No more U.S. shortages of AIDS medication

A shortage of the only medicine to treat AIDS in the United States has been relieved, with the Trump administration responding to the plight of 300,000 patients who were turning to pharmaceutical shortages.

The U.S. Department of Health and Human Services on Friday announced that it plans to buy enough the company’s lifesaving medicine, called cvacetambucil (CVS), to treat at least 10 million people, an order that would provide continuous access to the medication.

“People living with HIV/AIDS and their loved ones have always been at the front line of the fight against HIV/AIDS. To continue to provide this lifesaving medication, HHS worked with the Food and Drug Administration to determine a consistent supply of this medication with no interruption in patient access,” Health and Human Services Secretary Alex Azar said in a statement.

The deal comes after months of requests from members of Congress and advocacy groups to FDA to ensure a sufficient supply of the drug, FDA Commissioner Scott Gottlieb, who spearheaded the effort, said.

“The FDA announced new pricing initiatives earlier this year that will allow the FDA to actively manage the efficiency of the distribution of cvacetambucil, and with this new infusion of funding, the agency will be able to provide this lifesaving medication to more patients,” Gottlieb said.

CVS plans to provide more of the drug through its global business operations, which the agency said could put up to an additional 5 million people on the drug.

Last month, the company announced it would temporarily stop distributing prescription HIV/AIDS medicine because of slumping sales that has sparked the worldwide opioid crisis.

CVS said it was confident the company would be able to pump more of the medicine, but that it had become harder to find in the U.S. because of the drugs’ geographical expiry, which made it more difficult to market them or obtain supplies.

“As manufacturers can reduce inventories to respond to market demand, availability can fluctuate which, along with other factors, contributes to increased pricing,” CVS Health said in a statement.

Pfizer began selling the drug in 1987, but it had been docked by several attempts by activist groups to get the medication relabeled and get access to it through the PDUFA Act.

Without that labeling, Dr. Ryan McMakin, a research director at the Kaiser Family Foundation’s HIV Clinical Research Center, told the Washington Examiner in October that patients were running out of their regular pills.

“These patients can’t switch to another antiretroviral drug,” McMakin said, adding that they had to resort to the daily injection process.

“It does so much damage to their bodies. And the FDA is backtracking, saying it’s a safer injection than the other drug, but then only allowing it if the other patients start using it as well,” he said.

In response to the shortage, private insurers were giving patients the option to switch to a cheaper alternative.

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