21st Century Cures Hearing to Examine Barriers to Communication about Medicines

Outdated Regulations Prohibit Sharing of Scientifically Accurate Information to the Detriment of Patient Care

07.22.14 | By Stephanie Fischer

In May, the U.S. House Energy and Commerce Committee launched the 21st Century Cures initiative to speed the discovery, development, and delivery of new treatments and cures for patients.  The Committee is conducting a series of hearings and has released white papers on a range of topics to solicit input from patients, researchers, and leaders in government and industry.

Today, the Energy and Commerce Subcommittee on Health will hold a hearing on “21st Century Cures: Examining Barriers to Ongoing Evidence Development and Communication”. The background memo for the hearing notes that learning about new medicines continues after approval by the Food and Drug Administration (FDA) and recognizes the need for stakeholders in medicine and research to exchange information: “Learning and data sharing regarding safety and efficacy are happening through a multitude of platforms around the globe. Dialogue regarding this enhanced learning--whether through the Internet, social networks, or other platforms--should be facilitated among doctors, patients, researchers, and scientists because the free flow of data, research, and results related to what a therapy or combination of therapies does or does not do well and in what types of patients could help advance the discovery, development and delivery cycle.

I’ve previously written on the importance of enabling biopharmaceutical to engage in a dialogue with patients, particularly as patients increasingly rely on the internet for information on medicines. And they’re not alone. As noted in the Atlantic, “Wikipedia is the top source of information for both doctors and patients. Fifty percent of physicians use Wikipedia for information, especially for specific conditions.” That is rather alarming given 9 out of 10 Wikipedia entries on health are inaccurate.

Biopharmaceutical companies have the most complete and up-to-date information about the medicines that they research, develop and manufacture for use by patients.  However, due to outdated regulations, companies are often unable to proactively share information about medicines with physicians and other healthcare providers beyond what is contained in the labeling approved by FDA.

In comments to the Energy & Commerce Committee, the Society for Women’s Health Research noted that, “We believe open and transparent communication of important scientifically accurate data is important to advancing medical treatments in the digital age. Access to company data should be established in a way that provides for appropriate communication to health care professionals and patients on medication usage that could improve patients’ health outcomes. In particular, subgroup analysis can shed light on important sex differences that will help physicians tailor treatments differently to their male and female populations.”

Allowing biopharmaceutical companies to share data-driven and scientifically accurate information about the medicines is of particular importance to rare disease patients. While there are more than 450 medicines in development for rare disease, there are currently no approved treatment options for 95% of rare diseases. This means many patients, including me, are prescribed medicines that are approved by FDA to treat more common diseases.  I want the company that developed the medicine that I take off-label to be able to share information beyond what is in the approved labeling with my physician, so that he is as informed as possible when we make decisions about the most appropriate treatment option for me.

In testimony to the Energy and Commerce Subcommittee on Health earlier this month, a member of the Scientific Advisory Committee of the National Organization for Rare Disorders (NORD) noted that, “the government severely restricts what drug companies can say about new research and about off-label uses, thus cutting off information from the most knowledgeable sources. The Congress should seek new policies that permit drug companies to share appropriate information without fear of enforcement action.

The EveryLife Foundation also noted the importance of this issue to rare disease patients in comments to the Committee, stating that “Because companies cannot legally release data or talk about potential off-label use, patients use these drugs with no evidence of effectiveness and no understanding about correct dosing.”

To get the best possible health outcome for all patients, FDA should revise its regulations to allow companies to share truthful, scientifically accurate, and data-driven information with healthcare professionals to inform treatment decisions and get the best possible outcome for patients – like me. 

I appreciate that the Energy and Commerce Committee is highlighting this important topic as part of the 21st Century Cures initiative.  You can watch the Health Subcommittee hearing online at 3pm today ET and share your thoughts on Twitter using the hashtag #Path2Cures.


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