Life Science Compliance Update

September 29, 2016

Prescriber Education Campaign on Opioids Launched


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.

September 22, 2016

FDA Offers Update to Orange Book Website


In August 2016, the Food and Drug Administration (FDA) launched an updated web-based version of its “Orange Book,” the publication on drugs approved on the basis of safety and effectiveness.

This major revision of the Orange Book, known more formally as the Approved Drug Products with Therapeutic Equivalence Evaluations, is a first for the website and features an updated design with user-friendly search options. Users can now search for approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number. Groups of accordion panels can also be opened to reveal additional new features and contact information.

What is the Orange Book?

The Orange Book was first created in list form in an attempt to contain drug costs. Almost every state had adopted laws and/or regulations that encouraged the substitution of drug products. The state laws generally required either the substitution be limited to drugs on a specific list or that it be permitted for all drugs except those prohibited by a particular list. Due to the high volume of requests for FDA assistance in the late 1970s, it became apparent that the FDA was not going to be able to serve the needs of individual states and felt as though providing a single list based on common criteria would be preferable to evaluating drug products on the basis of differing definitions and criteria in various state laws.

On May 31, 1978, FDA Commissioner Donald Kennedy sent a letter to officials of each state, stating the FDA’s intent to provide a list of all prescription drug products that are approved by the FDA for safety and effectiveness, along with therapeutic equivalence determinations for multisource prescription products.

In 1979, the List was first distributed in January as a proposal. It included only currently marketed prescription drug products approved by the FDA through new drug applications (NDAs) and abbreviated new drug applications (ANDAs) under the provisions of Section 505 of the Food, Drug and Cosmetics Act.

A complete discussion of the background and basis of FDA’s therapeutic equivalence evaluation policy was published in the Federal Register on January 12, 1979 and the final rule was published on October 31, 1980. The first publication (October 1980) included appropriate corrections and additions to the final version of the List. Each subsequent edition has included new approvals and made appropriate changes in data.

On September 24, 1984, President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984, requiring that the FDA make publicly available a list of approved drug products with monthly supplements. The Orange Book satisfies this requirement.

The Orange Book Today

Interested parties can also download the Orange Book application in the Apple App Store or Google Play. The application, Orange Book Express, allows users to search by the same parameters as the website; search all marketing statuses (Rx, OTC, Discontinued) with one simple search; look up patent and exclusivity information; identify Reference Listed Drugs and determine if a drug product has a therapeutic equivalent; and browse patent delistings and newly added patents.  

This updated website is the latest move by the FDA to improve its online presence and follows the release of the 36th edition of the Orange Book in 2015.

The FDA intends to use the Orange Book to further its objectives of obtaining constant input and comments on the publication itself, and Agency procedures. If you have any comments on how the publication may be improved, send them to the Director, Division of Legal and Regulatory Support, Office of Generic Drugs, Center for Drug and Evaluation and Research, 7620 Standish Place, Rockville, MD, 20855-2773.

August 31, 2016

FDA and CMS Call for Nationwide Changes


Recently, CMS Administrator Andy Slavitt and FDA Commissioner Dr. Robert Califf wrote a joint letter to Gary Beatty, Chair of the Accredited Standards Committee X12 (ASC X12), asking that the organization add unique device identifiers (UDIs) for implantable medical devices on claims form. They argue that such a move would improve post-market surveillance and provide for better value-based reimbursement based on device performance.

Manufacturers and distributors are currently implementing UDIs and electronic health records (EHRs) are being tweaked to permit providers to record UDIs, but insurance claims forms have been the holdout. Some industry representatives believe that the changes to insurance claims forms would be costly because the technology to support the changes is not there.

The joint letter addresses the group that sets standards for sharing data gathered and used by the insurance – and other – industries. ASC X12 will release the next version of the insurance claims form for public comment in December 2016. That template is set to be released in 2021. The next update is not scheduled for another ten years.

Slavitt and Califf note that UDIs in claims forms have cost benefits because they would be able to help providers and payers calculate and compare total spending and outcomes and provide better data to track manufacturer rebates owed to the payer or provider. They acknowledge that including UDI will be a complex process and will require a change in workflow and systems for providers and billing companies, but that they are committed to a plan that minimizes impact on state Medicaid agencies, health plans, small physician practices and rural hospitals.

The day after the sending letter, Andy Slavitt tweeted, reiterating his stance:

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Health and Human Services (HHS) supports the idea “if sufficient funding and resources are provided to make the necessary Medicare claims processing system changes.”

Previously, CMS pushed back against adding UDIs to claims forms because of technical hurdles and high costs involving in overhauling the form. In Spring 2015, former Medicare Administrator Marilyn Tavenner noted that putting the UDI into electronic health records or device registries kept by companies should be sufficient to promote safety.

CMS’ Office of Inspector General stated that UDIs could save the agency money and offer valuable insights into population health. Other proponents of UDIs say they could more quickly identify dangerous devices, some of which (under the current system) have not been flagged until they hurt patients.

The letter also reflects the FDA’s current push to improve device evaluation and surveillance, as outlined in an editorial co-written by Dr. Califf.  Califf notes that a “key dilemma for device regulation is how to ensure timely access while also providing evidence to guide safe and appropriate use.” Presently, when a device receives approval for the United States market, “residual uncertainty about benefit and risk is typically addressed through postmarket evaluation,” as premarket studies do not typically reflect how a device will be used in practice.

However, Califf goes on to note, “current approaches to postmarket evaluation have limitations. Even though the FDA can require device makers to perform postmarket studies, patients have few incentives to enroll in a study once a device is marketed, and many FDA-mandated postmarket studies for devices have been delayed, scaled back, or never finished.”

Califf also seems frustrated that reporting of adverse events and device malfunctions depends on clinicians identifying and reporting a possible association, and therefore, it is likely that underreporting is common.

Califf calls for a “strategic approach to linking and using clinically based data sources, such as registries, electronic health records (EHRs), and claims data,” which could potentially “reduce the burdens of obtaining appropriate evidence across the life cycle of a device.” He believes that by “leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices.”


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