After the Food and Drug Administration approves a drug for production and sale, a section of the DEA known as the Office of Diversion Control decides how much of a drug can be manufactured. By law, the makers of Oxycodone and its generic forms have to present a quota approval application to Diversion Control. The office decides whether the amount requested can be manufactured. With the help of statistics provided by a former head of Diversion Control, Gene Haislip, Taylor discovered that in 1997 when Purdue Pharma first introduced Oxycontin, it was allowed to make 8.3 tons. This year, the DEA approved the manufacture of 105 tons.
Haislip tells Taylor DEA approved the increase in production in the face of a growing drug abuse epidemic, showing a “serious lack of accountability and oversight.” Says Haislip: “The DEA is the lone federal agency with the power to decide how much of the drug gets made and put out there; it alone has had all the responsibility to do something about this problem.” He told Taylor the agency should have learned from two examples in the 1970s and 1980s, when Diversion Control reduced quota requests for pill-based amphetamines and Methaqualone, the main ingredient in Quaaludes. When the quotas were reduced, illicit use of those drugs significantly decreased.
Asked why the agency allowed the production quota of Oxycodone to increase so much, DEA supervisory special agent Gary Boggs told Taylor the agency is required to set quotas at a level that “ensures an uninterrupted supply for the legitimate medical and scientific research needs of the United States, and that those needs are always changing as the population grows and as medical science finds different needs for products.” He said there are patients who need the drug for medical purposes and the agency cannot limit their access because of those who abuse it.
Taylor opines: “The fact is that the U.S. government has adopted a position on prescription painkillers that differs from its policy toward other controlled substances such as cocaine, heroin and marijuana: Unlike those drugs, the DEA says limiting the supply of the prescription painkillers will not reduce abuse.” He reports the agency’s lack of oversight in the production of Oxycodone is “perplexing” to state and local governments now battling prescription pill abuse crises in their areas. Ohio Department of Alcohol and Drug Addiction Services director Orman Hall told Taylor the “the loss of life and the carnage associated” with prescription drug abuse could have been prevented had the DEA limited the production of Oxycodone. (Read more)