WASHINGTON, D.C. (March 1, 2016) – Today the Pharmaceutical Research and Manufacturers of America (PhRMA) spokesperson Allyson Funk provided the following statement in reaction to a study published in BMJ on physician-administered drugs:
“Biopharmaceutical companies are committed to developing medicines that help patients live longer, healthier lives and, in recent decades, there have been tremendous advances in treatment options for patients including those with cancer, arthritis and hepatitis C.
“Every medicine approved by the U.S. Food and Drug Administration (FDA) offers a unique value to patients and ensuring access to the medicines they need to help them live longer, healthier lives should be a priority. Determining the right dose for patients happens in the earliest stages of the drug research and development process and is key to establishing the safety and effectiveness of new medicines prior to FDA approval.
“The drug development and manufacturing process for biologics, including oncology medicines, is extremely complex. Decisions regarding vial size are tied to a product’s initially approved dosage and labeled use, taking into account that different patients will have different needs. Vial fill size must be approved by FDA as part of the sponsor’s drug application and any excess volume must meet FDA standards outlined in regulations. After initial drug approval, a manufacturer must receive FDA approval to manufacture a new vial size, which requires significant data and will take several months to obtain approval.
“Our understanding of optimal use and dosing among diverse patient populations (e.g., sex, age, weight, metabolizing factors) continues even after FDA approval through the use of real-world evidence. Manufacturers are committed to working with FDA and Congress to create a more nimble regulatory approval process that enables manufacturers to modify their products as we learn about the safety, efficacy and manufacturing of new medicines from the real world clinical setting. We must ensure continued access to high quality, patient-centered care while continuing to encourage development of innovative, life-changing medicines.”
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 $600 billion in the search for new treatments and cures, including an estimated $51.2 billion in 2014 alone.
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