Bipartisan Agreement that News Reports Regarding the Ensuring Patient Access and Effective Drug Enforcement Act are Light on Facts

On December 12, 2017, the Senate Judiciary Committee held an oversight hearing to discuss the Ensuring Patient Access and Effective Drug Enforcement Act (the “Act”). The Act has been the subject of recent sensationalized news reports which included interviews with a purported DEA whistleblower and other former DEA employees. Continue Reading

Summit on Controlled Substances

I am excited to announce that I will be serving as the co-chair of the American Conference Institute’s Summit on Controlled Substances – Regulation, Litigation, and EnforcementThis is a one-of-a-kind event, bringing together subject matter experts from the pharmaceutical industry and government.  The Summit will address the most pressing topics in controlled substance regulation, litigation and enforcement, including

  • Suspicious Order Monitoring;
  • Abuse-deterrent opioid products;
  • State Prescription Drug Monitoring Programs;
  • State and Federal Enforcement actions against the supply chain; and
  • Policies and Politics of Controlled Substances.

Pre and post-conference workshops will also be available providing a primer on the fundamentals of the laws governing controlled substances and a simulated exercise on responding to a DEA inspection.

The Summit will be held in Washington, D.C. from January 29-31, 2018. Register today and use this code P10-999-DEA18 to receive a discount on registration fees.

An “Open Letter” to President Trump Regarding the Prescription Drug Abuse Epidemic

Dear President Trump,

For several years the prescription drug epidemic has ravaged communities across the United States. During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry. Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis. There have been many solutions put forth in the past several months. These solutions, while well-intended, failed to address the root causes of the epidemic – overprescribing of controlled substances. Mr. President, this is a unique opportunity for you to reset our approach to this crisis. As a first step, we need to reassess the enforcement-first approach of the past several years. Continue Reading

The Other Side of the Story: DEA Enforcement in the Opioid Crisis

Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the segment sought to educate viewers on the causes of prescription drug abuse and the alleged slowdown in enforcement efforts by the government, it is of course journalism and takes a strong position against drug companies. Aided by reporters from the Washington Post and former employees from the Drug Enforcement Administration (“DEA”), the 60 Minutes segment, while dramatic in its presentation, only told the facts relevant to the position it was taking – which is what makes good headlines. Continue Reading

West Virginia Imposes New Suspicious Order Reporting Requirements

The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month.  The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia. Continue Reading

Taxing Opioids to Address Prescription Drug Abuse

Federal and state policy makers struggle to come up with solutions to the ongoing opioid crisis. As with many areas of public policy, political leaders are turning to the tax laws as a possible way to curtail opioid abuse. In the past two years, there have been many proposals to impose special or excise taxes on the sale of opioids. To date none have passed. But we believe that without the implementation of other policies to address the issue, a number of states will impose taxes in the coming year. Continue Reading

DEA Prevails Over Masters Pharmaceutical, Inc.

On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances. Continue Reading

Oregon Adds Suspicious Order Reporting to Wholesale Distributor Requirements

Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017.

The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for failing to report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA). Continue Reading

Pharmacy Law Trends Q&A: Opioids, Specialty Drugs Among Top Issues for Retail Pharmacies

2017 Pharmacy Law Symposium-Art-vAThe opioid crisis in the United States continues to worsen, with the Centers for Disease Control reporting more than 33,000 human deaths by overdose in 2015 – up from about 29,000 in 2014 and quadruple the number in 1999. As in-house counsel from some of the nation’s 65,000 retail pharmacies prepare to meet in Chicago for Quarles & Brady’s 2017 Pharmacy Law Symposium this July, partners Amy Cotton Peterson and Roger Morris discussed the opioid epidemic. The partners also discussed specialty pharmacies, another important and evolving topic for those involved in the sector in 2017.

Q:  Given the severity of the opioid crisis, what are some of the challenges pharmacies are facing?

RM: Pharmacies – an important link in the chain that gets products from the manufacturer to the consumer – are continuing to be criminalized for the dispensing of opioids. This generates significant concerns for the pharmacies and their legal counsel, and some might wonder whether it’s worth it to continue selling opioids at all.

While deciding to discontinue carrying opioids would be a drastic step to take, it’s understandable that some pharmacies might at least entertain the notion, given the overall thorny nature of the issue. It’s worth noting that opioids make up only about 10 percent of all prescriptions.

Going deeper, pharmacies are faced with a lot of difficulties – how do they verify the validity of prescriptions? How do they determine if doctors are overprescribing, and what’s the pharmacist’s responsibility when it looks like they are? How do you work across state lines, given the different rules and regulations in each state? How do you work with different sets of records that might be maintained in a myriad of different ways?

We’ll address these questions, and more, at the Symposium in July.

Q. In what ways are pharmacies trying to address these problems?

ACP: Pharmacies, rightfully, have taken a lot of responsibility and initiative to address the epidemic. The steps they’ve taken include “Know Your Client” initiatives, in which pharmacists and wholesalers track suspicious ordering patterns. Some pharmacies are even using technologies like Google Maps to see if certain delivery locations have the potential to be pill mills.

Going a step further, regulatory requirements and state laws tell pharmacists what has to be on a prescription for it to be valid, but a lot falls on pharmacists’ professional judgment. Because there are gray areas – states don’t always make it easy to know what isn’t valid – pharmacies face some potential liability. To counter that, 49 states, the exception being Missouri, have Prescription Drug Monitoring Programs (PDMP), an electronic database that monitors prescriber and patient activity related to controlled substances such as opioids, for example. Some states have even gone as far as to enact regulations (some emergency) as to how PDMPs are monitored.

Arizona extended the reach of its PDMP by agreeing to share information with 22 other states, but there are major differences in how the data is kept in each state and by each pharmacy. Some states gather the data in real time, others daily and a few only weekly. Each state also identifies patients in different ways so that patient John Smith in Arizona might not be easily identified as Johnathan A. Smith Jr. in New Mexico even though they are the same person.

Big picture, the industry should step back and look at the overall processes from a public health perspective as opposed to a law enforcement perspective. Where’s the demand? Where’s the supply coming from? Where do the drugs end up?

Q: We’ve seen a growing trend with specialty pharmacies in recent years. What are the causes and challenges stemming from this growth?

ACP: Specialty pharmaceuticals, which treat complex and often rare diseases, are expensive and hard to handle, and their use is growing at a phenomenal rate. They’re expected to account for 50 percent of pharmacy revenues by 2020, and some estimates say they’ll surpass traditional brand name drug spend in the next few years. A growing number of hospitals and health systems, including the Cleveland Clinic, Rush University Medical Center and others have or are in the process of integrating specialty pharmacies.

RM: But this growth – which is spurred in part by an aging American population, but also innovation – brings with it a host of different licensure and regulatory issues. There’s also a lot of money on the line, as many of these drugs cost between $30,000 and $50,000 a month. This has generated a lot of excitement among manufacturers and developers, but when it comes to those distributing the drugs – pharmacies, among them – we’re really in a sort of “wild west” period when it comes to regulations.

Q: What are some best practices when it comes to specialty pharmacies that would be useful to pharmacies and their legal counsel?

RM: Specialty pharmacies must strictly comply with all pharmacy laws. Failure to be licensed correctly, at the facility or personnel level, can result in false or rejected claims. When prescriptions cost $30,000 each, a single misstep could eliminate any profit in this area for months. Moreover, specialty pharmacies must be vigilant in their compliance with Anti-Kickback and referral laws. Traditional gifts and benefits to prescribers from yesteryear are today’s inappropriate incentives.

To learn more about Quarles & Brady’s 2017 Pharmacy Law Symposium, or to register for the event, click here.

Alabama Battle Over Alprazolam is Done. For Now.

Prescription Medication Medicine Pill TabletsThe battle is over! For now.

Yesterday, Alabama lawmakers blocked the proposal to move Alprazolam into Schedule II, as well as blocking the other proposed changes described in this series of client updates. See here and here. The pharmacy community in Alabama took an active role in opposing these changes. According to this article from Alabama Live, members of the Alabama Pharmacy Association opposed this change and as noted in our most recent update, the Alabama Board of Pharmacy was also encouraging pharmacists to reach out to their legislators to share their concerns. It looks like all of this hard work has paid off. Will this come back? Hard to tell, but we will continue to watch how Alabama and other states try to manage and prevent the abuse of prescription medications.