Bloomingburg, NY - August 13, 2014 - Today, at the Wurtsboro Open Ridge Space in Bloomingburg, U.S. Senator Charles E. Schumer urged the federal Food and Drug Administration (FDA) to investigate and proactively address a potential nationwide shortage of doxycycline, an antibiotic that is critical in treating Lyme Disease in both humans and animals. Despite how important Doxycycline is for treating Lyme Disease, the FDA has yet to get involved in this potential shortage even though it could limit access to the drug and is already significantly driving up the price. Doxycycline—which is typically administered in 100 mg doses, two times per day to those affected by Lyme—used to be an affordable drug treatment, but according to a recent article in the Poughkeepsie Journal, the medication costs ten times more this year than it did last year. Schumer said that, with Lyme Disease rates already higher in 2014 than in past years, and the large prevalence of Lyme in Sullivan, Orange and Ulster Counties, Hudson Valley residents must have access to Doxycyline at a reasonable price. Therefore, Schumer called on the FDA to investigate and determine ways to mitigate this potential shortage. In addition, Schumer urged the FDA to more proactively address drug shortages, rather than wait for pharmaceutical companies to self-report them.
“Lyme Disease has been a public health problem for decades, and Sullivan and Orange Counties have been the epicenter of Lyme for as long as anyone can remember,” said Schumer. “After many years of treating the disease, medical professionals around the country agree that the best way to prevent Lyme’s worst short-term and long-term effects is with early detection and antibiotic treatment, usually Doxycycline. That is why it is so troubling to hear that the price of this important drug has gone through the roof due to a potential nationwide shortage. If the drug becomes unaffordable or – even worse – unavailable, it would be a serious problem for the thousands of local residents who need treatment right away. This year’s Lyme season is already worse than last year’s, and we should do everything we can to preserve patients’ access to the treatment they need. So I am calling on the FDA to step up to the plate and investigate this potential shortage and resulting price spike, and I am urging them to do everything in their power to mitigate the impact. We cannot allow the Lyme problem to get any worse.”
Schumer continued, “We also must make sure that the FDA is more proactive about addressing drug shortages over the long-term. Currently, they wait for a pharmaceutical company to report a shortage to them, but the FDA should step in and investigate as soon as there is even an inkling that a shortage may be on the horizon. We cannot afford for a shortage of any crucial drug to sneak up on us.”
The Hudson Valley has long been an epicenter for Lyme Disease, which is spread to humans primarily by deer tick bites and can cause severe fever, headache, joint pain and stiffness, heart palpitations and swollen lymph nodes. According to the New York State Department of Health, there were 796 reported cases of Lyme Disease in Sullivan County residents between 2002 and 2012. During the same time span, there were 7,391 reported cases of Lyme in Orange County and 4,551 reported cases of Lyme in Ulster County. And Lyme Disease rates are up throughout the state this year -- the CDC estimates that there have been approximately 2,000 cases in New York already this year, surpassing New York’s total number of Lyme cases in 2013. In addition, the CDC estimates that the actual number of patients with Lyme Disease is likely ten times higher than is reported, so the total for the state this year could be as high as 20,000. These totals underscore that Lyme Disease is a significant threat for every Hudson valley resident.
According to medical professionals, the best way to prevent the debilitating short-term and long-term impacts of Lyme Disease is to diagnose and treat it early with a course of antibiotics – usually doxycycline. The CDC notes that it is usually the patients who are diagnosed and treated later for Lyme Disease that have the highest risk of persistent or recurrent symptoms, otherwise known as Post-Treatment Lyme Disease Syndrome (PTLDS). That is why having unimpeded access to Doxycycline is so critical. However, according to the American Society of Health-System Pharmacists, there is currently a shortage of doxycycline that could put Lyme Disease patients’ ability to fill prescriptions for doxycycline at risk.
Schumer said that it would be a serious problem if the supply of Doxycycline was unfit to treat the growing number of patients with Lyme Disease. And already this potential shortage is having a major effect on the price of Doxycycline, which has skyrocketed over the past year. According to a study by the Drug Channels Institute, the cost of doxycycline has risen faster than any other generic drug over the past year, and the price of an individual had increased by as much as 6,000% at one point at the end of last year.
Schumer noted that it is traditionally the FDA’s role to manage drug shortages, and they usually wait to get involved until a drug manufacturer alerts them of a supply chain or manufacturing chain disruption. Schumer said that, given the recent price hikes and the opinion of national drug monitoring organizations that there is currently a shortage, the FDA should investigate now to determine how to alleviate it so that patients have access to this lifesaving treatment. Schumer said that preserving patients’ access to doxycycline, so they can begin taking the medication as soon as a tick bite is detected or Lyme Disease is diagnosed, is critical to keeping people healthy and out of doctors’ offices, which is why the FDA should quickly intervene.
Once a drug shortage is declared, the FDA works with the drug’s manufacturer to determine why the shortage is occurring – for example, whether it is the result of an interruption in the manufacturing process or due to regulatory challenges – and works with the same or other manufacturers to increase production of similar drugs in order to limit the impact of a shortage. Schumer said that, in the case of doxycycline, it is critical for the FDA to begin putting these emergency drug shortage procedures in place so that Hudson Valley residents are not faced with a situation where they are unable to access or afford a medication that could help prevent significant pain and suffering. Schumer said that there are other medications that can be used to treat Lyme Disease, but doxycycline is the most commonly recommended treatment, which further underscores the pressing need to avoid a shortage.
Schumer was joined by Assemblywoman Aileen Gunther; Nancy McGraw, Sullivan County Public Health Services Director; as well as other local Lyme Disease advocates.
“Sullivan County has some of the highest rates of Lyme Disease in the state," said Assemblywoman Aileen Gunther. "The cost and availability of doxycycline has reached critical mass. Our local pharmacists say that the their costs for doxycycline have increased from about $45 per bottle to about $1000 per bottle, with insurance reimbursement rates not nearly keeping pace. This is simply unsustainable. Insurance companies and pharmaceutical companies need to be held accountable. I appreciate Senator Schumer bringing attention to this critical issue."
“The shortage of doxycycline has been a significant problem for patients with Lyme, as it is generally the first line of defense,” said Pat Smith, President of the national non-profit Lyme Disease Association. “Couple that with the Centers for Disease Control & Prevention (CDC) announcement last year that new Lyme cases in the US are around 300,000 annually, which does not even include any of the other tick-borne diseases now emerging, many also treated with doxy, and you have had doctors and patients alike scrambling for treatment options. Now when doxy is available, the prices have skyrocketed so significantly that patients are sometimes unable to afford it.”
“The American Society of Health-System Pharmacists appreciates Senator Schumer’s efforts to mitigate and prevent drug shortages, in particular the shortage of doxycycline,” said Bona Benjamin, Director of Medication-Use Quality Improvement at the American Society of Health-System Pharmacists. “In addition, ASHP remains committed to working with Senator Schumer, the Food and Drug Administration and other health care supply stakeholders to ensure continued supply of doxycycline.”
Schumer noted that the doxycycline shortage does not just impact people’s health; it affects pets too. Lyme Disease is very prevalent in dogs, who often run around in wooded areas where ticks are common. Lyme Disease is not as chronic or damaging in dogs as it is in humans, but it can cause acute arthritis and many expensive trips to the veterinarian. Dogs with Lyme Disease are also more likely to bring ticks with Lyme Disease into contact with humans, so it is important to treat Lyme Disease in dogs as quickly as possible. Schumer noted that the current doxycycline shortage that is driving up prices will have an even greater impact on dog owners who need to treat their dogs because many pet owners do not have pet insurance, which can help offset the high costs of the antibiotic. In addition, Schumer noted that horses are another animal prone to get Lyme Disease, and they require a course of doxycycline that is much greater than humans. According to the same Poughkeepsie Journal article, horses can require up to 6,000 individual doxycycline pills in order to treat Lyme Disease, which, given the shortage, would cost more money than many pet owners can afford.
In addition to pushing FDA to investigate this current potential shortage, Schumer also urged the FDA to be more proactive in addressing drug shortages in the future. Currently, the FDA waits for a drug manufacturer to register a shortage before working to alleviate it, but Schumer said the FDA should proactively engage manufacturers when a drug shortage is suspected. Schumer said that he would consider introducing legislation that would give the FDA the authority it needs.
A copy of Schumer’s letter to FDA Commissioner Margaret Hamburg is included below:
Dear Commissioner Hamburg,
I write today to bring to your attention a potentially life-threatening drug shortage impacting a least a thousand New Yorkers who are suffering with Lyme disease. I urge the agency to investigate this potential drug shortage of doxycycline, one of the only medications available to treat Lyme disease. It is crucial that the Food and Drug Administration (FDA) take responsibility for the public health of U.S. citizens by effectively and efficiently managing drug shortages across the country.
As you know, doxycycline is a prescription antibiotic used to treat several different types of infections such as pneumonia, respiratory tract infections and Lyme disease by preventing the growth and spread of bacteria. The Centers for Disease Control and Prevention (CDC) report an estimated 1,972 cases in New York already this year, surpassing New York’s total number of Lyme cases in 2013. Furthermore, CDC estimates that there could be as many as 300,000 cases of Lyme in the United States. When Lyme disease is not caught and treated early it can cause severe fever, headache, joint pain and stiffness or, even worse, heart palpitations and swollen lymph nodes. Living with Lyme disease is painful and can be a life-long battle. This is why it is absolutely critical that the proper medications be readily available to patients.
In 2012, I strongly supported the Food and Drug Administration Safety Innovation Act (FDASIA) provisions which gave the FDA greater authority to mitigate drug shortages by requiring all drug manufacturers to provide early notification of supply and manufacturing chain disruptions. FDASIA also required FDA to issue and make available to the public noncompliance letters to manufacturers that do not properly or adequately report drug shortages. While FDASIA has prevented many drug shortages, I am concerned that more could be done to protect patients and want to work with you to alleviate all shortages. To that end, I ask that your staff provide mine with a comprehensive assessment of the doxycycline shortage and steps to ameliorate the current situation.
In addition to the provisions in FDASIA, the FDA proposed the “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug and Biological Products,” rule in November 2013 and I am informed that it is set to be finalized in January 2015. While there are a number of important improvements in the rule, I hope that you will work with manufacturers and patients to expand your agency’s role on drug shortages. For example, the FDA could be allowed to proactively engage manufacturers in the prevention of drug shortages, which would ultimately have a more significant impact on the citizens that rely on drugs that can be used to prevent and treat debilitating diseases.
Lyme disease is only one example of an illness that when left untreated can have serious and life-threatening consequences. The current potential shortage in doxycycline could potentially harm this growing population of patients with Lyme. I urge you to take immediate action to ensure that the FDA’s handling of drug shortage cases is functioning at its most efficient level.
I appreciate your consideration of this important matter, and please feel free to contact me should you have any questions.
Charles E. Schumer