We Need Reciprocity Of Drug Approvals To Address Critical Drug Shortages


By Henry I. Miller and John J. Cohrssen

Published in Issues and Insights

We hear a lot about rising drug prices, but largely ignored is a far more acute and worrisome problem: widespread shortages of critical medications, many of which are essential in medical practice.

University of Chicago researchers last year surveyed 719 pharmacists at large and small hospitals across the country and found that all of them reported experiencing at least one drug shortage in the past year, and 69% had experienced at least 50 shortages in that time. The majority are generic injectable pharmaceuticals commonly used in hospitals, including analgesics, cancer drugs, anesthetics, antipsychotics for psychiatric emergencies, and electrolyte solutions needed for patients on IV supplementation.

The FDA maintains a current list of drugs that are currently in shortage or whose shortage has been resolved. As of March 28, more than 100 drugs were on it, and the list read like the contents of the pharmaceuticals cabinet of a hospital ICU or emergency room.

Hospitals are scrambling to assure adequate supplies of drugs that are in short supply, or to find substitutes for them. In the University of Chicago study, one-third of hospitals actually had to ration drugs at least once. That means that some patients got the second or third choice of a drug treatment, increasing the likelihood that the drug will be ineffective or only marginally effective, or have unwanted side effects.

The FDA claims it is doing everything it can to address this problem, but that isn’t true.

For decades the FDA has resisted a definitive and straightforward solution to the problem of drug shortages: “reciprocity” of drug approvals with certain of the FDA’s foreign counterparts, so that an approval in one country would be reciprocated automatically (subject to the creation of approved labeling in appropriate format, and other paperwork) by the others.

Such reciprocity of approvals would make available numerous needed alternative drugs – especially those that are in common use and not experiencing shortages abroad – and it could have been in place decades ago if only the FDA had met its long-standing commitment to pursue it through the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

There has been some progress on harmonization at the margins. A number of countries now have a standardized dossier for seeking approval of new drugs, the U.S. accepts research conducted in other countries to support applications for the approval of new drugs and devices, and the FDA has established Good Manufacturing Practices for foreign production facilities.

The ICH’s agenda (supposedly) includes reciprocity of drug approvals among certain governments, but generations of FDA officials have resisted any such “delegation” of their responsibilities. When asked about the extent of the FDA’s cooperation on this issue, a senior European regulator quipped, “It’s like discussing the Thanksgiving dinner menu with the turkeys.”

The FDA has improvised procedures for importing drugs approved and marketed abroad that have not been approved in the U.S., but that “enforcement discretion” approach – a kind of ad hoc, unidirectional reciprocity – is legally questionable. In a footnote to the agency’s October 2013 Strategic Plan for Preventing and Mitigating Drug Shortages, the FDA acknowledged its awareness of a relevant recent court decision, Cook v. FDA (D.C. Circuit, Case No. 12-5176), in which the court prohibited the agency from using enforcement discretion to permit the importation of an unapproved drug for capital punishment execution, because the law is clear that an unapproved drug cannot come through U.S. Customs for marketing. The FDA’s terse response, “We are currently reviewing the decision in the context of our drug shortages program,” belies the existential importance of that decision.

The bottom line is that we need greater availability of medicines in the marketplace, and reciprocity of drug regulatory decisions would be an important advance. The White House and Congress should make it happen. Soon.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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