The Food and Drug Administration said Thursday it wants to more aggressively fight medication shortages that have led to rationing of some drugs and disrupted patient care.

The agency announced plans for a task force to find ways to improve the supply of crucial drugs. It’s a new approach for the drug regulator, which has very little control over drug makers’ operations. It generally can’t act until drug makers tell the agency that shortages are imminent or that it will stop making a drug.

FDA Commissioner Scott Gottlieb said the agency will ask Congress for the authority to allow it to intervene. He said he has a clear idea of changes needed in the FDA’s powers, regulations and drug reimbursement policies.

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“I feel we have a mandate to do this,” Gottlieb told the Associated Press, citing a recent letter from about 200 members of Congress urging changes and offering support.

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Most shortages involve low-profit generic pills and injections that are hospital workhorses, including injected painkillers, old cancer drugs, and saline solution needed to give IV medicines. Many are made by only a few companies, so when production problems occur, the few other drug makers can’t cover the shortfall. Last year, hurricanes knocked many drug factories in Puerto Rico and southern states out of commission for long stretches.

While the number of drugs in shortage is down from the peak several years ago, many shortages are lasting much longer, sometimes well over a year.

Currently, FDA inspectors can work with a manufacturer to quickly resolve quality problems that have shut down production. The agency also works to find alternate suppliers and expedite approval for them to sell that medicine.

A hearing is planned for the fall to get input from patients, manufacturers, and others.

A key issue, he said, is that generic drug makers increasingly are squeezed by middlemen — hospital group purchasing organizations and prescription benefit managers — paying them at rates barely above their production costs or even less. He said finding ways for the Veterans Administration, Medicare, and Medicaid to pay a bit more for the most crucial medicines could nudge private insurers to do the same.

Drug manufacturing expert Girish Malhotra, president of the consulting firm EPCOT International in Pepper Pike, Ohio, called the FDA’s plan a positive change but said he’s not sure it will solve the problems. He said the agency doesn’t have the expert staff needed for one aspect of the plan, supporting new technologies that can improve manufacturing.

Malhotra also suggested that FDA publicize anticipated shortages, to encourage foreign companies to jump on opportunities to sell those drugs in the U.S.

“How quickly will patients see results? That’s anybody’s guess,” he said.

— Linda A. Johnson

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  • I think it is very important to mention the fact that the DEA has cut production quota for CS II prescription opioids by 45% within the past two years. In 2017, they ordered the production to be cut for CS II opioids by 25%, except hydrocodone, which was cut by a third. Then in 2018, they cut the quota by another 20%. Sessions is talking about wanting them to cut the production even more for next year (2019).

    It only takes a split-second to become the victim of a disabling inoperable injury, causing you chronic severe intractable pain that never relents and can only be relieved through a strong opioid-based medication. Friends, your potential future suffering is in the hands of a bureaucratic government agency that does not know their a** from their elbow and has no medical licenses to practice medicine.

    These cheeseballs still haven’t figured out that most overdoses are due to heroin and illicitly-manufactured fentanyl, along with several other substances including alcohol. Wake up, America, or one day, you may be forced to find pain relief from the black market or through the barrel of a gun.

    https://www.painnewsnetwork.org/stories/2016/10/4/dea-cutting-opioid-supply-in-2017

    https://www.painnewsnetwork.org/stories/2017/11/10/dea-cutting-rx-opioid-supply-in-2018

    http://thehill.com/policy/healthcare/376335-sessions-to-dea-evaluate-opioid-production-quota

  • Excuse my ignorance but why would we want Medicare, Medicaid and the VA to pay MORE for drugs to “nudge” private insurers? Why not topple the house of cards altogether and STOP the legalized kickbacks (aka rebates) that have middlemen making obscene profits?

    The Mafia Bosses controlled who could and couldn’t pick up garbage in certain neighborhoods. Paying the sub-bosses MORE money to get your garbage picked up is NOT a solution to the problem. It is time for Congress to repeal Safe Harbor protections and bring down the GPO/PBM Mafia once and for all!

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