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.

March 23, 2016

Senate HELP Committee Continues Work on 21st Century Cures Corollary

Earlier this week, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on a package of legislative measures that are targeted at facilitating medical innovation. This hearing, the second in a set of three, is the Senate's response to the House-passed 21st Century Cures Act (H.R. 6). We wrote about the first hearing, and a recap can be found here.

While the second meeting featured much partisan debate and fanfare, the Committee advanced all seven medical innovation measures before them, with six passing by voice and one measure passing by roll call vote of 20-2.

In opening statements, Senator Lamar Alexander, Committee Chairman, acknowledged the anticipated contention on the panel over what he referred to as a "surge" of additional mandatory funding requested by Democrats for the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Even expecting contention, the Chairman expressed optimism about the Committee's capacity for compromise, stating that if the Committee successfully creates an innovation agenda, it may be the "most important legislation passed this year."

As may be expected, Ranking Member Senator Patty Murray and Senator Elizabeth Warren both showed strong support for increasing mandatory funding for the FDA and the NIH, each introducing an amendment to S. 1878: one to create a medical device evaluation system and the other to create a biomedical innovation fund. Senator Murray also expressed concern that some of these bills may increase FDA responsibilities and not compensate the FDA for that. While both senators started out firmly believing that any agreement needed to include increased funding, they both withdrew their amendments, including any requests for additional funding, in order to find other consensus points and come to an agreement.

The measures approved in the Committee are as follows:

The Advancing Hope Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act (FDCA) to expand the priority review voucher program for rare pediatric diseases to including treatments for both sickle cell disease and pediatric cancers. The voucher program will be extended by removing the provision that terminates the program one year after the FDA's issuance of three rare pediatric disease vouchers. However, a voucher may not be issued for a rare pediatric disease product, if a voucher was ever issued for the product as a tropical disease product. Additionally, a drug sponsor that intends to request a voucher for a rare pediatric disease drug must notify the FDA of their intent to do so upon submission of their new drug application.

The bill's sponsor, Senator Robert Casey explained that this program is integral to fostering innovation and incentivizing private companies to invest in rare children's diseases. Such an incentive is necessary because private companies tend to not see a return on research investment in this area.

This is the one measure passed via a roll call, following adoption of the following amendments: (1) specify the criteria for "rare pediatric disease," (2) insert a section related to rare pediatric disease product applications, (3) require the comptroller to conduct a study on the GAO report on the effectiveness of awarding priority review vouchers for the sponsorship of rare pediatric disease product application, and (4) require the results of the study to be reported to congress.

The Advancing Breakthrough Medical Devices for Patients Act of 2015

This bill amends the FDCA to expand the FDA's priority review of breakthrough medical devise to include all classes of devices. Currently, only new or highest risk (Class III) devices are eligible. However, this bill would make it so that upon a sponsor's request, the FDA would be forced to determine whether a device meets the criteria for priority review as a breakthrough device.

To expedite the development and review of designated medical devices, the FDA must: "assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive and timely communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, [and] assign staff to address questions by institutional review committees concerning investigational use of the device."

Senator Richard Burr emphasized the idea that this measure would not change the standards that devices are required to meet in order to reach the market, but instead simply changes the approach by which device approvals can be accelerated.

The Medical Countermeasures Innovation Act of 2015

This bill encourages the development of medical countermeasures in case of biological attacks and naturally occurring outbreaks. This bill is intended to build upon the Pandemic and All-Hazards Preparedness Act, by leveraging the innovation of the private sector through priority review vouchers. The urgency of this problem has been exemplified with the Ebola and Zika outbreaks over the past year.

The Medical Electronic Data Technology Enhancement for Consumers Health Act

This bill amends the FCPA to exclude several classes of devices from FDA-regulation as a medical device. Some of the included classes are: administrative, operational, or financial records software used in health care settings; software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment; electronic patient records, excluding software for interpreting or analyzing medical image data; software for clinical laboratory testing, excluding software for interpreting or analyzing test data; and software that provides medical recommendations and the basis for those recommendations to health care professionals, excluding software for acquiring, processing, or analyzing medical images or signals.

The bill also states that the FDA must classify a medical device accessory according to its intended function, not the classification of the medical device with which it is used.

This measure was adopted without any discussion.

The Combination Product Regulatory Fairness Act of 2015

This bill attempts to address regulations on combination drug and device products. There was little discussion accompanying this bill, but Senator Casey did briefly speak out in favor of the measure, noting that it will allow for improved communication with the FDA and manufacturers.

The Patient-Focused Impact Assessment Act of 2015

This bill amends the FDCA to require the package of information published by the FDA upon approval of a new drug to include documentation of efforts to assess patient engagement. The required documentation must include identification of patient-focused drug development tools and an explanation of whether certain information was reviewed or examined, including any patient preferences and patient-reported or caregiver-reported outcomes. The FDA is also required to annually summarize, and publish, the data that is collected in this documentation.

Senator Susan Collins, a cosponsor of the bill, believes that patient input is a valuable resource and should play a larger role in FDA decision-making.

The Adding Zika Virus to the FDA Priority Review Voucher Program Act

This bill also amends the FDCA, to add the Zika virus to the list of tropical diseases under the priority review voucher program. The priority review voucher program awards a voucher to the sponsor of a new drug or a new biological product that is approved to prevent or treat a tropical disease, which allows the holder of the voucher to have a future new drug or biological product application acted upon by the FDA within six months.

Chairman Alexander mentioned at the outset of this meeting that the Zika virus is a top concern and priority for the HELP panel.

The final HELP Committee on medical innovation is slated for April 6, 2016, at which time Chairman Alexander hopes to have a final package ready for floor consideration.

May 19, 2015

"Reconnecting the Dots — Reinterpreting Industry–Physician Relations" Provides A Balanced Look At Physician-Industry Collaboration and Conflicts of Interest


Lisa Rosenbaum, MD recently published an article entitled “Reconnecting the Dots—Reinterpreting Industry-Physician Relations,” in The New England Journal of Medicine. Rosenbaum’s article provides a refreshingly balanced analysis of financial conflicts of interest in medicine. “Although most observers agree that we must mitigate the risk of bias introduced by these relationships, the benefits wrought by interactions between physician-scientists and industry at the basic or translational research level are equally clear,” she states. “The question, then, is how to best manage conflicts of interest while preserving the collaborations on which medical advances depend.”

Collaborations and Conflicts of Interest

“Physician-industry interactions have been critical to the development of a large percentage of the medical products that allow physicians to prevent heart attacks, cure cancers, and restore mobility to the elderly,” Thomas Stossel, M.D., a distinguished Harvard hematologist and research recently noted. “Despite such progress and the role of physician-industry interactions in fomenting it, physicians are reducing or severing their relationships with biopharmaceutical and medical device companies out of fear that their patients will mistakenly view such interactions as a sign of corruption, rather than expertise.”

To this end, Rosenbaum sets out to find a “reasoned approach” to physician-industry interactions that acknowledges both the benefits of the collaboration, while recognizing the risks of bias involved. To lay the foundation of her paper, she starts off by describing the release of “controversial new cholesterol guidelines” in November 2013, which expanded the target population for preventative statin therapy. The criticism against the guidelines was swift, she noted from experience, from those who believed that the primary beneficiary of these guidelines would be the pharmaceutical industry.

In a New York Times op-ed, for example, a cardiologist and another physician and industry critic argued that making more patients eligible for statin therapy would “benefit the pharmaceutical industry more than anyone else.” Objecting to using statins for primary prevention, they drew from a medical journal article that one of them had coauthored emphasizing the frequency of side effects. This frequency turned out to be exaggerated, necessitating an erratum in the journal. Yet no one was questioning the editorialists’ credibility in the public press; rather, the editorialists challenged the credibility of the guideline writers: “The American people deserve to have important medical guidelines developed by doctors and scientists on whom they can confidently rely to make judgments free from influence, conscious or unconscious, by the industries that stand to gain or lose.”

Rosenbaum’s article provides a counter to such industry-skeptics, who are often amazingly uncritical in their dismissal of important industry-collaborative efforts. “One could argue that people also deserve to know that statins are, in many cases, the best drugs we have to prevent cardiovascular disease and that the committee had spent 5 years reviewing the evidence to identify the patients who would benefit most,” she writes.

She also outlines the steps taken to avoid the introduction of conflicts into the guidelines, given that 7 of the 15 committee members did have current or previous industry ties:

  • First, the members with current industry ties were not allowed to vote on the quality of the evidence statements or the recommendations, and none of the members without industry ties have developed ties since the guidelines were published.
  • Second, because of past concerns about conflicts, the committee used an independent contractor, appointed by the National Heart, Lung, and Blood Institute, to choose the studies on which the recommendations were based.
  • Third, though the controversy centered on primary prevention for people whose 10-year risk of a cardiovascular event exceeds 7.5%, the guidelines make clear that this cut point is merely a threshold for initiating discussion about statins, rather than a mandate to start treatment with one.
  • Fourth, the resulting guidelines are actually no boon to companies selling patent-protected drugs: most statins are available in generic versions, and the guidelines recommend against using (patent-protected) drugs that improve lipid levels but that hadn’t, at the time of guideline writing, been proven to improve outcomes.

Despite laying out the facts behind the guidelines, Rosenbaum notes: “the greater difficulty is that whereas a rational approach to regulating industry interactions requires careful parsing of such nuances, our general feelings about industry interactions, as the easy dismissal of the statin guidelines illustrates, can be impervious to relevant detail.”

On cue, a response to Rosenbaum’s article in Health News Review did indeed seem impervious to the details: “Dr. Rosenbaum makes a nice try at reinterpreting financial conflicts between physicians and pharma, but however one twists and turns it, the dots still reconnect into dollar signs.” The article’s conclusion? “Don’t trust what comes out of a drug company (or medical journals?) and verify, verify, verify.”

One of the many interesting points Rosenbaum raises in her article is that discussions of bias have been limited to the financial. In fact, she argues, bias is perhaps strongest and most risky when scientists or doctors have a professional stake in the outcomes of their research: discovering a breakthrough, developing novel treatments, publishing journal articles, etc.

Rosenbaum does not gloss over the harm greed can cause, outlining the misleading Vioxx studies that minimized the drug’s risks and ultimately resulted patient harm. However, she believes an overemphasis on a drug’s risks can be harmful as well. “Vioxx’s continued relevance to our management of physician–industry interactions lies in the lingering impression that some companies will do anything to profit, even if it means suppressing evidence to patients’ detriment — an impression reinforced by subsequent Big Pharma scandals,” states Rosenbaum.

Perhaps the most memorable two paragraphs of Rosenbaum’s article are when she pinpoints the reasons behind many deep set suspicions of industry: 

For the many physicians whose primary interactions with industry are of the marketing variety, the beneficial nature of other industry relationships may lack emotional traction. We see the attractive pharmaceutical reps in our offices. We eat the lunches (or walk away hungry). Our patients, heeding the “Ask your doctor” mantra of drug ads, request medications we may not believe should be prescribed. We hear that our prescription habits are being monitored so that we can be targeted for better sales. And we observe colleagues, their suits sharp, their skin tanned from a free Hawaiian vacation, their children’s college education covered, and though we may take some satisfaction in eschewing pharmaceutical largesse, still, for some, the resentment burns.

By contrast, how visible to us are physician-scientists whose National Institutes of Health grant applications go unfunded, and who therefore increasingly rely on industry support for their laboratories? Does it cross our minds, when we prescribe statins after a myocardial infarction, how much collaboration between industry and physician-scientists was required to develop them? When we read an editorial by someone who is “conflict-free,” do we wonder whether someone else whose industry ties prevented authorship might have had unique expertise to share? Of course, the fact that the benefits of industry interactions are often imperceptible does not excuse the more easily imagined offenses. But the visibility imbalance helps explain why our aversion to certain industry behaviors deeply colors our overall impressions of industry.

Read Rosenbaum's full article in the New England Journal of Medicine here.  



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