The Drug Enforcement Administration (DEA) has said it plans to remove the drug used to treat HIV from all new prescription drugs it produces.
A draft rule released Tuesday said it would also remove it from older, older-quality drugs sold in the US, including the hepatitis C drug PrEP, the antiretroviral drug Truvada and the injectable drug Naloxone.
The move is part of the agency’s efforts to reduce its reliance on costly and addictive drugs like fentanyl and heroin to fight the spread of the virus, which kills more than 5,000 Americans a day.
Fentanyl and heroin have been found in the blood of some people who have tested positive for HIV.
Last month, the FDA approved two injectable drugs to help combat the spread, including Nalboxin, which the agency said could reduce HIV infection by 95%.
But some drug companies have argued the drugs can be more dangerous than other drugs.DEA spokesman Tom Vinger said the agency had been working to find a way to eliminate the drugs from prescription drugs, even though it was too early to tell how it would go about doing so.
“The drugs have been on the market for some time and there’s been plenty of time for the market to evolve, so we’re taking this step now,” he said.
“It’s important to note that this decision does not impact any of our existing drug products and is not intended to change the availability of these drugs.”
He said the FDA has already decided to pull the drugs off the market and they would be available through a second batch of generic versions.
“As part of our continuing efforts to develop new and more efficient methods to safely and effectively treat patients with HIV, the agency will begin to phase out the use of fentanyl and will begin the process of rolling back the use and distribution of other opioid drugs,” Vinger wrote in an email.
“These drugs have proven to be more than just an effective tool for fighting the virus; they are a lifesaver, reducing the transmission of HIV and AIDS.”
While we do not yet have all the information that will be needed to determine whether or not to remove these drugs from the market, we are taking this action to protect patients and ensure that patients and their families are able to receive the lifesaving medications they need.”DEA did not immediately respond to a request for comment.
In a letter to the FDA last month, Dr. Richard Anderson, a drug safety expert at Johns Hopkins University, said the drugs are not effective at stopping infection but they could help people to stop taking them.
The agency will also review the use in clinical trials of a generic version of NalBoxin.”
We will continue to carefully consider the science before making this decision, including evaluating whether the use is appropriate and whether the new drug offers an equivalent benefit,” Vig said in the statement.
In an interview last month with the Wall Street Journal, Anderson said he thinks the new drugs are “probably safer than other generic opioids.””
They are safe.
It’s not a good thing, but I don’t think it’s a disaster. “
The new drug may actually be a little less potent than the older drug.
It’s not a good thing, but I don’t think it’s a disaster.
The drug may be safer than the old drug.”
Dr. Richard Cavanagh, a professor of infectious diseases at the University of Pennsylvania, told the Wall St Journal the drugs were “not as effective as we might have hoped.”
The FDA did not respond to questions from the Journal about whether it was considering withdrawing the drugs or stopping their use altogether.
The decision comes after the FDA rejected a bid from a drugmaker last year to sell its new injectable version of Truvadysafenix, saying it would be more expensive to make and had less value than a generic form.
The FDA had previously rejected a $100,000 offer from an unnamed pharmaceutical company for a drug similar to NalXboxin to treat the HIV virus.