If you are looking to stay informed on legal issues as they pertain to pharmacy, pharmaceuticals and related products and services, there’s still time to register for the American Society for Pharmacy Law Fall Meeting. You’ll learn from industry experts on topics critical to managing the legal risk and compliance inherent in pharmacy operations while earning up to 15 hours of continuing legal and pharmacy education credits.

Having attended and presented multiple times and now as a sponsor, I can tell you that this is the must-attend industry conference for pharmacy law.

2019 ASPL Fall Meeting
Developments in Pharmacy Law Seminar XXX
November 7-10, 2019
Westin San Diego Gaslamp Quarter San Diego, California

I will be co-presenting with Kimberly Frazier from Walmart, covering the topic of “Dispensing Controlled Substances: Navigating a Minefield of Contradictions.” We will be providing an overview of the current enforcement and litigation landscape and will address the various minefields that pharmacists must traverse when dispensing controlled substances. Keynote speaker Carmen Catizone, Executive Director National Association of Boards of Pharmacy, will share his thoughts on the future of pharmacy regulation. Other conference topics include ethics, telepharmacy, online pharmacies, CPB and cannabis, employment law, patient safety, drug pricing reform, privacy, litigation enforcement, attorney-client privilege and more.

For more information and registration, visit www.aspl.org.

Hope to see you there!

Is “Suspicious Order” about to be defined?

The recently-released DOJ OIG Review of the Drug Enforcement Administration’s Regulatory and Enforcement Efforts to Control the Diversion of Opioids has met with extensive media coverage focused on the sexier aspects of the story. What did DEA do or not do to stem the opioids crisis? What internal battles may have led DEA to drop the ball in some aspects of the response? These are important questions, but they have been well-covered.

Instead, we are going to focus on a handful of the nine recommendations (listed below) made by the IG and DEA’s and ODAG’s responses. Continue Reading Problems Identified, Solutions Proposed: the OIG Review of DEA

While acknowledging the safety of the approved daily doses of OTC loperamide for adults (8mg per day) and prescription loperamide (16mg per day), the FDA recently approved new package-size and package-type limits for the brand-name OTC tablet and capsule forms of the drug. Here are the products affected by the FDA’s notice:

  • Imodium A-D
  • Imodium Multi-Symptom Relief
  • Be Health Loperamide HCl Capsules

Loperamide has been referred to as the “poor man’s methadone,” due to effects of abusing the drug via high doses. This has led to reports of “serious heart problems and deaths associated with loperamide,” with “the majority” relating to abuse and misuse of the drug.

The FDA’s action limits the package sizes by “limiting each carton to no more than 48mg” (24 tablets or a 6-day supply at maximum approved use) and provides for unit-dose packaging for the affected products, which the FDA believes “may reduce medication overdose and death.”

The FDA also requested that “online distributors take voluntary steps to help reduce the risks of loperamide abuse and misuse by not selling more than one package of these drugs to each customer.”

Finally, the FDA announced that it “is also taking steps to make sure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.” These efforts relate to generic manufacturers and liquid loperamide products as well. This is a continuation of a 2018 FDA request.

 

 

 

Image by Petra Göschel from Pixabay

Quota Reductions

DEA is out with its proposed 2020 aggregate production quotas for Schedule I and II controlled substances, and they have been reduced dramatically from 2019’s numbers. From the press release:

DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in the amount of allowable production of these opioids since 2016.”

How’d They Get There?

Why the size of the decrease? Aside from the obvious political pressures attendant to legitimate concern over the proliferation of the opioid crisis and, perhaps, some less-legitimate political posturing, the DEA cites the usual factors and a significant new one. As always, DEA consults “many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturer’s disposition history and forecasts; data from DEA’s internal system for tracking controlled substance transactions; and past quota histories.”

Continue Reading DEA Proposes Decreasing Opioid Quotas for 2020

Jeffrey Stein, M.D.; Decision and Order

Uttam Dhillon, DEA Acting Administrator, issued a final order today in the case of the revocation of a New York doctor’s DEA registration. But its implications go well beyond this doctor’s circumstances.

The Facts

Here are the basics. Dr. Jeffrey Stein was convicted of tax-related crimes in the Southern District of New York in 2015. Specifically, Dr. Stein had provided false receipts and other fabricated documents to his accountant to reduce the amount of taxes he would have to pay and, in turn, to mislead the IRS Auditor into believing that the claimed expenses were legitimate. Dr. Stein pled guilty to these charges. Of particular relevance to today’s order, Dr. Stein had used, among the fabricated materials, “the names of four disabled military veterans (including two former patients whose identities he obtained as a result of his work for the V.A, [and] . . . created bogus invoices in the names of those veterans.”

Continue Reading DEA Decisions: Registrations Not Automatically Revoked by Medicare/Medicaid Exclusions

Last week was an active week when it comes to marijuana policy. The Drug Enforcement Administration (DEA) announced that it will begin considering (and approving?) applications to allow for the manufacture (growing) of marijuana for research purposes. Shortly thereafter, United States Surgeon General, Vice Admiral Jerome M. Adams (Dr. Adams), issued an advisory regarding the significant adverse effects of marijuana use by adolescents and by women during pregnancy. Both developments could foreshadow the long road ahead for marijuana legalization advocates seeking DEA’s removal of marijuana from its listing as a schedule I controlled substance.

Continue Reading DEA and the Surgeon General Issue Statements Regarding Marijuana

Just as there are several factors that contributed to the opioid epidemic, there are a myriad of solutions that, in tandem, will make a difference in the lives of those impacted by opioid abuse and may prevent others from misusing and abusing these drugs. Roger Krone and his team at Leidos are executing a program that should be emulated by companies across the United States.

After receiving an email from an employee whose son recently lost his life to a drug overdose, Leidos CEO Roger Krone directed the creation of a corporate responsibility program focusing on drug abuse awareness, prevention, and treatment. The CEO Pledge was born from this initiative.

Continue Reading Be Part of the Solution to the Opioid Crisis – Make the Pledge!

On July 23, 2019, the Food and Drug Administration (FDA) announced the issuance of a Warning Letter to the manufacturer of certain products containing cannabidiol (CBD). Specifically, the FDA provided a laundry list of examples where Curaleaf, Inc. (Curaleaf) made unsubstantiated claims on its website and on social media “that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.” The FDA considers Curaleaf’s actions as the “illegal selling of unapproved products,” pursuant to the Federal Food, Drug, and Cosmetic Act.

Continue Reading FDA Issues Another Warning Letter Involving CBD Products

As I have previously written, there is a long list of regulatory changes coming from DEA in the next few years.  Rather than publish one or more of the long overdue regulations listed on DEA’s Regulatory Agenda, on April 30, 2019, the agency will publish a Final Rule creating a “discretionary review” process allowing the Administrator to review an Administrative Law Judge’s (“ALJ’s”) denial of a request for an interlocutory appeal.  Note that this is a Final Rule, not a Notice of Proposed Rulemaking.  The agency was able to bypass the traditional notice and comment rulemaking process by categorizing this rule as a Rule of Agency, pursuant to the Administrative Procedure Act.  As such, the rule is effective immediately.

Requests for interlocutory appeals can take many forms in a DEA administrative proceeding.  Often, they are a result of a procedural or evidentiary ruling by an ALJ during the prehearing process.  DEA regulations currently give ALJs broad authority to rule on a request to seek an interlocutory appeal.  The ALJ’s decision to deny a request for an interlocutory appeal is not reviewable.  Until now.

Continue Reading Does the New Rule on Interlocutory Appeals Undermine the Independence of DEA’s ALJs?

As you undoubtedly should know by now, on April 22, 2019, the United States Attorney for the Southern District of New York entered into a Deferred Prosecution Agreement (the “Agreement”) with the Rochester Drug Co-operative, Inc. (“RDC”).

Specifically, the government announced that

“RDC agreed to accept responsibility for its conduct by making admissions and stipulating to the accuracy of an extensive Statement of Facts, pay a $20 million penalty, reform and enhance its Controlled Substances Act compliance program, and submit to supervision by an independent monitor.”

Continue Reading Key Takeaways from the Rochester Drug Co-Op Deferred Prosecution Agreement