Press Pulse

The National Law Review
31 March 2016

Required Black Box Warnings on Immediate Release Opioids

Closely following on recent efforts undertaken by states and the Centers for Disease Control to curb opioid abuse (review further here and here), the U.S. Food and Drug Administration (FDA) last week announced that it will require black box warnings on immediate-release opioids highlighting the risk of “misuse, abuse, addiction, overdose and death,” to combat what the agency described as an epidemic of addiction.

RALEIGH — An N.C. House Select Committee studying the practice of step therapy by health insurance companies last week focused on barriers to access to abuse-deterrent opioids, a topic gaining some attention with rampant reports of opioid abuse.

In North Carolina, there were 1,358 overdose deaths due to opioids in 2014, and the number of drug overdose deaths, a majority from prescription drugs, has doubled in the past 15 years, according to Centers for Disease Control statistics.

CJ Arlotta
Forbes
29 March 2016

The U.S. Food and Drug Administration (FDA) last week publicly released a draft guidance on the agency’s outlook on supporting the development of generic versions of approved opioids with abuse-deterrent formulations (ADFs), with the intention of also ensuring that these formulations are no less abuse-deterrent than the brand name drug.

Melanie Garunay
White House Blog
29 March 2016

Summary: Today in Atlanta, President Obama will join individuals in recovery, family members, medical professionals, and law enforcement officials at the National Rx Summit.

Today, as part his efforts to escalate the fight against the prescription opioid abuse and heroin epidemic, the President will join individuals in recovery, family members, medical professionals, and law enforcement officials at the National Rx Drug Abuse & Heroin Summit in Atlanta, Georgia.

The US Food and Drug Administration (FDA) released a new draft guidance intended to ensure that generic versions of abuse-deterrent opioids meet the same standards for abuse deterrence as their brand-name counterparts for public comment on Thursday.

The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. Today’s actions are among a number of steps the agency recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

WPXI News
15 March 2016

Last summer, Antypas demonstrated a fairly new crush-deterrent pill on the market. “(If it’s unable to be crushed), you can’t inhale it. You can’t get that rush at once,” he said. The pill is also 10 to 15 times more expensive than a traditional tablet and is often not covered by insurance. However, the rules may be about the change.

There is a great concern about opioid abuse and potential overprescription in the United States. However, there is no reason to expect opioids ever will be completely removed from the market. That is why one key analyst firm believes the development of abuse-deterrent formulations (ADF) of opioids creates a risk that older non-ADFs may be removed from the market, and that this creates a huge risk and opportunity in the space.

Canadian Prime Minister Justin Trudeau’s three days in Washington are packed with glitzy dinners and VIP luncheons sandwiched around high-level meetings on climate change, trade, refugees and the global fight on terrorism.

That crowded agenda ought to include America’s growing opioid crisis — and Canada’s complicity in the problem — a bipartisan group of lawmakers made clear this week.

House and Senate members penned a letter calling for stronger action from the Trudeau administration on the flood of Canadian painkillers ravaging American communities.