Drugs

Allow Communication on Safe, Effective Drug Use: Industry

Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) say that federal regulations governing information-sharing about medicines have not kept pace with data-driven medicine and need to be updated. In a joint online blog post, representatives of the two stakeholder groups write that there must be new and clearer regulatory standards to allow biopharmaceutical companies to communicate about the safe and effective use of medicines with other parties in the healthcare system. “Greater sharing of information between biopharmaceutical companies, payers, and healthcare professionals can benefit patient care and insurance coverage by ensuring more patients receive the best treatment for them,” the post says.

PhRMA and BIO endorsed principles on responsible sharing of truthful and non-misleading information about medicines with healthcare professionals and payers that they say should guide the establishment of responsible, science-based parameters for accurate and trusted information-sharing under a modernized regulatory framework.

Three key concepts of the PhRMA/BIO principles are:

commitment to science-based communication;
commitment to provide appropriate context about data; and
commitment to tailoring communications to the intended audience.

“The regulatory framework needs to be modernized to reflect the rapidly evolving science and increased pace of the development and understanding of innovative medicines,” the post concludes. “Many types of data and analysis can benefit patient care, including rare disease populations, patients who participate in large registries, and all of us who expect that our healthcare professionals and insurance companies will have access to timely high-quality information that is accurately presented. Removing current regulatory barriers and clarifying the ability of companies to share truthful and non-misleading information about medicines are essential to our collective ability to realize the full potential of 21^st century medicines and, ultimately, help ensure that patients are able to get the right medicines at the right time for them.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome