FDA is asking the public to send in ideas for combating drug shortages

Posted on February 13, 2013 by FDA Voice

By: Valerie Jensen

FDA has made progress over the last year or so in preventing and resolving shortages of important drugs — including chemotherapies, anesthetics and antibiotics. Nevertheless, the agency believes that even more can be done and is therefore turning to the American public for advice, as explained in a Federal Register notice published this week. What the public tells FDA will help inform the agency’s development of a strategic plan that will ultimately enhance FDA’s response to preventing and mitigating drug shortages.

FDA has long been tackling the problem of drug shortages, and since October 2011, has stepped up its efforts to encourage drug and biological product manufacturers to report if they know of any circumstances that could lead to a drug shortage, including temporary interruptions in manufacturing. Such early notification is the agency’s most powerful tool to address drug shortages—we can’t work to prevent, mitigate, or resolve a shortage if we don’t know about it. Along these lines, FDA supported efforts to expand the FD&C Act’s early notification requirements as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted on July 9, 2012. Happily, these efforts have been paying off. For example:

The number of shortages is now less than half of what it used to be. There were 117 in 2012, down from 251 in 2011.
Many more shortages are now being averted. We prevented 195 in 2011. Last year, we prevented 282.

We expect the requirements in FDASIA to further enhance FDA’s efforts to work with manufacturers and other stakeholders to prevent or alleviate shortages. When notified of a potential or actual shortage, FDA can take a number of actions, as appropriate, including: expediting inspections and reviews of regulatory submissions, working with the manufacturer to solve the underlying problem contributing to the shortage, identifying alternative manufacturing sources, exercising enforcement discretion for the shipment of a critically needed drug with special instructions to healthcare providers, and using enforcement discretion for the temporary importation of non-U.S. product.

One shortage of a drug that improves or saves the life of even one patient is one shortage too many. More can be done to prevent shortages.

As required by FDASIA, FDA has also formed an internal Drug Shortages Task Force to develop a strategic plan to enhance the agency’s efforts to address and prevent drug shortages. Among other things, the strategic plan will include blueprints for enhanced coordination, communication, and decision making within FDA and with other federal agencies; and plans for effective communication in the event of a shortage, including who should be alerted about potential or actual drug shortages and what information should be shared.

FDA wants to hear from all interested stakeholders on the strategic plan. The agency published a Federal Register notice, posted Feb. 11, which provides additional information and seeks input on six targeted questions related to the Strategic Plan and to preventing and mitigating drug and biological product shortages. Comments will be accepted through Thursday, March 14, 2013.

Valerie Jensen, a pharmacist and expert on drug shortages, is associate director at FDA’s Center for Drug Evaluation and Research

Six Month Check-Up: FDA’s Work on Drug Shortages

Posted on May 3, 2012 by FDA_Voice

By Margaret Hamburg, M.D.

This week marks the six-month anniversary of President Obama signing an Executive Order to help FDA in our ongoing efforts to prevent and resolve prescription drug shortages. At FDA, we saw the Executive Order as an important step in bringing awareness to this critical public health issue and signaling the necessary tools and resources, such as early notification and additional staff, FDA must have to help address this problem. Following the Executive Order, we sent out letters to drug manufacturers asking them to voluntarily report to FDA if they saw the emerging potential for a drug shortage.

Six months later, I am both amazed and delighted to see the progress that’s been made. Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts – and the numbers really tell the story. Since reaching out to industry, there has been a six-fold increase in early notifications from manufacturers. Also in that six month timeframe, we have been able to prevent 128 drug shortages, and we’re seeing fewer numbers of shortages occur – 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year. This data is a testament to how FDA exercises flexibility and discretion in much of our work on drug shortages and the importance of strong collaboration and constant communication with industry, health professionals, and patients.

But these are simply statistics. Consider instead the impact of our work on patients, who need particular drugs to treat life-threatening diseases. For instance, supplies of methotrexate, a cancer drug used to treat childhood leukemia and osteosarcoma, are currently meeting all demand, and we do not expect any further supply issues. Also, to address the shortage of Doxil (liposomal doxorubicin), a drug used for ovarian cancer and other cancer regimens, FDA exercised enforcement discretion for the importation of Lipodox, another brand of liposomal doxorubicin, from India, meeting patient needs until Doxil is available again.

While many shortages of cancer drugs are resolving, we are still working hard to address others. Leucovorin injection, a cancer drug that is used along with methotrexate for children with a serious form of leukemia, has been in short supply for some time. We are working with the manufacturer, Teva Pharmaceuticals, to produce additional shipments in the coming weeks to help improve supplies. Mustargen (Mechlorethamine HCl) – another cancer drug used in multiple cancer regimens — has also been in shortage. FDA has worked with the manufacturer to resume production of Mustargen, and the company is planning to have product available again by August.

We are equally concerned about other types of drugs in shortage. Anesthesia drugs, such as benzodiazepines and fentanyl injections, have recently been in short supply. Here again, early notification is helping. One manufacturer, Hospira, notified FDA of anticipated delays in supply of the critical anesthesia drug propofol. This advanced notice allowed FDA to work with the other manufacturer of propofol who was able to increase supplies to keep the product available for patients undergoing surgery.

Drug shortages remain a serious, complex problem, and the agency remains extremely concerned about all current and potential drug shortages, not just those that I mentioned. Our efforts require a multifaceted approach involving industry, regulators, payers, and others. And we’re working with Congress on bipartisan legislation to expand early notification of drug supply problems that could cause shortages. All of us have a responsibility to help ensure that patients have reasonable access to the drugs they need. Drug manufacturers in particular have a responsibility to manufacture quality drugs and to have a process to ensure supply continuity of critical drugs.

In a blog I wrote earlier this year, I reminded readers that “the critical issue of drug shortages isn’t about industry; it isn’t about government, or even about the drugs themselves. It is about getting people the treatments they trust, they need, and they rely on.” While that remains as true as ever, I would like to add a different kind of reminder. Today’s six-month check-up demonstrates what government and industry can accomplish when we work together. While there’s no simple solution, we are making progress. And we’ll remain vigilant – doing all we can and using every resource available – to make sure patients have access to the critical medicines they need, when they need them.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration

Hope on the Horizon

Posted on February 23, 2012 by FDA_Voice

By: Margaret Hamburg, M.D.

This week we were once again reminded that the critical issue of drug shortages isn’t about industry, it isn’t about government, or even about the drugs themselves. It is about getting people the treatments they trust, they need, and they rely on. One person who understands this all too well is Sara Stuckey from Lincoln, Illinois. Sara’s son, six-year old Nate, has been on the cancer drug methatrexate since he was diagnosed with leukemia back in 2009. The drug is the preferred treatment for the disease. Unfortunately, due to the shortage, Nate’s doctor informed Sara that he only had enough of the drug for Nate’s treatment this week.

At a briefing Tuesday hosted by the FDA for representatives from industry, health professional and patient organizations, as well as the FDA team that has been working day and night to address this problem, Sara Stuckey shared her story.

Watch videos from the FDA Progress on Drug Shortages briefing.

Sara talked about Nate, the little boy, who is the “laid-back” one in her family. She explained how the family has learned to be flexible, working around Nate’s disease, compromised immune system, and chemotherapy treatment. For this family and many others, methotrexate is a life-saving drug. So, when Sara heard about a possible shortage of the drug, she talked to Nate’s clinic. They said there was just enough supply for a week but that there were alternatives. Still, Sara was left with many questions and concerns – the same questions any parent would be asking if their child faced a life-threatening illness.

Sara Stuckey speaks at "FDA Progress on Drug Shortages," a briefing held on February 21, 2012, about her son, six-year old Nate.

View photos from the FDA Progress on Drug Shortages briefing.

The good news for Sara and Nate – and many other children and families – is that the shortage has been averted.

FDA has prioritized review of and approved a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals and expects that product to become available in March and continue indefinitely.

At Tuesday’s briefing, the CEO of Hospira, another company that manufactures the drug, said that supplies are being ensured for months to come. Hospira expedited release of additional supplies, resulting in 31,000 vials of new product – enough for more than one month’s worth of demand – being shipped to hundreds of U.S. hospitals and treatment centers on Tuesday.

And FDA is actively working with other manufacturers of methotrexate who have also stepped up to increase production in order to meet patient needs, including Mylan and Sandoz Pharmaceuticals.

To remedy the critical shortage of another cancer drug Doxil (liposomal doxorubicin), the FDA took proactive steps needed to increase available supply for patients in the U.S. For Doxil, there will be temporary importation of a replacement drug, Lipodox (liposomal doxorubicin), which is expected to end the shortage and fully meet patient needs in the coming weeks.

Still, we cannot stop there. At Tuesday’s briefing, we heard from representatives of the American Cancer Society, the American Society of Clinical Oncology, the Children’s Oncology Group, and APP, as well as Hospira. All spoke forcefully for working together to prevent future shortages from affecting the lives of both children and adults. It is enough for families to cope with disease; adding real or potential shortages to their list of worries is more than unfortunate.

Members of the FDA Drug Shortages team

This event reminded us of the human impact of drug shortages – as well as what can be done when we work together. We hope this can be a model for future efforts as we move forward, working with our partners in industry, with health professionals, and with patient advocates to find answers that will work for families like Nate’s.

While there is no simple solution to resolving drug shortages, we are doing all that we can to make sure patients have access to the critical medicines they need when they need them. I’d like to give a special thanks to the FDA Drug Shortages team and all the other staff throughout our agency for their hard work and leadership on this topic.

We are making progress. Hope is on the horizon.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration.