FDA wants drug companies to look at potential for abuse

Jan 30, 2010 By Andrew Zajac

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 new voluntary guidelines to assist drugmakers in figuring out which compounds should be placed under the Controlled Substances Act, which regulates the handling, record-keeping and dispensing of controlled substances -- in some cases imposing criminal penalties for misuse.

The guidelines urge researchers to look beyond traditional indicators such as whether a compound is addictive to other characteristics that could lead to abuse. Advances in chemistry and biochemistry have created new properties in drugs that may include previously unrecognized abuse potential in humans, according to the FDA.

While officials said no specific event triggered the FDAs guidance, Michael Klein, director of the agency's Controlled Substance Staff, 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 is best known as part of the cocktail of drugs that caused the death of pop star Michael Jackson.

It currently is not considered 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 (health care) industry telling us, 'You need to take a look at it,' " said DEA spokeswoman Barbara Carreno.

Carreno said 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 , nurses and other medical professionals have found that the drug also induces a mild euphoria and other pleasant side effects and, since it's not a controlled substance, is relatively accessible in medical settings.

Anesthesiologist Scott Fishman said propofol is one of a number of drugs "which 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, FDA is saying, "let's do the testing instead of society doing the testing," said Fishman, who is chief of pain medicine at the University of California, Davis School of Medicine. "They're expanding this idea that abusable drugs aren't just the ones that are addictive."

Fishman predicted that drugmakers may balk at higher costs that may result from following the proposed guidelines.

A spokeswoman for the main industry trade group, Pharmaceutical Research and Manufacturers of America, said her organization had no comment because it has not had a chance to study the FDA document.

The FDA will collect industry and public comment for two months before issuing final guidelines.

The new guidelines dovetail with two other ongoing FDA drug-safety initiatives, one to improve medication labeling and use instructions and another to require risk-management plans for selected prescription drugs to ensure that hazards associated with them are minimized.

Explore further: Merck completes sale of consumer unit to Bayer

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

Google, Yahoo call for expanded online drug ads

Nov 12, 2009

(AP) -- Google, Yahoo and other Web companies joined the pharmaceutical industry Thursday in urging federal regulators to make it easier to pitch drugs in online advertisements.

FDA issues supplement rules

Jun 23, 2007

The U.S. Food and Drug Administration has issued new government standards for the manufacture of vitamins and dietary supplements.

Recommended for you

Merck completes sale of consumer unit to Bayer

15 hours ago

Drugmaker Merck said Wednesday that it completed the sale of its consumer care business, which makes products including Claritin allergy medication and Coppertone sun-care line, to German health care company Bayer for $14.2 ...

Viagra ads target women for first time

Sep 30, 2014

The maker of the world's top-selling erectile dysfunction drug on Tuesday will begin airing the first Viagra TV commercial in America that targets the less-obvious sufferers of the sexual condition: women.

User comments : 1

Adjust slider to filter visible comments by rank

Display comments: newest first

yyz
not rated yet Jan 30, 2010
I would of thought the FDA was aware of this when they moved testosterone to Schedule III a few years back, not for being addictive, but for having a moderate-high abuse potential.