FDA urges drug makers to pay more attention to abuse potential
The Food and Drug Administration is calling on pharmaceutical firms to give more attention to the potential for abuse of new drugs when subjecting them to pre-market testing.
The agency this week released a draft of voluntary guidelines to assist drug makers in figuring out which compounds should be placed under the Controlled Substances Act. The law regulates the handling, record-keeping and dispensing of drugs deemed to be dangerous or addictive if misused -- in some cases imposing criminal penalties for misuse.
The guidelines urge researchers to look beyond traditional indicators such as whether a compound is addictive and consider other characteristics that could lead to abuse. Advances in chemistry have created properties in drugs that may include previously unrecognized abuse potential, the FDA said.
Though FDA officials said no specific event triggered release of the guidelines, they pointed to the anesthetic propofol as an example of a drug that might be flagged for restrictions if subjected to more rigorous consideration of potential abuse.
Propofol was in the cocktail of drugs that caused the death of pop star Michael Jackson. It currently is not a controlled substance, but that status has been under review by the Drug Enforcement Administration, which enforces the Controlled Substances Act.
“Until recently, there hadn’t been much indication that it was being abused. But we have gotten calls from the [healthcare] industry telling us, ‘You need to take a look at it,’ ” said DEA spokeswoman Barbara Carreno.
She said the DEA initially had not thought propofol was subject to abuse because it required careful administration with a needle and was regarded simply as an anesthetic. But medical professionals have found that the drug also induces a mild euphoria and other pleasant side effects. Since it’s not a controlled substance, propofol is relatively accessible in medical settings.
Anesthesiologist Scott Fishman said propofol was one of a number of drugs that “were released for one purpose, and society -- or the street -- finds another use.”
In urging drug developers to cast a wide net for indicators of abuse potential, the FDA is saying, “Let’s do the testing instead of society doing the testing,” said Fishman, who is chief of pain medicine at the UC Davis School of Medicine. Fishman said drug makers might balk at the higher costs that could result from following the proposed guidelines.
A spokeswoman for the Pharmaceutical Research and Manufacturers of America said her organization had not studied the document.
The FDA will collect industry and public comment for two months before issuing final guidelines.