WASHINGTON – In trying to identify the culprit for the drug shortage crisis facing the nation, the Department of Health & Human Services (HHS) had only to look to the marketplace. But finding a solution isn't as easy.

Patent expirations, a rush to generic drugs, manufacturing capacity limitations, pricing issues and expanding use of oncology drugs have combined to create a record number of shortages in off-patent sterile injectables, according to a new report from the Office of the Assistant Secretary for Planning and Evaluation at HHS. (See BioWorld Today, May 6, 2011, and Sept. 27, 2011.)

Alluding to the report in a conference call with stakeholders Monday, FDA Commissioner Margaret Hamburg admitted that no one at the agency had realized how widespread the demand was for some of the oncology drugs that are now in short supply. To address those shortages and fend off future ones, the FDA must expand its understanding of how products are being used, she said.

The agency also identified several other steps it can take to prevent shortages. Number one on the list is early notification. "The data are clear that early notification has an impact," Hamburg said.

She sent a letter to drugmakers Monday reminding them of their legal obligations to report potential shortages of single-source drugs and encouraging them to voluntarily report other possible shortages. The letter came on the heels of an executive order signed Monday that directed the FDA to broaden reporting of potential shortages of certain drugs.

Currently, drugmakers are required to report only potential shortages of a sole-source drug. That would change if Congress passes the Preserving Access to Life-Saving Medications Act, S. 296 and H.R. 2245, which would mandate six months advance notice of all potential shortages unless there are certain extenuating circumstances. (See BioWorld Today, Sept. 26, 2011.)

Under the bill, a drugmaker that failed to notify the FDA could be assessed $10,000 per day in civil monetary penalties, up to a maximum of $1.8 million per event.

Getting early notice helps the FDA mitigate a shortage before it occurs. So far this year, the agency has warded off 99 shortages. "We are committed to doing everything we can to try and prevent shortages from happening in the first place," Hamburg said.

But when a shortage can't be avoided, the agency plans to work with the manufacturer to release as much information as possible so patients and providers can better plan for the shortage, Hamburg said. Several doctors testified during a recent workshop of being in the middle of treating a patient when they were informed that the drug they needed wasn't available.

Part of the problem is that much of the information about a shortage is considered confidential. The agency is developing guidance and regulations to clarify and enhance the information that's provided.

In response to another issue raised at the September workshop, the FDA is providing additional staff to work on preventing and mitigating shortages. Its Drug Shortage Program consists of four staffers. That may have been adequate a few years ago when only 56 new shortages were reported. But those four employees are being overwhelmed by a problem that has more than tripled in magnitude, the Stakeholder Workgroup of the Drug Shortage Summit told the agency. (See BioWorld Today, Sept. 28, 2011.)

The FDA also proposed a number of long-term strategies to deal with the crisis:

identify factors that contribute to success or failure in preventing shortages and continue exploring new approaches to prevent shortages under the agency's existing authorities;

identify the quality issues in manufacturing practices that have contributed to severe shortages and develop approaches to addressing them;

encourage manufacturers to develop and maintain a backup plan for manufacturing and for sources of active pharmaceutical ingredients and other essential components;

explore development of a sentinel reporting network to facilitate early warning of shortages;

encourage wholesalers to develop and publicize their procedures for distributing drugs in shortage;

improve the Drug Shortage Program's website as a communications tool for providers and others.

In discussing the strategies Monday, Hamburg said, "We all feel a sense of urgency" to tackle the shortage problem. But she acknowledged that "we are limited in many aspects of what can really be done."

That sense of urgency was reflected in the president's executive order, which called on the FDA to expedite the review of new manufacturing sites, drug suppliers and manufacturing changes to help prevent shortages.

"The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety," President Barack Obama said in a press release. "This is a problem we can't wait to fix."

His order also instructs the FDA to work with the Department of Justice to investigate potential hoarding of medications or price gouging when a shortage occurs. Given the volume of shortages, a largely unregulated "gray market" has sprung up that is selling affected drugs at prices up to 4,000 percent above the usual market price.

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