Press Release

PhRMA Statement on Need to Modernize FDA Regulations Governing Information-Sharing about Medicines

PhRMA August 31, 2016

WASHINGTON, D.C. (August 31, 2016) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President, Law, Jeff Francer, issued the following statement:

“Patients, payers and providers seek more science-based information about the safety, effectiveness and value of treatments for patients, but FDA’s current federal regulations governing information-sharing about medicines have not kept up with this new reality.

“PhRMA is pleased that FDA has recognized that ‘relevant, truthful, and non-misleading scientific or medical information regarding unapproved uses of approved medical products may help health care professionals make better individual patient decisions.’ Given our increasingly data-driven, value-based health care system, we hope that FDA will act quickly to define new and clearer regulatory standards to permit responsible sharing of information and data about medicines with other parties in the health care system.

“As outlined in PhRMA’s recently announced Principles on Responsible Sharing of Truthful and Non-Misleading Information, greater sharing of information between biopharmaceutical companies, payers and health care professionals can benefit patient care and insurance coverage by ensuring more patients receive the best treatment for them.” 


About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than half a trillion dollars in the search for new treatments and cures, including an estimated $58.8 billion in 2015 alone.

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