NEJM Commentary Rekindles Debate on Communicating CER

July 18, 2013

A commentary published on July 18 in the New England Journal of Medicine is rekindling the debate about comparative effectiveness research (CER) and the pharmaceutical industry’s ability to communicate health information.

Tufts Medical Center economist Peter Neumann, ScD, who authored the commentary, suggests that Section 114 of the Food and Drug Administration Modernization Act of 1997 be “extended to allow drug companies to promote comparative effectiveness research to health plans and other payers. The law would retain its prohibition against such promotions directly to doctors or patients.”

Dr. Neumann’s paper continues the discussion of this issue that kicked off last year with a conference hosted by the National Pharmaceutical Council, a series of articles in Health Affairs, and the federal circuit court of appeals decision on US v. Caronia.

So what does this mean, and why does this debate matter? As NPC has explained before,

To understand industry’s challenge, it is important to recognize two key issues. First, the type of research used by the Food and Drug Administration (FDA) to make drug approval and labeling decisions is more stringent than the information that can be used by other health care decision makers. Second, FDA regulates the type of research that can be discussed by industry in most forums, but not by other stakeholders.

For a new drug to gain FDA approval, a company must provide “substantial evidence” of effectiveness, a standard under which “at least two major clinical trials are required for product approval, although one trial with supporting evidence is sufficient in limited circumstances.” This “substantial evidence” forms the basis for the drug’s labeling, and manufacturers face stiff fines and penalties if they go beyond the labeling claims when marketing or discussing the use of a product outside limited venues recognized to constitute non-promotional scientific exchange.

Although these clinical trials are considered the “gold standard” in research, most of the millions of dollars in CER that will be funded by PCORI will be derived from observational studies, data pulled from claims and payer databases, literature reviews and other public resources, none of which is considered acceptable for approval purposes by the FDA. With an increasing number of payers, academics and government agencies turning to observational methods of conducting CER, the trend leaves industry out of the conversation.

FDA officials have made statements acknowledging industry’s right to dispute unsupported CER evidence as long as the communication is not promotional in nature and reflects the patients, endpoints, and uses specific to the drug’s labeling. With CER studies examining a variety of off-label outcomes and being published in a range of venues outside of scientific journals, the role companies may have in the conversation is significantly reduced.

In a worst-case scenario, a payer could share an inadequate study about off-label use of a drug with its network of health care providers and patients. The results, which have not been subjected to any external oversight or transparency in the research protocol or analysis plan, would likely shape patients’ and providers’ views of the drugs involved and contribute to decision-making. Relying on such an inadequate study could lead to poor patient outcomes and rising costs. Even if the company that produces the drug spots the misleading information, existing communications rules potentially prevent the company from sharing insights on the study’s results and limitations with doctors and patients.

This unequal ability to communicate harms the very people who stand to benefit most from CER findings – the patients and health care providers facing medical decisions. The current communications environment increases the risk that useful details will be withheld or misleading information will go unchallenged. Decision-makers deserve to hear all viewpoints and weigh each source’s potential biases for themselves.

Given the potential penalties that would be incurred for violating the rules, however, companies will be hesitant to participate in open discourse about CER without clear guidance from the FDA. To open communication channels, the FDA will need to articulate standards that encourage dialogue and information-sharing.
Blog Post

CER Tweets of the Week: NPC and PCORI at AMCP 27th Annual Meeting & Expo (April 6-10)

This week, comparative effectiveness research (CER) stakeholders tweeted from the Academy of Managed Care Pharmacy’s 27th Annual Meeting and Expo (#...
Press Release

State Medicaid Directors Share Views on Comparative Effectiveness Research And Its Impact on Policy in National Pharmaceutical Council Survey

(Washington, DC, April 16, 2015)—A new survey conducted on behalf of the National Pharmaceutical Council (NPC) shows that state Medicaid directors...
Blog Post

CER Tweets of the Week: NPC in JCER, PCORI Multiple Sclerosis Workshop (March 30 – April 3)

This week, comparative effectiveness research (CER) stakeholders on Twitter shared the Journal of Comparative Effectiveness Research’s (@fsgcer)...
Blog Post

CER Tweets of the Week: NPC’s CER Survey 2015 Webinar, PCORnet to Engage Health Systems (March 23-27)

This week, several comparative effectiveness research (CER) stakeholders participated in a conversation on Twitter during the National Pharmaceutical...
Press Release

State Medicaid Directors Share Views on Comparative Effectiveness Research And Its Impact on Policy in National Pharmaceutical Council Survey

(Washington, DC, April 16, 2015)—A new survey conducted on behalf of the National Pharmaceutical Council (NPC) shows that state Medicaid directors...
Press Release

NPC Highlights Stakeholder Views on Comparative Effectiveness Research and the Environment for Health Care Decision-Making

(Washington, DC, March 26, 2015)—A new survey of health care stakeholders reveals continued optimism that comparative effectiveness research (CER)...
Press Release

NPC Study Outlines When & How Health Decision-Makers Should Consider Individual Patient Differences

Washington, DC (July 29, 2014)—New research led by the National Pharmaceutical Council (NPC) can assist health care stakeholders to understand when...
Press Release

NPC Annual Stakeholder Survey: Comparative Effectiveness Research Is Important, But Impact on Health Care Decision-Making Is Still on the Horizon

(Washington, DC, May 19, 2014)—A new survey of health care stakeholders reveals continued optimism for the use of comparative effectiveness research...
Commentary and Testimony Page

Chain Drug Review – Commentary: “Health Care Outlook for 2015”

This commentary was originally published in the January 5, 2015 issue of Chain Drug Review.By: Dan Leonard, President, National Pharmaceutical...
Commentary and Testimony Page

NPC Comments on PCORI Proposal for Peer Review of Primary Research and Public Release of Research Findings

November 7, 2014Dr. Joe SelbyExecutive DirectorPatient-Centered Outcomes Research Institute1828 L St., NW, Suite 900Washington, DC 20036Dear Dr....
Commentary and Testimony Page

The State of CER and the Environment for Health Care Decision Making

This month, NPC released its third annual survey on stakeholders’ views on comparative effectiveness research (CER), “The State of Comparative...
Commentary and Testimony Page

Keeping Our Eye on the CER Ball

Until the cherry blossoms begin to bloom later next month, most of the water cooler conversations in Washington will focus on the federal budget....
YouTube Videos

Comparative Effectiveness Research and the Environment for Health Care Decision-Making

During a March 26, 2015 webinar, the National Pharmaceutical Council discussed the results of its annual stakeholder survey on comparative...
YouTube Videos

Real-World Impact of Comparative Effectiveness Research Findings on Clinical Practice

National Pharmaceutical Council Chief Science Officer Robert W. Dubois, MD, PhD, discusses a peer-reviewed study suggesting that changes are needed...
YouTube Videos

Using Real-World Evidence to Increase Health Care Access, Improve Quality & Reduce Costs

Mitchell Sugarman, vice president of health economics, policy and payment at Medtronic Cardiac and Vascular Group, explains that health care decision...
YouTube Videos

CER and the Environment for Health Care Decision-Making

The National Pharmaceutical Council’s (NPC) fourth annual survey of health care stakeholders is continuing to shed light on the current environment...
Blog Post

CER Tweets of the Week: NPC and PCORI at AMCP 27th Annual Meeting & Expo (April 6-10)

This week, comparative effectiveness research (CER) stakeholders tweeted from the Academy of Managed Care Pharmacy’s 27th Annual Meeting and Expo (#...
Blog Post

CER Tweets of the Week: NPC in JCER, PCORI Multiple Sclerosis Workshop (March 30 – April 3)

This week, comparative effectiveness research (CER) stakeholders on Twitter shared the Journal of Comparative Effectiveness Research’s (@fsgcer)...
Blog Post

CER Tweets of the Week: NPC’s CER Survey 2015 Webinar, PCORnet to Engage Health Systems (March 23-27)

This week, several comparative effectiveness research (CER) stakeholders participated in a conversation on Twitter during the National Pharmaceutical...
Blog Post

#TBT: 5 Years Later—Comparative Effectiveness Research Survey & the ACA

As part of our “Throwback Thursday” blog series, we’re taking a look at a topic that’s currently in the news and tagging it with previous...
  •  
  • 1 of 13
  • >