Life Science Compliance Update

March 21, 2017

Dr. Janet Woodcock on the Opioid Epidemic


The United States Food and Drug Administration (FDA) offers a podcast series, known as the Director’s Corner, that features the director of the FDA Center for Drug Evaluation and Research (CDER). One of the most recent episodes featured an interview with Dr. Janet Woodcock, by Colleen Labbe from the CDER Office of Communications, who discussed the way the FDA has been addressing the opioid epidemic affecting many communities around the United States.

CDER’s Response to FDA Labeling Changes

One of the first questions asked of Dr. Woodcock was what, exactly, CDER did with regard to the various opioid safety labeling changes that were announced in 2016. Dr. Woodcock noted that “part of our effort has been to change the labels – the actual instructions for use and warnings and so forth on opioid labels – to get more information to practitioners.” CDER has actually changed the product labels for hundreds of opioid products with numerous updates, including adding a boxed warning with safety information on all the immediate release opioid products. Dr. Woodcock said that the reason for the boxed warning on immediate release opioid products has to do “with their inherent risks – we strengthened the warnings about their risks.”

CDER also added a warning about using benzodiazepines – also known as “benzos.” Benzos, as well as opioids, have respiratory depression characteristics, and in the event of an overdose, patients can increase their risk of very serious problems, including death.

Additionally, Dr. Woodcock noted, pregnant women should be on treatment for their opioids and not abusing opioids throughout their pregnancy. She continued, “there are medication-assisted treatments, such as methadone and buprenorphine, that the FDA has approved, that are fairly widely used for treatment of opioid addiction. But there can be risks to the newborn from the mother being chronically on these, and that can be managed in the hospital properly and can be dealt with.” However, Dr. Woodcock and CDER wanted to draw more attention to these potential problems, so more information was added to the labels, referring to this as the “NOW Syndrome,” which stands for neonatal opioid withdrawal syndrome.

Decline in Opioid Prescriptions

Labbe asked Dr. Woodcock about the decline in the number of prescriptions written for opioids over the last three years, and what she believes has contributed to the drop. Dr. Woodcock responded, “I think this is a sustained collaborative effort among the federal agencies – including FDA – plus state governments, local agencies, professional societies, and hospitals, to address the epidemic by putting out guidelines, such as CDC did. States and other localities have limited the amount of medicines that can be prescribed at once. FDA upscheduled certain drugs and put them in a schedule where you can’t as easily get prescriptions, like just phone in and get a whole lot of extra refills, and so forth.”

Prescriber Education

Dr. Woodcock stated that the FDA has worked for a long time on prescriber education and referred to the Risk Evaluation Mitigation Strategy (REMS) program, where the FDA required that manufacturers of extended release or long-acting opioids provide funding for independent, continuing medical education groups to develop continuing medical education (CME) on these topics, which had to meet FDA-developed criteria.

The FDA has “long advocated as part of the administration’s initiative that prescribers should be required to get training as part of their DEA registration,” and held a meeting in 2016 focused on the training of prescribers. The FDA continues to review ways to ensure prescribers are properly trained and educated without “making a huge burden on the health care system,” but in the meantime, “medical schools and nursing schools, and other places are making sure there is training for new trainees about opioids. Many states have made pain management training or opioid training mandatory for state licensure.”

What Does the Future Hold?

As far as future CDER efforts to address the opioid epidemic, it will be “considering another recommendation, which is that the immediate release opioids be added to the REMS program that we already have for the extended-release/long acting” opioids. CDER also plans to expand the “blueprint” for the requirements that a practitioner should be trained on to include pain management. CDER wants to ensure that practitioners are trained on pain management and “aren’t just automatically reaching for the prescription pad every time people come in with a complaint of pain.”

CDER also plans to work with stakeholders about mandatory training and how it can be ensured that all practitioners (physicians, nurse practitioners, dentists, etc.) who prescribe opioids are “armed with the correct tools to understand the uses and liabilities of these drugs and the alternatives to them.”

February 13, 2017

Drug Wholesalers to Pay $36 Million Over West Virginia Pill Mill Claims


Two prescription drug wholesalers – AmerisourceBergen Corp. and Cardinal Health Inc. – will pay $16 million and $20 million, respectively, to resolve West Virginia’s claims relating to their distribution of controlled substances in the state, according to Governor Earl Ray Tomblin. The settlement – in which neither company admitted to any wrongdoing – is believed to be the largest pharmaceutical settlement in state history, after lawsuits dragged on for more than four years in Boone County Circuit Court and spanned the terms of two attorneys general.

In 2012, McGraw filed lawsuits against Cardinal Health, AmerisourceBergen and a dozen smaller drug distributors for their role in a drug supply chain that includes doctors who write prescriptions for nonmedical purposes and “pill mill” pharmacies that dispense excessive numbers of painkillers. Attorney General Patrick Morrisey inherited the case upon taking office in January 2013.

These deals are the latest in several settlements stemming from a case brought against more than one dozen companies by the attorney general’s office, along with the Department of Health and Human Resources and Department of Military Affairs and Public Safety.

The settlement money will go toward drug treatment programs to help West Virginians addicted to opioid drugs, such as heroin and prescription painkillers. The money will be kept in a special account at the State Auditor’s office. Gov. Tomblin said, “We’ve taken steps to combat drug abuse in West Virginia with distributors, prescribers, and pharmacists, and the money from this settlement will help us expand those efforts with additional treatment and long-term recovery options.”

In addition to the settlement payments, Cardinal Health and AmerisourceBergen agreed to promptly alert state authorities when they see suspicious drug orders from pharmacies.

“We believe that the best possible way to manage this issue is to encourage drug distributor customers, like pharmacists and physicians who work directly with patients, to prescribe and order pain medications responsibly and appropriately,” said Gabe Weissman, an AmerisourceBergen spokesman. “Simultaneously, we will continue to do our part to provide the safe and efficient distribution network that ensures product availability for the treatments that preserve or enhance quality of life for patients with legitimate needs, while working with all partners to limit and prevent abuse.”

Cardinal Health has said that its hydrocodone and oxycodone sales make up only a small fraction — about 7 percent — of its total doses of prescription drugs shipped to West Virginia. Hydrocodone is sold under brand names like Lortab and Vicodin. Oxycodone is known better under its OxyContin brand name.

“While the company denies the state’s allegations, Cardinal Health recognizes that the epidemic of prescription drug abuse is a multifaceted problem driven by addiction and demand,” the drug wholesaler said in a news release.

Previous settlements, with nine smaller wholesalers, have netted the state more than $11 million.

Last January, Morrisey’s office sued McKesson Corp., the second-leading prescription opioid shipper to West Virginia. That case remains stuck in federal court, with no settlement expected anytime soon.

The state’s settlement with Cardinal Health and AmerisourceBergen won’t end all litigation the companies face in West Virginia. In late December, the McDowell County Commission filed suit against those firms and McKesson, alleging the wholesalers contributed to the county’s opioid epidemic by shipping far too many pain pills there.

November 23, 2016

Emanuel Announces Efforts to Combat Opioid Abuse Including Registering Pharmacetical Sales Reps


In early October, Chicago mayor Rahm Emanuel announced a “series of efforts to combat heroin and opioid addiction throughout Chicago.” According to a press release on the City of Chicago’s website, “these proposed efforts would increase the City’s annual investment in addiction treatment by 50 percent…and create improved regulation of pharmaceutical representatives.”

Chicago seems to place much of the blame on pharmaceutical representatives marketing to medical professionals. As such, Mayor Emanuel proposes to “establish a pharmaceutical representative license above the current Limited Business Licensing required for these individuals in Chicago.”

Chicago seems to be following in the footsteps of Washington, DC, noting that “pharmaceutical representatives will be required to receive additional training and education and provide the city with information on opioid sales and marketing.” Through this extra licensing, the city would enable medical professionals to report complaints against pharmaceutical representatives for deceptive and/or unethical behavior and monitor, audit, and adjudicate such complaints. Part of the additional training would focus on prescription abuse, ethics, and marketing practices from programs certified by the city.

Sometime this month, the city expects to introduce an ordinance that would require the extra licensing. The city is also considering requiring pharmaceutical representatives to track which doctors they contact, and potentially supply names to the city upon request. The ordinance would also require licensed representatives to record the number of health providers they contact and the drug information they offer, keep track of when and to whom they hand out samples, and note whether the physicians are compensated for their time.

According to Dr. Julie Morita, commissioner of Chicago’s Department of Public Health, the city is working on how it would enforce the ordinance and punish violators, though pulling a representative’s license might be one such possibility.

The licenses would cost roughly $750 per representative, annually (compared to the $175 fee in Washington, DC). The estimated $1 million in license fees would support the licensing program as well as help support treatment for addiction. When asked if the ordinance was just another way for the city to make money and add to their revenue rolls, Dr. Morita stated it was about protecting the health and well-being of Chicagoans.

Other Efforts

The city of Chicago has long been known to aggressively challenge marketing practices of the pharmaceutical industry, most notably by filing a lawsuit against several opioid manufacturers. In addition to the additional licensing requirement, Emanuel plans to expand investments to treat heroin and opioid addictions, including $700,000 in new funding that will be focused on opioid treatment deserts where there is a disproportionate level of addiction and the need is greater than the availability of services.

Chicago will also invest $250,000 in naloxone, going to the Chicago Recovery Alliance, to increase access to the overdose antidote in the communities that have been hit the hardest by the opioid epidemic.

Focusing on education and awareness of addiction prevention and treatment, Chicago has secured $350,000 for education campaign (including a $300,000 grant from Pfizer and two $25,000 grants from CVS and Walgreens). The education campaign will include outreach to community and to the healthcare providers who prescribe opioids, helping them to understand the dangers of opioid addiction and apply recent guidelines from the Centers for Disease Control and Prevention to prevent overprescribing.

These efforts follow a July agreement between Pfizer and Chicago, where both parties agreed to a painkiller marketing code, which we highlighted in the October issue of Life Science Compliance Update.

Industry Response

The Chicago Tribune reached out to the Pharmaceutical Research and Manufacturers of America, asking for comment. PhRMA had not yet been able to review the details and substance of Chicago’s proposal, noting instead, “Industry interactions with health care professionals, however, are extensively regulated by the U.S. Food and Drug Administration. Patchwork local and state initiatives are likely to disrupt the existing federal regulation of important scientific information that benefits both providers and patients.”


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