Life Science Compliance Update

September 30, 2016

FDA Announces Dates for Public Hearing on Off-Label Communication Regulation

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In late August, the United States Food and Drug Administration (FDA) announced that it will hold a two-day public hearing November 9th and 10th to obtain input from a broad cross-section of the health care industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, health care organizations, and payors and insurers, regarding the appropriate regulation of manufacturers’ communications about off-label uses for their marketed medical products.

This hearing follows a 2014 announcement by the FDA that it was going to engage in a comprehensive review of the regulatory framework related to firms’ communications about unapproved uses of approved or cleared medical products – products that may be legally introduced into interstate commerce for at least one intended use. The FDA is performing this review to ensure that implementation of FDA Authorities “best protects and promotes the public health in view of ongoing developments in science and technology, medicine, health care delivery, and constitutional law.

This hearing also comes amid a series of high-profile losses for the FDA and the DOJ in the government’s attempt to prohibit and criminalize truthful, non-misleading off-label marketing. Take, for example, the Amarin case, where Amarin and the FDA entered into a formal settlement after the Southern District of New York granted a preliminary injunction against the FDA’s threats to treat Amarin’s truthful and non-misleading off-label marketing about Vascepa, as a violation of the Food, Drug, and Cosmetic Act (FDCA). The court ruled that the FDA was impermissibly chilling truthful, non-misleading speech in violation of the First Amendment.

In the notice, the FDA lays out nine categories of issues, posing roughly thirty questions it hopes will be addressed through the public hearing and comment process. Some of the thirty questions include the following:

  • What are the drawbacks and risks of making more information related to unapproved uses of drugs and medical devices available to practitioners, payors, and patients? What safeguards can be put in place to mitigate these drawbacks and risks?
  • What effect will increased communications have on patient incentives to enroll in clinical trials?
  • How do these changes affect incentives for firms to seek FDA approval or clearance of new uses?
  • What criteria should FDA consider in determining whether a study or analysis that is the basis of a firm’s communication is scientifically appropriate to support the presentations or conclusions in the communication?
  • What information is most important to health care professionals and other entities in allowing them to judge the validity and utility of firms’ communications about unapproved uses, and why?
  • What information should firms communicate to make audiences aware that the product is unapproved for the use discussed?
  • What information should firms disclose in order to make sure audiences are not misled (e.g., product risks, nature and weight of evidence supporting unapproved use, regulatory history relating to unapproved use, and financial involvement of firms in described research)?
  • How should FDA monitor firms’ communications about unapproved uses, and what actions should FDA take with respect to communications it determines are false or misleading or otherwise raise public health issues?

Some of these questions mirror those raised by the FDA in a 2011 request for comments on communications and activities related to off-label uses of marketed products. The questions asked in this 2016 notice, however, signify that the FDA is significantly reshaping its approach on how it regulates off-label communications.

If you are interested in attending or presenting at the public hearing, you must register by October 19, 2016. Electronic or written comments will be accepted after the public hearing until January 9, 2017.

Webinar: Open Payments Retrospect and Looking Forward

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On October 13, 2016, qordata will be hosting a webinar, “Retrospect and Looking Forward: A Review of Two Full Years of Open Payments Data and Media Coverage, The Indications for the Future.”

With three years of published public data available through CMS submissions in Open Payments, the media is working hard at mining transparency data to bring health care fraud cases to the enforcement authorities’ attention. As time passes by, the government is also enhancing the ways in which it prosecutes, arrests and penalizes those engaged in fraud. With the media working hard to bring these cases to light, pharma companies need to work more efficiently in terms of documenting their spend data.

Presenting the webinar will be our very own Thomas Sullivan, along with Zafar Ahmed of qordata. The webinar will go through the 2014-2015 Open Payments data, discuss the media on Open Payments during the week of the 2015 release, evaluate prosecutions using Open Payments, deliberate the CMS questions on Open Payments, assess Congressional actions on Open Payments, and review global ag spend and media.

In this webinar, Thomas Sullivan will give a detailed review of the 2014-2015 Open Payments Data, evaluate persecutions and provide an in-depth assessment of the congressional actions on Open Payments.  He will further provide information about the ways in which Open Payments data and other tied in spend reports are being evaluated by the media in hopes of finding data anomalies.

Chief Compliance Officers, Directors of Compliance, Managers of Compliance, and any other interested parties are encouraged to attend and register here.

September 29, 2016

Prescriber Education Campaign on Opioids Launched

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We have been hearing for years about the opioid crisis our country is facing, a crisis that was partially brought about by abuse of prescription pain relievers. From Congressional investigations, to Executive branch actions, to a letter from the Surgeon General, many of our country’s leaders are concerned about the epidemic and are constantly trying to craft solutions.

The Partnership for Drug-Free Kids, an organization committed to helping families struggling with their son or daughter’s substance abuse, created the “Search and Rescue” campaign, a prescriber education campaign developed with support from the Food and Drug Administration (FDA) that gives healthcare providers the resources they need to prescribe opioids responsibly and prevent the misuse and abuse of medicine in their practices. The campaign was piloted in Maryland and Rhode Island in 2014, and expanded to six states in 2015. On September 15, 2016, the Partnership for Drug-Free Kids announced the national launch of the campaign.

The goal of the “Search and Rescue” campaign is to equip prescribers with skills to be proactive in identifying and helping patients at risk for prescription drug abuse. The campaign will attempt to connect prescribers to training, information, and resources that can help educate them, and the FDA encourages them to share the educational content with their peers.

FDA and Partnership Comments on “Search and Rescue”

Dr. Janet Woodcock, the Director of the FDA’s Center for Drug Evaluation and Research (CDER), is, along with the FDA, “proud to support this campaign to educate and inform providers about the risks of addiction and the misuse and abuse of opioids in their efforts to treat their patients’ pain responsibly and prevent the misuse and abuse of these drugs.” She further noted, “educating the healthcare community on appropriate prescribing of prescription opioid medications is a cornerstone of the FDA’s Opioid Action Plan, and continues to be a top priority for the agency, as well as for the Department of Health and Human Services (HHS) and across the federal government.”

According to Marcia Lee Taylor, President and CEO of the Partnership, “Today’s opioid epidemic has reached alarming and tragic proportions, with 78 opioid overdose deaths occurring daily in the United States. Addressing this dire national problem requires a multi-pronged approach, involving parents, educators, community leaders, treatment professionals and healthcare providers. The Partnership is proud to apply its communications expertise to the challenge of reaching and helping educate prescribers, who can and must be a huge part of the solution.”

The Website

The Search and Rescue website offers many resources for providers, including information on each state’s PDMP, brief educational videos, a database with accredited CME/CE REMS-compliant activities, an opioid risk assessment, links to a SAMHSA treatment locator to help patients find a local opioid treatment program, and a quick fact sheet for prescribers. 

Other Ways Search and Rescue is Helping

The “Search and Rescue” campaign makes innovative use of social media, optimized search, and earned media to reach family physicians, physician assistants and nurse practitioners, focusing on sending them to the website to learn more.

The Partnership is working with other national organizations, including the American Medical Association Task Force to Reduce Prescription Opioid Abuse, the American Academy of Pediatrics, the American Dental Association (ADA), and others, to promote “Search and Rescue” to their members.

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