Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages

Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages
Authors Janet Woodcock and Marta Wosinska of FDA explore why and how these shortages may have been created. From the abstract: “The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments. The US Food and Drug Administration’s (FDA’s) need to use its regulatory flexibility, on behalf of patients, to avoid shortages of medically necessary drugs may further strengthen the incentive to “push the envelope” on quality. These dynamics may have produced a market situation in which quality problems have become sufficiently common and severe to result in drug shortages.”


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Drug Shortages, PhRMA, FDA, and the world

What are the causes of drug shortages? Can we predict and prepare for shortages? 
-some links for background reports

FDADrug Shortages - Review and Discussion of Key Issues

Summary of the Jan. 6, 2012 Meeting of the Science Board to the FDA

IMS Health IncorporatedDrug Shortages: A Closer Look at Products, Suppliers and Volume Volatility
The drug shortages problem is of increasing concern for patients, clinicians and policymakers. Using IMS Health’s comprehensive, proprietary data on the drug supply chain, we examine the issue from an entirely new point of view, offering insights and recommendations to help the FDA, pharmacists and other healthcare stakeholders monitor and respond to this important issue.

The Pew Charitible Trust
After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs
Pharmaceutical manufacturers and distributors work together in a robust system to deliver high-quality products, but drug manufacturing and distribution have become increasingly complex in recent years. Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers and distributors.

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

http://blogs.fda.gov/fdavoice/index.php/2012/05/six-month-check-up-fdas-work-on-drug-shortages/

Lawmakers seek faster approval process for shortage drugs, from AMEDnews.com

A House subcommittee adds legislative language on shortages to the user-fee reauthorization bill.

By Charles Fiegl, amednews staff. Posted April 30, 2012.

An expedited review track as well as studies on regulations and manufacturing are being considered as possible solutions to national shortages of certain drugs.

The House Energy and Commerce health subcommittee held an April 18 hearing on draft language addressing drugs in short supply. Lawmakers are seeking to add the provisions to the reauthorization of the Prescription Drug User Fee Act. The act, which expires this year, sets fees for Food and Drug Administration reviews of drug approval applications. The law sets performance goals for drug reviews while raising hundreds of millions of dollars from manufacturers seeking approval of their products.

• Fees support most of the drug review process
• See related content

Drug companies and public health advocates want federal lawmakers to use reauthorization of the 20-year-old law to tackle the drug shortage problem. There are 214 drugs in short supply, according to the American Society of Health-System Pharmacists.

Provisions in the subcommittee draft of the reauthorization legislation seek to end approval delays and improve FDA programs. The bill would establish quotas for drugs in shortage and establish expedited reviews of major manufacturing changes for drugs that are, or have the potential to be, in short supply.

“In talking with patients, manufacturers and providers, they tell me it is one of the best parts of the discussion draft and it will really help with shortages,” said Rep. Joe Pitts (R, Pa.), the subcommittee’s chair.

However, the FDA already has the authority to conduct these expedited reviews, Janet Woodcock, MD, director of the agency’s Center for Drug Evaluation and Research, told the subcommittee. But officials expedite a review only if notified earlier during the review process.

214 drugs were in short supply in April 2012. 

 

to continue article...

Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report

Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report

PUBLIC HEALTH

Groups Seek Congressional Action on Drug Shortages

Discounted generic drug application fees proposed as incentive to curb shortfalls.

MICHAEL FITZHUGH

The Burrill Report

“We believe appropriate mechanisms, such as a generic user fee program, could provide a crucial economic tool for FDA to provide incentives to manufacturers, and should be enacted as quickly as possible”

A group of more than 30 organizations seeking to address drug shortages in the United States has written a letter urging Congressional action to solve the problem.

The letter, sent to Senator Tom Harkin, D-Iowa, by groups representing clinicians, healthcare facilities, drug manufacturers, and patient advocates, urges Congress to consider implementing a generic user fee program in the upcoming Prescription Drug User Fee Act reauthorization, or PDUFA.

 The fees could be used to allow the U.S. Food and Drug Administration to “offer reduced application fees for products in short supply, or discounted fees if a company demonstrates that its contingency plans are sufficient to reduce the risk of a shortage if production is halted,” they suggest.

for complete article, please visit the Burrill Report link:
Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report