterated products are readily available on the open market and represent one of the most lucrative avenues of organized crime.

If the FDA were required to oversee this process, as proposed, a significant regulatory oversight system would be required. The former Commissioners question the likelihood of the agency getting the resources it would need to fulfill such a monumental task:

Obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges.

Studies on importation have forecasted the effects on access and savings in the U.S. to be small – potentially too small to ever reach the patient. The Commissioners write:

Any improved access and cost savings resulting from importation are likely to be minimal. Studies examining this issue have estimated that importation would likely have only a small, incremental effect on cost and access for drugs in the U.S. market; further, these small savings might not be passed on to patients, even if consumers are able to obtain a legitimate imported drug.

The letter also notes:

The current U.S. drug distribution system, as overseen by the FDA, ensures good manufacturing practices and the quality and security of an increasingly complex supply chain.

Read the full letter here.