WASHINGTON -- Health officials lobbied Congress to step up its fights against opioids. The FDA pitched in, by adding a boxed warning for certain opioid products and by releasing draft guidance to help drugmakers develop safer generics.
Officials to Congress: Help Needed for Overdose Fight
Government health officials pressed a House committee for more resources to address the rise in overdose deaths from legal and illicit opioids at a hearing on Tuesday.
The Senate overwhelmingly passed the Comprehensive Addiction and Recovery Act earlier in March, which would authorize the Attorney General to distribute grants for the treatment of opioid addiction for prisoners, increase opioid abuse prevention efforts, and expand the availability of the anti-overdose drug naloxone (Narcan).
A related version is now under review by the House. Its version of the legislation was introduced in February 2015 and currently has 107 co-sponsors (75 Democrats, 32 Republicans). The bill currently has no funding and a Republican majority in the Senate recently rejected an amendment that would have added $600 million.
FDA Releases Draft Plan for Abuse-Deterrent Opioid Generics
In its second move on opioids in a week, the FDA released a draft guidance for industry on development of generic versions of abuse-deterrent opioids.
The guidance, when finalized, will help ensure that generic abuse-deterrent opioids "are no less abuse-deterrent than their brand-name counterparts," FDA commissioner Robert Califf, MD, said on a call with reporters.
The 31-page document outlines the studies and data formats manufacturers should use to satisfy the agency that a generic opioid is equivalently abuse-deterrent. Guidance documents are not binding, but most companies follow them because they spell out the FDA's preferences on regulated products.
Earlier this week, the agency announced label changes to immediate-release opioids like Vicodin, including a boxed warning on the risk of misuse, abuse, addiction, overdose, and death.
The new indication also reserves the drugs for pain "severe enough to require opioid treatment" that doesn't respond to other therapies.
Insurer Group to Pilot Program for Improving Doc Directories
America's Health Insurance Plans (AHIP) is launching a pilot program to ensure that physician directories are more up to date, the organization announced Wednesday.
"Provider directories are a key consumer tool ... It is essential that provider directories reflect the most updated and accurate information about providers," said Marilyn Tavenner, CEO of AHIP, in Washington, on a phone call with reporters. "The goal of this initiative is to identify what works and what doesn't. At the end of the 6-month pilot, we hope to put forth best practices for data reporting and accuracy that will benefit consumers."
"We recognize that it takes both providers and health plans to make this work," said Paul Markovich, president and CEO of Blue Shield of California, in San Francisco. "We've focused on making it as simple as possible for providers to update this information." Markovich is leading AHIP's task force on provider directories.
FDA Proposes End to Powdered Gloves
Most powdered gloves would be banned in the U.S. under an FDA proposal announced Monday.
"While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients, and other individuals who are exposed to them, which cannot be corrected through new or updated labeling," the agency said.
The FDA explained that the powder on latex gloves (but not synthetic gloves) can become aerosolized and carry allergenic proteins. These contribute to airway allergic reactions, surgical adhesions, and wound inflammation, the agency said.
Taming the Beast of Healthcare Spending
Healthcare consolidation and the rise in prescription drug costs have increased healthcare spending to unsustainable levels, health policy experts said at a briefing of the National Coalition on Health Care here on Monday.
While experts appeared to agree on the drivers of healthcare costs, their approaches to containing these costs differed.
Paul Ginsburg, PhD, director of the Brookings Center for Health Policy and professor of health policy at the University of Southern California, noted that payment reform has caused a shift towards consolidation among both providers and insurers.
"My reaction to that is not to abandon payment reform. My reaction is to proceed with it, but work harder to deal with the effects of consolidation on prices," he said.
Congress is on recess.
On Tuesday, the FDA's Psychopharmacologic Drugs Advisory Committee will discuss Nuplazid (pimavanserin) oral tablets for the proposed indication of psychosis associated with Parkinson's disease.
On Thursday, the Department of Health and Human Services (HHS) will solicit stakeholder feedback about the HHS-operated risk-adjustment program.
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