Amendment to CSA Closer to Becoming Law

DEA Chronicles welcomes guest blogger Julia Hudson, a Q&B Health Law attorney.

On September 30, 2015, the Improving Regulatory Transparency for New Medical Therapies Act moved one step closer to becoming federal law by passing the Senate Health, Education, Labor and Pensions Committee.  The bill, which was introduced on February 2, 2015 and passed in the House on March 16, 2015, is now heading to the full Senate for discussion and possible vote.

We herald the progress of this bill with particular enthusiasm given that it has arrived on the same day as the D.C. District Court’s decision to grant the FDA’s Motion for Summary Judgment in the case initiated by Eisai, Inc.  Eisai is a drug manufacturer who was forced to wait a year for the DEA to schedule two of its drugs that had already received FDA-approval.  After unsuccessfully taking up the issue with the DEA and facing an entire year of lost market exclusivity, Eisai took the FDA to court, challenging the FDA’s interpretation that a period of new chemical entity exclusivity begins when the FDA approves the product.  However, the court found itself bound to defer to the FDA’s position.

The court’s decision in Eisai suggests that the only relief in sight for manufacturers may be through legislative action.  The Improving Regulatory Transparency for New Medical Therapies Act promises to provide the solution that manufacturers like Eisai have been hoping for.  The Act would provide manufactures with clarity and security on timing for the following milestones:

  • Market exclusivity begins after the date of DEA scheduling, rather than after FDA-approval.
  • The DEA must schedule a controlled substance no later than 90 days after it receives a recommendation for controls or FDA-approval.
  • The DEA must act on applications to manufacture a Schedule III, IV, or V drug for use in a clinical trial within 180 days of receiving the application.
  • The DEA must act on an application to manufacture a Schedule I or II drug for use in a clinical trial within 90 days of the close of the notice period, which must be opened no later than 90 days after the application is accepted for filing.

We will continue to provide updates on the progress of this bill as it moves forward.


DEA Administrator Overrules ALJ, Revokes Distributor Registration in Sweeping Decision

The Chronicles welcomes guest blogger Katea Ravega, a Q&B Health Law attorney.

In a 308-page decision dated September 8, 2015, the new Acting Administrator of the DEA, Chuck Rosenberg, issued an Order revoking the DEA registration of wholesale distributor Masters Pharmaceuticals, Inc. (“Masters”). In doing so, the Administrator rejected the recommendation from DEA’s own Administrative Law Judge (“ALJ”) that Masters retain its DEA registration.

Masters was accused of failing to report hundreds of suspicious orders. Focusing on just 7 of Masters’ pharmacy customers located in Florida, the Administrator concluded that Masters’ registration should be revoked because (1) Masters failed to report suspicious orders from the pharmacies on numerous occasions; (2) Masters failed to acknowledge its misconduct; (3) senior Masters’ officials acknowledged that they were well aware of the oxycodone epidemic in Florida; (4) Masters did not follow its own Policies and Procedures for detecting and reporting suspicious orders (including components of the Policies and Procedures that require more than the applicable laws); and (5) revocation is justified by DEA’s interest in deterring future misconduct on the part of Masters and others in the industry.

The Administrator provided a thorough assessment of the parties’ exceptions to the ALJ’s recommended decision and analyzed in detail the evidence involving orders placed by the seven Florida pharmacy customers. The lengthy opinion discusses compliance obligations, entrenches the concept of “due diligence” on customers into the Agency’s case law, and provides insight into the Agency’s expansive concept of what makes an order “suspicious.”   Look for future blog posts with detailed discussion on the effects that this Final Order may have on compliance obligations and practices for other registrants.

The full Decision and Order is available here.  It will be published in the Federal Register on September 15, 2015.  Masters has 30 days to file a Petition for Review with the U.S. Circuit Court of Appeals.

GAO Issues Another Report Involving DEA

On July 27, 2015, the Government Accountability Office (GAO) released a report titled, Prescription Drugs: More DEA Information about Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access.  GAO’s report examined, (1) to what extent registrants interact with DEA about their CSA responsibilities, and registrants’ perspectives on those interactions, (2) how state agencies and national associations interact with DEA, and their perspectives on those interactions, and (3) stakeholders’ perspectives on how DEA enforcement actions have affected prescription drug abuse and diversion and access to those drugs for legitimate needs.

GAO’s survey results concluded, among other things the following:

  • Registrants vary in the extent of their interaction with DEA and awareness of DEA resources, and while generally satisfied, some want additional information and guidance.
  • State agencies and national associations interact with DEA through joint task forces or meetings, and while generally satisfied, some associations want improved communication.
  • Many registrants have changed certain business practices as a result of DEA enforcement actions and reported these changes have limited legitimate access.
  • While providing additional guidance to registrants about their CSA roles and responsibilities cannot ensure that registrants are meeting them, by doing so DEA will have a greater assurance that registrants understand their CSA responsibilities.

GAO’s report recommended that DEA take the following three actions:

  • Identify and implement means of cost-effective, regular communication with distributor, pharmacy, and practitioner registrants, such as through listservs or web-based training.
  • Solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting.
  • Solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly.

In response to this report, DEA described the actions that it plans to take to implement the three recommendations, although in some instances the agency asserts that the survey results are based on anecdotal data.  DEA officials also indicated that they do not believe there is a need for more registrant guidance or communication.  However, DEA has stated that its goal is bringing registrants into compliance rather than taking enforcement actions, and DEA can move closer towards this goal by improving its communications and information sharing with registrants, consistent with federal internal controls standards.


Amanda Klopt, Legal Intern, Washington, D.C. Office


DEA to Continue Take Back Programs


On September 23, 2014, DEA announced that its ninth Take Back Day would be the agency’s last.  The announcement was made shortly after DEA published the Final Rule implementing the Secure and Responsible Drug Disposal Act of 2010.  The regulations promulgated by DEA allow “authorized collectors” the opportunity to receive and securely dispose of prescription medications.

The moratorium on conducting Take Back Days was short lived.  DEA’s new Acting Administrator, Chuck Rosenberg, recently announced that DEA would revive the Take Back Program.  Administrator Rosenberg issued a challenge to the American people: “We need you to clean out your medicine cabinet; we need you to give us the stuff in your medicine cabinet that can hurt you or your loved ones.”

Take Back Programs have proven to be an effective tool in reducing the supply of unused and unwanted medication.   During the four years that DEA conducted nine Take Back Days, the agency collected approximately 2,411 tons of unused prescription medication.  That is an astounding figure which leads to an obvious question.  Are doctors prescribing more medication than patients need?  While DEA often states that pharmacies are “the last line of defense,” prescriptions originate with doctors.  The amount of unused medication collected from the general public should cause the medical community to do a thorough self-assessment.  Better education and self-enforcement of the medical community when it comes to prescribing controlled substances is a crucial part in protecting the public health and safety from prescription drug abuse.

We applaud DEA’s efforts in reviving the Take Back Program.

Rising Heroin Use Linked to Rx Opiate Abuse

The Chronicles welcomes guest blogger Jazzmin Lewis, a summer associate in Q&B’s Indianapolis office. Jazzmin is entering her final year at Indiana University-Maurer School of Law.

Heroin Use and Abuse of Other Substances

Annual average percentage of past-year heroin users with past-year selected substance abuse or dependence (Source:CDC)

Last week the Center for Disease Control and Prevention (CDC) released its Morbidity and Mortality Weekly Report regarding the recent increase in heroin use in the United States. The report shows that the annual rate of heroin use rose from 1.6 per 1,000 people in 2002-2004 to 2.6 per 1,000 people in 2011-2013, causing increased rates of heroin-related deaths. This increase has occurred simultaneously with an epidemic of prescription opioid abuse. In fact, the study shows that abuse or dependence on opioid pain relievers is the strongest risk factor for heroin abuse and those who abuse prescription pain relievers are 40 times more likely to abuse heroin. The percentage of heroin users with opioid abuse or dependence more than doubled from 20.7% in 2002-2004 to 45.2% in 2011-2013. With the increased availability and the decreased price of heroin in the United States, the abuse of prescription opioids appears to be a gateway to heroin for individuals.  In years past, abuse of or dependence on alcohol and cocaine were more prevalent among heroin users than the abuse of or dependence on prescription opiates.  The CDC study shows that now abuse of or dependence on prescriptions drugs is more prevalent among heroin users than is the abuse of alcohol or cocaine.

Heroin and prescription drug abuse has been a problem in the United States for many years, and this study shows that it is only getting worse. So how do we fix this growing problem? The CDC recommends interventions such as prescription drug monitoring programs to reduce inappropriate prescribing of opioids and enable the early identification of persons demonstrating problematic use. The CDC seems to agree with the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO). A previous post on international perspectives described the solution to reducing opioid abuse set fourth by the UNODC and WHO. In order to combat this issue, these two organizations suggest decreasing the inappropriate prescribing of opioids and inappropriate sale by pharmacies without a prescription. United States Senator Jon Tester is another advocate for reducing inappropriate prescribing of opioids. He recently proposed legislation that will provide safer and more effective pain management services for Montana veterans by requiring strict opioid prescription guidelines. The legislation has the overall goal of treating veterans while also helping eliminate prescription drug abuse.

Public health agencies have concluded that reducing inappropriate prescribing is a key part of solving prescription drug abuse. And after this disturbing report linking prescription opioid abuse to heroin use, the call for stricter regulations regarding opioid prescribing is like to grow louder. Stay tuned to the DEAChronicles for updates on new legislative and regulatory proposals to more tightly regulate the prescribing of prescription opiates.

By Jazzmin Lewis

Jazzmin Lewis


DEA Announces Major Enforcement Action

DEA-HandcuffsOn May 20, 2015, DEA issued a press release regarding a recent major enforcement action in Arkansas, Alabama, Louisiana, and Mississippi. Operation Pilluted targeted alleged pill mills that were engaged in the illegal distribution of oxycodone, hydrocodone and Xanax. The operation resulted in the arrest of 280 individuals, including 22 doctors and pharmacists. Executing 21 search warrants and 71 seizure warrants, law enforcement seized 51 vehicles, 202 weapons, more than $12 million and nearly $7 million in real property. DEA obtained the voluntary surrender of 40 DEA registrations and issued two Orders to Show Cause and Immediate Suspension of Registration. Enforcement actions aimed at the physicians who issue prescriptions without a legitimate medical  purpose stops prescription drug diversion at the source and we applaud DEA for focusing its efforts on those physicians and other individuals involved in prescription drug trafficking.

Large operations, such an Operation Pilluted, have a ripple effect on the legitimate prescribing and distribution of controlled substances. Pharmacies that fill illegitimate prescriptions often fill many legitimate prescriptions as well. When they are shuttered, the demand – legitimate and otherwise – will shift elsewhere. Legitimate patients will continue to need access to their medications even if their physician no longer has a DEA registration. Likewise, drug abusers will continue to seek access to narcotics. Demand for controlled substances will shift to other retail pharmacies as a result of these closures (the balloon effect), requiring pharmacies and distributors to remain vigilant and closely scrutinize prescriptions and orders for controlled substances. We have observed and written about the unintended consequences that often accompany large enforcement operations, namely restricting access to prescriptions controlled substances for legitimate patients. This is an issue that the supply chain, pharmacists, DEA and other government agencies must work together to avoid in the wake of large enforcement operations.  Pharmacies and distributors should ensure that any identified “red flags” are adequately resolved. Close coordination with regulators, where practicable, is a prudent measure to ensure that legitimate patient needs continue to be met.

Senate Committee Questions DEA on Quota Process

57339493On May 5, 2015, the United States Senate, Caucus on International Narcotics Control held a hearing exploring the findings and recommendations of a Government Accountability Office investigation into the Drug Enforcement Administration’s management of its quota process.  The hearing, called by Senators Grassley and Feinstein, sought to explore the connection between DEA’s quota process and pharmaceutical drug shortages in the United States.

At the hearing, DEA and the Food and Drug Administration announced that the agencies recently entered into a Memorandum of Understanding to facilitate collaboration between the agencies, including greater information sharing.  While the hearing was generally cordial, Senator Whitehouse did press DEA on its historic failures to issue quota in a timely manner.  Senator Whitehouse questioned whether DEA was able to effectively manage its administrative and regulatory responsibilities and whether those functions should be transferred out of DEA.  Specifically, Senator Whitehouse noted that “dissatisfaction with DEA’s level of capability and performance as an administrative regulator runs very deep and is very broad” and that DEA is running the risk of losing bi-partisan support on Capitol Hill.

Rx Denied: A Prescription for Misery


Center-20150403-00124WESH TV of Orlando aired a special investigative report on April 2, 2015 detailing the unintended consequence of the crackdown on “pill mills” in Florida.  State of Pain reveals that some patients with severe medical conditions are having difficulty finding pharmacies willing to fill their prescriptions for controlled substances.  The causes for this are many and include pharmacists’ fear of regulatory action, skepticism because of the deceitful schemes of drug abusers and dealers, and regulatory pressure on the entire supply chain to be very cautious when distributing and dispensing prescription controlled substances.

There are two bad outcomes that physicians, pharmacies and regulators must prevent:  1) drugs getting into the wrong hands, and 2) drugs not getting into the right hands.  We don’t have to chose between these outcomes.  We must prevent both bad outcomes.  The reality is that if DEA or other regulators are taking enforcement action, a bad outcome has already occurred.  So here’s a twist on an old adage that might just be a prescription for avoiding bad outcomes.  An ounce of prevention is worth a pound of enforcement.  Clear guidelines from regulators and open communication between regulators and industry are my prescription for prevention.  Even good legislative efforts like H.R. 471 are no substitute for common sense guidelines and communication.  They are the prescription to ensure patient access to needed medications while preventing prescription drugs from falling into the wrong hands.

State of Pain provides perspectives from Governor Rick Scott, Florida Attorney General Pam Bondi, NABP President Carmen Catizone, Senators Nelson and Rubio, patients, and others.

GAO Report Criticizes DEA Quota Process

PillsOn March 4, 2015, the Government Accountability Office (GAO) released a report titled, Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved.  GAO’s report examined, (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA’s administration of the quota process, and (4) coordination between DEA and FDA to prevent and mitigate shortages. GAO’s report concluded, among other things the following:

  • DEA has not effectively administered the quota process that limits the amount of controlled substances available for use in the United States;
  • DEA has failed to meet statutory and regulatory deadlines for setting quota for more than the last decade (something we have discussed on this blog);
  • DEA’s weak internal controls jeopardize the agency’s ability to effectively manage the quota process;
  • DEA lacks critical management information because it does not have performance measures related to setting quotas, nor does it monitor data to assess its performance;
  • DEA does not have reasonable assurance that the quotas it sets are in accordance with its requirements and cannot ensure continuity of its operations, as it does not have protocols, policies, training materials, or other documentation to manage the quota process; and
  • DEA and FDA have not established a sufficiently collaborative relationship to deal with drug shortages.

In response to this report, DEA asserts that there is no causal relationship between its quota process and drug shortages.  The agency also took exception to the methodology and data analysis in GAO’s review.  With that said, DEA acknowledged its repeated failure to issue quota in a timely manner, attributing its lack of compliance to its own regulations to inadequate staffing. Upon issuance of the GAO report, Senators Grassley and Feinstein scheduled a hearing before the Caucus on International Narcotics Control, to discuss the findings of GAO’s report.  The hearing is planned for April 14, 2015.    

Second Bill Introduced in the Senate to Amend the Controlled Substances Act

cap1As we previously reported, on February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.  Also on that date, the Senators introduced legislation that would also amend the Controlled Substances Act, as well as the Food, Drug, and Cosmetic Act.  This legislation addresses, among other things, the scheduling of new molecule entities (“NME”) that have been approved by the Food and Drug Administration (“FDA”).  If passed, the legislation will require the Drug Enforcement Administration (“DEA”) to issue an Interim Final Rule placing the NME in the appropriate drug schedule within 90 days of receipt of the scientific and medical evaluation and recommendations from the Secretary of Health and Human Services or within 90 days of receipt of notification from the FDA of approval and scheduling recommendation of the NME. This is companion legislation to the Improving Regulatory Transparency for New Medical Therapies Act, which was recently introduced in the House and approved by the Subcommittee on Health, Energy and Commerce Committee. The average time for DEA to schedule NMEs has significantly increased over the past several years – from 49 days in the late 1990s to 238 days in recent years.  In 2013, Eisai  Inc. sued DEA to timely schedule Fycompa, a drug therapy approved to treat epilepsy.  Ultimately, Eisai had to wait more that a year for DEA’s scheduling action which negatively impacted patient access to an FDA-approved drug and significantly reduced the company’s marketing exclusivity period.