This article was published with permission from The Burrill Report.
All of a sudden the mainstream media — highlighted by a much ballyhooed piece in The New York Times’ Week in Review — has discovered the problem of drug shortages. Unfortunately, it’s not a new problem.
According to a recent analysis, the frequency and impact of drug shortages have risen to critical levels, more than tripling since 2005, and affecting all segments of the health care community. In 2010, more than 240 drugs were either in short supply or completely unavailable, and more than 400 generic equivalents were back-ordered for more than five days. In most instances, these did not progress to critical shortages, but point to instabilities in the supply chain that cause national concern. Many of the drugs identified in 2010 remain unavailable or in short supply in 2011.
Some 77% of drugs in short supply in 2010 were sterile injectable products, critical in the acute care setting. Recent media coverage highlights the plight of patients and physicians faced with shortages for cancer drugs, anesthetic agents, and critical care medications that have contributed to delays in treatment and surgery or changes in care plans. Drug backorders cause patients to receive substitute therapies that add expense to patient care.
Quality and manufacturing problems are a major reason for shortages. However, there are other contributors, such as production delays and problems obtaining raw materials and components from suppliers. Discontinuations also contribute to shortages. The FDA can't require a firm to keep making a drug it wants to discontinue.
It is time not to fix the blame, but to fix the problem. Let’s start with the FDA.
In 2010, there were 178 drug shortages reported to the FDA. Is that a solid number? It’s hard to say, because current regulations do not require companies to notify FDA of shortages. The only requirement is that companies inform the agency six months in advance of discontinuing sole-source, medically necessary drugs.
For example, in the same year 38 shortages were prevented when companies voluntarily notified the FDA of potential issues that could lead to shortages, giving the agency an opportunity to work with the company to avoid a shortage.
The agency’s Drug Shortage Program (DSP) resides within the FDA’s Center for Drug Evaluation and Research. The DSP was established to address potential or actual shortages of drugs that have a significant impact on public health. DSP works with pharmaceutical manufacturers, review divisions, compliance, and other components of FDA to manage product shortages through communication, facilitation and negotiation.
When the drug shortage is for a generic product (as it often is), the FDA works with other firms making the drug to help them ramp up production if they are willing to do so. Often they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these facilities to help resolve shortages of medically necessary drugs.
But the FDA can't require the other firms to increase or commence production.
The agency tries to do the best it can with limited authority, spare resources, and shared staff. In addition to direct communication with industry, the DSP also gets reports from health care professionals, patients/individuals or professional organizations using the email address email@example.com. But, as you can imagine, there is not a lot of email traffic. And there is no social media effort to promote either its purpose or existence.
The FDA’s Drug Shortage Program is a good start. But it’s not getting the job done. The problem is getting worse. The FDA needs both more authority and greater resources. In short, more needs to happen.
The Institute for Safe Medication Practices surveyed 1,800 health care practitioners, and found more than half of respondents frequently or always encounter difficulties associated with drug shortages.
The top three problems fall squarely within the zone of appropriate FDA attention and action. They include:
Survey respondents felt “unsupported” by the FDA and are perplexed regarding why the United States is experiencing drug shortages of “epic proportion that are often associated with third-world countries.”
Should the issues of both authority and funding for the FDA’s efforts to mitigate drug shortages be hung on the Prescription Drug User Fee Act Christmas tree as the legislation is renewed or addressed in separate legislation? Whether it’s one or the other, it’s an issue that must be addressed with urgency before it becomes a question of American lives.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.