WEB FEATURE: FDA guidance aims to encourage abuse-deterrent painkillers
SILVER SPRING, Md. — One of the most serious drug abuse problems in the country doesn’t involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.
In August 2010, Purdue Pharma introduced an abuse-deterrent formulation of OxyContin (oxycodone) extended-release tablets, and Endo Pharmaceuticals received FDA approval for its crush-resistant version of Opana ER (oxymorphone) in December 2011. Both drugs, long popular targets for abusers, are designed to become ineffective after crushing, a method used by abusers who then snort or inject them.
To date, however, FDA-approved drug labeling has not included language about abuse deterrence, nor has the agency given anyone the claim of reduced abuse liability. But in the new draft guidance, the agency explains its current thinking about the studies it said companies should conduct to demonstrate that a given formulation of an opioid drug has abuse-deterrent properties, how the agency will evaluate the studies and what labeling claims may be approved. The agency said it would seek public comment on the guidance over the next 60 days.
"The agency believes that new technologies that are effective to reduce abuse are very important for us to incentivize," FDA Center for Drug Evaluation and Research deputy director for regulatory programs Douglas Throckmorton said in a conference call with reporters. "It’s the reason we are putting out this draft guidance today."
The FDA’s announcement comes amid a problem that has seen tremendous growth in the past several years. According to the Centers for Disease Control and Prevention, 2 million people reported abusing prescription painkillers for the first time within the last year, with 71.6% of those obtaining, buying or stealing them from friends or relatives. Misuse and abuse of prescription painkillers led to more than 475,000 emergency room visits in 2009, a figure that nearly doubled over the course of five years, and the drugs were involved in 14,800 overdose deaths in 2008 — more than cocaine and heroin combined.
With abuse comes related violent crime: According to the Drug Enforcement Administration, armed robberies of pharmacies jumped 81% in the five years leading up to 2011. That has prompted efforts like RxPatrol, established by Purdue Pharma as a way to collect and share pharmacy crime data between pharmacies and law-enforcement agencies.
Studies have indicated that adding abuse-deterrent features can reduce abuse of the opioids that have them, but can also steer drug abusers toward other opioids, legal and illegal. According to one 2,566-patient study conducted last year by researchers at Washington University in St. Louis and Nova Southeastern University in Florida, the number of drug abusers who abused OxyContin fell from 35.6% to 12.8% after the introduction of the abuse-deterrent version, while abuse of such opioids as hydrocodone and other oxycodone formulations rose slightly, and abuse of high-potency fentanyl and hydromorphone rose significantly, from 20.1% to 32.3%. Of all opioids used at least once to get high in a 30-day period, OxyContin fell from 47.4% to 30%, but heroin use nearly doubled. The study also found that while 24% found a way to defeat the abuse-deterrent properties of the new version of OxyContin, 66% indicated that they had switched to another opioid, most commonly heroin.
“Our nation is in the midst of a prescription drug abuse epidemic,” Office of National Drug Control Policy director Gil Kerlikowske said. “While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic. This guidance is a vital component of the administration’s comprehensive effort to reduce prescription drug abuse in America, and we commend the FDA for its commitment to this challenge.”
Consumerism, budgets, ACA issues to weigh on healthcare industry in 2013
NEW YORK — Ten issues will take center stage as the healthcare industry moves to meet the requirements of the Patient Protection and Affordable Care Act, according to a new report by PricewaterhouseCoopers.
The report found that the pace will likely quicken this year due to technology, consumerism, budgetary pressures and the healthcare reform law converging on the sector, which represents one-fifth of the U.S. economy. To assemble the report, PwC’s Health Research Institute collected input from PwC Health Industries professionals who work with hospitals, physician groups, drug and device companies and employers, in addition to polling 1,000 U.S. consumers.
"Health organizations can hear the thundering footsteps of 30 million newly insured Americans on the horizon," PwC U.S. health industries leader Kelly Barnes said. "By this time next year, the major provisions of the health-reform law will be in effect, and the health industry has a lot of work to do before then. It’s now a foot race to 2014. The evolution of health care that has been in effect over the past several years will become a full-scale transformation in 2013."
The top 10 issues facing the industry, PwC said, are:
States are on the front lines of Affordable Care Act implementation
State officials will have to decide over the next year how to run insurance exchanges, whether to expand Medicaid coverage and what type of insurance market regulation is needed as information technology and the question of how to create a single, seamless entry point to the exchange will present a challenge.
Revolution in health coverage
The report found that nearly one-quarter of surveyed consumers said they were likely to buy health insurance from nontraditional sources, such as a retail store, up from 18% in 2011. Meanwhile, consumers’ rising voice on how they spend their healthcare money and state insurance exchanges are prompting the health industry to compete on attributes similar to the retail industry — namely price, convenience and transparency.
Medical technology industry braces for excise tax impact
A 2.3% excise tax on medical device companies took effect on Jan. 1, which could represent $29.1 billion for the federal government over the next 10 years. The industry is unlikely to be able to pass the tax on to consumers, however.
Caring for dual eligibles
Often considered the most vulnerable patients, dual eligibles are those patients who qualify for both Medicare and Medicaid, making up many of the 16 million people the Affordable Care Act who will add to Medicaid rolls by 2019. Lack of care coordination between the two programs leads to "skyrocketing" costs due to waste, and 70% of state Medicaid spending on these patients goes to long-term care. The result is that states are increasingly turning to managed care companies to better coordinate care and seeking innovative solutions.
Convenience of mobile may come at a cost
While doctors and nurses are bringing their own mobile devices to work, many hospitals don’t yet have a secure enough environment to protect sensitive patient information, and 69% of surveyed consumers said they were concerned about the privacy of medical information if providers can access it on mobile devices, and only 46% of hospitals have a security strategy to regulate the use of mobile devices.
Cost reduction is down, while transformation is up
Hospitals are scrambling to reduce their costs due to reimbursement reseting under the healthcare-reform law and pressure from the federal budget crisis and price-conscious consumers. According to the report, 40% of consumers postponed care in 2012 because of costs.
Customer ratings hit the pocketbooks of healthcare companies
Paying for performance will take on new meaning in 2013 as consumer reviews generate penalties and bonuses for hospitals and insurers. This could mean a bonus payout of more than $3 billion for insurers and a hold back of $850 million for providers this year.
Meeting the new expectations of pharma value
Physicians now have less say in patient decisions than insurers and large providers, while reimbursement has replaced regulatory approval as the final hurdle in the path to drug and device development. Drug and medical device companies will have to prove their worth in health outcomes by demonstrating value and comparative effectiveness.
Employers rethink their healthcare role
Employer-based coverage has been a cornerstone of U.S. healthcare for nearly 70 years, but the two may not be inseparable. With the Supreme Court’s decision to uphold the Affordable Care Act and President Barack Obama’s re-election, employers may be able to explore alternative approaches provided by state and private exchanges.
The building blocks of population health management
Medicare’s accountable care organization and patient-centered medical home initiatives laid a foundation for improving population health, but other collaborations are fueling growth in population health management. More companies this year are likely to form partnerships to build their population health information technology infrastructures and share responsibility for patient outcomes and satisfaction, data collection and analysis, member education and engagement with a focus on at-risk populations.
Watson appoints former GPhA executive as VP government affairs
PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has hired a former executive from the Generic Pharmaceutical Association to head lobbying at the federal and state level, the company said Wednesday.
Watson announced the appointment of James Fenton as VP U.S. government affairs. In the new position, Fenton will work out of Watson’s Washington offices and will be responsible for leading the company’s expanded federal and state government affairs activities.
Fenton previously served as the GPhA’s SVP government affairs, directing the industry group’s government affairs efforts and playing a role in the passage of the Generic Drug User Fee Act. Before working for GPhA, Fenton worked for 15 years in the office of former Democratic Sen. Christopher Dodd of Connecticut, most recently as chief of staff.