Pressure builds on the DEA to stem the supply of prescription drugs, but at what cost?
(Lev Facher, STAT) WASHINGTON – In a bland Northern Virginia office building nestled between a Costco and a freeway interchange, a dozen government scientists have spent the past year crunching numbers and making the following determination:
In 2018, drug makers will be allowed to produce no more than 98,145 kilos (108 tons) of oxycodone, 38,047 kilos (42 tons) of morphine, and 1,342 kilos (1.5 tons) of fentanyl.
The precise limits are set as part of a little-known process in which, every year, the Drug Enforcement Administration regulates the volume of controlled substances that can be produced in the United States.
The process was started nearly five decades ago to ensure that drug makers produced enough medicines to avoid shortages.
But in the midst of a national opioid epidemic, fresh scrutiny of the quota system has spread to Capitol Hill, where Democratic lawmakers are pressing the DEA to use it for another reason – to help stem supply.
“It is clear that we need to reduce the amount of oxycodone and hydrocodone that DEA approves for manufacture each year and hold Big Pharma accountable for manufacturing a product that is leading to the deaths of hundreds of people every day,” said Sen. Edward Markey (Mass.), who has introduced a number of bills aimed at addressing the opioid crisis.
Rarely, however, has the quota system been used to eliminate or constrain supply for a class of drugs similar to opioids – created to fill a medical need but with consequences that, in at least some cases, have outweighed the medical benefits.
The lone historical exception is that of the sedative methaqualone, which was marketed until the early 1980s as Quaalude. The drug became so abused that it quickly fell out of favor with the medical community, and in conjunction with nose-diving prescription rates and manufacturer interest, the DEA began to lower the quota for methaqualone production in 1973. It hit zero in 1981.
But opioids are not quite analogous. No medical group thinks they are without merit when properly distributed, and a substantial number of pain patients would suffer if denied access to them.
Many experts are not sure using the quota system as a tool to constrain supply is a sound idea – and instead believe the focus should be on reducing prescriptions.
The DEA could have considered tightening quotas to address the crisis more than a decade ago, “when we were clearly already in the middle of an opioid crisis and it was clear the prescribing of OxyContin was happening at a rate much greater than could be clinically needed,” said Andrew Kolodny, the co-director of the Opioid Policy Research Collaborative at Brandeis University.
Displayed with permission from STAT via Repubhub. Also of interest: These Individuals Use $50,000+ of Rx Annually