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Schumer Urges FDA to Tighten Control of Hydrocodone, Among Most Highly Abused & Widely Prescribed Drugs in Upstate NY - Rx Painkillers Have Caused More Deaths Than Cocaine, Heroine Combined

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Today, in an effort to help combat an unprecedented spike in prescription drug abuse in New York State, U.S. Senator Charles E. Schumer called on the Food and Drug Administration (FDA) to swiftly approve regulations to make it harder to access painkillers that contain hydrocodone. Specifically, Schumer urged FDA Commissioner Hamburg to accept last week's recommendations from the Drug Safety and Risk Management Advisory Committee -- an expert panel of doctors and scientists -- to reclassify hydrocodone as a Schedule II controlled substance. Schumer also supported the recommendation to limit access to high-level refills of such drugs over short periods of time.

Hydrocodone is among the most widely prescribed drug in New York and the country, has rapidly increased in abuse levels, and is highly dangerous. Schumer noted that in 2011, the Upstate New York Poison Control Center reported over 12,800 cases of prescription drug abuse. Over the past year, Schumer has worked closely and effectively with the FDA to help stem the abuse of hydrocodone, and highlighted the importance of policy that strikes a balance between appropriate access to pain relief medications, and preventing prescription drugs from getting in the wrong hands.

"Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs," said Schumer. "With a key hurdle recently cleared, the FDA must tighten up control of one of the most highly prescribed -- and abused -- drugs on the Upstate New York market."

"The federal government must do everything in its power to restrict the use of hydrocodone to those patients who actually need it, and I'm urging the Food and Drug Administration to support its drug safety panel's recommendation to reclassify hydrocodone as a Schedule II drug, to help end this scourge that has caused our country to see more overdose deaths from this drug than seen with heroin and cocaine combined. Stricter federal rules must be put in place regarding the regularity and quantity with which we prescribe these painkillers, so that our children, parents, spouses and friends don't continue to fall prey to them each day."

Schumer highlighted that on January 24 and 25th, a federally-convened drug safety panel, called the Drug Safety and Risk Management Advisory Committee, issued a recommendation to increase hydrocodone's classification from Schedule III to Schedule II, by a vote of 19-10. Schedule II substances have a high potential for abuse, which may lead to severe psychological or physical dependence. Schedule II drugs include narcotics like oxycodone (Oxycontin) and morphine, and stimulants like methamphetamine and amphetamine. Now, Schumer noted, FDA Commissioner Hamburg must approve these expert recommendations, which will then be sent to the Department of Health and Human Services (HHS) for a positive recommendation to the Drug Enforcement Administration. Schumer noted that approval by FDA is the greatest hurdle in reclassifying such drugs, as the DEA requested this change. At that point, greater restrictions would be implemented in how doctors can prescribe hydrocodone, the quantity that can be prescribed, and the ways it can be stored in doctor's offices. Schumer noted that while New York State considers hydrocodone a Schedule II narcotic, a federal law is critical to ensure that abusers or dealers cannot easily obtain the drug from neighboring states.

Schedule II controlled substances require a written or electronic prescription which must be signed by the practitioner. The refilling of a prescription for a controlled substance listed in Schedule II is prohibited, therefore a new prescription must be issued each time a patient needs a refill. Schumer noted that in terms of issuance of multiple prescriptions for Schedule II substances, an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided several conditions, including a legitimate medical purpose for each drug, written instructions on each prescription, determination that undue risk of abuse is not created, and permissibility under state law.

Schumer noted that the uptick in abuse and overdoses involving prescription painkillers--a class of drugs that includes hydrocodone, methadone, oxycodone, and oxymorphone--are a public health epidemic. According to Center for Disease Control (CDC), for example, these drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, and that trend has only increased. These drugs are widely misused and abused: about one in 20 people in the United States, ages 12 and older, used prescription painkillers non-medically in 2010. The CDC also notes that most prescription painkillers are prescribed by primary care and internal medicine doctors and dentists, not specialists, and that roughly 20% of prescribers prescribe 80% of all prescription painkillers. Hydrocodone is one of the most commonly prescribed prescription drugs in the United States, with 47 million Americans receiving prescriptions for it in 2011 alone. It is prescribed for anything from wisdom tooth extractions to broken bones, and Schumer noted that often such strong medications are unnecessary, or are prescribed in too high a quantity for certain ailments. Schumer stated that this demonstrates a critical need for better control and more appropriate distribution of this class of drugs.

Schumer acknowledged that many patients seek the legitimate use of hydrocodone for pain management, and access for those individuals should be preserved. However, it is among some of the most highly abused substances, and can cause serious health conditions, and often death, as a result. In addition to serving as a potential catalyst of chronic dependence, crime and suicide, hydrocodone spurs a number of serious health side effects, including nausea, constipation, urinary retention and in higher amounts, depressed respiration. While long term use can lead to dependence and addiction, withdrawal symptoms include restlessness, muscle and bone pain, insomnia, diarrhea, and vomiting. Severe liver damage can occur when large doses of hydrocodone in combination with acetaminophen, as is commonly practiced.

Although the FDA has declined to recommend the category change previously, Schumer is urging the FDA to consider their own recent efforts in curbing hydrocodone, in addition to the recommendation of last week's expert panel. Last January, Schumer worked closely with the FDA to avoid approval of a pure hydrocodone product, given its abuse potential. This effort culminated in the December 2012 vote by the FDA's Anesthetic and Analgesic Drug Products Advisory Committee against a recommendation of approval for a single-entity hydrocodone product, in part because of concerns about abuse potential. Schumer hopes to continue his positive work with the FDA to curb the threat of hydrocodone abuse, and urged the Commissioner to approve the panel's expert recommendations.

Prescription drug abuses cases were found in every part of the state in 2011, the most recent full year of data. According to the Upstate Poison Control Center:

· In the Capital Region, there were 1,452 reported cases of prescription drug abuse during 2011

· In Central New York, there were 3,103 reported cases of prescription drug abuse during 2011

· In the Rochester Finger Lakes Region, there were 2,063 reported cases of prescription drug abuse in 2011

· In the Hudson Valley, there were 1,428 reported cases of prescription drug abuse in 2011

· In Western New York, there were 2,324 reported cases of prescription drug abuse in 2011

· In the Southern Tier, there were 1,431 reported cases of prescription drug abuse in 2011

· In the North Country, there were 1,070 reported cases of prescription drug abuse in 2011

A copy of Sen. Schumer's letter appears below:

Dear Commissioner Hamburg:

I write today to urge the Food and Drug Administration (FDA) to consider and accept the recent recommendation of the Drug Safety and Risk Management Advisory Committee that products containing hydrocodone should be reclassified as Schedule II controlled substances. Hydrocodone products are currently in Schedule III.

As you know, on January 24-25, 2013, the Advisory Committee met and voted on the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone. The panel voted 19-10 to reclassify hydrocodone products as Schedule II and I hope that the FDA will consider accepting the recommendation and forward it to the Department of Health and Human Services for consideration.

Your agency has estimated that 47 million American patients were given prescriptions for hydrocodone in 2011. According to an October 2012 study using data from the National Survey on Drug Use and Health, the rate of prescription painkiller abuse among American youth is 40 percent higher than in previous generations. The study also found a more than 500 percent increase in the number of people seeking treatment for addiction to prescription opioids between 1997 and 2007.

I am aware that the FDA had rejected several previous requests by the Drug Enforcement Administration to reclassify hydrocodone products. I hope that the thoughtful consideration of the Advisory Committee will convince the agency that reclassification will help to combat prescription drug abuse in the United States.

Last January, I wrote to you about the potential dangers of approval of a pure hydrocodone product. I was pleased to see that in December 2012 the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted against a recommendation of approval for a single-entity hydrocodone product, in part because of concerns about abuse potential. I agree with the Committee that abuse potential is a serious public health issue and I am glad your agency is carefully examining this problem and how new drugs could affect it.

I, like you, believe that any policy must strike a balance so that patients who are suffering have access to pain relief medications, but I am very concerned that not enough is currently being done to truly tackle this crisis and prevent prescription drugs from getting in the wrong hands. I urge FDA to accept the Committee's recommendation, and work to ensure that appropriate patient access is preserved.

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