November 18, 2011 - The American Pain Foundation (APF) released survey results showing that 17% of adults with chronic pain who have tried to reach their primary pain care providers with questions face difficulties doing so. Full Story.
November 14, 2011 - The U.S. DEA is seeing a dramatic increase in the cross-border smuggling of prescription narcotic pills in the past year. Full Story.
October 25, 2011 - States are one-by-one doing what is needed to address prescription drug abuse, such as passing legislation to implement prescription monitoring programs (PMPs) and inter-state data sharing networks; and closing down illegitimate pain clinics that route pain drugs to the addicted. Full Story.
October 18, 2011 - U.S. Senator Herb Kohl, Chairman of the Senate Special Committee on Aging, has introduced legislation to address unintended consequences of the U.S. Drug Enforcement Administration’s (DEA) scrutiny of pain medication prescribing practices in nursing homes across America. Full Story.
October 5, 2011 - The conflicting problems of chronic pain and prescription drug abuse directly and indirectly cost U.S. taxpayers, insurers and employers more than $323 billion annually, according to a new study. News Release.
September 16, 2011 - More children are showing up in emergency rooms due to prescription drug poisonings, according to new research from the Cincinatti Children's Hospital Medical Center. Full story.
August 25, 2011 - Google, Inc. has agreed to pay $500 million in a settlement with the Justice Department in order to avoid prosecution on charges it knowingly accepted illegal advertisements from Canadian online pharmacies for years. The U.S. government said the ads led to illegal imports of prescription drugs and could have put American consumers at risk of taking mislabled or tainted medicine. Full story.
August 23, 2011 - The Food and Drug Administration (FDA) is postponing the Arthritis Advisory Committee meeting scheduled for September 13, 2011, due to the fact that the Agency recently received submissions from some of the investigational new drug (IND) application holders for anti-nerve growth factor (Anti-NGF) antibody drug products that contain large quantities of new information that will requireadditional time for Agency review prior to the advisory committee meeting. For more information contact (301) 796-9001 or This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
August 1, 2011 - The American Academy of Pain Medicine (AAPM) released a position statement in response to media reports and comments from government officials on the prescription pain drug–related deaths of several military personnel undergoing chronic pain care. In it, the AAPM warns against the use of generalizations and oversimplification when discussing the treatment of chronic pain, especially among the military. Full story.
May 7, 2011 - In a television interview broadcast to more than 220 million households in more than 100 countries, a CLAAD spokesperson called for insurance companies to “take steps that will prevent people from being able to obtain insurance benefits to go ‘doctor shopping’”. News release. Video.
April 19, 2011 - ONDCP, FDA, and DEA officials released a federal action plan to address prescription drug abuse. The CDC has deemed the abuse of prescription medications a public health "epidemic." As part of the federal plan, FDA will long-acting and extended-release opioid manufacturers to create a single, shared system for prescriber training and patient education. Full story. ONDCP plan. FDA REMS materials.
April 19, 2011 - The Food and Drug Administration announced it will require long-acting and extended-release opioid manufacturers to create a single, shared system for prescriber training and patient education. Full story. CLAAD memo on FDA approach to REMS (January 4, 2010).
April 11, 2011 - The Food and Drug Administration’s policies prevent the widespread use of new medications designed to be more resistant to tampering for purposes of abuse. As a result, law enforcement and public health officials must continually fight the same battles over different drugs. Full story.
March 21, 2011 - Representative Michael Grimm (NY-13) hopes to introduce a bill that makes the federal Drug Enforcement Administration set up a "secure Web portal" for physicians and pharmacists across the country to access, requiring them to report any prescriptions electronically. The resulting prescription database would update in real-time, meaning pharmacists can spot duplicate prescriptions instantly, he said. The congressman's announcement comes just days after city and state authorities announced they had taken action on a 31-person drug-dealing ring peddling oxycodone out of an ice cream truck on Staten Island's South Shore. Full story.
March 8, 2011 - Senator Jay Rockefeller, Chairman of the Senate Finance Subcommittee on Health Care, appeared at a press conference this week to talk about his Prescription Drug Abuse Prevention and Treatment Act of 2011. The bill aims to prevent the unsafe use of prescription drugs and reduce the number of deaths from prescription drugs by promoting both physician and patient education and creating a uniform reporting system for painkiller-related deaths. Press release.
March 2, 2011 - According to a recent United Nations report, the abuse of prescription drugs is the fastest-growing drug related problem in the country, with the number of addicts far outstripping those who use cocaine. Full story.
January 25, 2011 - An Army inspector general’s report estimates that 25% to 35% of about 10,000 ailing soldiers assigned to special wounded-care companies or battalions are addicted or dependent on drugs — particularly prescription narcotic pain relievers. Full story.
November 4, 2010 - All members of the U.S. House of Representatives’ Caucus on Prescription Drug Abuse who sought re-election this November won another two-year term in Congress. Representatives Mary Bono Mack (CA-45), Harold Rogers (KY-05), Stephen Lynch (MA-09), and Connie Mack (FL-14) are expected to continue dedicating special efforts to address prescription drug abuse through their participation in the voluntary organization for Members of Congress. Representative Bill Delahunt (MA-10), a founding member of the Caucus on Prescription Drug Abuse, is retiring at the end of this year.
September 22, 2010 - The Ohio Prescription Drug Abuse Task Force will provide Governor Ted Strictland and the General Assembly solutions that policymakers hope will outline a way out of the state's prescription drug abuse mess. Full story.
September 16, 2010 - The U.S. Department of Health and Human Services' Substance Abuse and Mental Health Services Administration (SAMHSA) today released the results of the latest (2009) National Survey on Drug Use and Health. The survey provides new data on a problem communities across the nation are confronting each day: prescription drug abuse. Read more (PDF).
July 23, 2010 - As pain relievers introducing limits to abuse come to market, the FDA is grappling with the best way to encourage manufacturers to communicate risks vs. benefits and ensure safety. Full story.
July 20, 2010 - Bob Pack and April Rovero have become activists to help curb prescription drug abuse. Citizen petition.
July 19, 2010 - Although drugmakers are welcoming a final version of a classwide opioid risk evaluation and mitigation strategy (REMS), they believe it should protect patient safety without hindering reasonable access to the products.
"Drugmakers Want Balance Between Safety and Patient Access in Opioid REMS", Drug Industry Daily, July 19, 2010. FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431, +1 (703) 538-7600 www.fdanews.com.
July 15, 2010 - A bill to ban step therapy is currently under consideration in California’s general assembly. CLAAD support this bill. States should abandon blind cost-saving measures such as step therapy, as the detriments to patient medical care and the public health outweigh the financial benefits. Health care professionals must be able to prescribe medications that are best suited to their patients’ unique medical needs. Full story.
July 15, 2010 - The Substance Abuse and Mental Health Services Administration (SAMHSA) reported on July 15 that the rate of prescription drug abuse cases in adults 12 years of age or older increased fourfold between 1998 to 2008. This increase was not specific to any one population. It occurred in almost every demographic group. SAMHSA Report.
July 14, 2011 - Researchers of a new study advise dentists to take a medical history of patients, including substance use problems, and coordinate better with oral surgeons. Dentists prescribe 12% of all immediate-release opioids, second only to general practitioners. Full story.
July 11, 2011 - White House Director of National Drug Control Policy, Gil Kerlikowske, released the Administration's 2011 National Drug Control Strategy at events in Ohio today. The Strategy coordinates a government-wide public health and safety approach to reduce drug use and its consequences in the United States. Read the full Strategy.
July 9, 2011 - With Florida's new law designed to shut down illegitimate pain clinics taking effect on July 1, doctors and lawmakers worry that drug abuse treatment facilities may not have the funding or capacity to provide detox and drug treatment services to a new influx of patients. Full story.
June 29, 2010 - In the FDA’s proposed Risk Evaluation and Mitigation Strategies (REMS) for the entire class of long-acting and extended-release opioids released June 28, patient and prescriber registries were notably absent. Instead, the REMS proposal uses patient and prescriber education as a deterrent against the diversion, misuse, and abuse of these medications.
The absence of a registry in the proposed REMS is likely a response to public input that requiring a registry might burden prescribers and pharmacists to the extent that they would stop prescribing and dispensing the opioids. The FDA is pointing to education as a method to deter abuse and minimize the burden on practitioners. The FDA additionally suggested the use of incentives, as opposed to a mandate, for prescribers to take training, such as offering continuing education credits.
The release of the proposed REMS precedes the joint committee meeting on July 22 and 23 to review the long-acting and extended-release REMS. When the REMS recommendations are finalized, the FDA must, by law, request REMS proposals, including an implementation timetable, from pharmaceutical sponsors of the medications.
March 25, 2010 - Congresswoman Mary Bono Mack (CA-45) on March 25 proposed H.R. 4956, the Stop Oxy Abuse Act of 2010. The bill would limit the approval of extended release oxycodone medications, such as OxyContin®, to the treatment of severe pain, as opposed to moderate-to-severe pain. Six Members of the U.S. House of Representatives co-sponsored the measure. Bill text.
March 11, 2010 - The Food and Drug Administration (FDA) "would be very open to" having greater authority to mandate single Risk Evaluation and Mitigation Strategies (REMS) for multiple medications of the same class, Principal Deputy Commissioner Joshua Sharfstein stated during a March 10 hearing of the House Energy and Commerce Subcommittee on Health.
Under current law, the manufacturer of each on-the-market medication subject to a new REMS requirement has the flexibility to submit to the FDA a REMS proposal tailored to address the medication's unique characteristics. Coordination with the manufacturers of similar medications is permissible but not mandatory.
The FDA's acknowledgment that it does not under current law have the authority to mandate a one-size-fits-all REMS for multiple medications is a new development.
The FDA's insistence on mandating uniform REMS for distinct medications remains problematic. A one-size-fits-all REMS reduces manufacturer incentives to develop safer medications and threatens patient and public health by ignoring the specific risks of different drugs.More information:
February 19, 2010 - The Food and Drug Administration (FDA) has "not yet made the findings required" by law to require Risk Evaluation and Mitigation Strategies (REMS) for nine brand-name long-acting and extended-release opioid pain relievers already on the market, FDA stated in a letter dated February 3.
In response to a Freedom of Information Act request on behalf of the Center for Lawful Access and Abuse Deterrence, FDA conceded that it has not yet established that REMS are necessary to ensure that the benefits of each of the drugs outweigh their risks. The FDA also admitted that it has not yet met the statutory burden necessary to impose the more onerous REMS restrictions known as "elements to assure safe use."
More detailed information on the statutory requirements relating to REMS is available in CLAAD's Review of the FDA's Approach to Implementing a Class-Wide REMS for Long-Acting and Extended-Release Opioids.
December 4, 2009 - The Center for Drug Evaluation and Research (CDER), an office of the Food and Drug Administration (FDA), held a public meeting in College Park, Maryland, on “Risk Evaluation and Mitigation Strategies (REMS) for Certain Opioids.” The FDA heard recommendations from an industry working group (IWG) comprised of representatives from 16 pharmaceutical companies regarding how best to further develop REMS.
Many stakeholders are concerned that the class-wide REMS mandate for long-acting and extended release opioids may decrease access to pain care, particularly in vulnerable populations such as women, minorities, and those in rural areas. The IWG proposed a phased approach that would implement a temporary REMS as soon as possible, allowing time for data collection and development of final REMS components. Key elements of the intermediate REMS include patient education through improved medication guides, patient-prescriber agreements (PPA), patient medication info sheets (PMIS), and enhanced prescriber education that would include enrollment in a voluntary training program.
The IWG also supports requiring prescriber education as a prerequisite for Drug Enforcement Administration (DEA) registration. This requirement would broaden the DEA’s authority, which would require Congressional authorization. The FDA, however, questioned whether the DEA registration proposal was the best method of education certification.
Another point of interest for the FDA was whether an incentivized voluntary training program would be preferable to a mandatory training certification program.
The FDA did not reveal a steadfast timeline for moving forward, but indicated that it would hold its next public advisory committee meeting in the spring of 2010.
