FDA Developing Plans to Fight National Opioid Epidemic

Earlier this fall, President Donald Trump declared the opioid epidemic to be a national public health emergency, making combatting it a priority for the federal government and states that have been hardest hit. In response to President Trump’s announcement, the Food & Drug Administration has begun eyeing strategies that would cut back on access to the drugs, how they are dispensed, and how to treat those who have become addicted. Opioids, a narcotic, are a class of pain-relieving drugs that affect the central nervous system and are derived from opium. Commonly known opioids include heroin, fentanyl, morphine, codeine, oxycodone, and hydrocodone. Vicodin, Oxycontin, and Norco are some brand name opioids that are frequently used to treat everything from dental pain to post-surgical pain, as well as a variety of other pain-inducing conditions in between.

2015 data from the CDC shows that 52,000 people died from an opioid overdose that year and that more than half of those deaths were caused by a legally prescribed or illegally obtained prescription medication.

New Rules Likely to Upset Drug Companies and Consumers
FDA commissioner Dr. Scott Gottlieb plans to implement a new rule that would force drug companies to package opioids in a 2, 4, 6, or 8 day supply, thus controlling the amount that are distributed at once. Instead of a pill bottle containing 30 days worth of pills, manufacturers would have to absorb the cost of producing pricier ‘blister packs’ that the FDA hopes would limit the amount of pills to which users have access in one sitting. Dr. Gottlieb also believes that this new packaging method would be especially effective for controlling immediate release formulations, which are the most widely prescribed form of opioids and also the drug with the highest addiction rates.

Also, the FDA is debating allowing physicians to still prescribe 30 day supplies, but in order to do so would have to complete some sort of ‘mandatory education.’ Dr. Gottlieb says that the time between making a decision to move forward on these new rules and the implementation of them could be short. They are already in talks with drug companies and have most of the plans in place.

While speaking to CNBC Squawk Box, host Rebecca Quick asked Dr. Gottlieb if the drug companies would be unhappy. He said he knows they’ll be facing higher packing costs, as well as reduced sales, but that they also have the option to raise the cost of the drug.

Alternatives to Current Opioid Treatment
Dr. Gottlieb also says that while there are currently 3 available medications used for the treatment of opioid addiction, there is potential for other manufacturers to enter the market. He said one of the biggest missed opportunities is a longer acting formulation, something that could be taken beyond the typical treatment period.  According to him, the FDA is in talks with companies to encourage the development of other treatments and “open up the market.”


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