Congress Mulls Fining Drug Firms for Not Reporting Shortages

Congress Mulls Fining Drug Firms for Not Reporting Shortages

June 14th, 2012 // 1:33 pm @

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As the US Senate and House prepare to reconcile their differing versions of the Food and Drug Administration Safety and Innovation Act, which most people still refer to as PDUFA, a coalition of 20 organizations representing physicians, hospitals, and patient advocacy groups appears to have given up on the possibility that drugmakers will be hit with civil penalties for failing to report looming medication shortages.

The issue has resonated for two years as the list of drugs in short supply grows stubbornly long (see here), despite reports from some oncologists that shortages of some cancer medications have eased recently. Nonetheless, many other medicines, such as some controlled substances (read here) remain elusive amid ongoing debate over manufacturing gaffes, government quotas and opportunistic pricing.

Both versions of PDUFA would require drugmakers to offer the FDA early notification of any pending shortages in hopes the agency can somehow compensate by reaching out to other suppliers on an emergency basis, a step already taken twice this year (back story). However, the bills do not mention the possibility of any fines for failing to sufficiently report shortages in advance, an omission that has riled doctors, hospitals and patients.

Nonetheless, the coalition – which includes such organizations as the American College of Surgeons, the American Academy of Pediatrics, the American Hospital Association, the American Society of Clinical Oncology, the Academy of Managed Care Pharmacy and the Children’s Hospital Association – appears to have acquiesced to the political realities that fines may not be implemented, even though they clearly believe in punishing recalcitrant drugmakers.

“We continue to believe that monetary penalties would represent the most effective mechanism to encourage reporting,” they wrote late last week to Tom Harkin, who chairs the Senate Health, Energy, Labor and Pension Committee; Mike Enzi, the ranking member of the committee; Fred Upton, who chairs the House Energy and Commerce Committee; and Henry Waxman, the ranking member on that committee.

“However, given that this is currently not an option in either bill, we support the approach taken in the House version whereby a failure to report by a manufacturer would trigger an automatic letter by FDA to that company requesting an explanation of why it did not report to FDA. As these letters and responses would be a matter of public record, as are other FDA enforcement actions, manufacturers would be held accountable for justifying failure to report a stoppage in production of a life‐saving product that could result in patient harm or death” (read the House and Senate letters).

In other words, the coalition is counting on a mix of public shame and unstated repurcussions to force change. To what extent this will matter is unclear. A Boehringer Ingelheim unit called Ben Venue Laboratories was responsible for various shortages last year before ending contract manufacturing at a troubled facility that repeatedly drew the ire of inspectors from the FDA and European Medicines Agency. There was even the embarrassment of a can of urine being found in a storage area (see this).

Meanwhile, investors worry over consent decrees – Hospira is regularly floated as a candidate (look here) – and there is always the threat of lawsuits. Just the same, not every episode is so dramatic or the outcome so definitive. Perhaps civil penalties are needed, but the political reality may not accommodate the notion.


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