Legislative Fixes Focus on Controlled Substance Issues

By Larry K. Houck –

Early March on Capitol Hill has seen a flurry of legislation designed to combat a number of perceived controlled substance problems, including opioid treatment, pain management, drugs marketed to kids and pill mills.

Prescription Drug Abuse Prevention and Treatment Act of 2011

Senator Jay Rockefeller (D-WV) introduced the ambitious “Prescription Drug Abuse Prevention and Treatment Act of 2011” that would amend the Controlled Substances Act (“CSA”) in several ways.  S. 507 would require health care practitioners to complete 16 hours of specialized pain management training before they could register to prescribe or dispense methadone and other opioids, then complete at least 16 hours of training every three years.  The bill would also award grants to states and non-profit groups for educating consumers about methadone and opioid abuse. 

The bill would require establishment of a Controlled Substances Clinical Standards Commission comprised of representatives from responsible federal agencies.  The Commission would develop guidelines for “appropriate and safe dosing” for methadone including recommendations for maximum daily doses, abuse reduction, initiation of methadone pain management for prescribing practitioners, and education for patients and practitioners for maintenance therapy and pain management.  The bill requires the Commission to establish methadone dosing guidelines for pain management and opioid treatment programs within two years after enactment of the bill with updating at least every three years thereafter. 

In addition, the bill would restrict dispensing or prescribing methadone 40 mg. diskettes consistent with the Drug Enforcement Administration’s (“DEA’s”) policy.  DEA previously sent letters to manufacturers getting them to agree to restrict distribution of 40 mg. methadone dispersible tablets to authorized opioid detoxification and maintenance treatment programs and hospitals.

Lastly, the bill provides for $25 million per year to fund interoperable prescription drug monitoring programs in each state through the National All Schedules Prescription Electronic Reporting program.

Saving Kids from Dangerous Drugs Act of 2011

Senators Diane Feinstein (D-CA) and Chuck Grassley (R-IA) introduced legislation aimed at fighting drug misuse and abuse by minors by enhancing penalties for those who add flavorings to controlled substances or otherwise market them to children.  S. 513, known as the “Saving Kids from Dangerous Drugs Act of 2011,” would increase penalties for adults who knowingly manufacture schedule I or II drugs that are combined with a beverage or candy product, that are marketed or packaged to appear similar to a beverage or candy product or that are modified by a flavoring or coloring to distribute or sell it to minors.  Individuals who alter a drug in such a manner would be subject to up to 10 years imprisonment for a first offense and up to 20 years imprisonment in addition to the penalty for the underlying offense.  Increased penalties would not apply to a drug that has been approved by FDA if its contents, marketing and packaging has not been altered from the approved form or if it has been altered by a practitioner for a legitimate medical purpose in the usual course of professional practice.

Pharmacies have at times added child-friendly flavors to prescription drugs to make them more palatable to pediatric patients.  We assume that the “practitioner” exemption would apply to pharmacists acting in this manner. 

Pill Mill Crackdown Act of 2011

A third bill introduced in the House would double prison sentences and triple fines for “pill mill” operators.  “Pill mills” are clinics, doctors’ offices or pharmacies that dispense or prescribe powerful opioids for other than legitimate medical purposes or in an inappropriate manner.  (Under 21 C.F.R. § 1306.04(a), for a controlled substance prescription to be effective, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice).  The “Pill Mill Crackdown Act of 2011,” was introduced by Representative Vern Buchanan (R-FL) and co-sponsored by 29 members, including 15 Florida members.  Last month DEA and other federal, state and local law enforcement officers made 22 arrests and seized over $2.2 million in cash at pain clinics in South Florida.

H.R. 1065 would also potentially have the most far-reaching impact on current controlled substance requirements by rescheduling hydrocodone combination products including Vicodin, Lorcet, Lortabs and Norco from schedule III to the more restrictive schedule II.  Prescriptions for schedule II drugs, except in limited circumstances, must be written and cannot be refilled; schedule III drug prescriptions may be written, telephoned or faxed and can be refilled up to five times within six months.  Schedule II drug transfers require DEA Official Order Forms and registrants must implement heightened security.  DEA has observed that hydrocodone is the most frequently prescribed opiate in the U.S. and that diversion and abuse of the drug has been escalating.  As of October 2009, the agency was reviewing a petition to reschedule hydrocodone combination products to schedule II.

The three bills have been referred to committee:  S. 507 to the Committee on Health, Education, Labor and Pensions, S. 513 to the Committee on the Judiciary, and H.R. 1065 to the Energy and Commerce Committee.