Life Science Compliance Update

June 20, 2017

Ohio Sues Drugmakers Over Opioid Crisis

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Ohio Attorney General Mike DeWine filed a lawsuit against five drug companies on May 31, 2017, alleging that they fueled the opioid addiction crisis by misrepresenting the addictive risks of the painkillers they manufacture. The lawsuit, filed against Purdue Pharma L.P., Johnson & Johnson, Teva Pharmaceutical Industries Ltd., Allergan PLC, and Endo International PLC’s Endo Health Solutions Unit, says the companies violated the Ohio Consumer Sales Practices Act and created a “public nuisance.”

DeWine believes that the companies have been dishonest with both doctors and the general public about the risk of the painkillers. In an interview, he said opioid addiction has “taken an extraordinary human and financial toll on Ohio,” and that the “addiction crisis has placed great financial burdens on the state.”

“You have so many people today who can’t pass a drug test, who can’t work in a factory, who can’t be employed to drive a car or work around machinery or be store manager at McDonald’s because they can’t pass a drug test,” DeWine said.

The Allegations

The Ohio complaint alleges the drug companies violated the Ohio Consumer Sales Practices Act through marketing programs that “falsely deny or trivialize the risks of opioids while overstating the benefits of using them for chronic pain.” The state says the false marketing included medical journal advertising and sales representative statements.

It also alleges the companies engaged in misleading marketing by funding outside groups that have advocated for wider treatment of pain. These groups were “seemingly unbiased and independent patient and professional organizations” but disseminated information that played down the risks of opioids, the complaint alleges.

Ohio is seeking an injunction to prevent the companies from making “misrepresentations” of drug risks, as well as civil penalties to compensate the state for additional costs incurred, associated with the opioid addiction crisis.

Company Response

In a statement about the Ohio case, Johnson & Johnson, parent of Janssen Pharmaceuticals, which sells Duragesic, said: “We firmly believe the allegations in this lawsuit are both legally and factually unfounded. Janssen has acted appropriately, responsibly and in the best interests of patients regarding our opioid pain medications, which are FDA-approved and carry FDA-mandated warnings about the known risks of the medications on every product label,” said the company, referring to the U.S. Food and Drug Administration.

Purdue said, “We share the attorney general’s concerns about the opioid crisis and we are committed to working collaboratively to find solutions.” Allergan and Endo declined to comment.

State Actions Are Becoming More Prevalent

This is not the first action filed against pharmaceutical manufacturers alleging improper marketing of painkillers. However, DeWine said Ohio’s lawsuit is among the most comprehensive taken by any state against a broad group of opioid painkiller makers. He believes there is only one similar lawsuit, filed by Mississippi in state court in December 2015, alleging similar wrongdoing against the same five companies. That suit is pending.

Elizabeth Burch, a law professor at the University of Georgia, expressed sentiments that may sound familiar to some in the industry. The Ohio lawsuit is unsurprising to Burch, considering that Purdue has paid settlements in the past.

“A lot of states are looking for money to subsidize substance-abuse programs. As they do that and as previous states reach settlements, there is blood in the water at this point,” she said.

Whether Burch’s assessment is accurate or not, it is a valid point. As this case was filed in state court, no other states will be joining as plaintiffs, but we will keep an eye on this case, as well as any other state actions taken against industry companies.

June 15, 2017

Gottlieb Establishes Committee to Address Opioid Crisis

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FDA Commissioner Scott Gottlieb – sworn in on May 11, 2017 – has established a steering committee to address the opioid crisis and advise regulators on such steps as prescription limits. Gottlieb, who said overuse of painkillers was his top priority during his confirmation hearing, wrote in a blog post that he “believes it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.”

Before announcing the steering committee, Gottlieb made sure to acknowledge the work that has been done by FDA to date, and how many people are working hard on this problem.

Gottlieb noted the committee will address whether the FDA should mandate training for health professionals and work with providers to ensure the number of doses prescribed is closely related to the condition for which a patient is being treated. Gottlieb mentioned how there are few situations when a patient needs a 30-day supply of opioids. The committee will also consider whether the agency's drug review process for opioids adequately considers risk and the potential for abuse.

Specifically, there are three initial questions Gottlieb has asked the Steering Committee to answer. They are:

  1. Are there circumstances under which FDA should require some form of mandatory education for health care professionals, to make certain that prescribing doctors are properly informed about appropriate prescribing recommendations, understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment?
  2. Should FDA take additional steps, under our risk management authorities, to make sure that the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication? For example, only a few situations require a 30-day supply. In those cases, we want to make sure patients have what they need. But there are plenty of situations where the best prescription is a two- or three-day course of treatment. So, are there things FDA can do to make sure that the dispensing of opioids more consistently reflects the clinical circumstances? This might require FDA to work more closely with provider groups to develop standards for prescribing opioids in different clinical settings.
  3. Is FDA using the proper policy framework to adequately consider the risk of abuse and misuse as part of the drug review process for the approval of these medicines? Are we doing enough when we evaluate new opioid drugs for market authorization, and do we need additional policies in this area?

The actions are the first Gottlieb has taken on opioid misuse since taking the helm of the FDA. The steering committee will be made up of senior agency leaders and will solicit public comment.

Gottlieb closes his blog by noting,

Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic.

May 23, 2017

FDA Public Meeting on Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics

Public-meeting

In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers.

Under the REMS, the training must be provided by accredited providers and cover all elements of the agency's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. However, while the agency set goals for prescriber participation, prescribers were not required under the REMS to go through with the training.

On May 9th and 10th, 2017, the Food and Drug Administration held a public meeting, discussing how to train health care providers on pain management and the safe use of opioid analgesics. This meeting follows a May 2016 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss whether the risk evaluation and mitigation strategy (REMS) for ER and LA opioids would reach intended goals.

In addition to the joint Advisory Committee advice on prescriber education, a Request for Information (RFI) was posted by the Department of Health and Human Services (HHS) Assistant Secretary of Planning and Education on July 8, 2016, seeking comments on the most promising approaches in prescriber education/training programs and effective ways to leverage HHS programs to implement/expand them.

The FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (May 2017) lists draft revisions to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids. The proposed Blueprint broadens the current Blueprint to include information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). The draft also provided context for discussions at the public meeting.

Electronic or written comments to the Blueprint may be submitted by July 10, 2017.

The 2017 public workshop on May 9 and 10 attempted to build on one of the requests outlined in that RFI: the request for suggestions of additional activities HHS and its federal partners can implement to support universal prescriber education on appropriate pain management and opioid analgesic prescribing.

The workshop had three main goals. First, participants discussed the role that health care provider training plays – within the broader context of ongoing activities – to improve pain management and the safe use of opioids. Second, participants commented the best way to provide health care providers who prescribe or are directly involved in the management or support of patients with pain appropriate training in pain management and the safe use of opioids. Finally, participants discussed various issues and challenges that are associated with possible changes to federal efforts to educate health care providers on pain management and the safe use of opioids.

Opening Session

During the opening session, Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), discussed the extent of opioid prescribing and considerations in addressing prescriber training. She said that there are 200 million prescriptions for opioids dispensed annually, contributing to a “surge in opioid-related substance abuse disorders.”

Dr. Woodcock said that historically, “the liabilities of prescribing opioids were minimized” for an “entire generation of prescribers.” She cited alternative modalities, such as physical therapy and cognitive and behavioral therapy, and said the selection of a pain treatment modality should be a “sophisticated decision that weighs costs and benefits.” She noted that although opioids will remain a “mainstay in many situations,” including acute trauma, there should be a “renewed understanding that any opioid prescription confers risk.”

Dr. Doug Throckmorton, CDER’s Deputy Director for Regulatory Programs, said the meeting would focus on improving prescriber education while continuing access to appropriate treatment. He said healthcare worker education is a part of the FDA’s Opioid Action Plan. He pointed to a variety of inter-agency efforts, such as the Department of Health and Human Services’ multi-pronged opioid plan, the Surgeon General’s efforts, National Institutes of Health Centers of Excellence in Pain Education, and Centers for Disease Control and Prevention (CDC) opioid prescribing guidelines.

Veterans Affairs Experience

Dr. Bernie Good, Chair of the Medical Advisory Panel for Pharmacy Benefits Management at the VA, provided an overview of the VA’s efforts to ensure appropriate prescribing of opioids and combat opioid abuse. He said that in 2000, the VA mandated pain as fifth vital sign, encouraging veterans’ feedback on their pain severity. Approximately 30,000 VA prescribers had written at least one opioid prescription and the thought was that if veterans have to provide regular feedback on their pain severity, perhaps less prescriptions would be written.

In 2014, the VA started an academic detailing programs on opioid medications involving one-on-one meetings between a clinical pharmacist and prescriber. The VA has 285 academic detailers, and 10,436 clinical staff have been detailed. Dr. Good said that there has been a 58 percent reduction in high-dose opioid prescribing among those receiving detailing compared with 34% reduction among those without detailing.

Dr. Good noted that VA providers have mandatory training on opioids and that as part of the VA’s Opioid Safety Initiative, the VA distributes individualized prescriber and regional reports and identifies high-risk patients.

Risk Evaluation and Mitigation Strategies (REMS) Options and Considerations

Doris Auth, Acting Director of the FDA’s Office of Medication Error Prevention and Risk Management, discussed options and considerations for using FDA REMS authority under Federal Food, Drug, and Cosmetics Act (FFD&CA) to assure prescriber training on opioid medications. She noted that REMS can have elements to assure safe use and can be restrictive or non-restrictive.

She provided examples of how prescriber education could be required under REMS. For instance, the acne drug isotretinoin has a REMS known as the iPLEDGE program to prevent fetal exposure and reduce the risk of birth defects. It requires informing providers and patients about the risk of fetal exposure, initial documentation of a negative pregnancy test, pharmacy authorization from the REMS program, a medication guide with each prescription, a voice or web-based authentication prior to dispensing, patient enrollment and informed consent, an ongoing monthly negative pregnancy test for female patients, and other dimensions.

Ms. Auth reviewed a potential structure for an opioid REMS involving training. She said there could be:

  • No patient enrollment or patient-specific requirements; and
  • Required prescriber training prior to dispensing.

She believes that such a program would be quite a bit larger than any existing REMS and at least double the size of the current extended-release/long-acting opioid REMS. If pursued, it would involve ninety manufacturers, some of which would have multiple products.

Andrew Rosenberg, JD with the CME Coalition, Thomas Sullivan of Rockpointe and others gave comments at the meeting to reinforce that education is a valuable tool in fighting the opioid epidemic.  To encourage clinician's to participate in the Opioid REMS the CME Coalition recommended that FDA work with CMS to include Opioid REMS CME as an improvement activity in the Quality Payment Program.

Overall the value of continuing education in the REMS program is perhaps the most valuable tool that the government and others can engage to help reduce opioid deaths.

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