Jill Wechsler
|
The United States is caught in an epidemic of prescription-drug overuse and abuse, and federal enforcers are revving up forces
to counter illegal diversion of approved drugs. Nearly 7 million Americans abuse psychotherapeutic drugs, according to a survey
by the Department of Health and Human Services (HHS), and prescription drug abuse now exceeds that of cocaine and heroin.
Consequently, manufacturers of opioids and other painkillers, along with prescribers and drug distributors, face increased
scrutiny from the Drug Enforcement Administration (DEA) and other regulators seeking to monitor drug distribution and prescribing
more aggressively. A House Energy and Commerce subcommittee held hearings in April 2011 and again in March 2012 to examine
how DEA is tracking and preventing inappropriate prescription-drug use, the effectiveness of state prescription drug-monitoring
programs, and how well manufacturers, distributors and pharmacists prevent illegal diversion. Subcommittee Chair Rep. Mary
Bono Mack (R–CA), has pressed for policies to aggressively curb access to painkillers and anxiety drugs more severely since
the suicide of her son related to oxycontin abuse.
Of the thousands of pharmaceuticals approved by FDA for US marketing, about 250 are regulated by the the Controlled Substances
Act of 1970 (CSA). Some 80 drugs with high abuse potential but important medical uses fall under schedule II, including sleep
aides, diet pills, antidepressants, psychiatric drugs and antihyperactive therapies, as well as painkillers. Another 150 drugs
have relatively low abuse potential and are in schedules III–V with minimal restrictions, while more than 130 schedule I drugs
are dangerous and not approved for any uses.
DEA and other federal and state agencies have responded to the sharp rise in abuse of opioids and other legal drugs as part
of the 2011 Prescription Drug Abuse Action Plan released last year by the White House Office of National Drug Control Policy.
DEA agents have been closing down illegal online pharmacy sites and rogue pain clinics, particularly in Florida, that dispense
thousands of prescriptions for pain medicines. A main DEA thrust is to target drug wholesalers and distributors that fail
to detect and halt diversion; DEA recently moved to shut down a Cardinal Health distribution facility and four pharmacies
in Florida allegedly for overlooking highly excessive oxycodone orders.
Recent legislation also authorizes more aggressive efforts to remove leftover prescription drugs from family medicine cabinets,
and DEA is holding another national "take-back" initiative this month, aiming to collect tons of expired or unwanted medicines
for proper incineration. Brand and generic-drug manufacturers support these efforts, but are wary of proposals from the state
of Washington and a California county that call for manufacturers to foot the bill for more extensive collection of leftover
prescriptions. 
